Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CIMETIDINE
KOTRA PHARMA (M) SDN. BHD.
CIMETIDINE
100 ml mL; 60 ml mL
KOTRA PHARMA (M) SDN. BHD.
AXCEL CIMETIDINE-200 SUSPENSION Cimetidine (200mg/5ml) _ _ 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Axcel Cimetidine-200 Suspension is used for. 2. How Axcel Cimetidine-200 Suspension works. 3. Before you use Axcel Cimetidine-200 Suspension. 4. How to use Axcel Cimetidine- 200 Suspension. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Cimetidine-200 Suspension. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL CIMETIDINE-200 SUSPENSION IS USED FOR Axcel Cimetidine-200 Suspension is used to treat: • Active ulcers in the stomach and intestine and recurrent ulceration. • Persistent indigestion symptoms. • Nonsteroidal anti-inflammatory drug (NSAIDs) - induced lesions (ulcers, erosions) and symptoms. • Gastro-esophageal reflux disease (content of the stomach comes up into the esophagus (food pipe)). • Zollinger-Ellison syndrome and other cases of high gastric secretion. • To be used with enzyme supplements in people with pancreatic problems. HOW AXCEL CIMETIDINE-200 SUSPENSION WORKS Cimetidine belongs to a group of medicines called H2-receptor antagonists. Cimetidine inhibits both the secretion of gastric acid and reduces pepsin enzyme output. It also has a beneficial effect in maintaining the integrity of the gastric lining barrier. BEFORE YOU USE AXCEL CIMETIDINE- 200 SUSPENSION _-When you must not use it _ Do not take Axcel Cimetidine-200 Suspension if: • You are allergic or hypersensitive to Cimetidine or other ingredients. • You are pregnant or nursing mother unless essential. _-Before you start to use it _ Tell your doctor if you: • You have a history of digestive ulcer, particularly the elderly. • You have severely impaired kidney function. • You have medication treatment or with illness that could cause falls in blood cell count. Cimetidine treatment can mask the symptoms and allow transient healing of gastric cancer. Your doctor may plan some tests to exclude Přečtěte si celý dokument
MAL 19940271A should particularly be borne in mind in patients of middle age and over with new or recently changed dyspeptic symptoms. Care should be taken for patient with a history of peptic ulcer, particularly the elderly, being treated with cimetidine and non-steroidal anti-inflammatory agent are observed regularly. It should be avoided during lactation unless essential. In patients in drug treatment or with illness that could cause falls in blood cell count, the possibility that H2 receptor antagonism could potentiate this effect should be borne in mind. Exclude malignancy in gastric ulcer. Use in pregnancy should be avoided unless essential for benefit. Dosage to be reduced in patients with severely impaired renal function. SIDE EFFECTS: Agranulocytosis, headache, myalgia, arthralgia, sinus bradycardia, tachycardia, heart block and reversible impotence. Diarrhoea, tiredness, dizziness, rash in small number of patients. Gynaecomastia, rarely. Decreased white blood cell counts including agranulocytosis mostly in patients also receiving drug known to reduce blood counts. Very rare cases of thrombocytopenia and aplastic anaemia. A few cases of reversible confusion, mostly in elderly and/or severely ill patients. Rare cases of hepatitis, pancreatitis and interstitial nephritis. DRUG INTERACTIONS: Cimetidine apparently through an effect on certain microsomal enzymes system, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulant, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressant, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs. Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clin Přečtěte si celý dokument