Leflunomide 10mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 this medicine (listed in section 6),
• 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.

Talk to your doctor, pharmacist or nurse before taking Leflunomide

• if you have ever suffered from inflammation of the lung (interstitial lung disease).
• if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.
• if you are male and wish to father a child as it cannot be excluded that Leflunomide passes into semen, reliable contraception should be used during treatment with Leflunomide. Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide and take certain medicines to remove Leflunomide rapidly and sufficiently from their body. You will then need a blood test to make sure that Leflunomide has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
• if you are due to have a specific blood test (calcium level). Falsely low levels of calcium can be detected.

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:

• 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,
• warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine,
• teriflunomide for multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer,
• duloxetine for depression, urinary incontinence or in kidney disease in diabetics,
• alosetron for the management of severe diarrhoea,
• theophylline for asthma,
• tizanidine, a muscle relaxant,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indomethacin, ketoprofen for pain or inflammation,
• furosemide for heart disease (diuretic, water pill),
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide which is absorbed by the body.

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.

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 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.

• The active substance is leflunomide.
  One film-coated tablet contains 10 or 20 mg of leflunomide.
• The other ingredients are: cellulose microcrystalline, pregelatinized starch (maize starch 1500), povidone (E1201) (k30), crospovidone (E1202) (Type A), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as Opadry II White OY-LS-28908 in the 10mg film-coating [consisting of: titanium dioxide (E171), lactose monohydrate, hypromellose 15cP (E464), macrogol/PEG 4000, hypromellose 3cP (E464), hypromellose 50cP (E464)] or Opadry OY-SR-6497 in the 20mg film-coating [consisting of: hypromellose 15cP (E464), titanium dioxide (E171), macrogol 6000, talc, iron oxide yellow (E172)].

• Leflunomide 10mg film-coated tablets are white, round biconvex tablets.
• Leflunomide 20mg film-coated tablets are yellow, round biconvex, with a scoreline on one side. The scoreline is for the purpose of identification only.

The tablets are packed in bottles and aluminium (Alu/Alu) foil blisters of 30 tablets.

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