Leflunomide Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Leflunomida Aurovitas 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Leflunomida Aurovitas belongs to a group of medicines known as antirheumatic agents. It contains leflunomida as the active substance.

Leflunomida Aurovitas 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 (reduced 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 Aurovitas

Do not take Leflunomida Aurovitas:

• if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin, 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 a condition affecting the immune system (e.g., AIDS),
• if you have bone marrow disorders 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 may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Leflunomida Aurovitas.

• 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 leflunomide passes into semen, reliable contraceptive methods must be used during treatment with leflunomide. Men who wish to father a child should consult their doctor, who may 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 should then wait at least another 3 months before attempting to father a child.
• If you are scheduled to have, or have recently had, a specific blood test (calcium levels). 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. Leflunomide may impair wound healing.

Occasionally, leflunomide 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 infection. 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 widespread rash, fever, elevated liver enzymes in the blood, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

Your doctor will perform regular blood tests before and during treatment with leflunomide to monitor 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 develop chronic diarrhea of unknown origin. You may need additional tests to establish a differential diagnosis.

Consult your doctor if you develop skin ulcers during treatment with leflunomide (see also section 4).

Children and adolescents

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

Other medicines and Leflunomida Aurovitas

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 and other oral anticoagulants (blood thinners), 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 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 colestyramine (used to lower high cholesterol) or activated charcoal, as these medicines may reduce the amount of leflunomide 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 leflunomide treatment.

Vaccinations

Talk to your doctor if you need to be vaccinated. Some vaccines should not be administered while you are being treated with leflunomide, nor for a certain period after treatment has ended.

Taking leflunomida Aurovitas with food, drinks, and alcohol

Leflunomide may be taken with or without food.

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

Pregnancy and breastfeeding

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

Inform your doctor if you plan to become pregnant after stopping leflunomide treatment, 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 about 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 pregnancy is confirmed, 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 this medicine while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

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

Leflunomida Aurovitas contains sodium.

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

Leflunomida Aurovitas contains lactose.

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

3. How to take Leflunomide Aurovitas

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

The recommended initial dose of leflunomide is 100 mg once daily for the first three days.

After this, the usual maintenance dose required for most people is:

• 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 begin to notice 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 Leflunomide Aurovitas than you should

If you have taken more leflunomide than you should, inform your doctor immediately or contact the nearest hospital emergency department. If possible, bring the medicine or its packaging along to show the doctor.

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

If you forget to take Leflunomide Aurovitas

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, pharmacist, or nurse.

4. Possible adverse effects

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

Tell 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, as these may indicate serious reactions that can sometimes be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Tell your doctor immediately if you experience:

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

Common adverse effects (may affect up to 1 in 10 patients)

• mild decrease in 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 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 effects (may affect up to 1 in 100 patients)

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

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

• increased number of a type of white blood cell called eosinophils (eosinophilia); mild decrease in white blood cells (leucopenia); and decreased numbers of all blood cells (pancytopenia),
• marked increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values in certain 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 effects (may affect up to 1 in 10,000 patients)

• severe decrease in certain white blood cells (agranulocytosis),
• severe allergic reactions and potentially severe allergic reactions,
• inflammation of small 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 may sometimes be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other adverse effects with unknown frequency may also occur, such as kidney 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 ulcers (round, open skin ulcers through which underlying tissues can be seen), which may occur with unknown frequency.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report it 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 Aurovitas

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 pack and blister after EXP. The expiry date refers to the last day of the month indicated.

For Al-Al blister: Store below 30°C.

For HDPE bottle: This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to 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 Leflunomida Aurovitas 10 mg

• The active substance is leflunomide. Each tablet contains 10 mg of leflunomide.
• The other components are:

Tablet core: monohydrate lactose, pregelatinized starch (corn starch), povidone (K-30), colloidal anhydrous silica, crospovidone (type B), magnesium stearate.

Tablet coating: polyvinyl alcohol, talc (E553b), titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate.

Appearance of the product and contents of the pack

Film-coated tablet.

Leflunomida Aurovitas 10 mg film-coated tablets EFG: [Size: approximately 7.2 mm]

White or almost white, round, biconvex, film-coated tablets marked “LF” on one side and “10” on the other.

Leflunomida Aurovitas 10 mg film-coated tablets EFG are available in blister packs and HDPE bottles.

Pack sizes:

Blister pack: 10, 15, 30, 60, 90 and 100 film-coated tablets.

HDPE bottles: 30 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D, 5th floor

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Leflunomid PUREN 10 mg Filmtabletten

Belgium: Leflunomide AB 10 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Spain: Leflunomida Aurovitas 10 mg comprimidos recubiertos con película EFG

France: Leflunomide Arrow 10 mg, comprimé pelliculé

Italy: Leflunomide Aurobindo

Netherlands: Leflunomide Aurobindo 10 mg, filmomhulde tabletten

Poland: Leflunomide Aurovitas

Portugal: Leflunomida Generis

Date of the most recent revision of this leaflet: February 2026

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/