What is Leflunomide medac?
Leflunomide medac is a medicine that contains the active substance leflunomide. It is available as white round tablets (10 mg and 20 mg).
Leflunomide medac is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Arava.
What is Leflunomide medac used for?
Leflunomide medac is used to treat adults with active rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints).
The medicine can only be obtained with a prescription.
How is Leflunomide medac used?
Leflunomide medac therapy should be started and supervised by a doctor experienced in the treatment of rheumatoid arthritis. Your doctor must perform blood tests to check the patient's liver function, white blood cells and platelets before prescribing Leflunomide medac, and regularly during treatment.
Treatment with Leflunomide medac should be started with a loading dose of 100 mg once a day for three days, followed by a maintenance dose. The usual recommended maintenance dose is 10 mg to 20 mg once a day. Usually the medicine starts to work after 4-6 weeks. Its effect can further improve for up to six months.
How does Leflunomide medac work?
The active substance in Leflunomide medac, leflunomide, is an immunosuppressant. This substance reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide exerts this action by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply. With less lymphocytes, there is less inflammation and it helps control the symptoms of rheumatoid arthritis.
What studies have been performed on Leflunomide medac?
Because Leflunomide medac is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine Arava. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Leflunomide medac?
Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Leflunomide medac been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Leflunomide medac has been shown to have comparable quality and to be bioequivalent to Arava. Therefore, it is the opinion of the CHMP that, as in the case of Arava, the benefits outweigh the identified risks. The Committee therefore recommended that Leflunomide medac be granted marketing authorization.
Further information on Leflunomide medac
On 27 July 2010, the European Commission granted a marketing authorization valid throughout the EU for Leflunomide medac to Medac, Gesellschaft für klinische Spezialpräparate mBH. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Leflunomide medac can be found here. For more information about treatment with Leflunomide medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 06-2010
