国家: 马耳他
语言: 英文
来源: Medicines Authority
ROXITHROMYCIN
Sanofi Malta Limited
J01FA06
ROXITHROMYCIN
FILM-COATED TABLET
ROXITHROMYCIN 150 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2005-09-28
RULID® 150 MG COATED TABLET _roxithromycin _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet, you may need to read it again. • If you have any questions, if you have any doubt, ask your doctor or pharmacist. • This medicine has been prescribed for you. Never give it to someone else, even if their symptoms are the same as yours, it may harm them. • 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 is and what it is 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 IS AND WHAT IT IS USED FOR? Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01FA06 (J: anti- infectives). It is used for the treatment of bacterial infections caused by sensitive bacteria (which may be destroyed by this antibiotic). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RULID 150 MG COATED TABLETS? If your doctor has told you that you have an intolerance to some sugars, contact your doctor before using this medicine. If a widespread, severe skin rash occurs, including skin blistering or peeling as well as signs of flu and fever (Steven Johnson syndrome), a general unwell feeling, fever, chills and muscle aches (toxic epidermal necrolysis) or a red, scaly rash with bumps under the skin and blisters (Acute generalised exanthemaotous pustulosis) refer to a doctor immediately since these skin effects may be life threatening. DO NOT USE RULID 150 MG COATED TABLETS: - If you are allergic to antibiotics of the macrolide or any component of the medication. You can find the list of components in section 6. - If you are taking any other medicines, make sure that the combination with Rulid is not contra-indica 阅读完整的文件
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Rulid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg roxithromycin. 3. PHARMACEUTICAL FORM Coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The therapeutic indications are based on the antibacterial activity and pharmacokinetic properties of roxithromycin. 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 defined as susceptible to the drug: • Proven beta-hemolytic streptococcus A throat infections, as an alternative to betalactam treatment, especially when betalactams cannot be administered. • 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 with no 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 other 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 _ _ Page 2 of 11 _ _ In patients with throat infections, treatment duration is 10 days. 4.3 CONTRAINDICATIONS This medicine MUST NEVER BE USED in the following situations: allergy to macrolides. in combination with: o vasoconstrict 阅读完整的文件