Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
leflunomide
medac Gesellschaft für klinische Spezialpräparate mbH
L04AA13
leflunomide
Selective immunosuppressants
Arthritis, Rheumatoid
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).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: 19
Authorised
2010-07-27
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER LEFLUNOMIDE MEDAC 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 medac is and what it is used for 2. What you need to know before you take Leflunomide medac 3. How to take Leflunomide medac 4. Possible side effects 5. How to store Leflunomide medac 6. Contents of the pack and other information 1. WHAT LEFLUNOMIDE MEDAC IS AND WHAT IT IS USED FOR Leflunomide medac belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide. Leflunomide medac 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 in moving, pain, and patches of red, scaly skin (skin lesions). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE MEDAC DO NOT TAKE LEFLUNOMIDE MEDAC • 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), peanut or soya or to any of the other ingredients of this medicine (listed in section 6), or if you are all Baca dokumen lengkap
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Leflunomide medac 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide. Leflunomide medac 15 mg film-coated tablets Each film-coated tablet contains 15 mg of leflunomide. Leflunomide medac 20 mg film-coated tablets Each film-coated tablet contains 20 mg of leflunomide. _Excipients with known effect _ Leflunomide medac 10 mg film-coated tablets Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin. Leflunomide medac 15 mg film-coated tablets Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin. Leflunomide medac 20 mg film-coated tablets Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Leflunomide medac 10 mg film-coated tablets White to almost white, round film-coated tablet with a diameter of about 6 mm. Leflunomide medac 15 mg film-coated tablets White to almost white, round film-coated tablet, debossed with “15” on one side with a diameter of about 7 mm. Leflunomide medac 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 halves. 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. 3 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 carefu Baca dokumen lengkap