Do not take Arava
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or to any of the other ingredients of Arava,
- if you have any liver problems,
- if you have moderate to severe kidney problems,
- if you have severely low numbers of proteins in your blood (hypoproteinaemia),
- if you suffer from any problem which affects your immune system (e.g. AIDS),
- if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets,
- if you are suffering from a serious infection,
- if you are pregnant, think you may be pregnant, or are breast-feeding.
Take special care with Arava
- if you have ever suffered from tuberculosis or interstitial lung disease (lung disease),
- if you are male and wish to father a child. As it can not be excluded that Arava passes into semen, reliable contraception should be used during treatment with Arava. Men wishing to father a child should contact their doctor who may advise them to stop taking Arava and take certain medicines to remove Arava rapidly and sufficiently from their body. You will then need a blood test to make sure that Arava has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Arava can occasionally cause some problems with your blood, liver or lungs. It may also cause some serious allergic reactions, or increase the chance of a severe infection. For more information on these, please read section 4 (Possible side effects).
Your doctor will carry out blood tests at regular intervals, before and during treatment with Arava, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
Arava is not recommended for use in children and adolescents below 18 years of age.Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is especially important if you are taking:
- other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
- a medicine called colestyramine (used to reduce high cholesterol) or activatedcharcoal as these medicines can reduce the amount of Arava which is absorbed by the body,
- phenytoin (used to treat epilepsy), warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Arava.
If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Arava, and for a certain amount of time after stopping treatment.
Taking Arava with food and drink
Arava may be taken with or without food.
It is not recommended to drink alcohol during treatment with Arava. Drinking alcohol while taking Arava may increase the chance of liver damage.
Pregnancy and breast-feedingDo not take Arava if you are, or think you may be pregnant. If you are pregnant or become pregnant while taking Arava, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Arava without using reliable contraceptive measures.
Tell your doctor if you plan to become pregnant after stopping treatment with Arava, as you need to ensure that all traces of Arava have left your body before trying to become pregnant. This may take up to 2 years. This may be reduced to a few weeks by taking certain medicines which speed up removal of Arava from your body.
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
For further information on the laboratory testing please contact your doctor.
If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Arava rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Do not take Arava when you are breast feeding, as leflunomide passes into the breast milk.
Driving and using machines
Arava can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.
Important information about some of the ingredients of Arava
Arava contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.