FAMOPSIN 40mg Film-coated tablet Ref.[28194] Active ingredients: Famotidine

Posology

Adults and the elderly

Duodenal ulcers and benign gastric ulcers

40 mg of famotidine once in the evening 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. For further treatment doses have to be adjusted according to the extent of acid secretion and the patient’s clinical response until acid secretion has been reduced to an acceptable level (e.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 daily dosage of twice 40 mg of famotidine (corresponding to two film-coated tablets of famotidine 40 mg film-coated tablets) is recommended.

Renal impairment

Famotidine is mainly excreted via the kidneys. In patients with impaired kidney function whose creatinine clearance amounts to less than 30 ml/min (serum creatinine above 3.0 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.

The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see section 4.8).

Patients with Zollinger-Ellison syndrome have tolerated doses up to 800 mg/day for more than a year without development of significant side effects.

The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

5 years.

Store below 25°C. Protect from light and moisture.

PVC/Aluminium blisters. Pack-sizes of 10, 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

No special requirements.