ULCEDINE Film coated table Ref.[28024] Active ingredients: Famotidine

Symptoms associated with carcinoma of the stomach can be masked by treatment with a histamine H₂-antagonist, which may delay diagnosis of the carcinoma. If gastric ulcer is suspected, the possibility of malignancy must be excluded before initiating therapy.

As famotidine is excreted by the kidney, plasma levels of famotidine are elevated in patients with severe renal impairment, dose reduction is recommended in such cases (see section 4.2).

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Clinically important drug interactions have not been identified. Famotidine does not interact with the cytochrome P450 linked drug metabolising system. Aminopyrine, diazepam, phenazone, phenytoin, propranolol, theophylline and warfarin are metabolised by this system. Testing of indocyanine green as an index of hepatic blood flow or hepatic drug extraction showed no significant effects.

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

Pregnancy

Ulcedine is not recommended for use in pregnancy. It should be prescribed only if use is essential, and the physician should weigh the potential benefits against the potential risks.

Breast-feeding

Famotidine is excreted in breast milk. Patients who are breast feeding should either stop breast feeding or stop taking Ulcedine.

As dizziness, headaches or fatigue may occur, patients should make sure they are not affected before driving or operating machines.

Ulcedine is generally well tolerated.

The following adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); 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); Frequency not known (cannot be estimated from the available data).

Immune system disorders

Uncommon: anaphylaxis

Psychiatric disorders

Uncommon: reversible psychic disturbance (including depression, anxiety, agitation, confusion and hallucination), anorexia, fatigue.

Nervous system disorders

Rare: headache, dizziness.

Gastrointestinal disorders

Rare: diarrhoea and constipation have been reported.

Uncommon: dry mouth, nausea and/or vomiting, abdominal discomfort/distension, cholestatic jaundice, flatulence.

Skin and subcutaneous tissue disorders

Uncommon: rash, urticaria and pruritus, angioedema.

Very rare: In very rare cases, with H2 antagonists, toxic epidermal necrolysis has been reported, alopecia.

Musculoskeletal and connective tissue disorders

Uncommon: arthralgia, muscle cramps.

Reproductive system and breast disorders

Rare: Gynaecomastia has been reported rarely, in most cases it was reversible on therapy cessation.

Investigations

Uncommon: abnormalities of liver enzymes.

Pancytopenia, leucopenia and isolated cases of worsening existing hepatic disease have been reported, definitive causality with famotidine therapy has not been established.

There are no reports of clinically significant effects on endocrine or gonadal function.

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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.