Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cimetidine
Arrow Generics Ltd
A02BA01
Cimetidine
800mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY. This leaflet contains a summary of the information about your medicine, Cimetidine Tablets. YOUR MEDICINE Your medicine is in the form of a tablet. There are three strengths of Cimetidine Tablets available, 200 mg, 400 mg and 800 mg. The 200 mg tablet contains 200 mg of the active ingredient Cimetidine, whilst one 400 mg tablet contains 400 mg of active ingredient and one 800 mg tablet contains 800 mg of Cimetidine. Each tablet also contains sodium starch glycollate, povidone, magnesium stearate, purified water, microcrystalline cellulose (only found in 200 mg and 400 mg tablets), maize starch (only found in 200 mg and 400 mg tablets), E464, E171, E172, E132, polyethylene glycol, polyvinylpyrrolidone, hydroxypropylcellulose and carnauba wax. Cimetidine Tablets 200 mg are available in blister packs of 60 tablets. Cimetidine Tablets 400 mg are available in blister packs of 60 tablets. Cimetidine Tablets 800 mg are available in blister packs of 30 tablets. Your pharmacist will dispense the number of tablets prescribed by your doctor. Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Herts, EN6 1TL. HOW DOES YOUR MEDICINE WORK ? Your tablet contains Cimetidine, which helps to prevent the secretion of acid from the stomach. This means that these tablets can help treat conditions characterised by too much stomach acid, including ulcers of the small intestine, non-cancerous gastric (stomach) ulcers including those caused by non-steroidal anti-inflammatory drugs, recurrent ulcers and ulcers at the site of gastric surgery, reflux oesophagitis (burning pain in the gullet due to reflux of stomach acid). It can also help in the treatment of persistent dyspeptic (indigestion) symptoms with or without ulceration. Cimetidine can also help prevent bleeding from the stomach or duodenum due to stress ulcers in seriously ill patients; or prevent the aspiration of acid into the lungs in patients about to receive general anaest Прочетете целия документ
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 Прочетете целия документ