ARAVA

This medicine contains the active ingredient leflunomide which belongs to disease-modifying antirheumatic medicines. These medicines reduce the inflammation caused by immune system antibodies that attack tissues of the body. Leflunomide is prescribed for the treatment of active rheumatoid arthritis (inflammation, swelling and pain of joints, fever, anemia, tiredness) or active psoriatic arthritis (inflammation, swelling and pain of joints, skin lesions).

Is Leflunomide suitable for me?

Leflunomide is not suitable for everyone. Do not use it

• if you are allergic to leflunomide or to other ingredients of this medicine
• if you have kidney or liver problems
• if you have low numbers of proteins in your blood (hypoproteinaemia)
• if you have low numbers of red or white cells in your blood
• if you have severe infection
• if you are pregnant, planning to get pregnant, or breastfeeding

In particular, you must tell the doctor if you:

• are pregnant, planning to get pregnant, or breastfeeding 
• have any signs of infection
• have liver problems
• have kidney problems
• have ever had tuberculosis or interstitial lung disease
• have a problem which affects your immune system, such as AIDS.

Leflunomide interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Leflunomide?

This medicine is available in form of a film-coated tablet.

You should take leflunomide exactly as instructed by your doctor or pharmacist. The dose is determined according to your needs and condition.

• For the first three days of the treatment, the usual dose is 100 mg taken once a day.
• The maintenance dose for rheumatoid arthritis is 10 or 20 mg taken once a day.
• The maintenance dose for psoriatic arthritis is 20 mg taken once a day.

 Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor instructed. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day. Do not take two doses together if you miss a dose.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Leflunomide side effects?

Like all medicines leflunomide can cause side effects, including:

Common side effects:

• mild allergic reactions
• loss of appetite, weight loss
• tiredness
• headache, dizziness
• tingling of the skin
• mild increase in blood pressure
• colitis
• diarrhea
• nausea, vomiting
• inflammation of the mouth or mouth ulcers
• abdominal pain
• an increase in some liver test results
• increased hair loss
• eczema, dry skin, rash, itching
• tendonitis

Uncommon side effects:

• decrease in the number of red blood cells (anaemia)
• decrease in the number of blood platelets (thrombocytopenia)
• decrease in the levels of potassium in the blood
• anxiety
• taste disturbances
• urticaria (nettle rash)
• tendon rupture
• increase in the levels of fat in the blood (cholesterol and triglycerides)
• decrease in the levels of phosphate in the blood

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.