البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
roxithromycin
Sandoz Pty Ltd
Roxithromycin
Registered
_ _ _Roxithromycin AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 71.AN.M.1.0 _ _ _ _ _ _Page 1 _ ROXITHROMYCIN AN FILM-COATED TABLETS _ROXITHROMYCIN _ CONSUMER MEDICINE INFORMATION WHAT IS THIS LEAFLET This leaflet answers some common questions about Roxithromycin AN. 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 risk 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 ROXITHROMYCIN AN IS USED FOR This medicine is used to treat various infections caused by bacteria such as: acute pharyngitis (sore throat and discomfort when swallowing) tonsillitis sinusitis acute bronchitis (infection of the bronchi causing coughing) pneumonia (lung infection characterised by fever, malaise, headache) skin and soft tissue infections non gonococcal urethritis impetigo (bacterial infection causing sores on the skin). It contains the active ingredient roxithromycin. Roxithromycin belongs to a group of medicines called macrolides. It works by killing or stopping the growth of the bacteria that are causing the infection. However, Roxithromycin AN does not have any effect on viral infections such as the flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE ROXITHROMYCIN AN _ _ _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: roxithromycin, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. any other macrolide antibiotic (such as azithromycin, clarith اقرأ الوثيقة كاملة
190206-Roxithromycin AN-pi Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION ROXITHROMYCIN AN (ROXITHROMYCIN) TABLETS 1. NAME OF THE MEDICINE Roxithromycin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Roxithromycin AN 150 mg tablets contain 150 mg roxithromycin. Each Roxithromycin AN 300 mg tablets contain 300 mg roxithromycin. It is a white crystalline powder. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Roxithromycin AN 150 mg film-coated tablets: white, round, convex film-coated tablets, scored on one face, embossment R 150. Roxithromycin AN 300 mg film-coated tablets: white, round, convex film-coated tablets, scored on one face, embossment R 300. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS _Adults_: Roxithromycin AN is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms. • Upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. • Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. • Skin and skin structure infections. • Nongonococcal urethritis. _Children: _ Roxithromycin AN 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible microoganisms. • Acute pharyngitis. • Acute tonsillitis. • Impetigo. _ _ Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. 190206-Roxithromycin AN-pi Page 2 of 12 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS _ The recommended dosage is 300 mg per day, which may be taken according to one of the following dosage regimens. _Usual dosage: _ Roxithro اقرأ الوثيقة كاملة