Leflunomide ratiopharm 10 mg film-coated tablets

Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines.

Leflunomide ratiopharm is used to treat adult patients with active rheumatoid 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 anemia (lack of red blood cells).

Do not take Leflunomide ratiopharm

• 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. Steven-Johnson syndrome), peanut or soya or to any of the other ingredients of Leflunomide ratiopharm,
• 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 or breast-feeding.

Take special care with Leflunomide ratiopharm

• if you have ever suffered from tuberculosis (a lung disease),
• if you are male and wish to father a child, as Leflunomide ratiopharm can cause birth defects in new born infants. To minimise any possible risk, men wishing to father a child should contact their doctor who may advise you to stop taking Leflunomide ratiopharm and take certain medicines to speed up the removal of Leflunomide ratiopharm from your body. You

will then need a blood test to make sure that Leflunomide ratiopharm has been sufficiently removed from your body, and you should then wait for at least another 3 months.

Leflunomide ratiopharm 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).

Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide ratiopharm, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.

Leflunomide ratiopharm 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.

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,
• a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the body,
• phenytoin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.

If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide ratiopharm.

Vaccinations

If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment.

Taking Leflunomide ratiopharm with food and drink

Leflunomide ratiopharm may be taken with or without food.
It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm. Drinking alcohol while taking Leflunomide ratiopharm may increase the chance of liver damage.

Pregnancy and breast-feeding
Do not take Leflunomide ratiopharm if you are, or think you may be pregnant. Women of childbearing potential must not take Leflunomide ratiopharm without using reliable contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide ratiopharm, as you need to ensure that all traces of Leflunomide ratiopharm 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 ratiopharm from your body. In either case it should be confirmed by a blood test that Leflunomide ratiopharm 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 ratiopharm 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 ratiopharm from the body, as this may decrease the risk to your baby.

Do not take Leflunomide ratiopharm when you are breast-feeding, as leflunomide passes into the breast milk.

Driving and using machines
Leflunomide ratiopharm can make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive, or use machines.

Important information about some of the ingredients of Leflunomide ratiopharm Leflunomide ratiopharm 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.

Leflunomide ratiopharm contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

Always take Leflunomide ratiopharm exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dosage of Leflunomide ratiopharm is 100 mg once daily for the first three days. After this, most patients need a dose of:

• 10 or 20 mg Leflunomide ratiopharm once daily, depending on the severity of the disease.

Swallow the tablet whole and with plenty of water.

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 ratiopharm over long periods of time.

If you take more Leflunomide ratiopharm than you should
If you take more Leflunomide ratiopharm 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 Leflunomide ratiopharm
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 product, ask your doctor or pharmacist.

Like all medicines, Leflunomide ratiopharm can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Leflunomide ratiopharm:

• if you experience weakness, feel 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:

• 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 Leflunomide ratiopharm 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)

• a slight decrease in the number of white blood cells (leucopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually insignificant),
• tiredness (asthenia),
• headache, dizziness,
• abnormal skin sensations like tingling (paraesthesia),
• mild increase in blood pressure,
• diarrhoea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• an increase in some liver test results,
• increased hair loss,
• eczema, dry skin, rash, itching,
• tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
• an increase of certain enzymes in the blood (creatine phosphokinase).

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

• a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia),
• a decrease in the levels of potassium in the blood,
• anxiety,
• taste disturbances,
• urticaria (nettle rash),
• tendon rupture,
• an increase in the levels of fat in the blood (cholesterol and triglycerides),
• a decrease in the levels of phosphate in the blood.

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

• an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells (pancytopenia),
• severe increase in blood pressure,
• inflammation of the lung (interstitial lung disease),
• an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice,
• severe infections called sepsis which may be fatal,
• an increase of certain enzymes in the blood (lactate dehydrogenase).

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

• a marked decrease of some white blood cells (agranulocytosis),
• severe and potentially severe allergic reactions,
• inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
• problems in the nerves of the arms or legs (peripheral neuropathy),
• inflammation of the pancreas (pancreatitis),
• severe liver injury such as liver failure or necrosis which may be fatal,
• severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Leflunomide ratiopharm is stopped) may also occur with a not known frequency.

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 Leflunomide ratiopharm after the expiry date which is stated on the outer carton and on the bottle after EXP. The expiry date refers to the last day of that month.

Keep the bottle tightly closed in order to protect from moisture.

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 Leflunomide ratiopharm contains

• The active substance is leflunomide. One film-coated tablet contains 10 mg of leflunomide.
• The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating

What Leflunomide ratiopharm looks like and contents of the pack

Leflunomide ratiopharm 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.

The tablets are packed in bottles.
Pack sizes of 30 and 100 film-coated tablets per bottle are available.

Not all pack size may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
info@ratiopharm.de

Manufacturer

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien ratiopharm Belgium S.A. TélTel 32 2 761 10 11 LuxembourgLuxemburg ratiopharm S.A. Luxemburg TélTel 35 2 40 37 27

ratiopharm GmbH, Te 49 731 402 02 Magyarország ratiopharm Hungária Kft. Tel 36 1 273 2730

eská republika ratiopharm CZ s.r.o. Tel 420 2 510 21 122 Malta ratiopharm GmbH, Il ermanja Tel 49 731 402 02

Danmark ratiopharm AS Tlf 45 45 46 06 60 Nederland ratiopharm Nederland bv Tel 31 23 7070 840

Deutschland ratiopharm GmbH Tel 49 731 402 02 Norge ratiopharm AS Tlf 47 66 77 55 90

Eesti ratiopharm Eesti büroo Tel 372 6838 006 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel 43 1 97 007

ratiopharm GmbH, 49 731 402 02 Polska ratiopharm Polska Sp.z.o.o Tel 48 22 335 39 20

España ratiopharm España, S.A. Tel 34 91 567 29 70 Portugal ratiopharm, Comércio e Indústria de Produtos farmacêuticos Lda Tel 351 21 424 80 00

France Laboratoire ratiopharm S.A. Tél 33 1 42 07 97 04 România ratiopharm GmbH, Germania Tel 49 731 402 02

Ireland ratiopharm UK Ltd, United Kingdom Tel 44 239 238 6330 Slovenija ratiopharm GmbH, Nemija Tel 49 731 402 02

Ísland ratiopharm GmbH, skaland Sími 49 731 402 02 Slovenská republika ratiopharm Slovensko s.r.o. Tel 421 2 57 200 300

Italia ratiopharm Italia s.r.l. Tel 39 02 28 87 71 SuomiFinland ratiopharm Oy PuhTel 358 20 180 5900

ratiopharm GmbH, 49 731 402 02 Sverige ratiopharm AB Tel 46 42 37 0740

Latvija ratiopharm Latvijas prstvniecba Tel 371 67499110 United Kingdom ratiopharm UK Ltd Tel 44 239 238 6330

Lietuva
ratiopharm atstovas Lietuvoje
Tel: + 370 5 212 3295

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