Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Kent Pharma (UK) Ltd
A02BA01
Cimetidine
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
CIMETIDINE 200MG, 400MG AND 800MG TABLETS 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, pharmacist or nurse • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cimetidine is and what it is used for 2. What you need to know before you take Cimetidine 3. How to take Cimetidine 4. Possible side effects 5. How to store Cimetidine 6. Contents of the pack and other information 1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR The name of your medicine is Cimetidine 200mg Tablets Cimetidine 400mg Tablets or Cimetidine 800mg Tablets (all called Cimetidine in this leaflet). Cimetidine belongs to a group of medicines called “H2 antagonists”. Cimetidine works by lowering the amount of acid in your stomach. It can be used for the following: • To treat or prevent ulcers in your stomach and duodenum (the part of the gut the stomach empties into) • An inflamed food pipe (oesophagitis) where stomach acid has travelled up into your food pipe (acid reflux disease) • To prevent ulcers from bleeding in seriously ill people • The management of Zollinger-Ellison Syndrome. This is a problem with your pancreas where too much acid in the stomach can cause ulcers in your stomach, duodenum, gut and food pipe • The management of short bowel syndrome. This is where some parts of your bowel either do not work or have been removed • If your pancreas does not work and you are taking enzyme supplements to help you digest your food • For people at risk of breathing in acid from their stomach (aspiration). This might happen during an operation with a general anaesthetic Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimetidine 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cimetidine tablets contain 200mg of the active ingredient Cimetidine USP 3 PHARMACEUTICAL FORM Tablet. Cimetidine 200 mg Tablets are green round film coated tablets coded CIM on one side and 200 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 day (1 .6g Read the complete document