Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Sun Pharma UK Ltd
A02BA01
Cimetidine
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you. PL 15184/1640 Cimetidine 400mg Tablets Leaflet revision date: 27/03/19 Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you 5. HOW TO STORE CIMETIDINE TABLETS • KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. • Do not store above 25°C. • Store in the original package. • Do not take Cimetidine Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. • If your medicine becomes discoloured or shows any other signs of deterioration consult your pharmacist who will tell you what to do. • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT CIMETIDINE TABLETS CONTAIN • Each film-coated tablet contains 400mg of cimetidine • The other ingredients are lactose monohydrate, maize starch, povidone K30, sodium starch glycollate (Type A), colloidal anhydrous silica, magnesium Stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, quinoline yellow aluminium lake (E104), yellow iron oxide (E172) and indigo carmine. WHAT CIMETIDINE TABLETS LOOKS LIKE AND CONTENTS OF THE PACK Cimetidine Tablets are green capsule-shaped, biconvex, film coated tablet debossed CD on one side and plain on the other side. Each pack contains 60 film-coated tablets. MANUFACTURER AND LICENCE HOLDER This medicine is manufactured by Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. • Ac Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimetidine 400 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cimetidine Ph Eur 400 mg. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Pale green, oblong, film-coated tablet embossed with the company logo on one face and the code ‘275’ on the reverse, or plain on one side and embossed with ‘275’ or ‘CIM 400’ or ‘CIMET 400’ on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cimetidine is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output. Cimetidine is indicated for the following: 1. In the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents Recurrent and stomal ulceration and oesophageal reflux disease, and other conditions where reduction of gastric acid by cimetidine has been shown to be beneficial. 2. In the treatment of persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents. 3. In the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in critically ill patients. 4. Before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson´s) syndrome, particularly obstetric patients during labour. 5. To reduce malabsorption and fluid loss in short bowel syndrome. 6. To reduce degradation of enzyme supplements in pancreatic insufficiency. 7. In the management of Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The total daily dose should not normally exceed 2.4g. Dosage should be reduced in patients with impaired renal function. (see section 4.4). _Adults_ The usual dosage is 400 mg twice a day with breakfast and at bedtime. Alternatively for patients with duodenal or benign gastric ulceration, a sing Lestu allt skjalið