Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
FAMOTIDINE
Merck Sharp and Dohme Limited
FAMOTIDINE
40 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-02-01
PROPOSED PIL TEXT Mar 2013 Type II SPC 1 PACKAGE LEAFLET: INFORMATION FOR THE USER PEPCID ® 20 mg Film-coated Tablets PEPCID ® 40 mg Film-coated Tablets (FAMOTIDINE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Pepcid is and what it is used for 2. Before you take Pepcid 3. How to take Pepcid 4. Possible side effects 5. How to store Pepcid 6. Further information 1. WHAT PEPCID IS AND WHAT IT IS USED FOR Pepcid contains a medicine called famotidine (either 20 mg or 40 mg). This belongs to a group of medicines called ‘H 2 -blockers’. Pepcid works by lowering the amount of acid you produce in your stomach. Pepcid is used for: • preventing ulcers in your stomach (gastric ulcer) or the first part of your intestine (duodenal ulcer) • healing ulcers and to give you relief from symptoms. Pepcid may also be used to lower the chance that your duodenal ulcer will come back • treating ‘gastro-oesophageal reflux disease’ (GORD) caused by stomach acid and food from your stomach going back up into your food pipe (oesophagus), or for preventing the symptoms from coming back • ‘Zollinger-Ellison syndrome’ where your stomach produces too much acid. Talk to your doctor if you Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pepcid 40 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg of famotidine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Brown, round-cornered, square tablets, engraved ‘MSD 964’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duodenal ulcer. Prevention of relapses of duodenal ulceration. Benign gastric ulcer. Hypersecretory conditions such as Zollinger -Ellison syndrome. Healing of oesophageal erosion or ulceration associated with gastro -oesophageal reflux disease. Symptomatic relief of gastro -oesophageal reflux disease. Prevention of relapse of symptoms and erosions or ulcerations associated with gastro -oesophageal reflux disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is unnecessary to time the dose in relation to meals: bioavailability is not clinically affected by food in the stomach. In all cases the clinical response of the patient should be taken into consideration. In benign gastric and duodenal ulceration, the dose of ‘Pepcid’ is one 40 mg tablet at night. _Duodenal ulcer_ The recommended initial dose is one 40 mg tablet of ‘Pepcid’ at night. Treatment should continue for four to eight weeks. In most patients, healing occurs on this regimen within four weeks. In those patients whose ulcers have not healed completely after four weeks, a further four -week period of treatment is recommended. _Maintenance therapy_: For preventing the recurrence of duodenal ulceration, the reduced dose of 20 mg of ‘Pepcid’ at night is recommended. This 20 mg maintenance dose has been continued effectively in clinical studies for 12 months. IRISH MEDICINES BOARD ______________________ Soma hati kamili