Repso 20 mg film-coated tablets

Repso belongs to a group of medicines called anti-rheumatic medicines.

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).

Do not take Repso

• If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Steven-Johnson syndrome) or any of the other ingredients of Repso.
• 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, breast-feeding or you are still able to have a child and you are not using reliable contraception.

Take special care with 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 tuberculosis (a lung disease).
• If you are male and wish to father a child, as Repso can cause birth defects in new born babies. To reduce any possible risk, if you wish to father a child you should contact your doctor who may advise you to stop taking Repso and take certain medicines to speed up the removal of Repso from your 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.

Repso can occasionally cause some problems with your blood, liver or lungs. 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 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.

Use in Children

Repso is not recommended for use in children and adolescents below 18 years of age.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially if you are taking any of the following:

• Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine. Because you may get increased side effects, it is not recommended to take any of these medicines while you are taking Repso.
• Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
• 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 Repso.

Vaccinations

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.

Taking Repso with food and drink
Drinking alcohol while taking Repso may increase the chance of liver damage. Therefore, it is not recommended to drink alcohol during treatment.

Pregnancy and breast-feeding
Do not take Repso if you are pregnant, or think you may be pregnant.

If you are still able to have a child, you must not take Repso 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 Repso from your body.

If you think you may be pregnant while you are taking Repso, 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 speed up the removal of Repso from your body. This may decrease the risk to your baby.

If after stopping treatment with Repso you plan to become pregnant, you need to ensure that Repso has left your body before trying to become pregnant. This should be comfirmed by a blood test. If Repso has been sufficiently removed from your body, you should wait at least another 6 weeks before you become pregnant.

For further information on the laboratory testing please contact your doctor.

Repso passes into breast milk. Therefore, do not breast-feed during treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Repso may make you dizzy. This may affect your ability to concentrate or react properly. If this happens to you, do not drive or machines.

Important information about some of the ingredients of Repso

Repso contains lactose. 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 Repso exactly as your doctor has told you. You should 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 take more Repso than you should
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.

If you forget to take Repso
In case you forget to take a dose, take it as soon as you rememebr. 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, Repso 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 ulcersin 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:

• Pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood.
• Tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal.
• Any symptoms of an infection such as fever, sore throat or cough, as Repso 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).

Common side effects (affects 1 to 10 users in 100):

• 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.

Uncommon side effects (affects 1 to 10 users in 1,000):

• 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.

Rare side effects (affects 1 to 10 users in 10,000):

• 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).

Very rare side effects (affects less than 1 user in 10,000):

• An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
• A disorder of the nerves which can cause weakness, tingling or numbness.
• 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.

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 out of the reach and sight of children.

Do not use Repso 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Repso contains

• The active substance is leflunomide.
• Each Repso 20 mg film-coated tablet contains 20 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, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake and indigo carmine aluminium Lake.

What Repso looks like and contents of the pack

Repso 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ?20? on one side and ?L? on the other.

Repso stored in bottles are available in pack sizes of 30 and 100 film-coated tablets. Repso 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 and Manufacturer

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

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:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Pharma, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.