Repso

4). Posology  In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days. 1). The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.

 In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days. 1). The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months. There is no dose adjustment recommended in patients with mild renal insufficiency.

No dose adjustment is required in patients above 65 years of age. 2). Method of administration Repso tablets are tablets for oral use. The tablets should be swallowed whole with sufficient amounts of liquid. The extent of leflunomide absorption is not affected if it is taken with food.

g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin.

Tabulated list of adverse reactions Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4). Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia). Neoplasms benign, malignant and unspecified (incl.

cysts and polyps)Medicinal product no longer authorised 11 The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents. Blood and lymphatic system disorders Common: leucopenia (leucocytes > 2 G/l) Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia Very rare: agranulocytosis Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.

, aphthous stomatitis, mouth ulceration), abdominal pain; colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis Uncommon: taste disturbances Very rare: pancreatitis Hepatobiliary disorders Common: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)Medicinal product no longer authorised 12 Rare: hepatitis, jaundice/cholestasis Very rare: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal Skin and subcutaneous tissue disorders Common: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria Very rare: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme Not known: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Musculoskeletal and connective tissue disorders Common: tenosynovitis Uncommon: tendon rupture Renal and urinary disorders Not known: renal failure Reproductive system and breast disorders Not known: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility General disorders and administration site conditions Common: anorexia, weight loss (usually insignificant), asthenia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

g. methotrexate) is not advisable. The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks. g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped.

Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed. The procedure may be repeated as clinically necessary. For washout procedures and other recommended actions in case of desired or unintended pregnancy see section

1.  Patients with impairment of liver function. g. AIDS.  Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.

4).  Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group. g. in nephrotic syndrome. 6). Pregnancy must be excluded before start of treatment with leflunomide.

6).