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

Posology

Adults

Benign gastric ulcer

One 40mg tablet at night. Treatment should last four to eight weeks, unless endoscopy reveals complete healing earlier.

Duodenal ulcer

One 40mg tablet at night. Treatment should last four to eight weeks. Most patients experience healing within four weeks. If complete healing is not achieved at four weeks, a further four weeks of therapy is advised.

Prevention of reccurrence of duodenal ulcer (maintenance therapy)

One 20mg tablet at night.

Gastro-oesophageal reflux disease

One 20mg tablet twice a day, for six to twelve weeks. If associated with oesophageal erosion or ulceration, one 40mg tablet twice a day for six to twelve weeks.

Prevention of reccurrence of gastro-oesophageal reflux disease (maintenance therapy)

One 20mg tablet twice a day.

Zollinger-Ellison syndrome

Therapy-naive patients should be initiated on one 20mg tablet every six hours. The dosage should then be adjusted to the individual patient’s response. Daily doses of up to 800mg have been used without significant adverse effects or tachyphylaxis.

Patients transferring from another H₂ antagonist may be initiated at a higher starting dose, dependent upon the severity of the syndrome and the dose of the previously used H₂ antagonist.

Elderly

As previously recommended, but elderly patients are more likely to suffer from impaired renal function.

Impaired renal function

Famotidine is primarily excreted by the kidney, therefore caution should be observed in patients with impaired renal function. In those with severe renal impairment, creatinine clearance below 10ml/minute, dosage should be reduced to one 20mg tablet at night.

Paediatric population

Children

Not recommended.

Method of administration

Ulcedine film coated tablets are for oral administration only. They should be swallowed whole with a little water.

There has not been any report of overdosage. The procedure in such case is to remove unabsorbed material from the gastro-intestinal tract, clinically monitor the patient and therapy should be symptomatic and supportive.

Patients suffering from Zollinger-Ellison syndrome have tolerated a dosage of 800 mg daily for more than a year without the development of significant adverse effects.

5 years.

Store below 25°C, in original package, in order to protect from light.

Polyvinylchloride – aluminium blisters with a patient information leaflet in a carton.

Ulcedine 20mg is available in cartons of 30 and 100 tablets and Ulcedine 40mg in cartons of 20 and 100 tablets. For both strengths securitainers of 500 and 1000 tablets are also available.

Not all pack sizes may be marketed.

No special requirements for disposal.