The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 35533/0008.
Leflunomide 10mg. 20mg film-coated tablets
Leflunomide 10, 20mg film-coated tablets
1. What Leflunomide is and what it is used for
2. What you need to know before you take Leflunomide
3. How to take Leflunomide
4. Possible side effects
5. How to store Leflunomide
6. Contents of the pack and other information
Leflunomide belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Leflunomide is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain. Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Talk to your doctor, pharmacist or nurse before taking Leflunomide
Leflunomide can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs. It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systematic Symptoms [DRESS]), or increase the chance of a severe infection. For more information on these, please read section 4 (Possible side effects).
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Leflunomide can cause an increase in blood pressure.
Tell your doctor if you have unexplained chronic diarrhoea. Your doctor may perform additional tests for differential diagnosis.
Tell your doctor if you develop skin ulcers during treatment with Leflunomide (see also section 4).
Leflunomide is not recommended for use in children and adolescents below 18 years of age.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
This is especially important if you are taking:
If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide.
If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Leflunomide, and for a certain amount of time after stopping treatment.
Leflunomide may be taken with or without food.
It is not recommended to drink alcohol during treatment with Leflunomide. Drinking alcohol while taking Leflunomide may increase the chance of liver damage.
Do not take Leflunomide if you are, or think you may be pregnant. If you are pregnant or become pregnant while taking Leflunomide, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Leflunomide without using reliable contraceptive measures.
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide, as you need to ensure that all traces of Leflunomide 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 Leflunomide from your body.
In either case it should be confirmed by a blood test that Leflunomide 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 Leflunomide 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 speed up the removal of Leflunomide from the body, as this may decrease the risk to your baby.
Do not take Leflunomide when you are breast-feeding, as leflunomide passes into the breast milk.
Leflunomide can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual starting dosage of Leflunomide is 100mg once daily for the first three days. After this, most patients need a dose of:
Swallow the tablet whole and with plenty of water.
It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some patients may even still feel further improvements after 4 to 6 months of therapy.
You will normally take Leflunomide over long periods of time.
If you take more Leflunomide than you should, contact your doctor or get other medical advice. If possible, take your tablets or the box with you to show the doctor.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Leflunomide:
Tell your doctor immediately if you experience:
Common side effects
(may affect up to 1 in 10 people)
Uncommon side effects
(may affect up to 1 in 100 people)
Rare side effects
(may affect up to 1 in 1,000 people)
Very rare side effects
(may affect up to 1 in 10,000 people)
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterised by rash/ erythema on skin areas that are exposed to light) and psoriasis (new or worsening), DRESS and skin ulcer (round, open sore in the skin through which the underlying tissues can be seen),may also occur with a not known frequency.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Bottle: Keep the container tightly closed.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The tablets are packed in bottles and aluminium (Alu/Alu) foil blisters of 30 tablets.
This leaflet was last revised in 06/2022
1010078 - P4.2