País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
clindamycin hydrochloride
Apotex Pty Ltd
clindamycin hydrochloride
Registered
TERRY WHITE CHEMISTS CLINDAMYCIN CAPSULES _Contains the active ingredient Clindamycin hydrochloride_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Clindamycin is an antibiotic. It is used to treat infections in different parts of the body caused by bacteria. It works by killing or stopping the growth of the bacteria causing your infection. Clindamycin will not work against viral infections such as colds or flu. Clindamycin is recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CLINDAMYCIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Clindamycin for another reason. This medicine is available only with a doctor's prescription. Clindamycin capsules are not recommended in children for formulation reasons. Clindamycin is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing clindamycin or lincomycin • lactose or any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expi Llegiu el document complet
1 AUSTRALIAN PRODUCT INFORMATION –TERRY WHITE CHEMISTS CLINDAMYCIN CAPSULES (CLINDAMYCIN HYDROCHLORIDE) 1 NAME OF THE MEDICINE Clindamycin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clindamycin hydrochloride is white or almost white, crystalline powder, very soluble in water, slightly soluble in ethanol (96 per cent). It is a semi- synthetic antibiotic produced by a 7(S)- chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The pKa value is 7.6. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM The capsules consist of a white cap and white body imprinted with ‘Clin 150’. Each capsule contains 150 mg of clindamycin hydrochloride as active ingredient. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. ANAEROBES Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection. STREPTOCOCCI Serious respiratory tract infections; serious skin and skin structure infections, septicaemia. STAPHYLOCOCCI Serious respiratory tract infections; serious skin and skin structure infections; septicaemia; acute haematogenous osteomyelitis. PNEUMOCOCCI Llegiu el document complet