Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Famotidine
Viatris UK Healthcare Ltd
A02BA03
Famotidine
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FAMOTIDINE 20 MG FILM-COATED TABLETS FAMOTIDINE 40 MG FILM-COATED TABLETS famotidine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Famotidine is and what it is used for 2. What you need to know before you take Famotidine 3. How to take Famotidine 4. Possible side effects 5. How to store Famotidine 6. Contents of the pack and other information 1. WHAT FAMOTIDINE IS AND WHAT IT IS USED FOR Famotidine belongs to a group of medicines called histamine (H 2 ) antagonists or anti-ulcer medicines. These anti-ulcer medicines control the levels of acid in the stomach. Famotidine can lower the amount of acid you produce in your stomach. Famotidine can be used for the following: • To help treat non-cancerous stomach ulcers and ulcers in the first part of your intestine (duodenal ulcers) • To help prevent the return of ulcers in the first part of the intestine • To help treat Zollinger-Ellison syndrome (with a condition caused by too much stomach acid) • To help treat acid reflux (burning pain caused by stomach acid escaping back up the food pipe) and the symptoms of an inflamed food pipe (oesophagitis) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMOTIDINE DO NOT TAKE FAMOTIDINE IF: • you are allergic to famotidine or any of the ingredients of this medicine (listed in section 6) or to any other medicines called H 2 antagonists WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Famotidine if: • you have kid Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Famotidine 20 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg famotidine Excipient with known effect: Each tablet contains 3.42 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablet White, film coated, D shaped, biconvex tablets marked with ‘G’ on one side and ‘FD/20’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Famotidine tablets are indicated for the following conditions; Duodenal ulcers Prevention of relapses of duodenal ulceration Benign gastric ulcers Zollinger-Ellison syndrome Symptomatic treatment of mild to moderate reflux oesophagitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 2 _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 Read the complete document