País: Israel
Língua: inglês
Origem: Ministry of Health
ROXITHROMYCIN
SANOFI - AVENTIS ISRAEL LTD
J01FA06
FILM COATED TABLETS
ROXITHROMYCIN 150 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
ROXITHROMYCIN
For the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ENT bronchopulmonary, genital and skin manifestations.
2014-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only RULID 150 MG FILM-COATED TABLETS Active ingredient: each tablet contains roxithromycin 150 mg. Inactive ingredients – see section 6. Read this leaflet carefully in its entirety before using the medicine. Keep this leaflet; you may need to read it again. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. If a side effect worsens or if you experience a side effect not mentioned in this leaflet, please refer to a doctor or pharmacist. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for the treatment of infections caused by bacteria susceptible to roxithromycin, such as infections of the respiratory tract, including, nose, ear and throat, skin infections, and infections of the genitals. THERAPEUTIC GROUP: Macrolide antibiotic. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to roxithromycin or to any of the additional ingredients contained in the medicine (see section 6), or to other antibiotics of the macrolides group (e.g., erythromycin). • you are being treated concomitantly with ergot derivatives (for treatment of migraine), such as ergotamine and dihydroergotamine. • you are being treated concomitantly with colchicine (to treat gout). • you are being treated concomitantly with medicines such as: cisapride (for treatment of reflux [gastroesophageal reflux]), pimozide (a neuroleptic preparation), or antiallergics containing terfenadine or astemizole. • when you are breastfeeding and your baby is being treated with the medicine cisapride (see PREGNANCY AND BREASTFEEDING section). If you are taking other medicines, confirm that there is no contraindication to their Leia o documento completo
1 RULI-PO-150MG-14.0 RULID TABLETS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RULID 150 mg, film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Roxithromycin 150 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ENT bronchopulmonary, genital and skin manifestations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: 300 mg per day, i.e. 1 x 150 mg tablet in the morning and evening, preferably before meals. Treatment duration Treatment duration for throat infections is 10 days. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Allergy to Macrolides • Coadministration with: o vasoconstrictive ergot alkaloids: dihydroergotamine, ergotamine (see section 4.5). o Colchicine (see section 4.5). • Concomitant therapy with medicines having a narrow therapeutic window and being substrates of CYP3A4 (such as, astemizole, terfenadine, cisapride or pimozide (see section 4.5). • Women breast-feeding an infant who is treated with cisapride (see section 4.6). • 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS 2 Excipient with known effect This medicinal product contains glucose. It should therefore not be used in patients with glucose-galactose malabsorption syndrome. Liver failure _ _ _ _ Administration of roxithromycin is not recommended in patients with severe liver failure. In patients with mild to moderate liver failure, roxithromycin should be used with caution. If it must be administered in these subjects, regular liver function tests are required and if necessary, the dose should be reduced. Renal ifailure The amount of active substance and its metabolites eliminated by the renal route is small (10% of the oral dose). No dose adjustment is therefore required in patients with kidney failure. Elderly subjec Leia o documento completo