FAMOTIDINE

Posology Adults Duodenal ulcers - The initial recommended dose is 40 mg of famotidine to be taken at night. Healing generally occurs in most patients within 4 weeks. This period, however, may be shortened if an endoscopic examination reveals that the ulcer has healed.

However, in those patients whose ulcers have not healed within this 4 week period, treatment should continue for a further 4 weeks. Prevention of relapses of duodenal ulceration – To prevent ulcers from reoccurring the recommended dose is 20 mg of famotidine to be taken at night Benign gastric ulcers – The recommended dose of 40 mg of famotidine to be taken at night.

Treatment should continue for between 4-8 weeks unless earlier healing is revealed by endoscopy. Zollinger-Ellison syndrome – Patients who are not receiving any antisecretory therapy should be started on a dose of 20 mg of famotidine every 6 hours.

The dosage should then be adjusted to individual response. Doses up to 800 mg daily have been used up to one year without the development of significant adverse effects or tachyphylaxis. If the desired inhibition of acid secretion cannot be attained with a daily dosage of 800 mg, alternative treatment should be considered to regulate acid secretion, since no long term experience with dosages of more than 800 mg of famotidine/day have been recorded.

Treatment should be continued for as long as necessary. Patients who have been receiving other H2-receptor antagonist treatment may be switched directly to famotidine treatment at a higher dosage than the initial dosage that is usually recommended.

The starting dosage will depend on the severity of the disease and the dosage of the last dose of H2-antagonist previously used. Symptomatic treatment of mild to moderate oesophagitis – The recommended dose in case of mild oesophagitis is 20 mg of famotidine twice daily, in case of mild to moderate oesophagitis the recommended dose is 40 mg twice daily.

Generally treatment should be conducted for 6 weeks. If the condition has not improved, treatment should be continued for a further 6 weeks. Elderly The dosage regimen recommended for elderly patients is the same as for adults. Use in impaired renal function.

Famotidine is primarily eliminated via the kidneys. For patients with impaired renal function in whom creatinine clearance is less than 30ml/min, the daily dosage of famotidine should be reduced by 50%. Caution is advised in patients with renal impairment.

Dialysis patients should also take dosages that are reduced by 50%. Famotidine 20 mg tablets should be administered at the end of dialysis or thereafter since some of the active ingredient is removed via dialysis. Paediatric population The efficacy and safety of famotidine in children have not been established.

Method of administration For oral use. 2).

Famotidine has been demonstrated to be generally well-tolerated. Adverse reactions are ranked under the heading of frequency, the most frequent first, 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), including isolated cases and 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 System Organ Class Common Uncommon Rare Very rare Psychiatric disorders reversible psychological disturbances including depression, anxiety disorders, agitation, disorientation, confusion, hallucinations, insomnia, reduced libido Nervous system disorders headache, dizziness Taste disorder convulsions, grand mal seizures (particularly in patients with impaired renal function), paresthesia, somnolence Cardiac disorders Atrioventricular block with H2- receptor antagonists administered intravenously, arrhythmias, QT prolongation (especially in patients with impaired renal function) Respiratory, thoracic and mediastinal disorders interstitial pneumonia sometimes fatal Gastrointestinal disorders constipation, diarrhoea dry mouth, nausea and/or vomiting, abdominal discomfort or distension, flatulence, Hepatobiliary disorders liver enzyme abnormalities, hepatitis, cholestatic jaundice.

Isolated cases of worsening of existing hepatic disease. System Organ Class Common Uncommon Rare Very rare 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.

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 The presence of gastric malignancy should be excluded prior to the use of famotidine for the treatment of gastric ulcers. Symptomatic response of gastric ulcer following treatment with famotidine do not preclude the presence of gastric malignancy.

Renal dysfunction As famotidine is excreted primarily via the kidney, caution should be exercised when treating patients who are suffering from impaired renal function. 2). Paediatric population The safety and efficacy for the use of famotidine in children has not been established.

Use in the 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.

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.

1 or to other H2-receptor antagonists. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H2- receptor antagonists.