Leflunomide medac 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Leflunomida medac 10 mg film-coated tablets EFG

leflunomide

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 pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Leflunomida medac is and what it is used for
2. What you need to know before taking Leflunomida medac
3. How to take Leflunomida medac
4. Possible side effects
5. How to store Leflunomida medac

Contents of the pack and other information

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

Leflunomida medac belongs to a group of medicines known as antirheumatic drugs. It contains leflunomide as the active substance.

Leflunomida 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 systemic symptoms include loss of appetite, fever, fatigue, and anemia (reduction in the number of red blood cells in the blood).

Symptoms of active psoriatic arthritis include joint inflammation, swelling, limited mobility, pain, and red, scaly skin plaques (skin lesions).

2. What you need to know before taking Leflunomida medac

Do not take Leflunomida medac

• if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin rashes, or blisters, e.g., 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 in the treatment of multiple sclerosis).
• if you have any liver problems,
• if you have moderate to severe kidney problems,
• if you have a severe decrease in the concentration of proteins in the blood (hypoproteinemia),
• if you have a disorder affecting the immune system (e.g., AIDS),
• if you have a bone marrow disorder or have low levels of red or white blood cells or platelets in your blood,
• if you have a serious infection,
• if you are pregnant, think you might be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Leflunomida 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 a man and wish to father a child. Since it cannot be ruled out that Leflunomida medac passes into semen, reliable contraceptive methods should be used during treatment with Leflunomida medac. Men who wish to father a child should consult their doctor, who may advise stopping treatment with Leflunomida medac and taking certain medications to rapidly and sufficiently eliminate Leflunomida medac from the body. In this case, a blood test will be required to confirm that Leflunomida medac has been sufficiently eliminated from your body, after which you should wait at least another 3 months before attempting to father a child.
• if you are scheduled for a specific blood test (calcium level). A false decrease in calcium levels may be detected.
• if you are scheduled for or have recently undergone major surgery, or if you still have an unhealed wound after surgery. Leflunomida medac may impair wound healing.

Occasionally, Leflunomida medac may cause certain problems with the blood, liver, lungs, or nerves in the arms or legs. It may also cause serious allergic reactions (including drug rash with eosinophilia and systemic symptoms [DRESS syndrome]) or increase the risk of serious infections. For more information about these adverse effects, see section 4 (Possible side effects).

DRESS syndrome initially presents with flu-like symptoms and a skin rash on the face, followed by a widespread rash, fever, elevated liver enzymes in the blood, an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes.

Your doctor will perform blood tests regularly, both before and during treatment with Leflunomida medac, to monitor blood cells and liver function. Your doctor should also monitor your blood pressure regularly, as Leflunomida medac may cause an increase in blood pressure.

Consult your doctor if you experience chronic diarrhea of unknown origin. Additional tests may be needed to establish a differential diagnosis.

Inform your doctor if you develop a skin ulcer during treatment with Leflunomida medac (see section 4).

Children and adolescents

Leflunomida medac is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Leflunomida medac

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes 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 salts, D-penicillamine, azathioprine, or other immunosuppressants (e.g., methotrexate), as these combinations are not recommended.
• warfarin (used as a blood anticoagulant), as monitoring is required to reduce the risk of adverse effects with this medicine.
• 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 renal insufficiency.
• alosetron for control of severe diarrhea.
• theophylline for asthma.
• tizanidine, a muscle relaxant.
• 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 pills).
• 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 high cholesterol) or activated charcoal, as these medicines may reduce the amount of Leflunomida medac absorbed by the body.

If you are taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomida medac.

Vaccinations

Talk to your doctor if you need to be vaccinated. Some vaccines should not be administered while you are being treated with Leflunomida medac or for a certain period after treatment has ended.

Taking Leflunomida medac with food, drink, and alcohol

Leflunomida medac may be taken with or without food.

Do not drink alcohol during treatment with Leflunomida medac. Consuming alcohol during treatment with Leflunomida medac may increase the risk of liver damage.

Pregnancy and breastfeeding

Do not take Leflunomida medac if you are or think you might be pregnant. If you are pregnant or become pregnant while taking Leflunomida medac, there is an increased risk of having a child with serious birth defects. Women of childbearing potential must not take Leflunomida medac unless using reliable contraception.

Inform your doctor if you plan to become pregnant after stopping treatment with Leflunomida medac, as it is necessary to ensure that no residual Leflunomida medac remains in your body before conception. Elimination of the drug from the body may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications that accelerate the elimination of Leflunomida medac from the body. In any case, before becoming pregnant, you must have a blood test to confirm that Leflunomida medac has been sufficiently eliminated from your body, and after this test, you should wait at least 1 month before attempting to become pregnant.

For more information about laboratory tests, contact your doctor.

If you suspect you might be pregnant during treatment with Leflunomida medac or within two years after treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may recommend starting treatment with certain medications to rapidly and sufficiently eliminate Leflunomida medac from your body, thereby reducing the risk to your baby.

Do not take Leflunomida medac while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

Leflunomida medac may cause dizziness, which could affect your ability to concentrate and react. If this occurs, do not drive or operate machinery.

Leflunomida medac contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Leflunomida medac contains soya lecithin

Do not use this medicine if you are allergic to peanuts or soya.

Leflunomida medac contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially "sodium-free".

3. How to take Leflunomida medac

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual initial dose of Leflunomida medac is 100 mg of leflunomide once daily for the first three days. After this, most people require a dose of:

• For rheumatoid arthritis: 10 mg or 20 mg of Leflunomida medac once daily, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg of Leflunomida medac once daily.

Swallow the tablet whole with plenty of water.

It may take about 4 weeks, or even longer, before you start to notice improvement in your condition. Some patients may even experience further improvement after 4 to 6 months of treatment. Generally, Leflunomida medac should be taken for long periods of time.

If you take more Leflunomida medac than you should

If you take more Leflunomida medac than you should, consult your doctor or any other healthcare provider immediately. If possible, take the tablets or the pack with you to show the doctor.

If you forget to take Leflunomida 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 missed dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately and stop taking Leflunomide medac:

• if you feel weak, dizzy, or short of breath, because these may be symptoms of a severe allergic reaction,
• if you develop skin rashes or mouth ulcers, because these may indicate serious reactions that can sometimes be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Tell your doctor immediately if you experience:

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

Frequent adverse reactions (may affect up to 1 in 10 patients)

• mild decrease in the number of white blood cells (leucopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually insignificant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paraesthesia),
• mild increase in blood pressure,
• colitis,
• diarrhoea,
• nausea, vomiting,
• mouth inflammation, mouth ulcers,
• abdominal pain,
• increased results in some liver function tests,
• increased hair loss,
• eczema, dry skin, skin rash, and itching (pruritus),
• tendinitis (pain due to inflammation of the membrane surrounding tendons, usually in the feet or hands),
• increased levels of certain enzymes in the blood (creatine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Uncommon adverse reactions (may affect up to 1 in 100 patients)

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

Rare adverse reactions (may affect up to 1 in 1,000 patients)

• increase in blood cells called eosinophils (eosinophilia), mild decrease in white blood cells (leucopenia), and decrease in all blood cells (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values in some liver function tests that may lead to serious 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 adverse reactions (may affect up to 1 in 10,000 patients)

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Leflunomide medac Storage Instructions

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the bottle following EXP. The expiry date refers to the last day of the month indicated.

Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Leflunomida medac

• The active substance is leflunomide.

Each Leflunomida medac 10 mg film-coated tablet EFG contains 10 mg of leflunomide.

• The other components are monohydrate lactose, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate, and magnesium stearate (E 470b) in the tablet core, as well as lecithin (soybean), (alcohol) poly(vinyl), talc, titanium dioxide (E 171), and xanthan gum in the coating.

Appearance of the product and contents of the pack

Leflunomida medac 10 mg film-coated tablets EFG are white to off-white, round tablets with a diameter of approximately 6 mm.

The tablets are packed in bottles.

Leflunomida medac 10 mg film-coated tablets EFG: Available pack sizes are 30, 60 or 100 film-coated tablets per bottle.

Only some pack sizes may be marketed.

Marketing Authorization Holder

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Manufacturer responsible

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 07/2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.