FAMOPSIN 20mg Film-coated tablet Ref.[28193] Active ingredients: Famotidine

Gastric neoplasm

Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with famotidine. Symptomatic response of gastric ulcer to famotidine therapy does not preclude the presence of gastric malignancy.

Renal impairments

Since famotidine is excreted primarily by the kidney, caution should be observed in patients with impaired renal function. A reduction in daily dosage should be considered if creatinine clearance falls below 30 ml/min (see section 4.2).

General

In case of long-term treatment with high dosage, monitoring of blood count and liver function is recommended.

In case of long-standing ulcer disease, abrupt withdrawal after symptom relief should be avoided.

In patients with duodenal and benign gastric ulcers the H. pylori-status should be determined. For H. pylori-positive patients removal of the bacterium H. pylori by means of eradication therapy should be striven for whenever possible.

Elderly

When famotidine was administered to elderly patients in clinical trials, no increase in the incidence or change in the type of drug-related side effects was observed. No dosage adjustment is required based on age alone.

This medicinal product contains lactose and therefore should not be used by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

No drug interactions of clinical importance have been identified.

Famotidine does not interact with the cytochrome P450-linked drug metabolizing enzyme system. Compounds metabolized by this system which have been tested in man have included warfarin, theophylline, phenytoin, diazepam, propranolol, aminopyrine and antipyrine. Indocyanine green as an index of hepatic blood flow and/or hepatic drug extraction has been tested and no significant effects have been found.

Studies in patients stabilized on phenprocoumon therapy have shown no pharmacokinetic interaction with famotidine and no effect on the pharmacokinetic or anticoagulant activity of phenprocoumon.

In addition, studies with famotidine have shown no augmentation of expected blood alcohol levels resulting from alcohol ingestion.

Alterations of gastric pH may affect the bioavailability of certain drugs resulting in an altered absorption.

The absorption of ketoconazole and itraconazole could be reduced. Ketoconazole should be given 2 hours before famotidine administration.

Antacids may decrease the absorption of famotidine and lead to lower plasma concentrations of famotidine. Famotidine should therefore be taken 1 – 2 hours before the application of an antacid.

The administration of probenecid can delay the elimination of famotidine.

Concomitant use of probenecid and Famotidine should therefore be avoided.

The concomitant use of sucralfate should be avoided within two hours of the famotidine dose.

If famotidine, atazanavir and ritonavir are co-administered, a dose of 20 mg famotidine should not be exceeded. If a higher dose of famotidine is required (e.g. famotidine 40 mg) dose adjustment of atazanavir and ritonavir may be considered. Co-administration of famotidine, atazanavir, ritonavir and tenofovir should be avoided. If the combination of famotidine, atazanavir, ritonavir and tenofovir is judged unavoidable, close clinical monitoring is recommended.

Risk of loss of efficacy of calcium carbonate when co-administered as phosphate binder with famotidine in haemodialysis patients.

Pregnancy

Famotidine is not recommended for use in pregnancy, and should be prescribed only if clearly needed. Before a decision is made to use famotidine during pregnancy, the physician should weigh the potential benefits from the drug against the possible risks involved.

Breast-feeding

Famotidine is detectable in human milk. Nursing mothers should either stop this drug or stop nursing.

Some patients have experienced adverse reactions such as dizziness and headache while taking famotidine. Patients should be informed that they should avoid driving vehicles or operating machinery or doing activities which require prompt vigilance if they experience these symptoms (see section 4.8).

Tabulated list of adverse reactions

Frequencies are defined as common (≥1/100 to <1/10); uncommon (≥1/1.000 to <1/100); rare (≥1/10.000 to <1/1.000); very rare (<1/10.000), not known (cannot be estimated from the available data).

Adverse effects – causal relationship unknown

Rare cases of gynaecomastia, have been reported, however, in controlled clinical trials the incidences were not greater than those seen with placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 reporting system: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

Not applicable.