FAMOTIDINE

Posology Adults and the elderly Duodenal ulcers and benign gastric ulcers 40 mg of famotidine once before going to bed. Zollinger-Ellison syndrome If no preceding treatment with medicines which inhibit secretion has been conducted, the therapy of the Zollinger-Ellison syndrome should be initiated with 20 mg famotidine every 6 hours.

g. <10 mEq/h the hour before the next famotidine dose). If a dosage of 800 mg/d does not result in sufficient inhibition of acid secretion, an alternative therapy for the regulation of acid secretion should be considered, because there are no experiences with the long-term application of doses higher than 800 mg famotidine/d.

The therapy should be continued as long as it is clinically necessary. Patients who have been previously treated with other H2-receptor-antagonists can change immediately to a higher initial dose than that recommended for new patients.

The initial dose is dependent on the severity of the clinical picture and on the dose of medication taken prior to the change of medicine. Mild to moderate reflux oesophagitis In treating mild to moderate reflux oesophagitis, a twice daily dose of one 40 mg famotidine is recommended.

Renal impairment Famotidine is mainly excreted via the kidneys. 0 mg/100 ml) a reduction of the daily dose to 50% is recommended. For patients under dialysis a reduction of the daily dose to 50% is recommended as well. Famotidine 40 mg film-coated tablets should be given at the end or after dialysis, because part of the active ingredient will be removed in the course of dialysis.

Method and duration of administration Famotidine 40 mg Film-coated Tablets should be swallowed whole with some liquid. The film-coated tablets may be taken independently of meals. Duodenal ulcers and benign gastric ulcers The treatment of duodenal ulcers and benign gastric ulcers should be conducted for 4 to 8 weeks.

The period of time can be shorter if a healing of the ulcer can be endoscopically proved. In case the ulcers do not endoscopically heal after 4 weeks the treatment should be continued for another 4 weeks. Zollinger-Ellison syndrome The treatment should be continued as long as it is clinically necessary.

Mild to moderate reflux oesophagitis Generally, treatment should be conducted for 6 weeks. If 6 weeks treatment does not result in healing, treatment should be continued for another 6 weeks. Paediatric population The safety and efficacy of Famotidine 40 mg Film-coated Tablets in children has not been established.

Therefore, children should not be treated with Famotidine 40 mg Film-coated Tablets.

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).

System Organ Class Common Uncommon Rare Very rare Blood and lymphatic system disorders Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, pancytopenia Immune system disorders Hypersensitivity reactions (anaphylaxis, angioneurotic oedema, bronchospasm) Metabolism and nutrition disorders Anorexia Psychiatric disorders Reversible psychic disturbances including depression, anxiety disorders, agitation, disorientation, confusion, hallucinations, insomnia Nervous system disorders Headache, dizziness Convulsions, grand mal seizures (particularly in patients with impaired renal function), paresthesia, drowsiness, somnolence Respiratory, thoracic and mediastinal disorders Interstitial pneumonia sometimes fatal Gastrointestinal disorders Constipation, diarrhoea Dry mouth, nausea and/or vomiting, abdominal discomfort or distension, flatulence, dysgeusiaHepatobiliary disorders Liver enzyme abnormalities, hepatitis, cholestatic jaundice Skin and subcutaneous tissue disorders Rash, pruritus, urticaria Alopecia, Stevens Johnson syndrome/toxic epidermal necrolysis sometimes fatal Musculoskeletal and connective tissue disorders Arthralgia Muscle cramps Reproductive system and breast disorders Impotence, reduced libido General disorders and administration site conditions Fatigue Chest tightness Investigations Increase in laboratory values (transaminases , gamma-GT, alkaline phosphatase, bilirubin) 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 impairment Since famotidine is excreted primarily by the kidney, caution should be observed in patients with impaired renal function. 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.

1. • Patients with a history of hypersensitivity to other H2-receptor antagonists.