País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METRONIDAZOLE
DYNAPHARM (M) SDN BHD
METRONIDAZOLE
1000 Tablet Tablets
DYNAPHARM (M) SDN BHD
Consumer Medication Information Leaflet (RiMUP) DYNIDAZOL TABLET Metronidazole (200mg, 400mg) Page 1 of 2 What is in this leaflet 1. What DYNIDAZOL TABLET is used for 2. How DYNIDAZOL TABLET works 3. Before you use DYNIDAZOL TABLET 4. How to use DYNIDAZOL TABLET 5. While you are using it 6. Side effects 7. Storage and Disposal of DYNIDAZOL TABLET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What DYNIDAZOL TABLET is used for Metronidazole is used in the treatment and prevention of certain bacterial infections. How DYNIDAZOL TABLET works This medicine works by killing or stopping the growth of protozoa and bacteria. It also has a radiosensitising effect on hypoxic tumour cells. Before you use DYNIDAZOL TABLET - When you must not use it Do not take DYNIDAZOL TABLET if you have hypersensitivity to Metronidazole. Pregnancy and lactation Do not take DYNIDAZOL TABLET if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take DYNIDAZOL TABLET if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - Before you start use it Tell your doctor or pharmacist if: - Blood disorder - Active disease of the central nervous system - Severely impaired liver function - Taking other medicines Tell your doctor if you are under: - Alcohol usage - Warfarin-type oral anticoagulants treatment - Lithium treatment (for depressive disorders) - Phenobarbitone treatment (to control seizures) - Phenytoin treatment (to control seizures) - Cimetidine treatment (relieve heartburn) Inform your doctor if you are affected by Cockayne syndrome. Cases of severe liver toxicity or acute liver failure in patients with Cockayne syndrome have been reported with product containing Metronidazole. Stop taking Dynidazol Tablet and tell your doctor immediately if you develop: stomach pain, decreased appetite, nausea, vomiting, fever, unusual tiredness, yellowing of the skin & whites of the eyes, dark-coloured urine, light or clay-coloured stools or it Leer el documento completo
DYNIDAZOL DESCRIPTION CONTENT Dynidazol Tablet 200mg MAL19987009AZ TABLET Colour : White Shape : Round & Biconvex Each tablet contains: Metronidazole ........................ 200 mg Dynidazol Tablet 400mg MAL19973017AZ TABLET Colour : White Shape : Round, Flat & Scored Each tablet contains: Metronidazole ........................ 400 mg PHARMACODYNAMICS: Metronidazole is a 5-nitroimidazole derivative with activity against anaerobic protozoa and anaerobic bacteria; it also has a radiosensitising effect on hypoxic tumour cells. Its mechanism of action is thought to involve interference with DNA by a metabolite in which the nitro group of Metronidazole has been reduced. PHARMACOKINETICS: Metronidazole is readily absorbed following administration by mouth and bioavailability approaches 100%. Peak plasma concentrations of approximately 5 and 10 µg per mL are achieved an average of one hour after single doses of 250 and 500 mg respectively. Absorption may be delayed, but is not reduced overall by administration with food. Metronidazole is widely distributed. It appears in most body tissues and fluids including biles, bone, breast milk, cerebral abscesses, cerebrospinal fluid, liver and liver abscesses, saliva, seminal fluid, and vaginal secretions, and achieves concentrations similar to those in plasma. It also crosses the placenta and rapidly enters the foetal circulation. No more than 20% is bound to plasma proteins. Metronidazole is metabolised in the liver by side-chain oxidation and glucuronide formation. The plasma elimination half-life of Metronidazole is about 8 hours; that of the hydroxy metabolite is slightly longer. The half-life of Metronidazole is reported to be longer in neonates and in patients with severe liver disease; that of the hydroxy metabolite is prolonged in patients with renal failure. The majority of a dose of Metronidazole is excreted in the urine, mainly as metabolites; a small amount appears in the faeces. Depending on the assay method used, up to 80% of a dose has been recovered in the uri Leer el documento completo