Famosan® 20 mg, 40 mg
coated tablets
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Famotidinum 20 mg or 40 mg in 1 coated tablet.
- Indication group:
- antiulceric agent, H2-receptor antagonist
The following information is for health professionals only.
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Characteristics:
Famotidine, an antagonist of histamine H2-receptors with high binding specificity, inhibits diurnal and nocturnal gastric secretion, both basal and stimulated. It thus produces a decrease in both acidity and volume of gastric juice. Famotidine exerts high efficacy and prolonged action. It does not interfere with cytochome P 450 and does not inhibit oxidative biotransformation of other drugs.
Indications:
Prophylaxis and therapy of peptic ulcers in all locations, reflux esophagititis, hyperacidity-associated conditions, gastropathy induced by nonsteroidal antirheumatic drugs (NSAID), some types of functional gastropathy, conditions associated with a risk of aspiration of acid gastric contents, support of substitution therapy with pancreatic enzymes in chronic pancreatitis.
Contraindications:
Hypersensitivity to the active ingredient; urgency of administration should be considered carefully during pregnancy, during lactation, and in children (because of lack of experience). Caution is necessary in patients with serious affections of the kidney and liver.
Undesirable effects:
Famotidine is relatively well tolerated. Headaches, dizziness, confusion in the elderly, dry mouth, nausea, flatulence, constipation, diarrhoea, loss of appetite, and allergic skin reactions can occasionally occur. Sporadically there is an increase in liver enzymes, leukopenia and thrombocytopenia. Cardiac arrhythmia was observed very rarely.
Interactions:
By decreasing the acidity of gastric contents, famotidine decreases absorption of ketokonazol and itrakonazol. Antacids decrease absorption of famotidine. For this reason they should be administered 1-2 hours after famotidine administration. Concomitant administration of the preparation Famosan® coated tablets and sucralfate or complex bismuth salts is not suitable (acid gastric medium is necessary for their optimal effect).
Caution:
Prior to the commencement of treatment of a peptic ulcer, it is necessary to exclude its malignant character! Famotidine (in contrast to cimetidine and ranitidine) does not decrease the activity of alcohol-dehydrogenase and thus it does not prolong the biological half-life of alcohol.
Dosage:
Peptic ulcer treatment: 20 mg 2 times a day (morning and evening), or 40 mg once a day at bedtime (usually for 4-6 weeks). Reflux esophagitis treatment: 20-40 mg 2 times a day for 2-3 months.
Prophylaxis of a relapsing peptic ulcer: 20 mg daily in the long term.
Prophylaxis of an ulcer produced by the action of NSAID: 20 mg 2 times a day, or 40 mg once a day at bedtime.
Prophylaxis of aspiration of acid gastric contents: 20-40 mg in the evening before operation.
Other indications: usually 20-40 mg once a day.
Dosage should be decreased in renal insufficiency (in the case of creatinine clearance below 30 ml/min, 20 mg a day are administered). Tablets are taken unchewed, and they should be sufficiently washed down.
Package:
20, 50 or 100 coated tablets of 20 mg,
10, 20, 50 or 100 coated tablets of 40 mg.
For greater details about the preparation see the product data summary.
Date of the latest revision of the text: March 19, 2003.
The preparation is available on medical prescription only.