Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 300 mg
Sandoz Pty Ltd
Roxithromycin
Tablet, film coated
Excipient Ingredients: silicon dioxide; titanium dioxide; hypromellose; lactose monohydrate; croscarmellose sodium; poloxamer; magnesium stearate; microcrystalline cellulose; povidone; macrogol 4000
Oral
5 tablets
(S4) Prescription Only Medicine
Roxithromycin Sandoz is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms. Upper respiratory tract infection: acute pharyngitis, tonsilitis and sinusiti. Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Children Roxithromycin Sandoz 150mg 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 microorganisms. Acute pharyngitis. Acute tonsilitis. Impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be inititiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Visual Identification: White, round, convex film-coated tablets, scored on one face, embossment on other side: R300; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-07-11
ROXITHROMYCIN SANDOZ ® 1 ROXITHROMYCIN SANDOZ ® _roxithromycin film-coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Roxithromycin Sandoz. 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 SANDOZ 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) • exacerbation of chronic bronchitis • 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 Sandoz 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 SANDOZ _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, clarithromycin or erythromycin). Som Lees het volledige document
190206-Roxithromycin Sandoz-pi Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION ROXITHROMYCIN SANDOZ ® (ROXITHROMYCIN) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Roxithromycin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Roxithromycin Sandoz 150 mg film-coated tablets contains 150 mg roxithromycin. Each Roxithromycin Sandoz 300 mg film-coated tablets contains 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 Sandoz 150 mg film-coated tablets: white, round, convex film-coated tablets, scored on one face, embossment R 150. Roxithromycin Sandoz 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 Sandoz 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 Sandoz 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 microorganisms. • 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. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS _ 190206-Roxithromycin Sandoz-pi Page 2 of 12 The recommended dosage is 300 mg per day, which may be take Lees het volledige document