देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Leflunomide
Aspire Pharma Limited
L04AA; L04AA13
Leflunomide
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective immunosuppressants; leflunomide
Not marketed
2011-08-12
Package leaflet: Information for the user LEFLUNOMIDE 10, 20MG 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 is and what it is used for 2. What you need to know before you take Leflunomide 3. How to take Leflunomide 4. Possible side effects 5. How to store Leflunomide 6. Contents of the pack and other information 1. WHAT LEFLUNOMIDE IS AND WHAT IT IS USED FOR Leflunomide belongs to a group of medicines called anti- rheumatic medicines. It contains the active substance leflunomide. Leflunomide 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 Do not take Leflunomide 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) or to any of the other ingredients of this medicine (listed in section 6), if you have any liver problems, if you have moderate to severe kidney problems, if you have severely low पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Leflunomide 20mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg of leflunomide. Excipients with known effect: each tablet contains 38.40mg of lactose monohydrate equivalent to 36.48 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. - Leflunomide 20mg film-coated tablets are yellow, round biconvex, with a scoreline on one side. The score-line is for the purpose of identification only. 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. 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 (see section 4.4). _Posology_ In rheumatoid arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days. Omission of the loading dose may decrease the risk of adverse events (see section 5.1). The recommended पूरा दस्तावेज़ पढ़ें