Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Medreich Plc
A02BA01
Cimetidine
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 05060292740423
PACKAGE LEAFLET: INFORMATION FOR THE USER CIMETIDINE 200 MG, 400 MG & 800 MG TABLETS (CIMETIDINE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE CIMETIDINE TABLETS 3. HOW TO TAKE CIMETIDINE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CIMETIDINE TABLETS 6. FURTHER INFORMATION 1. WHAT CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Cimetidine Tablets. It contains the active ingredient called Cimetidine. Cimetidine belongs to a group of medicines called H 2 - antagonists. It works by preventing your stomach from producing too much acid. The tablets are used to: • Treat and prevent ulcers in your stomach and the first part of your small intestine; • Prevent acid coming up your throat; • Prevent your stomach from producing too much acid which could cause pain and discomfort, such as heartburn, indigestion or dyspepsia; • Prevent acid coming up from the stomach during childbirth; • Prevent ulcers caused by stress; • Prevent bleeding from ulcers. • Prior to general anaesthetic in patients at risk from stomach acid being sucked into the air passages (Mendelson’s Syndrome), particularly pregnant patients during labour. • to reduce malabsorption and fluid loss in short bowel syndrome. You should ask your doctor if you are unsure why you have been given Cimetidine Tablets. 2. BEFORE YOU TAKE CIMETIDINE TABLETS DO NOT TAKE CIMETIDINE TABLETS IF YOU: • have an allergy to cimetidine, or any of the other ingredients listed at the end of this leaflet. YO Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimetidine 400mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cimetidine tablets contain 400 mg of the active ingredient Cimetidine USP 3 PHARMACEUTICAL FORM Tablet. Cimetidine 400 mg Tablets are green capsule shaped film coated tablets coded CIM on one side and 400 on 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 in the treatment duodenal and benign gastric ulceration including that associated with non-steroidal inflammatory agents recurrent and stomal ulceration, oesophageal reflux disease and other conditions where reduction of gastric acid by Cimetidine has been shown to be beneficial: persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients; before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson’s) syndrome, particularly obstetric patients during labour; to reduce malabsorption and fluid loss in the short bowel syndrome; and in pancreatic insufficiency to reduce degradation of enzyme supplements. Cimetidine is also recommended in the management of the Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 single daily dose of 800 mg at bedtime can be used. Other effective regimens are 200 mg three times a day with meals and 400 mg at bedtime (1.0 g/day) and, if inadequate, 400mg four times a Perskaitykite visą dokumentą