Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Leflunomide
Mylan
L04AA13
Leflunomide
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5016695004150
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEFLUNOMIDE 10 MG FILM-COATED TABLETS LEFLUNOMIDE 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 or pharmacist. - 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 or pharmacist. 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. Leflunomide is used to treat adult patients with active rheumatoid 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 (reduction of red blood cells). 2. W HAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE DO NOT TAKE LEFLUNOMIDE - if you are allergic to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), to a medicine called teriflunomide (which is related to leflunomide) 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 levels of PROTEINS IN YOUR BLOOD (hypoproteinaemia), - if you suffer from any problem which affects your IMMUNE SYSTEM (e.g. AIDS), - if you have any probl Pročitajte cijeli dokument
OBJECT 1 LEFLUNOMIDE MYLAN 10 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 23-Oct-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Leflunomide Mylan 10 mg film-coated tablets 2. Qualitative and quantitative composition Leflunomide Mylan 10 mg film-coated tablets: Each tablet contains 10 mg of leflunomide. Excipient with known effect: Each film-coated tablet contains 18.81 mg of lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Leflunomide 10 mg film-coated tablets are white, round biconvex tablets with a diameter of about 6.1 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide 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), 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. 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 usually started with a lo Pročitajte cijeli dokument