Famosan 20 mg, Famosan 40 mg

Basic information

Composition

Famotidine 20 mg or 40 mg in 1 film-coated tablet

Pharmacotherapeutic group

Antiulcer agent, H2-receptor antagonist (ATC code: A02BA03)

Therapeutic indications

Prophylaxis and therapy of any pathological conditions associated with gastric hypersecretion and hyperacidity. Prophylaxis and therapy of peptic ulcers in all locations including acute (stress) ulcers induced by trauma, surgery, corticoid or nonsteroidal antirheumatic drug therapy. Other indications include Zollinger-Ellison syndrome, haemorrhagic gastropathy, reflux oesophagitis and functional gastropathy associated with hyperacidity and pyrosis. Famosan is an effective prophylaxis against bleeding from peptic lesions and before general anaesthesia in conditions associated with a risk of aspiration of acidic material. It also provides support in the treatment of acute pancreatitis.

Pharmacological properties

Famotidine, a histamine H2-receptor antagonist with high binding specificity, inhibits both basal and stimulated diurnal and nocturnal gastric secretion. It thus produces a decrease in both the acidity and volume of gastric juice. Famotidine shows high efficacy and prolonged action. It does not interfere with cytochrome P450, does not inhibit the oxidative biotransformation of other drugs and does not reduce alcohol dehydrogenase activity.

Pharmaceutical form

Coated tablets

More information

Posology and method of administration

Peptic or duodenum ulcer: 20 mg twice daily (morning and evening) or 40 mg once daily at bedtime (for 4–8 weeks).

Prophylaxis against a relapsing peptic ulcer: 20–40 mg once daily at bedtime.

Zollinger-Ellison syndrome: 20–40 mg every 6 hours. Maximum total daily dose must not exceed 480 mg.

Other indications specified: 20 mg twice daily (morning and evening) or 40 mg once daily at bedtime.

Tablets are swallowed unchewed and should be washed down with sufficient fluid.

Contraindications

Hypersensitivity to famotidine, to other H2-receptor antagonists or any of the excipients. Not suitable for lactating or pregnant women.

Interactions

There are no known clinically significant negative interactions with other drugs. Because antacid may reduce the absorption of famotidine, it should be administered 1–2 hours before the administration of antacid. Sucralfate should not be administered within 2 hours after administering famotidine. Concomitant administration of ketoconazole and itraconazole with famotidine may reduce their absorption. Ketoconazole should be administered 2 hours before administering famotidine.

Undesirable effects

Famotidine is very well tolerated. Headache, fatigue, constipation, diarrhoea, dizziness, loss of appetite, dry mouth, nausea and vomiting, mental disorders, cramps, increases in transaminase and bilirubin levels, and decreases in white blood cell and platelet counts do appear.

Special warnings and precautions for use

Before starting treatment for a peptic ulcer, it is necessary to rule out its malignant character. In case of renal insufficiency (creatinine clearance under 10 ml/min), the dose should be reduced. Safety and efficacy in children has not been determined.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

20, 50, 100 and 500 film-coated tablets of 20 mg;

10, 20, 50, 100 and 500 film-coated tablets of 40 mg.

Package available in the Czech Republic

20, 50, 100 coated tablets of 20 mg;

20, 50, 100 coated tablets of 40 mg.

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

30 August 2018

Product images