País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMPICILLIN TRIHYDRATE
KOMEDIC SDN BHD
AMPICILLIN TRIHYDRATE
1000 Capsules; 500 Capsules
MEDOCHEMIE LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PAMECIL CAPSULES Ampicillin trihydrate (250mg, 500mg) WHAT IS IN THIS LEAFLET 1. What PAMECIL is used for 2. How PAMECIL works 3. Before you use PAMECIL 4. How to use PAMECIL 5. While you are using it 6. Side effects 7. Storage and disposal of PAMECIL 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PAMECIL IS USED FOR Ampicillin trihydrate belongs to the group of medicines known as penicillin antibiotics. It is used to kill bacteria that cause infections in your body. HOW PAMECIL WORKS The active ingredient in your capsules is ampicillin trihydrate. It works by killing bacteria that cause the infections. BEFORE YOU USE PAMECIL _- When you must not use it _ Do not take PAMECIL if you: are hypersensitive (allergic) to this medicine or any of the other ingredients of PAMECIL or to other beta-lactam antibiotics (e.g. penicillins, cephalosporins) _ _ _- Before you start to use it _ Take special care with PAMECIL and tell your doctor or pharmacist if you: are allergic to beta-lactam antibiotics suffer from a blood disorder suffer from kidney problems have glandular fever or leukemia _ _ _Pregnancy and breast-feeding _ Do not use PAMECIL if you are pregnant, trying to become pregnant or suspect you may be pregnant. If you become pregnant while taking PAMECIL, stop taking it immediately and contact your doctor. _ _ Do not use PAMECIL if you are breast- feeding. Consult your doctor before taking the capsules as ampicillin is found in the milk in small amounts. _ _ _- Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal and complementary medicines. It is important to tell your doctor that you are taking: any other antibiotics, such as chloramphenicol, tetracyclines, erythromycins or sulphonamides allopurinol ( used to treat gout) probenecid ( used to treat gout) I Llegiu el document complet
1 PAMECIL 1. NAME OF THE MEDICINAL PRODUCT PAMECIL 250mg hard capsules PAMECIL 500mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PAMECIL 250mg: Each capsule contains 250mg ampicillin as ampicillin trihydrate PAMECIL 500mg: Each capsule contains 500mg ampicillin as ampicillin trihydrate 3. PHARMACEUTICAL FORM PAMECIL 250mg: Black-Scarlet hard gelatin capsule size “2” PAMECIL 500mg: Black-Scarlet hard gelatin capsule size “0”, elongated 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections. Parenteral usage is indicated where oral dosage is inappropriate. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _DOSAGE FOR ADULTS AND ELDERLY PATIENTS _ _Ear, Nose, Throat infections _ _: _ 250mg four times a day _Bronchitis _ _: _ Routine therapy 250mg four times a day _Pneumonia _ _: _ 500mg four times a day _Urinary tract infections _ _: _ 500mg three times a day _Gastrointestinal infections _ _: _ 500 to 750mg three to four times daily _Enteric infections _ _: _ _Acute: _1-2g four times a day for two weeks. _Carries: _1-2g four times a day for four to twelve weeks. _Gonorrhoea _ _: _ 2g orally with 1g of probenecid as a single dose. Repeated doses are recommended for the treatment of females. _ _ _PAEDIATRIC POPULATION _ Children less than 10 years old: Half adult routine dosage. All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. _RENAL IMPAIRMENT _ In the presence of severe renal impairment (creatinine clearance less than 10 ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, Llegiu el document complet