Leflunomide Stada 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Leflunomida Stada 10 mg film-coated tablets EFG

Leflunomida Stada 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Leflunomida Stada belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.

Leflunomida 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, red skin plaques, and scaly skin (skin lesions).

2. What you need to know before taking Leflunomida Stada

DO NOT take Leflunomida Stada

• 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) or to any of the other components 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 blood protein levels (hypoproteinemia),
• if you have any condition affecting your immune system (e.g., AIDS),
• if you have any bone marrow disorder or if you have low levels of red or white blood cells or low platelet counts,
• if you have a serious infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting Leflunomida Stada:

• if you have ever had lung inflammation (interstitial lung disease).
• if you have ever had tuberculosis or have been in contact with someone who has or has had tuberculosis. Your doctor may perform tests to determine whether you have tuberculosis.
• if you are a man and wish to father a child. Since it cannot be ruled out that leflunomide passes into semen, reliable contraceptive methods must be used during treatment with this medicine. Men who wish to father a child should contact their doctor, who will advise stopping leflunomide treatment and taking certain medications to rapidly and sufficiently eliminate leflunomide from the body. In this case, a blood test will be required to confirm that leflunomide has been sufficiently eliminated from your body, and you must then wait at least another 3 months before attempting to father a child.
• if you are due to have a specific blood test (calcium levels). False low calcium levels may be detected.
• if you are scheduled for, or have recently undergone, major surgery, or if you still have an unhealed wound following surgery. Leflunomide may impair wound healing.

Occasionally, leflunomide may cause problems with blood, liver, lungs, or nerves in the arms or legs. It may also cause serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms (DRESS)) or increase the risk of serious infection. For more information on these adverse effects, see section 4 (Possible side effects). DRESS initially presents with flu-like symptoms and a spreading facial rash accompanied by high temperature, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

Your doctor will perform regular blood tests before and during treatment with leflunomide to monitor your blood cells and liver function. Your doctor should also monitor your blood pressure regularly, as leflunomide 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 leflunomide (see section 4).

Children and adolescents

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

Other medicines and Leflunomida Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 and other oral anticoagulant medicines, as monitoring is required to reduce the risk of adverse effects of 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.
• indomethacin, 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 Stada absorbed by the body.

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

Vaccinations

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

Taking Leflunomida Stada with food, drinks, and alcohol

Leflunomida Stada may be taken with or without food.

Alcohol consumption is not recommended during treatment with leflunomide. Drinking alcohol during treatment may increase the risk of liver damage.

Pregnancy and breastfeeding

Do not take Leflunomida Stada if you are or think you may be pregnant. If you are pregnant or become pregnant while taking leflunomide, there is an increased risk of having a baby with severe birth defects. Women of childbearing potential must not take leflunomide unless using effective contraception.

Inform your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that no residual leflunomide 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 leflunomide from the body. In any case, before becoming pregnant, you must have a blood test to confirm that leflunomide has been sufficiently eliminated from your body, and after this test, you must wait at least 1 month before attempting to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you may be pregnant during treatment with leflunomide 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 leflunomide from your body, thereby reducing the risk to your baby.

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

Driving and using machines

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

Leflunomida Stada contains lactose

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

3. How to take Leflunomida Stada

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Swallow the tablet whole with plenty of water.

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

If you take more Leflunomida Stada than you should

If you take more Leflunomida Stada than prescribed, consult your doctor or any other healthcare provider. If possible, bring the tablets or the package to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Leflunomida Stada

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 forgotten doses.

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

4. Possible adverse effects

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

Contact your doctor immediately and stop taking leflunomide:

• 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.

Contact your doctor immediately if you experience:

• pallor, tiredness, or increased tendency to bruise, because these may indicate blood problems caused by an imbalance in the different types of blood cells,
• tiredness, 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 symptoms 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 people)

• mild decrease in white blood cell count (leucopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually insignificant),
• tiredness (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 certain 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 people)

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

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

• increase in blood cells called red blood cells or eosinophils (eosinophilia), mild decrease in white blood cell count (leucopenia), and decrease in all blood cells (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values in certain liver function tests that may indicate 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 people)

• 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,
• severe skin reactions that may be fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other adverse effects 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 areas of skin 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 unknown frequency.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Leflunomida Stada

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 packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Leflunomide Stada

• The active substance is leflunomide.

Leflunomide Stada 10 mg film-coated tablets EFG:

One film-coated tablet contains 10 mg of leflunomide.

Leflunomide Stada 20 mg film-coated tablets EFG:

One film-coated tablet contains 20 mg of leflunomide.

• The other components are: maize starch, povidone (E1201), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E470b) and monohydrate lactose in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171) and macrogol 8000 in the coating.

Leflunomide Stada 20 mg film-coated tablets additionally contain yellow iron oxide (E172).

Nature of the product and contents of the container

Leflunomide Stada 10 mg are film-coated tablets, white to off-white, round and biconvex.

Leflunomide Stada 20 mg are film-coated tablets, yellow, round and biconvex.

The tablets are packed in blisters.

Leflunomide Stada is available in pack sizes containing 30, 90, 100, 150 and 200 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH,

Muthgasse 36,

1190 Vienna,

Austria

or

Eurogenerics N.V.,

Heizel Esplanade B22,

B-1020 Brussels,

Belgium

or

Centrafarm Services B.V.,

Van de Reijtstraat 31-E,

4814 NE Breda,

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

AT Leflunomid STADA 10 mg/20 mg Filmtabletten

BE Leflunomide EG 10 mg/20 mg filmomhulde tabletten

ES Leflunomida STADA 10 mg/20 mg comprimidos recubiertos con película EFG

FI Leflunomide STADA 10 mg/20 mg kalvopäällysteiset tabletit

FR Leflunomide EG 10 mg/20 mg, comprimés pelliculés

LU Leflunomide EG 10 mg/20 mg comprimés pelliculés

NL Leflunomide CF 10 mg/20 mg filmomhulde tabletten

Date of the most recent revision of this leaflet: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/