You should deliver the savings account information (membership number, types code and you may target of branch) for the account the monthly installments might possibly be obtained from.
Generally, the brand new account has to be only otherwise together on your own identity. If you were with your latest lender or building neighborhood for lower than 3 years, you may need to give earlier lender info.
As the you happen to be trying to get car loan, it’s expected that you will have a valid driver’s permit. Without it, really funds loan providers usually instantly refute a credit card applicatoin.
If you fail to look for their license, or it is currently into the DVLA, you will need to provide extra private identification (e.grams. passport). To verify you actually have good driver’s licence, the brand new monetary institution will get in touch with this new DVLA.
Always, you’ll end up asked to include one or two proofs off target to verify your home is where you say you will do. Utility bills (elizabeth.g. council taxation, fuel, fuel, h2o, etc.) and you can particular types of bank comments are normally made use of.
You have to be called to your data (both entirely or jointly) and they will must be old during the last 90 days (90 days) to be recognized.
The brand new money bank may ask you to bring evidence of earnings depending on your a position information otherwise a career records. For individuals who apply an enthusiastic accountant, it has been trusted to obtain the provider and you may accountant get in touch with for every other to offer the needed files.
For individuals who keep the individual economic info, you might need to add bank statements to show your earnings. (more…)
Even if overdrafts normally commercially be used to own non-crisis commands, you really need to most likely believe other options basic, and if you find your own bank equilibrium continuously supposed bad, you should most likely feedback their spending habits and you may do up a great the latest funds.
Even the most similar to playing cards certainly all these items, a line of credit is largely an excellent pre-concurred credit limit that you can use when, and you are merely billed interest towards the fund you actually play with. (more…)
Achieving the job free trans online dating Germany that is opposite the newest stronghold, they camped, and you will bringing forth P’ers and you may Andronicos, it beheaded them. For the emperor had therefore demanded him or her. [This is since] throughout their rebellion, the fresh Abkhazes ended up being partners, as well as got promised supply so you’re able to your [territory] as much as one to place since the his show. For previously one [territory] got influenced by the Dawit’ the brand new Curopalate, perhaps not, yet not, because the his patrimonial genetics, but while the gift suggestions gotten regarding the emperor in return for [Dawit’s] dedicated behavior. [Dawit’] had promised whenever their passing, his area will be returned to the brand new emperor; but [this new conspirators] don’t bother about you to. Quite the opposite it amply provided gift ideas which have been maybe not theirs to give. For this reason, the brand new emperor purchased them to getting beheaded at this destination [g35].
It is not an option the regular Iranian woman wouldn’t mind you bringing rich and you may wealthy. Whenever you look after your following members of the family, it’s a massive including to you. For as long as limit marriage ceremonies within the Iran end up being prepared the, parents to your girls usually select a partner on her. Should you decide are able to create a positive effect toward him or her, it means that you nearly obtained.
But money is maybe not what is very important the fresh Iranian girls wishes. (more…)
Blues should be castrated, and you will lesbians may have the tongues stop and their minds bare. Yet not, during the time of the latest next works of appointment, it became obvious one progressive youthfulness, particularly students, try in virtually any possible way so you can prevent like medieval guidelines and you may official morality tend to will not correspond to what’s going on throughout the intimate spheres out-of Islamic community now. Most recent Polls populace showed that, such, for the Lebanon, simply 50% from brides get married virgins. Without one produces a fuss. It is simply the father of in past times sinned woman provides the main ransom money covered her towards the groom’s family members.
An even higher part of “spoiled” brides in the countries out of North Africa. Then the steeped sell the fresh new “used” beauties into terrible but still outlay cash more. An identical holds true having homosexuality. From inside the rich parents, men beginning to getting “spoiled” throughout the age of 5, plus in Arab prisons there was an unwritten legislation so you can immediately “lower” a pretty young convict, and you will first the new shields “work” toward your, and everybody else. Some of the speakers on meeting reported that the latest Saudis is famous for their unique passion for same-gender love, somehow they try and train the complete Arab world to live considering Sharia rules. (more…)
Keep out of reach of children.
Read the directions carefully before use.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredient: Paracetamol ……………………….. 650 mg
Excipients: Wheat starch, pregelatinized starch, magnesium stearate, sodium starch glycolate, talc, aerosil, strawberry-flavored powder, PVP K30, sodium benzoate.
PHARMACEUTICAL FORM: Tablet.
Product description: A white to off-white, fragrant caplet, a break-line on one side, a diamond-shaped on the other, intact edges.
Barcode:
THERAPEUTIC INDICATIONS: Treatment of painful symptoms in cases of headache, migraine, toothache, aches and pains caused by flu, sore throat, musculoskeletal pains, arthritis-induced pains, pains after vaccination or tooth extraction.
Antipyretic actions on patients with cold or diseases associated with fever.
POSOLOGY AND METHOD OF ADMINISTRATION: Hapacol 650 should be orally given every 4 hours and not more than 6 tablets per day.
Adults and children aged > 12 years: 1 tablet each time.
Do not take the drug by self-administration for relief of fever for more than 3 days or for relief of pain for more than 10 days.
Or as prescribed by the physician.
Notes:
* Maximum dose/24 hours: not more than 4 g and given every 4 hours.
* Prolonged self-administration should not be advised, consult a physician if:
– New symptoms occur.
– Fever gets high (39.50C) and lasts more than 3 days or recurs.
– Pain gets worse or lasts more than 5 days.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with glucose – 6 – phosphate dehydrogenase deficiency.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should avoid co-administration of paracetamol and aspartame-containing medicines or food.
Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing medicines or food.
Cautions should be taken in patients with previous anemia, liver and kidney failure.
Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
The physician should warn patients of serious signs of skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
USE IN PREGNANCY AND LACTATION:
Safety of paracetamol on foetus has not determined when administered to pregnant women. Therefore, the drug should be only used in pregnant women if clearly needed.
Studies in breast-feeding mothers showed that use of paracetamol causes no adverse effect in breast-fed infants
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the possibility of driving and operating machinery.
INTERACTIONS:
Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid and antituberculosis drugs may increase paracetamol-induced liver toxicity.
Chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
UNDESIRABLE EFFECTS:
Uncommonly: rash; nausea, vomiting; rephropathy, renal toxicity due to long-term abuse; neutropenia, pancytopenia, anemia.
Rarely: hypersensitive reactions
Please inform your doctor of all undesirable effects upon drug administration.
OVERDOSE: Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 – 10 g daily for 1 – 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of paracetamol overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.
In severe poisoning, mild stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure.
Treatment: Early diagnosis is very important in treatment of paracetamol overdosage.
In the event of severe paracetamol intoxication, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion.
Methionine, activated charcoal and/or salt cathartics are also advised to treat overdose.
PHARMACODYNAMIC PROPERTIES:
ATC code: N02B E01
Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamic heat-regulating center to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. Paracetamol produces analgesia by elevation of the pain threshold.
With therapeutic doses, the analgesic, antipyretic effects of paracetamol are similar to those of aspirin. Paracetamol appears to have little effect on cardiovascular and respiratory system, causes no acid – base balance, no gastric irritation, scratch, bleeding.
PHARMACOKINETIC PROPERTIES: Paracetamol is rapidly and completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized predominantly by the liver and excreted by the kidney.
PRESENTATION: Box of 10 blisters x 5 tablets. Box of 10 blisters x 10 tablets. Box of 25 blisters x 10 tablets. Bottle of 100 tablets. Bottle of 200 tablets.
SHELF-LIFE: 36 months from the manufacturing date.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SPECIFICATIONS: Manufacturer’s.
COMPOSITION:
Acetaminophen ………………………. 500 mg
Excipients q.s …………………………. 1 tablet
(Wheat starch, avicel, aerosil, magnesium stearate, sodium starch glycolate, PVP K30, sodium benzoate, green).
DOSAGE FORM: Tablet.
PRESENTATIONS:
Box of 10 blisters x 10 tablets.
Bottle of 200 tablets.
Barcode:
ACTIONS:
Acetaminophen produces analgesia, antipyresis. The drug acts on the hypothalamic heat-regulating center to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Acetaminophen lowers body temperature in patients with fever but rarely lowers normal body temperature.
With therapeutic doses, the analgesic and antipyretic effects of acetaminophen are similar to those of aspirin. Acetaminophen appears to have little effect on cardiovascular and respiratory system, causes no acid – base balance, no gastric irritation, scratch, bleeding.
Acetaminophen is rapidly and almost completely absorbed by the gastrointestinal tract. The elimination half-life of acetaminophen varies from about 1.25 to 3 hours. Acetaminophen is metabolized predominantly by the liver and excreted by the kidney.
INDICATIONS:
Treatment of painful symptoms in cases of headache, migraine, toothache, aches and pains caused by flu, sore throat, musculoskeletal pains, arthritis-induced pains, pains after vaccination or tooth extraction.
Antipyretic actions on patients with cold or diseases associated with fever.
CONTRAINDICATIONS:
Hypersensitivity to any component of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned that concurrent use of acetaminophen and aspartame-containing food or drug should not be recommended.
Patients with hypersensitivity (asthma) should not use concurrently acetaminophen and sulfite-containing food or drugs.
Cautions should be taken in patients with previous anemia, hepatic and renal impairments.
Because chronic, excessive consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
PREGNANCY AND LACTATION:
Safety of acetaminophen on foetus has not determined when administered to pregnant women. Therefore, the drug should be used in pregnant women if clearly needed.
Studies in breast-feeding mothers showed that acetaminophen cause no adverse effects at nursing infants
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the possibility of driving vehicles and operating machinery.
INTERACTIONS:
Chronic ingestion of large doses of acetaminophen has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid and other antituberculosis drugs may increase acetaminophen-induced liver toxicity.
Acetaminophen may cause liver damage if you consume more alcoholic drinks for a long time.
ADVERSE EFFECTS:
Uncommonly: rash; nausea, vomiting; rephropathy, renal toxicity due to chronic ingestion; neutropenia, pancytopenia, anemia.
Rarely: hypersensitive reactions
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Acetaminophen toxicity may result from a single toxic dose, from repeated ingestion of large doses of acetaminophen (e.g. 7.5 – 10 g daily for 1 – 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of acetaminophen overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.
In severe poisoning, mild stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure.
Treatment: Early diagnosis is very important in treatment of acetaminophen overdosage.
In the event of severe acetaminophen intoxication, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion.
Methionin, activated charcoal and/or saline cathartic are also advised to treat overdose.
DOSAGE & ADMINISTRATION:
Adults and children aged > 12 years: oral dose of 1 tablet each time.
Adults may take 2 tablets each time in severe cases.
The drug should be given every 4 hours and not more than 8 tablets daily.
Or as prescribed by the physician.
Notes:
* Maximum dose / 24 hours: not more than 4g and given every 4 hours.
* Prolonged self-administration should not be advised. Ask your physician if:
– new symptoms occur.
– fever gets worse (39.50C) and lasts for more than 3 days or recurs
– pain gets worse or lasts for more than 5 days.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 300C, protect from light
Specifications: Manufacturer’s.
COMPOSITION:
Paracetamol ……………………….. 500 mg
Excipients.q.s……………………….. 1 tablet
(Wheat starch, avicel, aerosil, magnesium stearate, sodium starch glycolate, PVP K30, sodium benzoate, HPMC, PEG 6000, titanium dioxide, talc).
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 10 blisters x 10 tablets.
Barcode:
ACTIONS: Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. With therapeutic doses, the analgesic, antipyretic effects of paracetamol are similar to those of aspirin. Paracetamol appears to have little effect on cardiovascular and respiratory system, causes no acid – base balance, no gastric irritation, scratch, bleeding.
Paracetamol is rapidly and almost completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized predominantly by the liver and excreted by the kidney.
INDICATIONS: – Treatment of painful symptoms in cases of headache, migraine, toothache, aches and pains caused by flu, sore throat, musculoskeletal pains, arthritis-induced pains, pains after vaccination or tooth extraction.
– Antipyretic actions on patients with cold or fever-associated diseases.
CONTRAINDICATIONS: Hypersensitivity to any component of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be advised no concurrent administration of paracetamol and aspartame-containing food or drugs.
Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs.
Cautions should be taken in patients with previous anemia, hepatic and renal impairments.
Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
PREGNANCY AND LACTATION:
Safety of paracetamol on foetus has not determined when administered to pregnant women. Therefore, the drug should be only used in pregnant women if clearly needed. Studies in breast-feeding mothers showed that paracetamol causes no adverse effect at breast-fed infants
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the possibility of driving vehicles and operating machinery.
INTERACTIONS: Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants. The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine) isoniazid and other antituberculosis drugs may increase paracetamol-induced liver toxicity. Paracetamol may cause liver damage if you consume more alcoholic drinks for a long time.
ADVERSE EFFECTS: Uncommonly: rash; nausea, vomiting; rephropathy, renal toxicity when long-term abuse; neutropenia, pancytopenia, anemia.
Rarely: hypersensitive reactions.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 – 10 g daily for 1 – 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of paracetamol overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.
In severe poisoning, mild stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure.
Treatment: Early diagnosis is very important in treatment of paracetamol overdosage. In the event of severe paracetamol intoxication, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours. The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. Methionine, activated charcoal and/or saline cathartic are also advised to treat overdose.
DOSAGE & ADMINISTRATION:
Adults and children aged > 12 years: oral dose of 1 tablet each time. Adults may be given 2 tablets each time in severe cases.
Hapacol Blue should be orally given every 4 hours and not more than 8 tablets daily. Or as prescribed by the physician.
Notes:
* Maximum dose/24 hours: not more than 4 g, given every 4 hours.
* Prolonged self-administration is not recommended. Ask a doctor if:
– new symptoms occur.
– fever gets high (39.50C) and lasts more than 3 days or recurs.
– pain gets worse or lasts more than 5 days.
Read the directions carefully before use
Consult the physician for more information
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light
Specifications: Manufacturer’s.
COMPOSITION:
Paracetamol……………………………. 500 mg
Caffeine ………………………………….. 65 mg
Excipients q.s…………………………. 1 caplet
(Pregelatinized starch, avicel, wheat starch, sodium starch glycolate, erythrosine lake color, talc, magnesium stearate, strawberry-flavored powder, PVP K30, sodium benzoate).
DOSAGE FORM: Caplets.
PRESENTATION: Box of 10 blisters x 10 caplets.
Barcode:
ACTIONS: Hapacol Extra is a combination of paracetamol and caffeine:
Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamic heat-regulating to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. With therapeutic doses, the analgesic, antipyretic effects of paracetamol are similar to those of aspirin. Paracetamol appears to have little effect on cardiovascular and respiratory system, causes no acid – base balance, no gastric irritation, scratch, bleeding. Paracetamol is rapidly and completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized predominantly by the liver and excreted by the kidney.
Caffeine stimulates all levels of the CNS. It helps to relieve pains and supports muscular activities to be acted easily. Caffeine is well absorbed by the gastrointestinal tract and obtained plasma maximum concentration in adults after 1 hour. The plasma half-life is about 3 to 7 hours. Caffeine is metabolized by the liver and excreted by the urine.
INDICATIONS: Relief of painful attacks including headache, migraine, sore throat, dysmenorrhea, pains after tooth extraction or dental surgeries, toothache, myalgia, tenodynia, traumatic injuries, arthritis- and sinusitis-associated pains, pains and aches due to cold, flu.
CONTRAINDICATIONS: Hypersensitivity to any component of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned that no concurrent administration of paracetamol and aspartame-containing food or drugs.
Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs.
The drug should be used with caution in patients with previous anemia, hepatic and renal failure.
Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
High doses of caffeine may cause hypertension; use with caution in patients with hypertension.
For the paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
PREGNANCY AND LACTATION:
The drug only gives pregnant and nursing women if really necessary.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the possibility of driving and operating machines.
INTERACTIONS:
Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid and other antituberculosis drugs may increase paracetamol-induced liver toxicity.
Chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Avoid concurrent administration of the drug with caffeine-containing drinks including tea, coffee, and some canned drinks. Half-life of caffeine has been increased by concurrent administration with antibiotics including ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, ofloxacin. No concurrent use of caffeine and phenytoin, fluvoxamine, terbinafine, cimetidin, methoxsalen, contraceptives, phenylpropanolamine, ephedrin, theophylline is recommended.
ADVERSE EFFECTS: Paracetamol rarely causes adverse effects. However, symptoms of allergy, rash, nausea, vomiting have been sometimes reported. In some cases, pancytopenia, hypoleukemia, anemia may occur. Prolonged use and high doses of paracetamol may lead to hepatic impairment (due to hepatolysis).
In concerning with caffeine: High doses of caffeine may cause hypertension, daytime somnolence. Besides, other side effects include nausea, vomiting, diarrhea, insomnia, headache, tremble, palpitations, anxiety have been reported.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Paracetamol overdosage: Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 – 10 g daily for 1 – 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal. Symptoms of paracetamol overdosage include nausea, vomiting, colic, cyanosis on skin, mucosa, and nails.
Treatment of overdosage:
In the event of severe paracetamol overdose, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. N-acetylcysteine should be administered as soon as possible, preferably within 36 hours of overdosage. N-acetylcysteine is more effective if administered within 10 hours of overdosage.
Methionin, activated charcoal and/or salt cathartics are also advised to treat overdose.
Caffeine overdosage has been rarely reported. They can be drowsiness, palpitation, agitation, and delirum.
DOSAGE & ADMINISTRATION: Adults and children aged > 12 years are orally given 1 to 2 caplets, 1 to 4 times daily.
Do not exceed 8 caplets daily.
The interval between oral doses should be at least 4 hours.
Or as prescribed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
COMPOSITION:
Fexofenadine HCl ………………………………………………. 180 mg
Excipients q.s …………………………………………………… 1 tablet
(Pregelatinized starch, microcrystalline cellulose M101, croscarmellose sodium, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, talc, red ferric oxide, orange E110).
DOSAGE FORM: Film coated tablet
PRESENTATION: Box of 2 blisters x 10 tablets.
Barcode:
PHARMACODYNAMICS:
Telfor contains the active ingredient Fexofenadine which is a selectively peripheral H1-receptor histamine antagonist and is used to treat the allergy. At the therapeutic dose, fexofenadine causes no drowsiness or other CNS effects. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.
PHARMACOKINETICS:
Fexofenadine is rapidly absorbed following oral administration. The plasma peak concentrations occur at 2 – 3 hours post-dose. Food reduces the plasma peak concentration by 17%. Fexofenadine is 60 to 70% bound to plasma proteins, primarily albumin and alpha1-acid glycoprotein. The mean elimination half-life of fexofenadine was 14.4 hours. Approximately 11% of an oral dose of fexofenadine is excreted in the urine, primarily as unchanged drug and 80% is excreted in faeces.
INDICATIONS:
Symptomatic treatment of unknown chronic urticaria in adults and children over 12 years old.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
PRECAUTIONS:
Patients with a history of or ongoing cardiovascular disease or previous prolonged QT interval should be warned. Avoid concurrently administrating fexofenadine with other antihistamine agents.
Caution and dose adjustment should be exercised in kidney failure patients and the elderly (over 65 years) who suffered from decreased renal function. Fexofenadine should be discontinued at least 24 to 48 hrs prior to intradermally injected antigen tests. The safety of fexofenadine 180 mg in children under 12 years of age has not been established.
PREGNANCY AND LACTATION:
There are no adequate data from the use of fexofenadine in pregnant women. Therefore, fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Data for content in human milk after administration of fexofenadine is not available; therefore, caution should be taken in breast-feeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Although fexofenadine rarely causes drowsiness, caution should be exercised in drivers and machine users.
INTERACTIONS:
Co-administration of fexofenadine with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine because of increased absorption and decreased elimination of fexofenadine. However, the interaction has no meaning of clinical significance.
Antacids containing aluminium and magnesium hydroxide gels cause a reduction in the bioavailability of fexofenadine, most likely due to binding in the gastrointestinal tract. Therefore, it is advisable to leave 2 hours between administration of fexofenadine and aluminium and magnesium hydroxide containing antacids.
Grapefruit juice reduces the absorption and exposure of fexofenadine.
ADVERSE EFFECTS:
Common: CNS disorders: drowsiness, fatigue, headache, insomnia, dizziness. Gastrointestinal disorders: nausea, indigestion. Others: viral infections (cold, influenza), dysmenorrhea, upper respiratory infections, itchy throat, cough, fever, otitis media, sinusitis, back pain.
Uncommon: CNS disorders: fear, sleep disturbances, nightmares. Gastrointestinal disorders: dry mouth, abdominal pain.
Rare: Skin disorders: rash, pruritus. Hypersensitivity reactions: angioedema, chest discomfort, dyspnea, flushing, anaphylactic shock.
Inform a physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Reports on acute toxicity of fexofenadine are limited; however, dizziness, drowsiness, and dry mouth have been reported.
Treatment: Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Hemodialysis did not effectively remove fexofenadine, from blood (up to 1.7% removed). There is no specific antidote.
DOSAGE & ADMINISTRATION:
Adults and children aged more than 12 years: oral dose of 1 tablet daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
COMPOSITION:
Diosmin ……………………… 450 mg
Hesperidin ……………………. 50 mg
Excipients q.s………………. 1 tablet
(Wheat starch, avicel, PVP, magnesium stearate, HPMC, PVA, PEG 6000, talc, titanium dioxide, red ferric oxide, yellow ferric oxide).
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 5 blisters x 10 tablets. Box of 10 blisters x 10 tablets.
Barcode:
ACTIONS: The main component of DilodinDHG is a micronized purified flavonoid fraction (diosmin, hesperidin) which is a vascular protecting agent. The drug develops its actions by inhibiting hyaluronidase, an enzyme producing capillary hyperpermeability. In case this enzyme is redundant, a hypodermic hemorrhage state occurs.
DilodinDHG acts on reducing varicose veins and venous stasis, normalizing capillary permeability and strengthening capillary resistance. DilodinDHG is used in the treatment of venous dysfunction, especially in haemorrhoids with the internal medicine method.
INDICATIONS: Treatment of the symptoms of acute haemorrhoidal attacks and chronic haemorrhoidal disease.
Treatment of the symptoms associated with venolymphatic circulatory failure e.g., footsore, heavy legs, swelling in the legs, varicose veins, post-phlebitis, cramps.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Pregnant women and breast-feeding mothers.
PRECAUTIONS: No documents have been reported.
PREGNANCY AND LACTATION: Animal studies have shown no teratogenicity; no harmful effect has so far been reported. No data recording the drug crosses breast milk. The drug should not be used in pregnant women and breastfeeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the ability to drive and operate machinery.
INTERACTIONS: No documents have been reported.
ADVERSE EFFECTS: Gastrointestinal disturbances. Mild neurovegetative disorders have been rarely reported.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: No documents have been reported.
DOSAGE & ADMINISTRATION: The oral doses are divided into 2 times, in lunch and dinner.
Acute haemorrhoidal attacks: 6 tablets daily for 4 days, then 4 tablets daily for 3 days, 2 tablets daily thereafter.
Chronic hemorrhoidal disease: 2 tablets daily.
Venous insufficiency (footsore, heavy legs, swelling in the legs, varicose veins, post-phlebitis, cramps): 2 tablets daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
Keep out of the reach of children.
Read all of this leaflet carefully before you start taking this medicine.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredients:
Magnesium lactate dihydrate ……………. 470 mg
(Equivalent to magnesium 48 mg)
Vitamin B6 ……………………………………. 5 mg
Excipients: Lactose monohydrate, microcrystalline cellulose M101, wheat starch, PVP K30, sodium starch glycolate, talc, magnesium stearate, hypromellose 2910 (6cp), hypromellose 2910 (15cp), polyethylene glycol 6000, titanium dioxide
PHARMACEUTICAL FORM:
Film coated tablet.
Product description: An oval, white to off-white, film coated tablet, plain on both sides, intact edges.
Barcode:
THERAPEUTIC INDICATIONS:
Treatment of magnesium deficiency, isolated or associated.
POSOLOGY AND METHOD OF ADMINISTRATION:
The tablets should be swallowed with a large glass of water.
FOR ADULTS AND CHILDREN AGED MORE THAN 6 YEARS
Adults: 6 to 8 tablets per day to be divided into 2 or 3 doses taken during meals.
Children: 10 to 30 mg/kg/day (0.4 to 1.2 mmol/kg/day) or children aged more than 6 years (weighing 20 kg and more) 4 to 6 tablets per day to be divided into 2 or 3 doses taken during meals.
Treatment will be discontinued upon normalization of magnesemia.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
Severe renal impairment with creatinine clearance less than 30 ml/min.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
In case of severe deficiency and malabsorption, treatment should be started by the venous route.
In the case of associated calcium deficiency, it is recommended that the magnesium repletion should be carried out before calcium therapy.
Sensory neuropathy can occur when using high doses of vitamin B6 (> 200 mg/day) over a long period of time (several months or years). This is generally reversible when treatment is discontinued.
This medicine contains lactose. It is not recommended in patients with lactase deficiency, galactose intolerance, or glucose/galactose malabsorption. It is needed to consult your physician before use.
USE IN PREGNANCY AND LACTATION:
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
INTERACTIONS:
Avoid concomitant administration of magnesium with preparations containing phosphate or calcium salts (since they inhibit the absorption of magnesium in the small intestine).
When tetracycline is co-prescribed, the interval between oral doses should be at least 3 hours. Due to containing pyridoxine, concurrent administration of Magnesi-B6 and levodopa should not be recommended.
UNDESIRABLE EFFECTS:
Diarrhea, abdominal pain, skin reactions, allergic reactions.
Inform your physician about any undesirable effects occur during the treatment.
OVERDOSE:
Signs and symptoms:
Overdosage of magnesium by the oral route does not generally lead to toxic reactions in normal kidney function. Magnesium poisoning, however, can develop in patients with renal insufficiency.
The toxic effects depend on the blood level of magnesium and the signs are as follows: decreased blood pressure, nausea, vomiting, central nervous system depression, decreased reflexes, ECG abnormalities, onset of respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.
Treatment: rehydration, forced diuresis. In patients with renal insufficiency, hemodialysis or peritoneal dialysis is necessary.
PHARMACODYNAMIC PROPERTIES
Clinically, serum magnesium concentrations: between 12 and 17 mg/L (1 to 1.4 mEq/L or 0.5 to 0.7 mmol/L) indicates a moderate magnesium deficiency. Less than 12 mg/L (1 mEq/L or 0.5 mmol/L) indicates a severe magnesium deficiency.
Magnesium deficiency can be primitive by congenital abnormalities (congenital hypomagnesemia) or secondary by inadequate intake (severe malnutrition, alcoholism, exclusive parenteral nutrition), digestive malabsorption (chronic diarrhea, digestive fistulas, hypoparathyroids), exaggerated renal losses (tubulopathy, diuretic abuse, chronic nephritis, primary hyperaldosteronism, cisplatin therapy).
PHARMACOKINETIC PROPERTIES:
After oral administration, approximately 1/3 of magnesium is absorbed in the small intestine, even soluble magnesium salts are slowly absorbed from the gastrointestinal tract. Approximately 25 – 30% of magnesium bound to plasma protein (albumin). Magnesium is eliminated mainly by the kidneys, the rate changes among individuals but is directly proportional to serum concentrations and glomerular filtration. The unabsorbed part is excreted in feces.
PRESENTATION: Box of 10 blisters x 10 fim coated tablets.
SHELF-LIFE: 24 months from the manufacturing date.
STORAGE CONDITIONS: Store in dry places, not exceeding 300C, protect from light.
SPECIFICATIONS: Manufacturer’s.
COMPOSITION:
Bisacodyl ……………………………………. 5 mg
Excipients q.s ……………………………1 tablet
(Lactose, avicel, wheat starch, magnesium stearate, talc, PVP K30, eudragit L 100, PEG 6000, titanium dioxide, black ferric oxide, tartrazine lake, orange E110).
DOSAGE FORM: Enteric film coated tablet.
PRESENTATION: Box of 4 blisters x 25 enteric film coated tablets.
Barcode:
ACTIONS:
Bisacodyl is a locally acting laxative from the triarylmethane group. Bisacodyl stimulates after hydrolysis the mucosa of the large intestine resulting in colonic peristalsis.
Bisacodyl is hydrolyzed mainly by enzymes of the enteric mucosa to the desacetylbisacodyl, which is absorbed and is partly eliminated in urine and bile as glucuronide. Thanks to bacterial separation, the active ingredient of free diphenol is formed in the large intestine. Bisacodyl coated tablets are formulated to be resistant to gastric and small intestinal juice. This results in a main release of the drug in the colon. After oral administration, only small amounts of the drug are absorbed. Bisacodyl is metabolized in the liver and is eliminated in urine. Following the oral administration of bisacodyl, the elimination was estimated to be approximately 6-8 hours.
INDICATIONS:
Treatment of constipation. For bowel evacuation before and after surgery. Before to take an X-ray of the colon.
CONTRAINDICATIONS:
Bisacodyl should not be used by patients undergoing surgical abdominal conditions, ileus, appendicitis, rectal bleeding, gastroenteritis.
Hypersensitivity to any components of the drug.
PRECAUTIONS:
The tablets should not be chewed but swallowed whole. Antacids and milk products should not be given one hour after taking the tablets. Bisacodyl should not be taken on a continuous daily basis for more than one week without asking your physician.
PREGNANCY AND LACTATION:
There are no risks reported when indicated bisacodyl to pregnant women and nursing mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
No documents have been reported.
INTERACTIONS:
Prolonged administration or overdose of bisacodyl can reduce the effects of potassium-sparing diuretics or potassium supplements.
– The concomitant use of bisacodyl and antacids, H2-receptor antagonists or milk products within one hour may reduce the resistance of the coating of the tablets and result in gastric irritation.
– Bisacodyl reduces the concentrations of digoxin; so it should be taken 2 hours before the ingestion of digoxin.
ADVERSE EFFECTS:
Rarely: colic, nausea.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Symptoms: lower abdominal pain accompanied with dehydration, particularly in children and the elderly.
Treatment: Absorption can be minimised or prevented by inducing vomiting or gastric lavage. Replacement of fluids and monitoring of serum potassium may be required. Administration of antispasmodics may be of value. Correction of electrolyte imbalance is especially important in the elderly and the young.
There is no specific antidote.
DOSAGE & ADMINISTRATION:
For the treatment of constipation:
Adults and children over 10 years: oral dose of 1 – 2 tablets at night. It is advisable to take larger doses (3 or 4 tablets) if required.
Children aged 6 – 10 years: oral dose of 1 tablet at night.
For bowel evacuation:
Adults and children over 10 years: oral dose of 2 tablets at night.
Children aged 6 – 10 years: oral doe of 1 tablet at night.
For preparing to take an X-ray of the colon:
Adults and children over 10 years: oral dose of 2 tablets at night, in two successive nights before taking an X-ray.
Children aged 6 – 10 years: oral dose of 1 tablet at night, in two successive nights before taking an X-ray.
Children younger than 6 years of age should not be indicated because the tablet is unable to be divided into small doses.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
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COMPOSITION:
Chymotrypsin … 21 microkatals (Equivalent to 4200 USP units)
Excipients q.s …………………………………………………… 1 tablet
(Compressible sugar, magnesium stearate).
DOSAGE FORM: Tablet.
PRESENTATION: Box of 2 blisters x 10 tablets. Box of 6 blisters x 10 tablets.
Barcode:
PHARMACODYNAMICS:
Chymotrypsin is a proteolytic enzyme, which acts on selective catalysis of peptide bonds adjoining to aromatic amino acids. The drug is used for reducing inflammation and soft tissue oedema associated with abscess, ulcer or injuries. It also helps fluidize the upper respiratory tract secretion in patients with asthma, bronchitis, pneumopathy, and sinusitis.
PHARMACOKINETICS:
No documents have been found.
INDICATIONS:
For the treatment of oedema associated with post-operative, post-traumatic, and burns conditions.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
The drug should not be used in patients with the risk of alpha-1 antitrypsin deficiency: chronic obstructive pulmonary disease, alveolar emphysema, nephrotic syndrome…
PRECAUTIONS:
It is not recommended for use in cataract surgery in patients under 20 years of age.
Chymotrypsin should not be used for patients with increased vitreous pressure and opened wound or patients with congenital cataracts.
PREGNANCY AND LACTATION:
Chymotrypsin should not be given to pregnant women and nursing mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
This drug does not affect the ability to drive or use machines.
INTERACTIONS:
Chymotrypsin is most often used in combination with other enzymes to enhance its treatment potential.
Chymotrypsin should not be co-administered with acetylcysteine.
Chymotrypsin should not be used together with anticoagulant agents, as it increases their effects.
ADVERSE EFFECTS:
Most common: Transient glaucoma. Used in ophthalmology: corneal edema, mild uveitis may occur.
Due to the antigenic properties of chymotrypsin, allergic reactions may occur when used at high dose.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
No documents have been reported.
DOSAGE & ADMINISTRATION:
Adults: sublingual use: 1-2 tablets x 3-4 times daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
The drug is for prescriptions only.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places; not exceeding 30oC; avoid sunlight and humidity.
Specifications: Manufacturer’s.
COMPOSITION:
Methylprednisolone …………………………………………………………. 16 mg
Excipients q.s…………………………………………………………………. 1 tablet
(Avicel M101, lactose monohydrate, dicalcium phosphate, aerosil, PVP K30, sodium lauryl sulphate, kollidon CL-M, talc, magnesium stearate)
DOSAGE FORM: Tablet.
PRESENTATION:
Box of 3 blisters x 10 tablets. Box of 10 blisters x 10 tablets.
Barcode:
PHARMACODYNAMICS:
Medlon contains the active ingredient Methylprednisolone, a glucocorticoid, which is an anti-inflammatory, anti-allergic agent with the capacity to profoundly inhibit the immune system. Due to methylation of prednisolone, the corticoid effect on sodium metabolism was excluded; so methylprednisolone rarely causes sodium, water retention and oedema. The anti-inflammatory activity of methylprednisolone is 20% stronger than that of prednisolone. A dose of 4 mg methylprednisolone has the same effect as 20 mg hydrocortisone.
PHARMACOKINETICS:
Bioavailability of methylprednisolone is about 80%. Peak plasma concentrations are obtained 1 – 2 hours after oral administration. It has an elimination half-life of about 3 hours. Methylprednisolone is metabolized in the liver and its metabolites are excreted in the urine.
INDICATIONS:
Treatment of inflammation and immune depression in: rheumatoid arthritis, systemic lupus erythematosus, certain angiitis, temporal arteritis and polyarteritis nodosa, sarcoidosis, bronchial asthma, chronic duodenal ulcer, hemolytic anemia, granulocytopenia, severe allergy including anaphylactic shock; in the treatment of cancers: acute leukemia, lymphoma, breast cancer, prostate cancer.
Methylprednisolone is also indicated in the treatment of primary nephrotic syndrome.
CONTRAINDICATIONS:
Hypersensitivity to methylprednisolone. Severe infections, excepting for septic shock and tuberculous meningitis. Skin injury due to virus, fungus or tuberculosis. Administration of live vaccines.
PRECAUTIONS:
Particular care is required in patients with osteoporosis, newly involved in connection of blood vessels, mental disorders, gastro-duodenal ulcer, diabetes, hypertension, heart failure; and in children during the growth phase. The common adverse effects of systemic corticosteroids may be associated in old age; treatment should be limited to the minimum dosage for the shortest period of time. Abrupt withdrawal of methylprednisolone dosage following prolonged treatment or presence of stress can lead to acute adrenal insufficiency. Large doses may affect the action of the vaccine immunization.
PREGNANCY AND LACTATION:
When administered for long periods during pregnancy, systemic corticosteroids may decrease birth weight. Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risk. Corticosteroids do not contraindicate to nursing mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug should be used cautiously because undesirable effects are possible in drivers, machinery operators.
INTERACTIONS:
Methylprednisolone is a cytochrome P450 enzyme inducer and is a P450 3A4 enzyme substrate; therefore, mutual inhibition of metabolism occurs with concurrent use of methylprednisolone with ciclosporin, erythromycin, phenobarbital, phenytoin, carbamazepine, ketoconazole, and rifampicin. The effect of methylprednisolone may be reduced by phenytoin, phenobarbital, rifampin and hypokalemic diuretics. Methylprednisolone may cause hyperglycemia; a higher dose of insulin should be recommended.
ADVERSE EFFECTS:
Adverse effects may occur following prolonged administration and high doses of methylprednisolone. Methylprednisolone inhibits prostaglandin synthesis, and therefore, it inactivates the actions of prostaglandin on gastrointestinal tract, including suppression of gastric acid secretion and protection of gastric mucous membrane.
Common: insomnia, excitable nerve; increased appetite, dyspepsia; hirsutism; diabetes; arthralgia; cataract, glaucoma; epistaxis.
Uncommon: dizziness, seizures, psychosis, pseudotumor cerebri, headache, mood changes, delirium, hallucination, cheeriness; edema, hypertension; acne, skin atrophy, bruise, hyperchromasia; Cushing’s syndrome; stomach ulcers, nausea, vomiting, abdominal distention, ulcerative esophagitis, pancreatitis; muscle weakness, osteoporosis, fractures; hypersensitive reactions.
Inform a physician about any adverse effects occur during the treatment.
OVERDOSE:
Symptoms of overdose associated with prolonged use include Cushing’s syndrome, muscle weakness, osteoporosis, adrenal suppression. Temporary discontinuation or termination of the drug should be considered.
DOSAGE & ADMINISTRATION:
Dosage requirements depend on the condition being treated and response of the patient. The initial dose should be 6 – 40 mg of methylprednisolone daily. A necessary dosage to maintain a desired therapeutic effect is lower than that to obtain an initial effect. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
In long-term treatment with large dose, the drug should be indicated in every other day when the diseases being controlled. This minimizes certain undesirable effects due to recovery time among doses.
In this therapy, methylprednisolone is given single morning dose every two days according to natural secretion time of glucocorticoids.
Acute asthma: 32 – 48 mg/day for 5 days. An additional treatment with a lower dose should be applied within one week. If the acute course disappears, the dosage should be reduced gradually and promptly.
Acute course of rheumatoid arthritis: 16 – 32 mg/day. Thereafter, the dosage should be reduced gradually and promptly.
Acute course of chronic ulcerative colitis: 8 – 24 mg/day.
Primary nephrotic syndrome: The initial dose should be 0.8 – 1.6 mg/ kg/day for 6 weeks, then reducing gradually the dosage for 6 to 8 weeks.
Hemolytic anemia due to immunity: 64 mg/day for at least 6 – 8 weeks.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places; not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
COMPOSITION:
Spiramycin ………………………………………………………………. 3,000,000 IU
Excipients q.s…………………………………………………………………… 1 tablet
(Aerosil, tapioca starch, talc, magnesium stearate, sodium starch glycolate, HPMC, PEG 6000, titanium dioxide).
DOSAGE FORM: Film coated tablets
PRESENTATION: Box of 2 blisters x 5 tablets.
Barcode:
PHARMACODYNAMICS:
Rovas contains Spiramycin which is a macrolide antibiotic. Spiramycin is bacteriostatic at serum concentrations but may be bactericidal at tissue concentrations. Mechanism of action of spiramycin is to bind reversibly to the 50S subunits of bacterial ribosome resulting in inhibition of protein synthesis. Spiramycin is active against Gram-positive organisms, Coccus spp. including Staphylococcus, Pneumococcus, Meningococcus, etc.
PHARMACOKINETICS:
Spiramycin is incompletely absorbed from the gastrointestinal tract. Drug absorption is approximately 20 – 50% of the dose. Peak plasma concentrations attained within 2 – 4 hrs after oral administration. Peak blood concentrations of a single dose may maintain 4 – 6 hrs. Bioavailability of spiramycin may be significantly reduced when the presence of food is in the stomach. Cmax is decreased by 70% and tmax is delayed by 2 hours in the presence of food. Spiramycin is widely distributed in the body. Spiramycin achieves high concentrations in lung, tonsils, bronchi, and sinuses. Penetration of spiramycin into cerebrospinal fluid is reported to be poor. The mean half-life is 5 to 8 hours. Spiramycin is mainly excreted in the bile. Only 2% of total drug is found in the urine after 36 hrs of oral administration.
INDICATIONS:
Spiramycin is suggested to be the second choice in treatment of respiratory tract infections, skin and genital infections caused by susceptible to bacteria.
Preventive treatment of meningitis caused by Meningococcus when patients contra-indicated in the prescription of rifampicin
Prevention of innate toxoplasmosis during pregnant period.
Prophylaxis of recurrences of acute rheumatism in penicillin-allergic patients.
CONTRAINDICATIONS:
A known history of hypersensitivity to spiramycin, erythromycin.
PRECAUTIONS:
The drug should be used with caution in patients with hepatic dysfunction because it may cause hepatotoxicity.
PREGNANCY AND LACTATION:
Spiramycin crosses the placenta; however, fetal blood concentrations are lower than maternal serum concentrations. Spiramycin does not cause bad effects in pregnant women. High concentrations are distributed into breast milk; therefore, breast-feeding is not recommended to women taking spiramycin.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The effect of spiramycin on the ability to drive, use machines is rarely reported.
INTERACTIONS:
Concomitant use of spiramycin with oral contraceptives causes ineffective contraception.
ADVERSE EFFECTS:
Common: nausea, vomiting, diarrhea, dyspepsia (following oral route).
Uncommon: General disorders: fatigue, nosebleed, sweating, chest pains; transient paresthesia, unsteadiness, muscle and joint contractures or pains, burning sensation, flushing (following intravenous injection); Gastrointestinal disorders: acute colitis; Skin disorders: skin rash, urticaria.
Rare: anaphylactic reactions, surinfections due to prolonged use of spiramycin.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSE:
No documents have been reported. In the event of overdosage, inform your doctor immediately.
DOSAGE & ADMINISTRATION:
Treatment dose:
Adults and children aged > 12 years: oral dose of 3,000,000 IU 3 times for 24 hours (1 tablet 3 times daily).
Prevention of meningitis caused by Meningococcus:
Adults and children aged > 12 years: oral dose of 3,000,000 IU every 12 hours (1 tablet twice daily).
Prophylaxis of innate toxoplasmosis in pregnancy:
Oral dose of 9,000,000 IU/day (3 tablets/day), in divided doses for 3 weeks. The dosage should be repeated every 2 weeks.
Alternate or coordinate administration with pyrimethamine/sulfonamide therapy should be given to get a better result.
Bioavailability of spiramycin may be decreased when the presence of food is in the stomach; so the drug should be taken at least 2 hours before a meal or 3 hours after a meal.
The therapy must be completely pursued.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
COMPOSITION:
Acyclovir ………………………… 800 mg
Excipients q.s…………………… 1 tablet
(Microcrystalline cellulose M101, wheat starch, ponceau, PVP K30, colloidal silicon dioxide, magnesium stearate, talc).
DOSAGE FORM: Tablet.
PRESENTATION: Box of 3 blisters x 10 tablets.
Barcode:
PHARMACODYNAMICS:
Acyclovir is similar to nucleoside. It interferes DNA synthesis and inhibits selectively viral replication, resulting in not affecting the metabolism of normal cells. Acyclovir is potently active against Herpes simplex virus type 1 (HSV-1) and less active against Herpes simplex virus type 2 (HSV-2) and Varicella zoster virus (VZV), cytomegalovirus (CMV).
PHARMACOKINETICS:
Oral bioavailability of acyclovir is about 20%. Oral acyclovir is mainly absorbed by the GI tract; the influence of food on the absorption of acyclovir was not apparent. Acyclovir is widely distributed in body fluids and organs including brain, kidney, lung, intestine, liver, spleen, uterus, mucosa, vaginal mucosa, tears, aqueous humor, seminal fluid, encephalospinal fluid. Plasma protein binding is relatively low (9 to 33%). Peak plasma concentrations of acyclovir usually occur with 1.5 to 2 hours. The elimination half-life of acyclovir is approximately 2 to 3 hours. Acyclovir is excreted principally in the kidneys as unchanged; a small amount of acyclovir is metabolized by the liver.
INDICATIONS:
reatment of initial and recurrent infections due to Herpes simplex virus type 1 and type 2 on skin and mucosa, Herpes simplex encephalitis.
Treatment of acute Herpes zoster infections (shingles), ocular shingles, pneumonia due to Herpes zoster in adults.
Treatment of initial and recurrent infections of genital Herpes.
Treatment of haemorrhagic chickenpox, chickenpox in immunodeficiency patients, chickenpox in newborn baby.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
PRECAUTIONS:
Renal failure has been observed with acyclovir therapy.
Caution should also be exercised when administering acyclovir to patients receiving potentially nephrotoxic agents.
Do not exceed the prescribed doses and the treatment period of time.
PREGNANCY AND LACTATION:
Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Acyclovir concentrations have been documented in breast milk. It should be administered to a nursing mother with caution.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug does not affect the ability to drive and use machinery.
INTERACTIONS:
Concurrent use of zidovudine and acyclovir may cause states of doze and deep sleep.
Probenecid is reported to inhibit the renal elimination of acyclovir, reduce the uric excretion and the purification of acyclovir.
Amphotericin B and ketoconazole enhance the antiviral effect of acyclovir.
ADVERSE EFFECTS:
Side effects in patients treated short-term with acyclovir are nausea, vomiting. Long-term treatment over 1 year has the potential for nausea, vomiting, diarrhea, colic, rash, headache (<5% of patients).
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Symptoms: Precipitation of acyclovir in renal tubules may occur when renal concentrations is excreted the solubility (2.5 mg/ml) or the serum creatinine is elevated. Adverse events that have been also reported in association with overdosage include renal failure, excitement, anxiety, convulsion, palpitation, hypertension, and dysuria.
Management: Hemodialysis is advised until recovery of renal function. The drug should be discontinued and patients should receive fluids and electrolytes.
DOSAGE & ADMINISTRATION:
For treatment of Herpes simplex infections:
– Adults and children aged > 2 years: oral dose of 200 mg (400 mg in immunodeficiency patients) 5 times daily every 4 hours for 5 – 10 days.
For suppression of recurrent Herpes simplex in immunocompromised patients, visceral transplant patients using the hypo-immune drugs, HIV-infected person, chemotherapy-treating individuals.
– Adults and children aged > 2 years: oral dose of 200 – 400 mg, 4 times daily.
For treatment of chickenpox and shingles:
– Adults: oral dose of 800 mg 5 times daily, for 7 days.
– Children: oral dose of 20 mg/ kg body-weight (maximum of 800 mg), 4 times daily for 5 days.
For patients with renal impairment: The dose for patients with renal impairment associated with HSV or Varicella zoster infections is similar to that of normal patients. However, the dose should be modified as follows:
– Creatinine clearance of 10 – 25 ml/ min: taking every 8 hours.
– Creatinine clearance of below 10 ml/ min: taking every 12 hours.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
Keep out of reach of children.
Read all of this leaflet carefully before you start taking this medicine.
The drug is for prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredients:
Domperidone ……………………………… 10 mg
Excipients:
Lactose, wheat starch, sodium starch glycolate, aerosil, magnesium stearate, PVP K30, HPMC, PEG 6000, titanium dioxide, talc.
PHARMACEUTICAL FORM: Film coated tablet.
Product description: A white to off-white, round, film-coated tablet, plain on both sides, intact edges.
Barcode:
THERAPEUTIC INDICATIONS:
Modom’S is indicated for the relief of the symptoms of nausea and vomiting.
POSOLOGY AND METHOD OF ADMINISTRATION:
Modom’S should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.
Usually, the maximum treatment duration should not exceed one week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more):
One 10mg tablet up to three times per day with maximum dose of 30 mg per day.
Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg.
Due to the need for accurate dosing, domperidone tablets are unsuitable for use in children and adolescents weighing less than 35 kg.
Hepatic impairment:
Modom’S is contraindicated in moderate or severe hepatic impairment (see Contraindications). Dose modification in mild hepatic impairment is however not needed.
Renal impairment:
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Modom’S should be reduced to once or twice daily depending on the severity of the impairment.
Or as directed by a physician.
CONTRAINDICATIONS:
Domperidone is contraindicated in the following situations:
In patients with vomiting after surgery. In patients with gastro-intestinal haemorrhage, mechanical obstruction. Children younger than 1 year of age. Frequent and long-term administration of domperidone.
In patients with moderate or severe hepatic impairment (see Pharmacokinetics).
In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure.
Co-administration with QT-prolonging drugs (see Interactions).
Co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see Interactions).
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Domperidone should be administered to Parkinsonian patients not more than 12 weeks. The possible nervous central adverse effects may happen. Domperidone should only be used in Parkinsonian patients when other safer antiemetic measures have failed. Domperidone should be administered with caution in patients with liver and kidney impairment.
Renal impairment:
The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.
Cardiovascular effects:
Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see Undesirable effects).
Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see Undesirable effects). A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Domperidone should be used at the lowest effective dose in adults and children.
Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patient with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see Contraindications). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should consult their physician.
Patient should be advised to promptly report any cardiac symptoms.
Related to lactose excipient:
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
USE IN PREGNANCY AND LACTATION:
Pregnancy:
Modom’S is contraindicated in pregnant women.
Breast-feeding:
Domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the women. Caution should be exercised in case of QTc prolongation risk factor in breast-fed infants.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Domperidone has no or negligible influence on the ability to drive or use machines.
INTERACTIONS:
The effect of domperidone is inhibited by anticholinergic agents, opioid analgesics and antimuscarinic drugs.
Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Concomitant use of the following substances is contraindicated:
QTc-prolonging medicinal products:
– anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)
– anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
– certain antipsychotics (e.g., haloperidol, pimozide, sertindole)
– certain antidepressants (e.g., citalopram, escitalopram)
– certain antibiotics (e.g., erythromycin, levofloxacin, moxifloxacin, spiramycin)
– certain antifungal agents (e.g., pentamidine)
– certain antimalarial agents (in particular halofantrine, lumefantrine)
– certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)
– certain antihistaminics (e.g., mequitazine, mizolastine)
– certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)
– certain other medicines (e.g., bepridil, diphemanil, methadone)
(see Contraindications)
Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e:
– protease inhibitors
– systemic azole antifungals
– some macrolides (erythromycin, clarithromycin and telithromycin)
(see Contraindications).
Concomitant use of the following substances is not recommended:
Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
(See Contraindications)
Concomitant use of the following substances requires caution in use:
Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
The above list of substances is representative and not exhaustive.
UNDESIRABLE EFFECTS:
Loss of libido, rash, and other allergic reactions. Galactorrhoea, menstrual disorders, dysmenorrhea, enlarged breast or breast tenderness due to elevated serum prolactin may be seen in patients with high doses of prolonged use.
Cardiac disorders:
Not known: ventricular arrhythmias, QTc prolongation, Torsade de pointes, sudden cardiac death (See Special warnings and precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the National Center or Regional center for Drug Information and Adverse Drug Reactions Monitoring.
Please inform your doctor of all undesirable effects upon drug administration.
OVERDOSE:
In the event of overdose, measures including diuresis, gastric lavage, standard symptomatic treatment should be given immediately. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
PHARMACODYNAMIC PROPERTIES
ATC code: A03FA03
Modom’S contains domperidone which is a dopamine antagonist with anti-emetic properties. The drug has almost no effect on dopamine receptors in the brain, so it has no psychiatrical and neurological effects. Domperidone stimulates the gastrointestinal peristalsis, causes cardiospasm hypertonia and increase in expanded amplitude of post-prandial pyloric spasm.
PHARMACOKINETIC PROPERTIES:
Domperidone is absorbed from the gastrointestinal tract, with peak plasma concentrations occurring at approximately 30 minutes. Domperidone is metabolized through the liver, intestines and is excreted in feces and urine.
PRESENTATION: Box of 10 strips x 10 film coated tablets.
STORAGE CONDITIONS: Store in dry places, not exceeding 300C, protect from light.
SPECIFICATIONS: Manufacturer’s.
COMPOSITION:
Trimetazidine dihydrochloride………………………….. 20 mg
Excipients q.s …………………………………………….. 1 tablet
(Lactose, avicel, PVP K30, stearic acid, aerosil, sepifilm, HPMC, PEG 6000, talc, titanium dioxide, ponceau lake color).
DOSAGE FORM: Film coated tablets.
PRESENTATION: Box of 2 blisters x 30 film coated tablets.
Barcode:
PHARMACODYNAMICS:
Mechanism of action: Trimetazidine inhibits beta oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase. In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the beta-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.
Pharmacodynamic effects: In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant haemodynamic effects.
PHARMACOKINETICS:
Absorption is rapid, with a plasma peak time at prior 2 hrs after administration and balanced state at 24 to 36 hrs after repeating a dose and stabilizing highly during the treatment. The elimination half-life of trimetazidine is 6 hrs. Elimination of trimetazidine is principally urinary as unchanged.
INDICATIONS:
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
CONTRAINDICATIONS:
– Hypersensitivity to the active ingredient or to any of the excipients listed in the composition.
– Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
– Severe renal impairment (creatinine clearance < 30ml/ min).
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations. The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine. These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought. Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment (see Adverse effects).
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected (see Dosage and administration):
– Patients with moderate renal impairment.
– Elderly patients older than 75 years old.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Trimetazidine may cause dizziness and drowsiness, which may affect ability to drive and use machine.
PREGNANCY AND LACTATION:
Clinical studies have not proved the safety of trimetazidine; so, Vastec should not be administered to these subjects.
INTERACTIONS:
No drug interactions have been identified. However, concomitant administration of Vastec and other drugs should be monitored.
ADVERSE EFFECTS:
Nervous system disorders: dizziness, headache, Parkinson’s symptoms (tremors, slow and difficult movements, increased muscle tone), unsteady gait, restless leg syndrome, related movement disorders Other important, usually reversible after taking medications, Sleep disturbances (insomnia, drowsiness)
Cardiac disorders: palpitations, palpitations, extrasystoles, tachycardia
Vascular disorders: arterial hypotension, orthostatic hypotension, which can lead to irritability, dizziness, or fall, especially in patients on antihypertensive drugs, flushing
Gastrointestinal disturbances: Abdominal pain, diarrhea, indigestion, nausea and vomiting, constipation
Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, Provincial generalized pyoderma (AGEP), Angioedema Weakness
Systemic disorders and drug use: asthenia
Blood and lymphatic system disorders: Agranulocytosis, thrombocytopenia, thrombocytopenic purpura
Liver – Bile Disorders: Hepatitis
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
No documents have been reported.
DOSAGE & ADMINISTRATION:
The dose should be one tablet of 20 mg three times a day during meals.
Special populations:
Patients with renal impairment: In patients with moderate renal impairment (creatinine clearance [30-60] ml/ min), the recommended dose is 1 tablet of 20 mg twice daily, i.e., one in the morning and one in the evening during meals. (See more in Contraindications, Warnings and Cautions)
Elderly patients: Elderly patients may have increased trimetadizine exposure due to age-related decrease in renal function.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20 mg twice daily in the morning and evening during meals.
Dose titration in elderly patients should be exercised with caution. (See more in Contraindications, Warnings and Cautions)
Paediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
Or as prescribed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
COMPOSITION:
Piracetam …………………………………. 800 mg
Excipients q.s ……………………………. 1 caplet
(Croscarmellose sodium, magnesium stearate, aerosil, sepifilm LP770).
DOSAGE FORM: Film coated caplet.
PRESENTATION: Box of 3 blisters x 10 caplets.
Barcode:
PHARMACODYNAMICS:
Piracetam, a cyclic derivative of gamma-aminobutyric acid acts to improve learning ability and memory due to the effect on neurotransmitters including acetylcholine, noradrenaline, and dopamine. Piracetam can alter neurotransmission and improve the metabolic environment of neurons.
Piracetam experimentally acts to resist metabolic disorders associated with ischemia by enhancing brain resistance to hypoxic state. Piracetam also enhances the mobilization and consumption of glucose without depending on oxygen supply, facilitates glucose conversion into pentose and maintains the synthesis of cerebral energy.
In addition, piracetam reduces platelet aggregation and in the conditions where there is abnormal rigidity of red blood cells, piracetam can restore the ability to deform and pass the capillaries. The drug acts to resist myoclonus.
PHARMACOKINETICS:
Piracetam is rapidly and completely absorbed after oral administration. Bioavailability of piracetam is close to 100%. Plasma maximum concentrations are achieved after 30 minutes, and at 2-8 hours in cerebrospinal fluid. The absorption of piracetam is not affected in long-term therapy. Piracetam diffuses to all tissues and crosses both blood-brain and placental barrier. Piracetam highest concentrations were in the cerebral cortex, frontal, parietal and occipital lobes, in the cerebral cortex and in the basal ganglia. The half-life is 4-5 hours in blood and 6-8 hours in cerebrospinal fluid. The half-life is increased in renal insufficiency patients. Piracetam is eliminated unchanged via kidneys.
INDICATIONS:
Treatment of symptoms associated with dizziness, headache, and severe delirium.
Improvement in symptoms in the elderly suffering from memory decline, dizziness, a lack of concentration or of alertness, behaviour disorders, personal negligence, dementia.
Treatment of acute ischemia, alcoholism, sickle cell anemia.
Supportive treatment of dyslexia in children.
Supportive treatment of myoclonus of cortical origin.
CONTRAINDICATIONS:
Hepatic impairment, severe renal impairment. Huntington’s disease.
PRECAUTIONS:
Patients with renal impairment; the elderly.
PREGNANCY AND LACTATION:
Piracetam should not be administered to pregnant women and nursing mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Piracetam does not affect the capability of driving vehicles and operating machinery.
INTERACTIONS:
Piracetam interacts with CNS stimulants, thyroid hormones, and warfarin.
ADVERSE EFFECTS:
Common: General disorders: fatigue. Gastrointestinal tract disorders: nausea, vomiting, diarrhea, abdominal pains, dyspepsia. Nervous system disorders: anxiety, irritability, headache, insomnia, drowsiness.
Rare: General disorders: dizziness. Nervous system disorders: tremor, sexual arousal.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Piracetam is non-toxic even a very high dose. Special measures is not necessary in overdose.
DOSAGE & ADMINISTRATION:
Piracetam is used following oral administration.
Adults: 1 caplet x 3 times daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer’s.
Keep out of reach of children.
Read all of this leaflet carefully before you start taking this medicine.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredients:
Montelukast (as montelukast sodium) ……….………. 4 mg
Excipients: Mannitol, microcrystalline cellulose type 101, aspartame, red ferric oxide, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, strawberry-flavored powder, tutti fruiti flavor, povidone.
PHARMACEUTICAL FORM: Chewable tablet.
Product description: An oval, brownish orange, chewable tablet, plain on one side, a sign ┼ on the other, intact edges.
Barcode:
THERAPEUTIC INDICATIONS: Montelukast is indicated in the treatment of asthma as add-on therapy in those 2 to 5 years old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma.
Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 years old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.
Montelukast is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
Montelukast is indicated for the relief of symptoms of daytime and night-time allergic rhinitis (seasonal allergic rhinitis in adults and children who are at least 2 years old and perennial allergic rhinitis in adults and children who are at least 6 months old).
POSOLOGY AND METHOD OF ADMINISTRATION:
The tablets are to be chewed or ground before oral administration.
The dosage for paediatric patients 2 – 5 years of age is one 4 mg chewable tablet daily.
For asthma, motelukast should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and allergic rhinitis should take only one montelukast dose daily in the evening.
If taken in connection with food, montelukast should be taken 1 hour before or 2 hours after food.
General recommendations:
The therapeutic effect of montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking montelukast even if their asthma is under control, as well as during periods of worsening asthma.
No dosage adjustment is necessary for paediatric patients in each age group and each sex, for elderly patients, those with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment.
Therapy with montelukast in relation to other treatments for asthma:
Montelukast may be used in combination for patients are following other therapies. The combination dose should be reduced:
Bronchodilators: Montelukast can be added to therapy for patients who are not adequately controlled with bronchodilators only. When there is evidence of clinical response, usually after the first dose, the dose of bronchodilator may be reduced if tolerated.
Inhaled corticosteroids are used concurrently with montelukast to have more treatment benefits for patients receiving inhaled corticosteroids. The dose of corticosteroids may be reduced if tolerated. However, the dose of corticosteroids must be gradually reduced under medical supervision. Montelukast should not be abruptly substituted for inhaled corticosteroids.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
SPECIAL WARNING AND PRECAUTIONS FOR USE:
Patients should be advised that oral montelukast is not for the treatment of acute asthma attacks.
While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montekulast should not be abruptly substituted for inhaled or oral corticosteroids.
Neuropsychiatric events have been reports in patients taking montelukast. Patients and prescribers should be discussed about the neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur.
Some events have been sometimes associated with the reduction of systemic corticosteroid therapy in patients taking other anti-asthma medications, including leukotriene receptor antagonists. They include eosinophilia, rash, shortness of breath, cardiac complications and/or neuropathy, presenting with Churg-Strauss syndrome, a systemic vasculitis associated with eosinophilia. A causal association with leukotriene receptor antagonists has not been established, caution and closely clinical monitor should be exercised when reducing systemic corticosteroids dose in patients taking montelukast.
The drug contains aspartame, a source of phenylalanine. Patients with phenylketonuria should not take this medicine.
USE IN PREGNANCY AND LACTATION:
There are no adequate and well-controlled studies in pregnant women. Montelukast may be used during pregnancy only if clearly needed.
It is not known if montelukast is excreted in human milk. It is used with caution in breast-feeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
No evidence shows that the drug affects the ability to drive and use machines.
INTERACTIONS:
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma and allergic rhinitis. In drug-interactions studies, the recommended dose of montelukast did not have important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisolone, oral contraceptives (ethinyl oestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4 such as phenytoin, phenobarbital and rifampicin.
In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolised by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolised by this enzyme (eg., paclitaxel, rosiglitazone, and repaglinide).
UNDESIRABLE EFFECTS:
Adverse reactions reported in post-marketing use are recorded by frequency and system organ class.
Very common (ADR ≥ 1/ 10)
Infections: upper respiratory infection.
Common (1/ 100 ≤ ADR <1/ 10)
Gastrointestinal disorders: diarrhoea, nausea, vomiting. Skin and subcutaneous tissue disorders: rash. Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST). General disorders and administration site conditions: fever.
Uncommon (1/ 1 000 ≤ ADR <1/ 100)
Immune system disorders: hypersensitivity reactions. Psychiatric disorders: agitation including aggressive behaviour or hostility, anxiety, depression, disorientation, illusion, insomnia, excitement. Nervous system disorders: dizziness, drowsiness, paraesthesia. Respiratory, thoracic and mediastinal disorders: epistaxis. Gastrointestinal disorders: dry mouth, dyspepsia. Skin and subcutaneous tissue disorders: bruising, urticaria, pruritus. Musculoskeletal and connective tissue disorders: arthralgia, myalgia. General disorders and administration site conditions: asthenia, fatigue, oedema.
Rare (1/ 10 000 ≤ ADR <1/ 1 000)
Blood and lymphatic system disorders: increased bleeding tendency. Psychiatric disorders: disturbance in attention, memory impairment. Cardiac disorders: palpitations. Skin and subcutaneous tissue disorders: angioedema.
Very rare (ADR < 1/ 10 000)
Immune system disorders: hepatic eosinophilic infiltration. Psychiatric disorders: hallucinations, disorientation, suicidal thinking and behaviour (suicidality). Respiratory, thoracic and mediastinal disorders: Churg-Strauss Syndrome (CSS), pulmonary eosinophilia. Hepatobiliary disorders: hepatitis. Skin and subcutaneous tissue disorders: erythema nodosum, erythema multiforme.
Please inform your physician of all adverse effects upon drug administration.
OVERDOSE:
No specific information is available on the treatment of overdose with montelukast. There were no adverse experiences in the majority of overdose reports. The most frequently occurring adverse experiences included somnolence, abdominal pain, thirst, headache, vomiting, and psychomotor hyperactivity. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.
PHARMACODYNAMICS:
ATC Code: R03D C03
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT). CysLT1 is found in the human airway. In asthma, leukotriene-medicated effects include airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal musosa after allergen exposure and are associated with symptoms of allergic rhinitis. CysLT in nose increases in airway resistance and symptoms of nasal obstruction.
Montelukast has an anti-inflammatory property. Montelukast strongly inhibits physiologic actions of LTC4, LTD4, LTE4 at the CysLT1; so it reduces the symptoms of asthma and allergic rhinitis. In asthmatics, montelukast causes bronchiectasis in 2 hours after ingestion.
PHARMACOKINETICS:
Montelukast is rapidly absorbed following oral administration. Food did not clinically affect when taking the drug for a long time. After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in the fasted state, Cmax is achieved 2 hours after administration. Montelukast is more than 99% bound to plasma proteins. Montelukast is extensively metabolized. Montelukast and its metabolites are excreted almost exclusively via the bile. The mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults.
PRESENTATION:
Box of 3 blisters x 10 chewable tablets.
SHELF-LIFE: 36 months from the manufacturing date.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SPECIFICATIONS: Manufacturer’s.
See more products
Japan-GMP is the Japanese Good Manufacturing Practice standard. In Japan, Japan-GMP has been established since 1974 and came into force in 1975, before EU-GMP (1989), and is constantly being updated to increase difficulty.
Japan-GMP is directly certified by Japan Medicines and Medical Devices Agency (PMDA). The agency is under the Ministry of Health, Labour and Welfare of Japan (MHLW).
In theory, Japan-GMP is equivalent to PIC/S-GMP of PIC/S, EU-GMP of Europe, CGMP-USA of the United States, etc. However, according to Pacific Bridge Medical (PBM), in fact, Japan-GMP often requires stricter quality control and assurance than western countries.
In December, 2020 in Can Tho, an announcement ceremony of JAPAN GMP certification for DHG Pharma’s medicine production line was held respectfully. Attending the ceremony were leaders of Can Tho City Department of Health, leaders of Mekong Delta hospitals, close customers, DHG Pharma’s leaders and employees.
