Leflunomide medac

Package leaflet: Information for the user

Leflunomide medac 10 mg film-coated tablets

leflunomide
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Leflunomide medac is and what it is used for
2. What you need to know before taking Leflunomide medac
3. How to take Leflunomide medac
4. Possible side effects
5. How to store Leflunomide medac
6. Contents of the pack and other information

1. What Leflunomide medac is and what it is used for

Leflunomide medac belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.
Leflunomide medac is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.
Symptoms of rheumatoid arthritis include joint inflammation, swelling, limited movement, and pain. Other symptoms that may affect the whole body include loss of appetite, fever, weakness, and anaemia (reduction in the number of red blood cells).
Symptoms of active psoriatic arthritis include joint inflammation, swelling, limited movement, pain, and red, scaly skin patches (skin lesions).

2. What you should know before taking Leflunomide medac

Do not take Leflunomide medac

• if you have previously experienced an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin or blisters, such as Stevens-Johnson syndrome), to peanuts or soy, or to 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 any liver problems,
• if you have moderate or severe kidney problems,
• if you have extremely low protein levels in the blood (hypoproteinemia),
• if you suffer from any condition affecting your immune system (e.g. AIDS),
• if you have any bone marrow disorder, or if your red blood cell or white blood cell count is low, or if your platelet count is reduced,
• if you have a serious infection,
• if you are pregnant, planning to become pregnant, or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Leflunomide medac

• if you have ever had lung inflammation (interstitial lung disease).
• if you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to check whether you have tuberculosis.
• if you are male and intend to father a child. Since it cannot be ruled out that Leflunomide medac passes into semen, you must use a reliable contraceptive method during treatment with Leflunomide medac. Men who intend to father a child should contact their doctor, who may advise stopping treatment with Leflunomide medac and taking certain medications to rapidly and adequately eliminate Leflunomide medac from the body. After this, a blood test must be performed to confirm that Leflunomide medac has been sufficiently removed from your body, and then you must wait at least another 3 months before attempting to conceive.
• if you need to undergo a specific blood test (calcium level). Falsely low calcium levels may be observed.
• if you are scheduled for, have recently undergone, or still have an unhealed wound following major surgery. Leflunomide medac may impair wound healing.

Rarely, Leflunomide medac can cause problems affecting the blood, liver, lungs, or nerves in the arms or legs. Leflunomide medac may also cause some serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or increase the risk of serious infections. For further information, see section 4 (Possible side effects).
DRESS syndrome initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, elevated liver enzymes and eosinophilia (a type of white blood cell) in blood tests, and swollen lymph nodes.
Before starting and during treatment with Leflunomide medac, your doctor will prescribe regular blood tests to monitor your blood cells and liver function. Your doctor will also check your blood pressure regularly, as Leflunomide medac may cause an increase in blood pressure.
Inform your doctor if you develop unexplained chronic diarrhea. Your doctor may perform additional tests for differential diagnosis.
Inform your doctor if a skin ulcer develops during treatment with Leflunomide medac (see also section 4).

Children and adolescents
The use of Leflunomide medac is not recommended in children and adolescents under 18 years of age.

Other medicines and Leflunomide medac
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription.
This information is particularly important if you are taking:

• other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive drugs (e.g. methotrexate), as these combinations are not recommended,
• warfarin and other oral anticoagulants (blood thinners), as monitoring is required to reduce the risk of side effects,
• teriflunomide for multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer,
• duloxetine for depression, urinary incontinence, or diabetic kidney disease,
• alosetron for managing severe diarrhea,
• theophylline for asthma,
• tizanidine, to relax muscles,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indometacin, ketoprofen for pain or inflammation,
• furosemide for heart disease (diuretic, water pill),
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• a medicine called cholestyramine (used to lower cholesterol) or activated charcoal, as these medicines may reduce the amount of Leflunomide medac absorbed by the body.

If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomide medac.

Vaccinations
If you need to be vaccinated, consult your doctor. Certain vaccinations should not be administered while taking Leflunomide medac, and for a certain period after stopping treatment.

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

Pregnancy and breastfeeding
Do not take Leflunomide medac if you are pregnant or think you might be pregnant. If you become pregnant while taking Leflunomide medac, the risk of having a baby with serious birth defects is increased. Women must not take Leflunomide medac without using reliable contraceptive measures when they are of childbearing age.
If you plan to become pregnant after stopping treatment with Leflunomide medac, it is important to inform your doctor in advance, as you must ensure that all traces of Leflunomide medac have been eliminated from your body before attempting to conceive.
Elimination of Leflunomide medac may take up to two years. This period can be reduced to a few weeks by taking certain medications that accelerate the removal of Leflunomide medac from your body.
In either case, before becoming pregnant, blood tests must confirm that Leflunomide medac has been sufficiently eliminated from your body, and then you must wait at least one additional month.
For further information about laboratory tests, contact your doctor.
If you suspect you are pregnant while taking Leflunomide medac or within two years after stopping treatment, you must inform your doctor immediately. Your doctor will arrange for a pregnancy test. If pregnancy is confirmed, your doctor will advise treatment with certain medications to rapidly and adequately eliminate Leflunomide medac from your body, thereby reducing the risk to your baby.

Do not take Leflunomide medac during breastfeeding, as leflunomide passes into breast milk.

Driving and using machines
Leflunomide medac may make you feel unsteady, and this sensation may affect your ability to concentrate and react. In this case, do not drive or operate machinery.

Leflunomide medac contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Leflunomide medac contains soy lecithin
Do not use this medicine if you are allergic to peanuts or soy.

Leflunomide medac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Leflunomide medac

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The starting dose of Leflunomide medac is usually 100 mg of leflunomide once daily for the first three days. Afterwards, most patients require:

• for rheumatoid arthritis: a daily dose of 10 to 20 mg of Leflunomide medac, depending on the severity of the disease.
• for psoriatic arthritis: a daily dose of 20 mg of Leflunomide medac.

Swallow the tablet whole with plenty of water.
It may take about 4 weeks or longer before you start to feel an improvement in your condition. Some patients may continue to experience further improvements even after 4 to 6 months of treatment.
Generally, Leflunomide medac is taken for long periods of time.

If you take more Leflunomide medac than you should
If you take more Leflunomide medac than prescribed, contact your doctor or seek medical advice immediately. If possible, take the tablets or the packaging with you to show your 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 almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with Leflunomide medac and contact your doctor immediately if:

• you experience a feeling of weakness, lightheadedness, or dizziness, or have difficulty breathing, as these symptoms may indicate a severe allergic reaction,
• you develop skin redness or mouth ulcers, as these may be signs of serious, sometimes fatal, allergic reactions (e.g., Stevens-Johnson syndrome,
  toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediately if you experience:

• pallor, fatigue, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells,
• fatigue, abdominal pain, or jaundice (yellowing of the eyes or skin), as these may indicate serious liver problems, which can be fatal,
• any signs of infection, such as fever, sore throat, or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
• cough or breathing difficulties, as these may indicate lung problems (lung interstitial disease or pulmonary hypertension),
• tingling, unusual weakness, or pain in the hands or feet, as these may indicate nerve problems (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• mild decrease in white blood cell count (leucopenia),
• moderate allergic reactions,
• loss of appetite, reduction in body weight (usually not significant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paraesthesia),
• moderate increase in blood pressure,
• colitis,
• diarrhoea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• increased values in certain liver function tests,
• increased hair loss,
• eczema, dry skin, redness, itching,
• tendinitis (pain due to inflammation of the sheath covering tendons, usually in hands or feet),
• increased levels of certain blood enzymes (creatine phosphokinase),
• nerve problems in arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• decrease in red blood cell count (anaemia) and decrease in platelet count (thrombocytopenia),
• decreased potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (red, itchy rash),
• tendon rupture,
• increased levels of fats in the blood (cholesterol and triglycerides),
• decreased phosphate levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• increase in blood cells called eosinophils (eosinophilia); mild decrease in white blood cells (leucopenia); reduction in all blood cell counts (pancytopenia),
• increased blood pressure,
• lung inflammation (lung interstitial disease),
• increased liver function test values that may lead to serious clinical conditions such as hepatitis and jaundice,
• severe infections known as sepsis, which may be fatal,
• increased levels of certain enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

• marked decrease in certain white blood cells (agranulocytosis),
• severe and potentially life-threatening allergic reactions,
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• severe liver damage such as liver failure or necrosis, which may be fatal,
• serious, sometimes fatal, reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as renal failure, decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is reversible when treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas exposed to light), psoriasis (onset or worsening), DRESS, and skin ulcers (a round, open sore in the skin through which underlying tissues can be seen) may occur at an unknown frequency.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leflunomide medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the
bottle after Exp. The expiry date refers to the last day of that month.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Leflunomide medac contains

• The active substance is leflunomide. Each Leflunomide medac film-coated tablet contains 10 mg of leflunomide.
• The other components are: lactose monohydrate, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate and magnesium stearate in the tablet core, as well as lecithin (soybean seeds), poly(vinyl alcohol), talc, titanium dioxide (E 171) and xanthan gum in the coating.

Description of the appearance of Leflunomide medac and contents of the pack
Leflunomide medac 10 mg film-coated tablets are white or almost white, round tablets with a diameter of approximately 6 mm.
The tablets are packed in bottles.
Leflunomide medac 10 mg film-coated tablets: packs containing 30, 60 or 100 film-coated tablets per bottle are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Κύπρος
Pharmanovia Benelux B.V. Gidamed Medical Supplies Ltd.
Tél/Tel: +31 76 560 0030 Τηλ: +357-257 510 30
[email protected] [email protected]

България Luxembourg/Luxemburg
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tél/Tel: +49 4103 8006-0
[email protected] [email protected]

Česká republika / Slovenská republika Magyarország
medac GmbH organizacni slozka medac GmbH
Tel: +420 774 486 166 Tel: +49 4103 8006-0
[email protected] [email protected]

Danmark / Sverige Malta
medac medac GmbH
Gesellschaft für klinische Tel: +49 4103 8006-0
Spezialpräparate G.m.b.H, Germany, branch office [email protected]
Tlf.: +46 44 7850 666
[email protected]

Deutschland Nederland
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Eesti / Latvija / Lietuva Norge
ViaSana medac
Tel: +370 5 2788 414 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Germany, branch office
Tlf: +47 90 63 81 04
[email protected]

Ελλάδα Österreich
medac GmbH EVER Valinject GmbH
Tel: +49 4103 8006-0 Tel: +43 7665 20555
[email protected] [email protected]

España Polska
Laboratorios Gebro Pharma, S.A. medac GmbH Sp. z.o.o.
Tel: +34 93 205 86 86 Tel: +48 22 430 00 30
[email protected] [email protected]

France Portugal
medac s.a.s. medac GmbH - Sucursal em Portugal
Tél: +33 437 66 14 70 Tel: +351 21 410 75 83
[email protected] [email protected]

Hrvatska România
Medis Adria d.o.o. medac GmbH
Tel: +385 (0) 1 230 34 46 Tel: +49 4103 8006-0
[email protected] [email protected]

Ireland Slovenija
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Ísland Suomi/Finland
Vistor hf. medac
Sími: +354 535 7000 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Germany, branch office
Puh/Tel: +358 10 420 4000
[email protected]

Italia
medac Pharma S.r.l.
Tel: +39 06 515912 1
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Package leaflet: Information for the user

Leflunomide medac 15 mg film-coated tablets

leflunomide
Read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Leflunomide medac is and what it is used for
2. What you need to know before taking Leflunomide medac
3. How to take Leflunomide medac
4. Possible side effects
5. How to store Leflunomide medac
6. Package contents and other information

1. What Leflunomide medac is and what it is used for

Leflunomide medac belongs to a group of medicines called disease-modifying antirheumatic drugs. It contains the
active substance leflunomide.
Leflunomide medac is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.
Symptoms of rheumatoid arthritis include joint inflammation, swelling, limited mobility, and pain. Other symptoms that may affect the whole body include loss of appetite, fever, loss of strength, and anaemia (reduction in the number of red blood cells).
Symptoms of active psoriatic arthritis include joint inflammation, swelling, limited mobility, pain, and red, scaly skin patches (skin lesions).

2. What you should know before taking Leflunomide medac

Do not take Leflunomide medac

• if you have previously experienced an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin spots or blisters, such as Stevens-Johnson syndrome), to peanuts or soy, or to 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 any liver problems,
• if you have severe or moderate kidney problems,
• if you have extremely low protein levels in the blood (hypoproteinemia),
• if you suffer from any condition affecting your immune system (e.g. AIDS),
• if you have any bone marrow disorder or if your red blood cell count, white blood cell count, or platelet count is low,
• if you have a serious infection,
• if you are pregnant, planning to become pregnant, or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Leflunomide medac

• if you have ever had lung inflammation (interstitial lung disease).
• if you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to check whether you have tuberculosis.
• if you are male and intend to father a child. Since it cannot be ruled out that Leflunomide medac passes into semen, a reliable contraceptive method must be used during treatment with Leflunomide medac. Men who intend to father a child should contact their doctor, who may advise stopping treatment with Leflunomide medac and taking certain medications to rapidly and adequately remove Leflunomide medac from the body. After this, a blood test must be performed to confirm that Leflunomide medac has been sufficiently eliminated from the body, and then you must wait at least another 3 months before attempting conception.
• if you need to undergo a specific blood test (calcium level). False low calcium levels may be observed.
• if you are scheduled for or have recently undergone major surgery, or if you still have an unhealed wound following surgery. Leflunomide medac may impair wound healing.

Rarely, Leflunomide medac can cause problems affecting the blood, liver, lungs, or nerves of the arms or legs. Leflunomide medac may also cause serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]) or increase the risk of serious infections. For further information, see section 4 (Possible side effects).
DRESS syndrome initially presents with flu-like symptoms and a facial rash, followed by widespread rash, fever, elevated liver enzyme levels and a type of white blood cell increase (eosinophilia) in blood tests, and swollen lymph nodes.
Before starting and during treatment with Leflunomide medac, your doctor will prescribe regular blood tests to monitor blood cells and liver function. Your doctor will also regularly check your blood pressure, as Leflunomide medac may cause an increase in blood pressure.
Inform your doctor if you develop unexplained chronic diarrhea. Your doctor may perform additional tests for differential diagnosis.
Inform your doctor if a skin ulcer develops during treatment with Leflunomide medac (see also section 4).

Children and adolescents
The use of Leflunomide medac is not recommended in children and adolescents under 18 years of age.

Other medicines and Leflunomide medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
This information is particularly important if you are taking:

• other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive drugs (e.g. methotrexate), as these combinations are not recommended,
• warfarin and other oral anticoagulants, as monitoring is required to reduce the risk of adverse effects,
• teriflunomide for multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer,
• duloxetine for depression, urinary incontinence, or diabetic kidney disease,
• alosetron for managing severe diarrhea,
• theophylline for asthma,
• tizanidine, to relax muscles,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indomethacin, ketoprofen for pain or inflammation,
• furosemide for heart disease (diuretic, water pill),
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• a medicine called colestyramine (used to lower cholesterol) or activated charcoal, as these medicines may reduce the amount of Leflunomide medac absorbed by the body.

If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomide medac.

Vaccinations
If you need to be vaccinated, consult your doctor. Certain vaccinations should not be administered while taking Leflunomide medac, and for a certain period after stopping treatment.

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

Pregnancy and breastfeeding
Do not take Leflunomide medac if you are pregnant or think you might be pregnant. If you become pregnant while taking Leflunomide medac, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Leflunomide medac without using reliable contraception.
If you plan to become pregnant after stopping treatment with Leflunomide medac, it is important to inform your doctor in advance, as you must ensure that all traces of Leflunomide medac have been eliminated from your body before attempting to conceive.
Elimination of Leflunomide medac may take up to two years. This period can be reduced to a few weeks by taking certain medications that accelerate the removal of Leflunomide medac from the body.
In either case, before becoming pregnant, blood tests must confirm that Leflunomide medac has been sufficiently eliminated from your body, and then you must wait at least one additional month.
For further information on laboratory tests, contact your doctor.
If you suspect you are pregnant during treatment with Leflunomide medac or within two years after stopping treatment, you must inform your doctor immediately, who will arrange for a pregnancy test. If pregnancy is confirmed, your doctor will advise treatment with certain medications to rapidly and adequately remove Leflunomide medac from your body, thereby reducing the risk to your baby.
Do not take Leflunomide medac during breastfeeding, as leflunomide passes into breast milk.

Driving and using machines
Leflunomide medac may make you feel unsteady, and this sensation may affect your ability to concentrate and react. In this case, do not drive or operate machinery.

Leflunomide medac contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Leflunomide medac contains soy lecithin
Do not use this medicine if you are allergic to peanuts or soy.

Leflunomide medac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Leflunomide medac

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The initial dose of Leflunomide medac is usually 100 mg of leflunomide once daily for
the first three days. Afterwards, most patients require:

• for rheumatoid arthritis: a daily dose of 10 to 20 mg of Leflunomide medac, depending on the severity of the disease.
• for psoriatic arthritis: a daily dose of 20 mg of Leflunomide medac.

Swallow the tablet whole with plenty of water.
It may take approximately 4 weeks or longer before you begin to notice an
improvement in your condition. Some patients may experience further improvement even
after 4 to 6 months of treatment.
Generally, Leflunomide medac is taken for long periods of time.
If you take more Leflunomide medac than you should
If you take more Leflunomide medac than recommended, contact your doctor or
seek medical advice immediately. If possible, bring the tablets or the packaging along to show your 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 almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Leflunomide medac and contact your doctor immediately if you:

• feel weak, lightheaded or dizzy, or have difficulty breathing, as these signs may indicate a severe allergic reaction;
• develop skin redness or mouth ulcers, as these signs may indicate serious, sometimes fatal, allergic reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediately if you experience:

• pallor, fatigue or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells;
• fatigue, abdominal pain or jaundice (yellowing of the eyes or skin), as these may indicate serious liver problems, which can be fatal;
• any signs of infection, such as fever, sore throat or cough, as this medicine may increase the risk of serious, potentially life-threatening infections;
• cough or breathing difficulties, as these may indicate lung problems (lung interstitial disease or pulmonary hypertension);
• tingling, weakness or unusual pain in the hands or feet, as these may indicate nerve problems (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• mild decrease in white blood cell count (leucopenia);
• mild allergic reactions;
• loss of appetite, weight loss (usually not significant);
• fatigue (asthenia);
• headache, dizziness;
• abnormal skin sensations such as tingling (paraesthesiae);
• moderate increase in blood pressure;
• colitis;
• diarrhoea;
• nausea, vomiting;
• inflammation of the mouth or mouth ulcers;
• abdominal pain;
• increased values in some liver function tests;
• increased hair loss;
• eczema, dry skin, redness, itching;
• tendinitis (pain due to inflammation of the sheath covering tendons, usually in hands or feet);
• increased levels of certain blood enzymes (creatine phosphokinase);
• nerve problems in arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• decrease in red blood cell count (anaemia) and decrease in platelet count (thrombocytopenia);
• low potassium levels in the blood;
• anxiety;
• taste disturbances;
• urticaria (red, itchy rash);
• tendon rupture;
• increased levels of fats in the blood (cholesterol and triglycerides);
• low phosphate levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• increase in blood cells called eosinophils (eosinophilia); mild decrease in white blood cells (leucopenia); reduction in all blood cells (pancytopenia);
• increased blood pressure;
• lung inflammation (interstitial lung disease);
• increased liver function test values, which may lead to serious clinical conditions such as hepatitis and jaundice;
• severe infections known as sepsis, which may be fatal;
• increased levels of certain blood enzymes (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

• marked decrease in certain white blood cells (agranulocytosis);
• severe, potentially life-threatening allergic reactions;
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis);
• inflammation of the pancreas (pancreatitis);
• severe liver damage, such as liver failure or necrosis, which may be fatal;
• severe, sometimes fatal, reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as kidney failure, decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is reversible when treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas exposed to light), psoriasis (onset or worsening), DRESS, and skin ulcers (a round, open sore in the skin through which underlying tissues are visible) may occur at an unknown frequency.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leflunomide medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the
bottle after Exp. The expiry date refers to the last day of that month.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Leflunomide medac contains

• The active substance is leflunomide. Each Leflunomide medac film-coated tablet contains 15 mg of leflunomide.
• The other components are: monohydrate lactose, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate and magnesium stearate in the tablet core, as well as lecithin (soybean seeds), poly(vinyl alcohol) alcohol, talc, titanium dioxide (E 171) and xanthan gum in the coating.

Description of the appearance of Leflunomide medac and package contents
Leflunomide medac 15 mg film-coated tablets are white or almost white, round tablets with a diameter of approximately 7 mm. The number "15" is printed on one side of the tablet.
The tablets are packaged in bottles.
Leflunomide medac 15 mg film-coated tablets: packs containing 30, 60, 90 or 100 film-coated tablets per bottle are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Κύπρος
Pharmanovia Benelux B.V. Gidamed Medical Supplies Ltd.
Tél/Tel: +31 76 560 0030 Τηλ: +357-257 510 30
[email protected] [email protected]

България Luxembourg/Luxemburg
medac GmbH medac GmbH
Tel:+49 4103 8006-0 Tél/Tel: +49 4103 8006-0
[email protected] [email protected]

Česká republika / Slovenská republika Magyarország
medac GmbH organizacni slozka medac GmbH
Tel: +420 774 486 166 Tel: +49 4103 8006-0
[email protected] [email protected]

Danmark / Sverige Malta
medac medac GmbH
Gesellschaft für klinische Tel: +49 4103 8006-0
Spezialpräparate G.m.b.H, Germany, branch [email protected]
Tlf.: +46 44 7850 666

Deutschland Nederland
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Eesti / Latvija / Lietuva Norge
ViaSana medac
Tel: +370 5 2788 414 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Germany, branch
Tlf: +47 90 63 81 04
[email protected]

Ελλάδα Österreich
medac GmbH EVER Valinject GmbH
Tel: +49 4103 8006-0 Tel: +43 7665 20555
[email protected] [email protected]

España Polska
Laboratorios Gebro Pharma, S.A. medac GmbH Sp. z.o.o.
Tel: +34 93 205 86 86 Tel: +48 22 430 00 30
[email protected] [email protected]

France Portugal
medac s.a.s. medac GmbH - Sucursal em Portugal
Tél: +33 437 66 14 70 Tel: +351 21 410 75 83
[email protected] [email protected]

Hrvatska România
Medis Adria d.o.o. medac GmbH
Tel: +385 (0) 1 230 34 46 Tel: +49 4103 8006-0
[email protected] [email protected]

Ireland Slovenija
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Ísland Suomi/Finland
Vistor hf. medac
Sími: +354 535 7000 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Germany, branch
Puh/Tel: +358 10 420 4000
[email protected]

Italia
medac Pharma S.r.l.
Tel: +39 06 515912 1
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

Leflunomide medac 20 mg film-coated tablets

leflunomide
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Leflunomide medac is and what it is used for
2. What you need to know before taking Leflunomide medac
3. How to take Leflunomide medac
4. Possible side effects
5. How to store Leflunomide medac
6. Contents of the pack and other information

1. What Leflunomide medac is and what it is used for

Leflunomide medac belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.
Leflunomide medac is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.
Symptoms of rheumatoid arthritis include joint inflammation, swelling, limited mobility, and pain. Other symptoms that may affect the whole body include loss of appetite, fever, loss of strength, and anaemia (reduction in the number of red blood cells).
Symptoms of active psoriatic arthritis include joint inflammation, swelling, limited mobility, pain, and red, scaly skin patches (skin lesions).

2. What you need to know before taking Leflunomide medac

Do not take Leflunomide medac

• if you have previously had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin rashes or blisters, such as Stevens-Johnson syndrome), to peanuts or soy, or to 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 any liver problems,
• if you have moderate or severe kidney problems,
• if you have extremely low levels of proteins in the blood (hypoproteinemia),
• if you suffer from any condition affecting your immune system (e.g. AIDS),
• if you have any bone marrow disorder, or if your red blood cell, white blood cell, or platelet counts are low,
• if you have a serious infection,
• if you are pregnant, planning to become pregnant, or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Leflunomide medac

• if you have ever had lung inflammation (interstitial lung disease).
• if you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to check whether you have tuberculosis.
• if you are male and intend to father a child. Since it cannot be ruled out that Leflunomide medac passes into semen, you must use a reliable method of contraception during treatment with Leflunomide medac. Men who intend to father a child should consult their doctor, who may advise stopping treatment with Leflunomide medac and taking certain medications to rapidly and sufficiently eliminate Leflunomide medac from the body. After this, a blood test must be performed to confirm that Leflunomide medac has been sufficiently removed from the body, and you must then wait at least another 3 months before attempting to conceive.
• if you need to undergo a specific blood test (calcium level). Falsely low calcium levels may occur.
• if you are scheduled for, have recently undergone, or still have an unhealed wound following major surgery. Leflunomide medac may impair wound healing.

Rarely, Leflunomide medac can cause problems affecting the blood, liver, lungs, or nerves of the arms or legs. Leflunomide medac may also cause serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or increase the risk of serious infections. For further information, see section 4 (Possible side effects).
DRESS syndrome initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, elevated liver enzymes and eosinophilia (increased white blood cells) in blood tests, and swollen lymph nodes.
Before starting and during treatment with Leflunomide medac, your doctor will prescribe regular blood tests to monitor blood cells and liver function. Your doctor will also check your blood pressure regularly, as Leflunomide medac may cause an increase in blood pressure.
Inform your doctor if you have unexplained chronic diarrhea. Your doctor may perform additional tests for differential diagnosis.
Inform your doctor if a skin ulcer develops during treatment with Leflunomide medac (see also section 4).

Children and adolescents
The use of Leflunomide medac is not recommended in children and adolescents under 18 years of age.

Other medicines and Leflunomide medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription.
This information is particularly important if you are taking:

• other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressants (e.g. methotrexate), as these combinations are not recommended,
• warfarin and other oral anticoagulants (blood thinners), as monitoring is required to reduce the risk of side effects,
• teriflunomide for multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer,
• duloxetine for depression, urinary incontinence, or kidney disease in diabetics,
• alosetron for managing severe diarrhea,
• theophylline for asthma,
• tizanidine, to relax muscles,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indomethacin, ketoprofen for pain or inflammation,
• furosemide for heart disease (diuretic, "water pill"),
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• a medicine called cholestyramine (used to lower cholesterol) or activated charcoal, as these medicines may reduce the amount of Leflunomide medac absorbed by the body.

If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomide medac.

Vaccinations
If you need to be vaccinated, consult your doctor. Certain vaccinations should not be given while you are taking Leflunomide medac, and for a certain period after stopping treatment.

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

Pregnancy and breastfeeding
Do not take Leflunomide medac if you are pregnant or think you might be pregnant. If you become pregnant while taking Leflunomide medac, the risk of having a baby with serious birth defects is increased. Women of childbearing potential must not take Leflunomide medac without using reliable contraception.
If you plan to become pregnant after stopping treatment with Leflunomide medac, it is important to inform your doctor in advance, as you must ensure that all traces of Leflunomide medac have been eliminated from your body before attempting to conceive.
Elimination of Leflunomide medac from the body may take up to two years. This period can be reduced to a few weeks by taking certain medications that accelerate the removal of Leflunomide medac from the body.
In either case, before becoming pregnant, blood tests must confirm that Leflunomide medac has been sufficiently eliminated from your body, and you must then wait at least another month.
For further information on laboratory tests, contact your doctor.
If you suspect you are pregnant while taking Leflunomide medac or within two years after stopping treatment, you must inform your doctor immediately. Your doctor will arrange a pregnancy test. If pregnancy is confirmed, your doctor will recommend treatment with certain medications to rapidly and sufficiently eliminate Leflunomide medac from your body, thereby reducing the risk to your baby.

Do not take Leflunomide medac during breastfeeding, as leflunomide passes into breast milk.

Driving and using machines
Leflunomide medac may make you feel unsteady, and this sensation may affect your concentration and reaction time. In such cases, do not drive or operate machinery.

Leflunomide medac contains lactose.
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Leflunomide medac contains soya lecithin.
Do not use this medicine if you are allergic to peanuts or soy.

Leflunomide medac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Leflunomide medac

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The initial dose of Leflunomide medac is usually 100 mg of leflunomide once daily for
the first three days. Afterwards, most patients require:

• for rheumatoid arthritis: a daily dose of 10 to 20 mg of Leflunomide medac, depending on the severity of the disease.
• for psoriatic arthritis: a daily dose of 20 mg of Leflunomide medac.

Swallow the tablet whole with plenty of water.
It may take approximately 4 weeks or longer before you begin to notice an
improvement in your condition. Some patients may experience further improvement even
after 4 to 6 months of treatment.
Generally, Leflunomide medac is taken for long periods of time.
If you take more Leflunomide medac than you should
If you take more Leflunomide medac than prescribed, contact your doctor or
seek medical advice immediately. If possible, bring the tablets or the
packaging along to show your 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 almost time for your next dose. Do not take a double dose to make up for the missed one.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Leflunomide medac and contact your doctor immediately if you:

• feel weak, lightheaded or dizzy, or have difficulty breathing, as these signs may indicate a severe allergic reaction,
• develop skin redness or mouth ulcers, as these signs may indicate serious, sometimes fatal, allergic reactions (e.g. Stevens-Johnson syndrome,
  toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediately if you experience:

• pallor, fatigue or bruising, as these may indicate blood disorders caused by an imbalance among the different types of blood cells,
• fatigue, abdominal pain or jaundice (yellowing of the eyes or skin), as these may indicate serious conditions such as liver failure, which can be fatal,
• any signs of infection such as fever, sore throat or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
• cough or breathing difficulties, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• tingling, weakness or unusual pain in the hands or feet, as these may indicate nerve problems (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• mild decrease in white blood cell count (leucopenia),
• moderate allergic reactions,
• loss of appetite, reduced body weight (usually not significant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paraesthesia),
• moderate increase in blood pressure,
• colitis,
• diarrhoea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• increased values in certain liver function tests,
• increased hair loss,
• eczema, dry skin, redness, itching,
• tendinitis (pain due to inflammation of the sheath covering tendons, usually in feet or hands),
• increased levels of certain blood enzymes (creatine phosphokinase),
• nerve problems in arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• decrease in red blood cell count (anaemia) and decrease in platelet count (thrombocytopenia),
• decreased potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (red, itchy rash),
• tendon rupture,
• increased levels of fats in the blood (cholesterol and triglycerides),
• decreased phosphate levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• increased number of blood cells called eosinophils (eosinophilia); mild decrease in white blood cell count (leucopenia); reduction in all blood cells (pancytopenia),
• increased blood pressure,
• lung inflammation (interstitial lung disease),
• increased liver function test values that may lead to serious clinical conditions such as hepatitis and jaundice,
• severe infections known as sepsis, which may be fatal,
• increased levels of certain blood enzymes (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

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

Other side effects such as kidney failure, decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is reversible when treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema in skin areas exposed to light), psoriasis (onset or worsening), DRESS, and skin ulcer (a round, open sore in the skin through which underlying tissues can be seen) may occur with unknown frequency.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leflunomide medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the
bottle after Exp. The expiry date refers to the last day of that month.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Leflunomide medac contains

• The active substance is leflunomide. Each Leflunomide medac film-coated tablet contains 20 mg of leflunomide.
• The other components are: monohydrate lactose, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate and magnesium stearate in the tablet core, as well as lecithin (soybean seeds), poly(vinyl alcohol), talc, titanium dioxide (E 171) and xanthan gum in the coating.

Description of the appearance of Leflunomide medac and contents of the pack
Leflunomide medac 20 mg film-coated tablets are white or almost white, round tablets with a diameter of approximately 8 mm and a division mark on one side of the tablet. The tablet can be divided into two equal parts.
The tablets are packed in bottles.
Leflunomide medac 20 mg film-coated tablets: packs containing 15, 30, 60 or 100 film-coated tablets per bottle are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Κύπρος
Pharmanovia Benelux B.V. Gidamed Medical Supplies Ltd.
Tél/Tel: +31 76 560 0030 Τηλ: +357-257 510 30
[email protected] [email protected]

България Luxembourg/Luxemburg
medac GmbH medac GmbH
Teл.: +49 4103 8006-0 Tél/Tel: +49 4103 8006-0
[email protected] [email protected]

Česká republika / Slovenská republika Magyarország
medac GmbH organizacni slozka medac GmbH
Tel: +420 774 486 166 Tel: +49 4103 8006-0
[email protected] [email protected]

Danmark / Sverige Malta
medac medac GmbH
Gesellschaft für klinische Tel: +49 4103 8006-0
Spezialpräparate G.m.b.H, Tyskland, filial [email protected]
Tlf.: +46 44 7850 666
[email protected]

Deutschland Nederland
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Eesti / Latvija / Lietuva Norge
ViaSana medac
Tel: +370 5 2788 414 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Tyskland, filial
Tlf: + 47 90 63 81 04
[email protected]

Ελλάδα Österreich
medac GmbH EVER Valinject GmbH
Τηλ: +49 4103 8006-0 Tel: +43 7665 20555
[email protected] [email protected]

España Polska
Laboratorios Gebro Pharma, S.A. medac GmbH Sp. z.o.o.
Tel: +34 93 205 86 86 Tel: +48 22 430 00 30
[email protected] [email protected]

France Portugal
medac s.a.s. medac GmbH - Sucursal em Portugal
Tél: +33 437 66 14 70 Tel: +351 21 410 75 83
[email protected] [email protected]

Hrvatska România
Medis Adria d.o.o. medac GmbH
Tel: +385 (0) 1 230 34 46 Tel: +49 4103 8006-0
[email protected] [email protected]

Ireland Slovenija
medac GmbH medac GmbH
Tel: +49 4103 8006-0 Tel: +49 4103 8006-0
[email protected] [email protected]

Ísland Suomi/Finland
Vistor hf. medac
Sími: + 354 535 7000 Gesellschaft für klinische
[email protected] Spezialpräparate G.m.b.H, Tyskland, filial
Puh/Tel: +358 10 420 4000
[email protected]

Italia
medac Pharma S.r.l.
Tel: +39 06 515912 1
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.