Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Essential Generics Ltd
A02BA01
Cimetidine
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5050204101022
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 only. Do not pass it on to others. It may harm them, even if their symptoms 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. 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. CONTENTS OF THE PACK AND OTHER 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 Histamine H2 - receptor antagonists and is used as anti-ulcer drug. It works by reducing the amount of acid in your stomach. The tablets are used to treat and relieve the following conditions: • Ulcers in the stomach (gastric ulcer) and in upper part of the intestine (duodenum ulcer) • Recurrent or stomach ulcers (ulcers that keep coming back or which have occurred following stomach surgery). • Ulcers in the stomach or duodenum which may be caused by non-steroidal anti-inflammatory drugs (NSAIDs, often used to reduce pain, fever and inflammation) • Acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (oesophageal reflux). • Persistent heartburn and stomach pain. • Upper abdominal pain particularly after meals • Prevent of internal bleeding from ulcers caused by stress in seriously ill patients. • For patients at risk of acid inhalation before general anaesthesia particularly pregnant women during labour (Mendelson's syndrome) Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimetidine 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains cimetidine Ph Eur 200 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale green, circular, biconvex, film-coated tablet embossed with the company logo on one face and the code ‘274’ on the reverse, or plain on one side and embossed with ‘274’ or ‘CIM 200’ or ‘CIMET 200’ on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cimetidine is a histamine H 2 -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 2.4 g. 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 Perskaitykite visą dokumentą