Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE
12Tablet Tablets; 16Tablet Tablets; 20Tablet Tablets; 30Tablet Tablets; 100Tablet Tablets
SANDOZ GMBH
CURAM ® FILM-COATED TABLET _ Consumer Medication Information Leaflet (RiMUP) _ (AMOXICILLIN & CLAVULANIC ACID 500/125 MG) WHAT IS IN THIS LEAFLET: 1. What CURAM is used for 2. How CURAM works 3. Before you use CURAM 4. How to use CURAM 5. While you are using it 6. Side effects 7. Storage and disposal of CURAM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CURAM IS USED FOR CURAM is used to treat infections such as middle ear and sinus infections, respiratory tract infections, urinary tract infections, skin and soft tissue infections including dental infections, bone and joint infections. HOW CURAM WORKS CURAM is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins that can sometimes be stopped from working (made inactive by bacteria). The other active component (clavulanic acid) stops this from happening. BEFORE YOU USE CURAM _WHEN YOU MUST NOT USE IT _ • If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Curam • If you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck • If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic PREGNANCY AND BREAST-FEEDING Curam should not be used while breastfeeding. If you are pregnant, or you think you might be pregnant, ask your doctor for advice before taking any medicine. Use should be avoided during pregnancy unless the benefit outweighs the risk. If you are not sure, talk to your doctor or pharmacist before taking Curam. _ _ _BEFORE YOU START USE IT _ Check with your doctor or pharmacist before taking this medicine if you: • any allergic conditions • fits/ convulsions • severe and persistent diarrhea • are being treated for liver or kidney problems In some cases, Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Curam ® 625 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg amoxicillin and 125 mg clavulanic acid. 3. PHARMACEUTICAL FORM Film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of common bacterial infections where oral therapy is indicated, including: • Upper respiratory tract infections (including ENT): sinusitis, tonsillitis, otitis media. • Skin and soft tissue infections: boils/abscesses, cellulitis, wound infections, intra-abdominal sepsis • Lower respiratory tract infections: acute and chronic bronchitis, pneumonia, lung abscess • Genito-urinary tract infections: cystitis, urethritis, pyelonephritis, septic abortion, pelvic infection • Other infections: osteomyelitis, peritonitis, postoperative infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years: Mild and moderate infections: one Curam 625 mg tablet twice daily. More severe infections and respiratory tract infections: one Curam 625 mg tablet, three times a day. Treatment with Curam should not be extended beyond 14 days without review. Elderly No dose adjustment is considered necessary. Dose in renal impairment Age Creatinine Clearance Dose Adults Mild impairment (>30ml/min) No change of dose Moderate impairment (10-30 ml/min) Curam 625 mg 12 hourly Severe impairment (<10ml/min) Not more than Curam 625 mg 24 hourly Children over 12 years old Similar reductions in dose should be made. Dose in hepatic functional impairment Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4). METHOD OF ADMINISTRATION For oral use. Curam is well absorbed whether taken with or before meals. Administer at the start of a meal to minimise potential gastrointestinal intolerance. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. • History of a severe immediate hypersensitivity reaction (e.g. ana Læs hele dokumentet