Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Teva UK Ltd
A02BA01
Cimetidine
800mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5017007011163
PATIENT INFORMATION LEAFLET CIMETIDINE 200MG, 400MG AND 800MG TABLETS 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 FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR 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 SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECT NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET 1. What Cimetidine is and what it is used for 2. Before you take Cimetidine. 3. How to take Cimetidine 4. Possible side effects 5. How to store Cimetidine 6. Further information 1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR The name of your medicine is Cimetidine Tablets. Cimetidine belongs to a group of medicines known as histamine H 2 receptor agonists. They work by reducing the amount of acid produced by your stomach (gastric acid). Acid plays a part in ulcer disease and the uncomfortable condition known as heartburn. Reducing the amount of acid produced can help ulcers to heal and give relief where gastric acid is causing discomfort. Cimetidine Tablets are used to: Treat and relieve the symptoms of stomach/duodenal ulcers Treat and relieve Zollinger-Ellison syndrome (excessive secretion of acid by the stomach) Treat and relieve ulceration of the oesophagus (gullet) caused by reflux of gastric juices Prevent the recurrence of stomach/duodenal ulcers. Treat or prevent ulcers caused by medicines such as non-steroidal anti- inflammatory drugs (NSAIDs), which are used to treat conditions such as arthritis. If you are taking this type of medicine, your doctor may prescribe Cimetidine Tablets for you to try to keep you free of ulcers. Improve absorption of food and reduce fluid loss in short bowel syndrome Prevent acid coming up the oesophagus (gullet) before an anaesthetic 2. BEFORE YOU TAKE CIMETIDINE DO NOT TAKE CIMETIDINE IF Y Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimetidine 800 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cimetidine Ph Eur 800 mg. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets. Pale green, oval, film-coated tablet embossed with the company logo on one face and the code ‘276’ on the reverse, or plain on one side and embossed with ‘276’ or ‘CIM 800’ or ‘CIMET 800’ 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 single Lire le document complet