Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SULPHAMETHOXAZOLE; TRIMETHOPRIM
KOMEDIC SDN BHD
SULPHAMETHOXAZOLE; TRIMETHOPRIM
1000 Tablets; 500 Tablets
MEDOCHEMIE LTD (Factory AZ)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ COTRIM TABLET Sulphamethoxazole /Trimethoprim (400mg/80mg, 800mg/160mg) 1 WHAT IS IN THIS LEAFLET 1. What Cotrim is used for 2. How Cotrim works 3. Before you use Cotrim 4. How to use Cotrim 5. While you are using it 6. Side effects 7. Storage and disposal of Cotrim 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COTRIM IS USED FOR Cotrim may be used to treat: - Repiratory tract infections - Ear and sinus infections - Urinary tract and prostates infection - Digestive tract infections - Skin infections HOW COTRIM WORKS Cotrim contains sulphamethoxazole and trimethoprim; or commonly known as Cotrimoxazole. Cotrimoxazole is an antibiotic that kills bacteria causing infection. BEFORE YOU USE COTRIM _When you must not use it _ Do not take Cotrim: - if you are allergic to sulphonamides, Cotrimoxazole and any of the ingredients in the product - if you have severe liver damage - if you have severe kidney damage or disease _Before you start to use it _ Tell your doctor or pharmacist if you: - have a history of severe allergic reactions or asthma - have liver, kidney disease, or any blood disorder (including porphyria) - have a protein disorder called phenylketonuria - have glucose-6-phosphate dehydrogenase (G6PD) deficiency - have high potassium or low sodium level - hav genetic disorders related to sugar intolerance _ _ _Pregnancy and Lactation _ If you are pregnant or trying for a baby or breastfeeding, ask your doctor or pharmacist for advice before taking Cotrim. Cotrimoxazole should not be taken during pregnancy, particularly in first trimester and also near the time of delivery, unless clearly necessary. If used during pregnancy, you must take folate as supplementation. Cotrimoxazole is secreted into breastmilk in small amounts. Therefore, cotrimoxazole should not be used when you are breastfeeding. _ _ _Taking other medicines _ Tell your doctor or pharmacist if you are taking: - rifampicin (to treat tuberculosis) - a Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cotrim 480mg Tablet Cotrim DS 960mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cotrim tablet contains sulphamethoxazole 400mg and trimethoprim 80mg. Each Cotrim DS tablet contains sulphamethoxazole 800mg and trimethoprim 160mg. The approved name for this combination is cotrimoxazole. Excipient with known effect: lactose monohydrate. Each 960mg tablet contains 20mg lactose monohydrate For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Cotrim 480mg Tablet: White, round, flat scored tablets embossed “MC” with diameter of 12.7mm Cotrim DS 960mg Tablet: White, capsule shaped, scored tablets, embossed “MC”, size 17.5mm x 8mm. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Respiratory infections including acute and chronic bronchitis (treatment and prophylaxis), also bronchiectasis, lung abscess, lobar and broncho-pneumonia. Pneumocystis carinii pneumonitis, sinusitis and otitis media. Urinary tract infections, including urethritis, cystitis, pyelitis, pyelonephritis and prostates. Gastro-intestinal tract infections caused by salmonella typhii and paratyphi, including the chronic carrier state; bacillary dysentery and cholera (as an adjuvant to fluid and electrolyte replacement). Skin infections, including pyoderma, abscesses and wound infections, septicaemia, gonorrhoea Other infections caused by a wide range of pathogenic bacteria including acute and chronic osteomyelitis, acute brucellosis, nocardiosis and actinomycetoma and in South American blastomycosis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Co-trimoxazole is used similarly to the sulphonamides but in a wider variety of infections, in addition to urinary-tract and lower respiratory tract infections. Co-trimoxazole is usually given by mouth in a dose of 960mg (trimethoprim 160mg and sulphamethoxazole 800mg) twice daily for up to 14 days; 2.88g daily in 2 or 3 divided doses may be given in severe infections. Lower doses are given for lon Citiți documentul complet