দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
ROXITHROMYCIN
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
J01FA06
ROXITHROMYCIN 150 mg
COATED TABLET
ROXITHROMYCIN 150 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2005-09-28
RULID® 150 MG COATED TABLET _roxithromycin _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet, you may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Rulid 150 mg coated tablets are and what they are used for 2. What you need to know before you take Rulid 150 mg coated tablets 3. How to take Rulid 150 mg coated tablets 4. Possible side effects 5. How to store Rulid 150 mg coated tablets 6. Contents of the pack and other information 1. WHAT RULID 150 MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR? Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01FA06 (J: anti- infectives). This medicine is used to treat certain bacterial infections caused by bacteria sensitive to this antibiotic (bacteria that can be killed by this antibiotic). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RULID 150 MG COATED TABLETS? If you have been told by your doctor that you have an intolerance to some sugars, contact him/her before taking this medicine. DO NOT USE RULID 150 MG COATED TABLETS: • If you are allergic to antibiotics of the macrolide group or to any of the ingredients of this medicine. See Section 6 for a full list of ingredients. • If you are taking other medicines, make sure that combined use with Rulid is not contraindicated (see “Other medicines and Rulid 150 mg coated tablets”), such as combination with colchicine, ergotamine, dihydroergotamine and cisapride. • If you are breast-feeding a child being treated with cisapride (see "Breast-feeding"). If you are unsure of anything, it is essential that you ask your doctor or pha সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Rulid 150 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Roxithromycin. ........................................................................................................................................ 150 mg For one coated tablet. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The therapeutic indications of roxithromycin are based on the antibacterial activity and pharmacokinetic properties. They take into account both the clinical studies performed on this medicinal product, and its position in the range of currently available antibacterial agents. Use of roxithromycin is limited to the treatment of infections caused by microorganisms which have been shown susceptible to the drug: • Proven beta-hemolytic streptococcus A throat infections, as an alternative to betalactam treatment, especially in cases where administration of betalactams is not possible. • Acute sinusitis: considering the microbiological characteristics of these infections, use of macrolides is indicated when betalactam treatment is not possible. • Superinfection of acute bronchitis. • Exacerbation of chronic bronchitis. • Community-acquired pneumonia in subjects: o without risk factors, o with no serious clinical symptoms, o with no clinical signs indicative of pneumococcal etiology. If atypical pneumonia is suspected, use of macrolides is indicated, irrespective of the severity and history. • Minor skin infections: impetigo, impetiginization of dermatoses, ecthyma, infectious dermo- hypodermitis (especially erysipelas), erythrasma. • Non-gonococcal genital infections. Official recommendations concerning the appropriate use of antibacterial agents should be taken into account. 4.2 DOSAGE AND MODE OF ADMINISTRATION POSOLOGY Adults: 300 mg/day, i.e. one 150 mg tablet, morning and evening, preferably before meal DURATION OF TREATMENT In patients wit সম্পূর্ণ নথি পড়ুন