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 which 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 physician experienced in the treatment of rheumatoid arthritis. The physician should perform blood tests to check the patient's liver function, white blood cells and platelets before prescribing Leflunomide medac , and regularly during treatment.
Leflunomide medac treatment should be started with a loading dose of 100 mg once daily for three days, followed by a maintenance dose. The usually recommended maintenance dose is 10 mg to 20 mg once daily. The medicine usually starts to work after 4-6 weeks. Its effect can further improve over a period of 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 does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for lymphocytes to multiply. With fewer lymphocytes, there is less inflammation and helps control the symptoms of rheumatoid arthritis.
How has Leflunomide medac been studied?
As Leflunomide medac is a generic medicine, the studies were limited to evidence designed to show that the medicine is bioequivalent to the reference medicine Arava. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Leflunomide medac?
Since Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
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 view of the CHMP that, as in the case of Arava , the benefits outweigh the identified risks. The Committee therefore recommended the granting of a marketing authorization for Leflunomide medac.
Other information about Leflunomide medac
On 27 July 2010, the European Commission granted Medac, Gesellschaft für klinische Spezialpräparate mBH a "marketing authorization" for Leflunomide medac, valid throughout the European Union. The "marketing authorization" is valid for five years. , after which it can be renewed.
For the full EPAR version of Leflunomide medac click here. For more information about Leflunomide medac therapy, read the package leaflet (also included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 06-2010
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