Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
leflunomide
Ratiopharm GmbH
L04AA13
leflunomide
Immunosuppressants
Arthritis, Rheumatoid
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: 16
Authorised
2010-11-28
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER LEFLUNOMIDE RATIOPHARM 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 Leflunomide ratiopharm is and what it is used for 2. What you need to know before you take Leflunomide ratiopharm 3. How to take Leflunomide ratiopharm 4. Possible side effects 5. How to store Leflunomide ratiopharm 6. Contents of the pack and other information 1. WHAT LEFLUNOMIDE RATIOPHARM IS AND WHAT IT IS USED FOR Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines. Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis. Symptoms of rheumatoid arthritis 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 anaemia (lack of red blood cells). Symptoms of active psoriatic arthritis 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 LEFLUNOMIDE RATIOPHARM DO NOT TAKE LEFLUNOMIDE RATIOPHARM - if you have ever had an ALLERGIC reaction to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), to peanut or soya or to any of the other ingredients of this medicine Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Leflunomide ratiopharm 10 mg film-coated tablets Leflunomide ratiopharm 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Leflunomide ratiopharm 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide. Leflunomide ratiopharm 20 mg film-coated tablets Each film-coated tablet contains 20 mg of leflunomide. Excipients with known effect _Leflunomide ratiopharm 10 mg film-coated tablets _ Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin. _Leflunomide ratiopharm 20 mg film-coated tablets _ Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Leflunomide ratiopharm 10 mg film-coated tablets White to almost white, round film-coated tablet with a diameter of about 6 mm. Leflunomide ratiopharm 20 mg film-coated tablets White to almost white, round film-coated tablet with a diameter of 8 mm and a break-mark on one side of the tablet. 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: • 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 pso Pročitajte cijeli dokument