Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to famotidine or to any of the excipients listed in section 6.1.
Since cross-sensitivity has been documented in this class, Ulceran should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
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 (less than 10 ml/min), dose reduction is recommended in such cases, see section 4.2.
Ulceran tablets contains lactose.
Patients with rare hereditary problems of galactose intolerance, 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, antipyrine 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.
Ulceran 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.
Famotidine is excreted in breast milk. Patients who are breast feeding should either stop breast feeding or stop taking Ulceran.
As dizziness, headaches or fatigue may occur, patients should make sure they are not affected before driving or operating machines.
Ulceran is generally well tolerated.
The adverse reactions are displayed by 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) and not known (frequency cannot be estimated from the available data).
Rare: headache, dizziness.
Very rare: depression, anxiety, agitation, confusion and hallucination.
Very rare: arthralgia, muscle cramps.
Uncommon: flatulence.
Rare: diarrhoea, constipation.
Very rare: dry mouth, nausea and/or vomiting, abdominal discomfort/distension.
Very rare: abnormalities of liver enzymes, cholestatic jaundice.
Not known: worsening existing hepatic disease.
Very rare: pancytopenia, leucopoenia, thrombocytopenia, agranulocytosis.
Very rare: anorexia, fatigue.
Very rare: A-V block.
Rare: gynecomastia.
Very rare: anaphylaxis, angioedema.
Very rare: rash, urticarial, pruritus, toxic epidermal necrolysis, alopecia,
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.
None known.
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