Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
leflunomide
Teva B.V.
L04AA13
leflunomide
Immunosuppressants
Arthritis, Rheumatoid; Arthritis, Psoriatic
Leflunomide is indicated for the treatment of adult patients with: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 may also increase the risk of serious adverse reactions even for a long time after the switching.
Revision: 11
Withdrawn
2011-03-14
38 B. PACKAGE LEAFLET Medicinal product no longer authorised 39 PACKAGE LEAFLET: INFORMATION FOR THE USER REPSO 10 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 Repso is and what it is used for 2. What you need to know before you take Repso 3. How to take Repso 4. Possible side effects 5. How to store Repso 6. Contents of the pack and other information 1. WHAT REPSO IS AND WHAT IT IS USED FOR Repso belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide. Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis. Rheumatoid arthritis is a crippling form of arthritis. The symptoms include inflammation of joints, swelling, difficulty moving and pain. Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells). Psoriatic arthritis is the combination of psoriasis and arthritis. The symptoms include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPSO DO NOT TAKE REPSO - If you are ALLERGIC to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis). - If you ha Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Repso 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide. _Excipients with known effect _ Each film-coated tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose. Repso 20 mg film-coated tablets Each film-coated tablet contains 20 mg of leflunomide. _Excipients with known effect _ Each film-coated tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Repso 10 mg film-coated tablets White, round film-coated tablets, engraved with “10” on one side and “L” on the other. Repso 20 mg film-coated tablets Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leflunomide is indicated for the treatment of adult patients with 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. Medicinal product no longer authorised 3 Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) Lesen Sie das vollständige Dokument