Repso
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. See section 4.
What Repso is and what it is used for
What you need to know before you take Repso
How to take Repso
Possible side effects
How to store Repso
Contents of the pack and other information
Medicinal product no longer authorised
Repso belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic 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).
Psoriatic arthritis is the combination of psoriasis and arthritis. The symptoms include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
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), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
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.
If you are woman of child-bearing age and not using effective contraception.
Talk to your doctor, pharmacist or nurse before taking 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 interstitial lung disease (feeling a shortness of breath).
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 Repso passes into semen, reliable contraception should be used during treatment with Repso. Men wishing to father a child should contact their doctor who may advise them to stop taking Repso and take certain medicines to remove Repso rapidly and sufficiently from their 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 before attempting to father a child.
Repso 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).
Medicinal product no longer authorised
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.
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.
Tell your doctor if you have unexplained chronic diarrhoea. Your doctor may perform additional tests for differential diagnosis.
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.
Especially if you are taking any of the following:
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.
Drinking alcohol while taking Repso may increase the chance of liver damage. Therefore, it is not recommended to drink alcohol during treatment.
Medicinal product no longer authorised
Tell your doctor if you plan to become pregnant after stopping treatment with Repso, as you need to ensure that all traces of Repso 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 Repso from your body.
In either case it should be confirmed by a blood test that Repso 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 Repso 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 Repso rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Repso may make you dizzy. This may affect your ability to concentrate or react properly. If this happens to you, do not drive or use machines.
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 Repso and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
The usual starting dose is 100 mg once a day for 3 days. After this the dose is:
For rheumatoid arthritis: 10 mg or 20 mg once daily depending on the severity of the disease.
For psoriatic arthritis: 20 mg once daily.
Repso tablets should be swallowed whole with plenty of water. Repso 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 Repso 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 Repso
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, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
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.
disease or pulmonary hypertension).
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.
Slight 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.
Colitis.
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, wrist or feet.
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.
Problems in the nerves of the arms or legs (peripheral neuropathy).
Medicinal product no longer authorised
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.
Decrease in the number of all blood cells (pancytopenia)
A pronounced reduction in the number of white blood cells, which makes infections more likely (leucopenia).
An increase in the number of blood cells called eosinophiles (eosinophilia).
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.
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 (see above and section 2) may also occur with an unknown frequency.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V. 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 that is stated on the outer carton, blister or tablet container after EXP. The expiry date refers to the last day of that month.
For tablets stored in tablet containers: Do not store above 30°C. For tablets stored in blisters: Do not store above 25°C.
Medicinal product no longer authorised
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.
The active substance is leflunomide.
Each film-coated tablet contains 10 mg of leflunomide.
The other ingredients are (see section 2 “Repso contains lactose”)
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.
Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Repso provided in tablet containers are available in pack sizes of 30 and 100 film-coated tablets. Repso provided in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Teva B.V. Swensweg 5 2031GA Haarlem
The Netherlands
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
Pharmachemie B.V. Swensweg 5
2031 GA Haarlem The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 3 820 73 73
UAB “Sicor Biotech” Tel: +370 5 266 0203
Medicinal product no longer authorised
Тева Фармасютикълс България ЕООД Teл: +359 2 489 95 82
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Teva Denmark A/S Tlf: +45 44 98 55 11
Teva Pharmaceuticals Ireland, L-Irlanda Tel: +353 51 321740
TEVA GmbH
Tel: +49 731 402 08
Teva Nederland B.V. Tel: +31 800 0228 400
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 97 007
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
Teva Pharma - Produtos Farmacêuticos Lda
Tél: +33 1 55 91 78 00 Tel: +351 21 476 75 50
Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000
Teva Pharmaceuticals Ireland Tel: +353 51 321740
Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
ratiopharm Oy, Finnland Sími: +358 20 180 5900
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11
Teva Italia S.r.l.
Tel: +39 02 89 17 98 1
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε., Ελλάδα Τηλ: +30 210 72 79 099
Teva Sweden AB Tel: +46 42 12 11 00
Medicinal product no longer authorised
UAB “Sicor Biotech” filiāle Latvijā Tel: +371 673 23 666
Teva UK Limited
Tel: +44 1977 628500