Do not take Repso
- If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Steven-Johnson syndrome) or any of the other ingredients of Repso.
- If you have liver problems.
- If you suffer from a severe condition that affects your immune system e.g. AIDS.
- If you have bone marrow problems, or if you have low numbers of red or white blood cells or a reduced number of blood platelets, due to causes other than rheumatoid or psoriatic arthritis.
- If you have a serious infection.
- If you suffer from moderate to severe kidney problems.
- If you have very low levels of protein in your blood (hypoproteinaemia).
- If you are pregnant, breast-feeding or you are still able to have a child and you are not using reliable contraception.
Take special care with Repso
- If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Repso from your body.
- If you develop swollen spongy gums, ulcers, and loose teeth (an infectious mouth disease known as ulcerative stomatitis) then you should contact your doctor who may advise you to stop taking Repso.
- If you switch to another medicine to treat your rheumatoid arthritis or if you have recently taken medicines that may be harmful to your liver or blood, your doctor may advise you to take certain medicines to speed up the removal of Repso from your body or may closely monitor you when you start taking Repso.
- If you have ever had tuberculosis (a lung disease).
- If you are male and wish to father a child, as Repso can cause birth defects in new born babies. To reduce any possible risk, if you wish to father a child you should contact your doctor who may advise you to stop taking Repso and take certain medicines to speed up the removal of Repso from your body. You will then need a blood test to make sure that Repso has been sufficiently removed from your body, and you should then wait for at least another 3 months.
Repso 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).
Before and during treatment with Repso, your doctor will carry out blood tests at regular times. This is to monitor your blood cells and liver. Since Repso can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Use in Children
Repso 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.
Especially if you are taking any of the following:
- Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine. Because you may get increased side effects, it is not recommended to take any of these medicines while you are taking Repso.
- Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
- Other medicines that are broken down by an enzyme called CYP2C9 e.g. phenytoin (an epilepsy treatment), warfarin and phenprocoumon (blood thinners), and tolbutamide (a type 2 diabetes treatment). Discuss with your doctor to find out if any medicine you are taking is broken down by CYP2C9.
If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue to use these after starting Repso.
Please discuss with your doctor if you have to take any vaccinations. Some vaccinations should not be given while taking Repso, and for a certain amount of time after stopping treatment.
Taking Repso with food and drink
Drinking alcohol while taking Repso may increase the chance of liver damage. Therefore, it is not recommended to drink alcohol during treatment.
Pregnancy and breast-feeding
Do not take Repso if you are pregnant, or think you may be pregnant.
If you are still able to have a child, you must not take Repso without using reliable contraception for at least 2 years after treatment. This 2 years may be reduced to a few weeks if you take a treatment, recommended by your doctor, which speeds up removal of Repso from your body.
If you think you may be pregnant while you are taking Repso, contact your doctor immediately for a pregnancy test. If you are pregnant, your doctor will discuss with you the risks to the pregnancy. Your doctor may recommend a treatment to speed up the removal of Repso from your body. This may decrease the risk to your baby.
If after stopping treatment with Repso you plan to become pregnant, you need to ensure that Repso has left your body before trying to become pregnant. This should be comfirmed by a blood test. If Repso has been sufficiently removed from your body, you should wait at least another 6 weeks before you become pregnant.
For further information on the laboratory testing please contact your doctor.
Repso passes into breast milk. Therefore, do not breast-feed during treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Repso may make you dizzy. This may affect your ability to concentrate or react properly. If this happens to you, do not drive or machines.
Important information about some of the ingredients of Repso
Repso contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product