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Human medicines European public assessment report (EPAR): Leflunomide ratiopharm, leflunomide, Date of authorisation: 28/11/2010, Revision: 17, Status: Authorised

Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient’s liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.

Leflunomide ratiopharm treatment starts with a ‘loading dose’ of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.

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