Leflunomide medac 10 mg film-coated tabletsLeflunomide medac 20 mg film-coated tablets

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

Leflunomide medac 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 anaemia (lack of red blood cells).

Do not take Leflunomide medac 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 medac, 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 medac

- if you have ever suffered from tuberculosis (a lung disease),
- if you are male and wish to father a child, as Leflunomide medac 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 medac and take certain medicines to speed up the removal of Leflunomide medac from your body. You will then need a blood test to make sure that Leflunomide medac has been sufficiently removed from your body, and you should then wait for at least another 3 months.

Leflunomide medac 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 medac, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly as Leflunomide medac can cause an increase in blood pressure.

Use in children

Leflunomide medac 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 medac which is absorbed by the body,

phenytonin 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 medac.

Vaccinations

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

Taking Leflunomide medac with food and drink

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

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

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

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

Driving and using machines
Leflunomide medac 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 medac

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

Always take Leflunomide medac 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 medac is 100 mg once daily for the first three days. After this, most patients need a dose of:
- For rheumatoid arthritis: 10 or 20 mg Leflunomide medac 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 medac over long periods of time.

If you take more Leflunomide medac than you should
If you take more Leflunomide medac 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 medac
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 medac can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Leflunomide medac:
- 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 medac 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 medac 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 medac 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 medac contains

The active substance is leflunomide. One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 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, polyvinyl alcohol, talc, titanium dioxide E171 and xanthan gum in the film-coating.

What Leflunomide medac looks like and contents of the pack

Leflunomide medac 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet. The tablet can be divided into equal halves.

The tablets are packed in bottles.
Leflunomide medac 20 mg film-coated tablets: Pack sizes of 15, 30, 60, 90 or 100 film-coated tablets per bottles are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

medac
Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg
Germany

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

medac
Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg
Germany

Production Site:
Theaterstr. 6
22880 Wedel
Germany

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

BelgiëBelgiqueBelgien Lamepro B.V. TélTel 31 162 51 49 04 Leflunomidemedac.eu medac GmbH 49 4103 8006 0 Leflunomidemedac.eu

medac GmbH Te. 49 4103 8006 0 Leflunomidemedac.eu LuxembourgLuxemburg medac GmbH TélTel 49 4103 8006 0 Leflunomidemedac.eu

eská republika Slovenská republika medac GmbH organizacni slozka Tel 420 543 233 857 Leflunomidmedac.eu Magyarország Axxess Kft. Tel 36 1 769 2287 Leflunomidemedac.eu

Danmark Norge Sverige medac Scandinavia Tlf 46 340 64 54 70 Leflunomidmedac.eu Malta medac GmbH Tel 49 4103 8006 0 Leflunomidemedac.eu

Deutschland medac GmbH Tel 49 4103 8006 0 Leflunomidmedac.eu Nederland medac GmbH Tel 49 4103 8006 0 Leflunomidemedac.eu

Eesti Latvija Lietuva ViaSana Tel 370 5 2788 414 Leflunomidemedac.eu Österreich medac GmbH Tel 49 4103 8006 0 Leflunomidemedac.eu

Alapis S.A. 30 2130 175064 Leflunomidemedac.eu Polska medacGmbH Sp. z.o.o. Tel 48 22 576 8060 Leflunomidmedac.eu

España Laboratorios Gebro Pharma, S.A. Tel 34 93 205 86 86 Leflunomidamedac.eu Portugal medac GmbH - Sucursal em Portugal Tel 351 21 410 75 83 Leflunomidamedac.eu

France medac GmbH Tél 49 4103 8006 0 Leflunomidemedac.eu România First Pharma Services S.R.L. Tel 40 31 416 30 58 Leflunomidemedac.eu

Ireland medac GmbH Tel 49 4103 8006 0 Leflunomidemedac.eu Slovenija Medis, d.o.o., Tel 386 1 589 69 00 Leflunomidmedac.eu

Ísland medac GmbH Sími 49 4103 8006 0 Leflunomidemedac.eu SuomiFinland medac GmbH sivuliike suomessa PuhTel 358 10 420 4000 Leflunomidemedac.eu

Italia medac GmbH Tel 49 4103 8006 0 Leflunomidemedac.eu United Kingdom medac UK Tel 44 01786458086 Leflunomidemedac.eu

This leaflet was last approved in