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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 11311/0660.
Leflunomide Tillomed 10 mg and 20mg Tablets
Leflunomide Tillomed 10 mg Tablets
Leflunomide Tillomed 20 mg Tablets
leflunomide
1. What Leflunomide Tillomed is and what it is used for
2. What you need to know before you take Leflunomide Tillomed
3. How to take Leflunomide Tillomed
4. Possible side effects
5. How to store Leflunomide Tillomed
6. Contents of the pack and other information
Leflunomide Tillomed belongs to a group of medicines called anti-rheumatic medicines. The active substance is leflunomide. It 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 or pharmacist 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 Systemic 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 ulcer during treatment with leflunomide (see also section 4).
Leflunomide is not recommended for use in children and adolescents below 18 years of age.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription.
This is especially important if you are taking:
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 Tillomed 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 remove leflunomide rapidly and sufficiently from your 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 medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.
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 dose of Leflunomide is one 100 mg tablet once daily for the first three days. After this, most patients need a dose of:
Swallow the tablet whole and with plenty of water. Leflunomide can be taken with or without food.
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 tablets 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking leflunomide:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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 (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS and skin ulcer (round, open sore in the skin through which the underlying tissues can be seen), may also occur with an unknown 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 label/blister and the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
HDPE bottle: After first opening use within 100 days.
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.
Leflunomide Tillomed 10mg tablets are white to off-white, round, biconvex tablets, debossed with 'EM58' on one side and plain other side.
Leflunomide Tillomed 20mg tablets are white to off-white, triangle, biconvex tablets, debossed with 'EM' on one side and '59' on other side.
Leflunomide Tillomed is available in blisters and High Density Polyethylene (HDPE) bottles of 30 and 100 tablets.
Not all pack sizes may be marketed
This leaflet was last revised in 09/2024