Leflunomide Teva
leflunomide
leflunomide
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.
What Leflunomide Teva is and what it is used for
What you need to know before you take Leflunomide Teva
How to take Leflunomide Teva
Possible side effects
How to store Leflunomide Teva
Medicinal product no longer authorised
Contents of the pack and other information
Leflunomide Teva belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Leflunomide Teva is used to treat adult patients with active rheumatoid arthritis.
Rheumatoid arthritis is a crippling form of arthritis. The symptoms 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 anemia (lack of red blood cells).
If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6).
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, think you may be pregnant, or are breast-feeding.
Talk to your doctor, pharmacist or nurse before taking Leflunomide Teva
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 Leflunomide Teva 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 Leflunomide Teva.
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 Leflunomide Teva from your body or may closely monitor you when you start taking Leflunomide Teva.
If you have ever had tuberculosis or interstitial lung disease (lung disease).
If you are male and wish to father a child. As it cannot be excluded that Leflunomide Teva passes into semen, reliable contraception should be used during treatment with Leflunomide Teva. Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide Teva and take certain medicines to remove Leflunomide Teva rapidly and sufficiently from their body. You will then need a blood test to make sure that Leflunomide Teva has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Medicinal product no longer authorised
Leflunomide Teva 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, 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 Leflunomide Teva, your doctor will carry out blood tests at regular times. This is to monitor your blood cells and liver. Since Leflunomide Teva can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially if you are taking any of the following:
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 Leflunomide Teva.
Please discuss with your doctor if you have to take any vaccinations. Some vaccinations should not be given while taking Leflunomide Teva, and for a certain amount of time after stopping treatment.
Drinking alcohol while taking Leflunomide Teva may increase the chance of liver damage. Therefore, it is not recommended to drink alcohol during treatment.
If you are still able to have a child, you must not take Leflunomide Teva 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 Leflunomide Teva from your body.
Medicinal product no longer authorised
If you think you may be pregnant while you are taking Leflunomide Teva, 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 remove Leflunomide Teva rapidly and sufficiently from your body. This may decrease the risk to your baby.
For further information on the laboratory testing please contact your doctor.
Leflunomide Teva passes into breast milk. Therefore, do not breast-feed during treatment. Ask your doctor or pharmacist for advice before taking any medicine.
Leflunomide Teva may make you dizzy. This may affect your ability to concentrate or react properly.
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 doctor that starts you on Leflunomide Teva and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis.
The usual starting dose is 100 mg once a day for 3 days. After this the dose is 10 mg or 20 mg once daily depending on the severity of the disease.
Leflunomide Teva tablets should be swallowed whole with plenty of water. Leflunomide Teva tablets can be taken with or without food.
It will take 4 to 6 weeks before you feel an improvement in your condition. Some people will notice further improvement after 4 to 6 months of treatment.
You will normally take Leflunomide Teva over long periods of time.
If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Medicinal product no longer authorised
In case you forget to take a dose, take it as soon as you remember. 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, 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 Teva:
If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a
serious allergic reaction.
If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Tell your doctor immediately if you experience:
Any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening.
A cough or breathing problems as these may indicate inflammation of the lung (interstitial lung disease).
unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Mild increase in blood pressure.
Reduction in the number of white blood cells, which makes infections more likely (leucopenia).
Skin sensation, i.e. burning, prickling, itching, or tingling (paraesthesia).
Hedache.
Dizziness.
Diarrhoea.
Nausea.
Vomiting.
Mouth ulcers or inflammation.
Abdominal pain.
Increased hair loss.
Eczema.
Rash.
Itching.
Dry skin.
Pain, swelling and tenderness most often in the hand or wrist.
An increase of certain enzymes in the blood (creatine phosphokinase).
Loss of appetite.
Weight loss (usually insignificant).
Lack or loss of strength (weakness).
Mild allergic reactions.
An increase in some liver test results.
Medicinal product no longer authorised
problems in the nerves of the arms or legs (peripheral neuropathy).
Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia).
Mild reduction in blood platelets, which increases the risk of bleeding or bruising.
Taste disturbances.
Nettle rash (urticaria).
Ruptured tendons.
Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm.
An increase in the levels of fat in the blood (cholesterol and triglycerides).
A decrease in the levels of phosphate in the blood.
Anxiety.
Severe increase in blood pressure.
Severe reduction in blood cells which can cause weakness, bruising or make infections more likely.
Severe reduction in the number of white blood cells, which makes infections more likely (leucopenia).
Blood disorder.
Inflammation of the lung (interstitial lung disease), which may be fatal.
An increase of lactate dehydrogenase (a blood enzyme).
Severe infections (including sepsis), which may be fatal.
Hepatitis (inflammation of the liver).
Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice).
An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Inflammation of the pancreas, which causes severe pain in the abdomen and back.
Severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Severe allergic reaction.
Inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis).
Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal.
Not known side effects (frequency cannot be estimated from the available data):
Kidney failure.
Abnormal decrease in the levels of blood uric acid.
Reversible male infertility.
Cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light)
Psoriasis (new or worsening)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep this medicine out of the sight and reach of children.
Medicinal product no longer authorised
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP. The expiry date refers to the last day of that month.
For tablets stored in bottles: Do not store above 30°C. For tablets stored in blisters: Do not store above 25°C.
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 active substance is leflunomide.
Each Leflunomide Teva 10 mg film-coated tablet contains 10 mg of leflunomide.
The other ingredients are:
Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate.
Tablet coating: titanium dioxide, polydextrose, hypromellose, triethyl citrate and macrogol 8000.
Leflunomide Teva 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Leflunomide Teva stored in bottles are available in pack sizes of 30 and 100 film-coated tablets. Leflunomide Teva stored in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Teva Pharma B.V. Computerweg 10
3542 DR Utrecht The Netherlands
Manufacturers:
Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Debrecen H-4042 Hungary
TEVA UK Ltd
Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Medicinal product no longer authorised
Pharmachemie B.V. Swensweg 5
2031 GA Haarlem The Netherlands
TEVA Santé Rue Bellocier 89107 Sens France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
UAB “Sicor Biotech” Tel: +370 5 266 02 03
Тева Фармасютикълс България ЕООД Teл: +359 2 489 95 82
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Magyarország Zrt Tel.: +36 1 288 64 00
Teva Denmark A/S Tlf: +45 44 98 55 11
Drugsales Ltd.
Τel: +356 21 419070
Teva GmbH
Tel: (49) 731 402 08
Teva Nederland B.V.
Tel: +31 (0) 800 0228400
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 661 0801
Teva Norway AS Tlf: +47 66 77 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 00 7
Teva Pharma, S.L.U Tél: +(34) 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +(48) 22 345 93 00
Teva Santé
Tél: +(33) 1 55 91 7800
Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 21 476 75 50
Medicinal product no longer authorised
Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000
Teva Pharmaceuticals Ireland Tel: +353 51 321740
Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
ratiopharm Oy Sími: +358 20 180 5900
Teva Pharmaceuticals Slovakia s.r.o. Tel: +(421) 2 5726 7911
Teva Italia S.r.l.
Tel: +(39) 028917981
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
Teva Sweden AB
Tel: +(46) 42 12 11 00
UAB Sicor Biotech filiāle Latvijā Tel: +371 67 784 980
Teva UK Limited
Tel: +(44) 1977 628500