Country: Кипар
Језик: Грчки
Извор: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
LEFLUNOMIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
L04AA13
LEFLUNOMIDE
10MG
FILM COATED TABLETS
LEFLUNOMIDE (0075706126) 10MG
ORAL USE
Εθνική Διαδικασία
LEFLUNOMIDE
Νομικό καθεστώς: Με Ιατρική Συνταγή; BOTTLE WITH 30 TABS (300000101) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή
COMPARATIVE TABLE PIL-EN VS PIL-GR PACKAGE LEAFLET: INFORMATION FOR THE USER AROTAN 10 MG FILM-COATED TABLETS AROTAN 20 MG FILM-COATED TABLETS Leflunomide 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Arotan is and what it is used for 2. What you need to know before you take Arotan 3. How to take Arotan 4. Possible side effects 5. How to store Arotan 6. Contents of the pack and other information 1. WHAT AROTAN IS AND WHAT IT IS USED FOR ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΧΡΉΣΤΗ AROTAN 10 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ AROTAN 20 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ Λεφλουνομίδη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. - Φυλάξτε αυτό το φύλλο οδηγιών χρήσης. Ίσως χρειαστεί να το διαβάσετε ξανά. - Εάν έχετε περαιτέρω απορίες, ρωτήστε το γιατρό, το φαρμακοποιό ή το νοσοκόμο σας. - Η συνταγή για αυτό το φάρμακο χορηγήθηκε αποκλειστικά για σας. Δεν πρέπει να δώσετε το φάρμακο σε άλλους. Μπορεί να τους προκαλέσε Прочитајте комплетан документ
1. NAME OF THE MEDICINAL PRODUCT Arotan 10 mg Film-coated tablets Arotan 20 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 10 mg strength: Each tablet contains 10 mg of leflunomide. Excipient(s) with known effect: Each tablet contains 80 mg of lactose monohydrate. For 20 mg strength: Each tablet contains 20 mg of leflunomide. Excipient(s) with known effect: Each tablet contains 160 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM For 10 mg strength: White to off-white, round, biconvex film coated tablets. For 20 mg strength: White to off-white, round, biconvex film coated tablets with one sided break-mark. _The tablet can be divided into equal doses._ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leflunomide is indicated for the treatment of adult patients with: 1 SUMMARY OF PRODUCT CHARACTERISTICS active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD). active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis. Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: before initiation of leflunomide, every two weeks during the first six months of treatment, and every 8 weeks thereafter (s Прочитајте комплетан документ