Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CIMETIDINE
MILRIN PHARMACEUTICAL CO. (M) SDN BHD
CIMETIDINE
1000Tablet Tablets
ASIAN PHARM LTD PART
DUOTRIC FILM COATED TABLET Cimetidine (200mg, 400mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Duotric is used for 2. How Duotric works 3. Before you use Duotric 4. How to use Duotric 5. While you are using it 6. Side effects 7. Storage and Disposal of Duotric 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DUOTRIC IS USED FOR Duotric is used for • Treatment of ulcer in upper part of the intestine (duodenal ulcer). • Prevention of duodenal ulcer and its recurrence. • Treatment of acid reflux in which the acidic content of the stomach flows back up into your food pipe. • Treatment of high gastric acid production conditions such as Zollinger-Ellison Syndrome. HOW DUOTRIC WORKS Duotric contain cimetine. Cimetidine belongs to a group of medicine called H2-receptor antagonist which act to suppress the secretion of gastric acid. BEFORE YOU USE DUOTRIC - _When you must not use it _ Do not take Duotric if you are allergic to cimetidine or any of the ingredients in this medicine. _ _ - _Before you start use it _ Tell your doctor if: • You have history of stomach, small intestine or food pipe ulcer. • You are pregnant or breastfeeding as cimetidine is secreted in human milk. • You have kidney or liver disease • You have gradual decrease in brain function • You have stomach cancer - _Taking other medicines _ Tell your doctor if you are taking • Warfarin-type anticoagulant (used to treat blood clots) • Phenytoin (used to treat seizures). • Propranolol, nifedipine (used to treat high blood pressure). • Chlordiazepoxide, diazepam (used to treat anxiety and alcohol withdrawal). • Certain tricyclic antidepressants. • Lidocaine (used to reduce pain or discomfort during medical procedures). • Theophylline (used to treat lung disease). • Metronidazole (antibiotic). • Any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE DUOTRIC - Прочетете целия документ
PACKAGE INSERT PACKAGE INSERT DUOTRIC FILM COATED TABLET 200MG DUOTRIC FILM COATED TABLET 400MG 1. NAME(S) AND STRENGTH OF ACTIVE INGREDIENT(S): DUOTRIC FILM COATED TABLET 200MG : Each tablet contains Cimetidine 200mg DUOTRIC FILM COATED TABLET 400MG : Each tablet contains Cimetidine 400mg 2. DOSAGE FORM: Film coated tablet. 3. DESCRIPTION: DUOTRIC FILM COATED TABLET 200MG Light-green, circular, biconvex,film-coated tablet with a central division line on one side. DUOTRIC FILM COATED TABLET 400MG Light green, oblong, biconvex, film-coated tablets with “ASP-400” imprinted on one side. 4. PHARMACODYNAMICS: ‘Duotric’ is a reversible competitive antagonist of the action of histamine that are extended on H 2 receptors. It markedly reduces the volume and concentration of gastric acid secreted in the fasting state and after stimulation by food, histamine, pentagastrin, insulin, 2 deoxyglucose, bethanecol and caffeine. By suppressing the secretion of gastric acid it creates a local environment that favours the spontaneous healing of the ulcer. It also make life more comfortable for the duodenal ulcer patient by relieving him/her of the nocturnal and sleep-disturbing pains that otherwise occur when hydrochloric acid secreted in response to a lack of food in the stomach, passes into the ulcerated duodenum. It is certainly a more effective curative agent than carbonoxolone and would become a most useful drug for the treatment of peptic ulcer. Controlled and uncontrolled studies in hospitalised and outpatients reveal that when cimetidine was given in a dosage of 0.82g daily for six weeks, 70-90% of patients with duodenal ulcer and 70-100% of patients with gastric ulcer experienced healing: in comparison, beneficial effects were observed in 30-70% of the ambulatory control patients and in almost 80% of the hospitalised control patients with duodenal and gastric ulcer. In most instances, these results were confirmed by direct endoscopic visualisation. 5. PHARMACOKINETICS: ‘Duotric’ is absorbed mostly from the small Прочетете целия документ