Famosan 10 mg

Basic information

Composition

Famotidinum 10 mg in 1 coated tablet

Pharmacotherapeutic group

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

Therapeutic indications

The drug is used for the short-term and symptomatic treatment of heartburn, gastric hyperacidity, and nausea. It can be taken by adults over 18 years of age without consulting a physician. Children under 16 years of age may take the drug only if recommended by a physician.

Pharmacological properties

Famotidine, a histamine H2-receptor antagonist 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 shows high efficacy and prolonged action. It does not interfere with cytochrome P-450, 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

Unless a physician recommends otherwise, adults usually take 1 tablet in case of complaints. This dose should bring relief for a period of about 9 hours. In the course of 24 hours, two tablets may be taken. Tablets are swallowed unchewed with sufficient fluid.

Contraindications

Hypersensitivity to famotidine and other H2-receptor antagonists, malignant nature of ulcer disease, children under 16 years of age (due to lack of experience), lactation. Therapeutic urgency should be considered during pregnancy, caution is required in patients with severe renal and hepatic impairment.

Interactions

Clinically relevant negative interactions with other drugs are not known. Famotidine affects neither the absorption of other drugs in the intestine nor their enzymatic biotransformation in the liver. By decreasing the acidity of gastric contents, H2-receptor antagonists decrease the absorption of ketoconazole and itraconazole. Famotidine should therefore be administered at least 2 hours after the administration of these drugs. Antacids (magnesium hydroxide and aluminum hydroxide) decrease the absorption of famotidine. For this reason they should be administered 1–2 hours after the administration of famotidine.

Undesirable effects

Famotidine is very well tolerated. Occasionally, headaches, vertigo, dry mouth, nausea, flatulence, constipation, diarrhoea, loss of appetite, allergic skin reactions may occur. Sporadically, there may be an increase in liver enzymes, leucopenia and thrombocytopenia.

Special warnings and precautions for use

Therapy should not exceed 5 days without consulting a physician. Patients with diagnosed ulcer disease, severe renal or hepatic disorders, middle-aged and elderly patients who have suffered indigestion-related weight loss (dyspeptic syndrome), swallowing difficulties and patients concomitantly using other medicinal products must consult a physician regarding the suitability of use of this product. As Famosan contains lactose, is not suitable for patients with Lapp-lactase deficiency or glucose and galactose malabsorption.

Availability

The medicinal product is sold over the counter and is not covered by health insurance.

Contents of container

10 coated tablets

Package available in the Czech Republic

10 coated tablets

SPC and PIL

Detailed information

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

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

1 March 2021

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