Leflunomide Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Leflunomide Viatris 10 mg film-coated tablets EFG

Read all of this 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 must not be given 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 Leflunomide Viatris is and what it is used for
2. What you need to know before taking Leflunomide Viatris
3. How to take Leflunomide Viatris
4. Possible side effects
5. How to store Leflunomide Viatris
6. Contents of the pack and other information

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

Leflunomide belongs to a group of medicines known as disease-modifying antirheumatic drugs (DMARDs). Leflunomide is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.

Symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, 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, difficulty moving, pain, and red, scaly skin patches (skin lesions).

2. What you need to know before starting Leflunomide Viatris

Do not take Leflunomide Viatris

• If you are allergic to leflunomide (especially a severe skin reaction, usually accompanied by fever, joint pain, red skin spots, or blisters, for example, Stevens-Johnson syndrome), to a medicine called teriflunomide (related to leflunomide), or to any of the other ingredients of this medicine (listed in section 6).
• If you have any liver problems.
• If you have moderate or severe kidney problems.
• If you have a severe decrease in blood protein levels (hypoproteinemia).
• If you have a condition affecting your immune system (e.g., AIDS).
• If you have a bone marrow disorder, or if you have a low number of red or white blood cells or platelets in your blood due to causes other than rheumatoid arthritis or psoriatic arthritis.
• If you have a serious infection.
• If you are pregnant, think you may be pregnant, or are breastfeeding.
• If you are a woman of childbearing potential and are not using an effective method of contraception.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting leflunomide:

• If you have ever had 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 have children, as it cannot be ruled out that leflunomide passes into semen, reliable contraceptive methods should be used during treatment with leflunomide. To reduce any potential risk, men who wish to have children should contact their doctor, who will advise them to discontinue treatment with leflunomide and take certain medications to help eliminate leflunomide rapidly and sufficiently from the body. A blood test will then be required to confirm that leflunomide has been sufficiently eliminated from the body, after which you must wait at least another 3 months before attempting to father a child.
• If you are scheduled to have a specific blood test (calcium levels). A falsely low calcium level 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 certain problems with the blood, liver, lungs, or nerves in the arms or legs. It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or increase the risk of developing a serious infection. For more information on this, see section 4 “Possible side effects”.

DRESS initially presents with flu-like symptoms and facial rash. Subsequently, the rash spreads, accompanied by high body temperature, increased blood levels of liver enzymes and a type of white blood cells (eosinophilia), and enlarged lymph nodes.

Your doctor will perform regular blood tests before and during treatment with this medicine to monitor your blood cells and liver function. Your doctor will 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. You may require additional tests to establish a differential diagnosis.

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

Children and adolescents

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

Taking Leflunomide Viatris with other medicines

Inform 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 (for example, chloroquine and hydroxychloroquine), intramuscular or oral gold salts, D-penicillamine, azathioprine, tumour necrosis factor alpha inhibitors (for example, adalimumab, infliximab), and other immunosuppressive agents (for example, methotrexate), as the use of these combinations is not recommended.
• A medicine called cholestyramine (used to reduce high cholesterol) or activated charcoal, as these medicines may reduce the amount of leflunomide absorbed by the body.
• A medicine called teriflunomide (used to treat multiple sclerosis).
• Warfarin and other oral anticoagulants (medicines used to thin the blood), as monitoring is necessary to reduce the risk of adverse effects from this medicine.
• Repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes.
• Daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer.
• Duloxetine, for depression, urinary incontinence, or liver disease in diabetics.
• Alosetron, for the treatment of severe diarrhoea.
• Theophylline, for asthma.
• Tizanidine, a muscle relaxant.
• Oral contraceptives (for example, ethinylestradiol and levonorgestrel).
• Rifampicin (used in the treatment of tuberculosis).
• Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, for infections.
• Indometacin, ketoprofen, for pain or inflammation.
• Furosemide, for heart conditions (diuretic, water tablets).
• Zidovudine, for HIV infection.
• Rosuvastatin, simvastatin, atorvastatin, pravastatin, for hypercholesterolaemia (high cholesterol).
• Sulfasalazine, for inflammatory bowel disease or rheumatoid arthritis.
• Cimetidine (for excess stomach acid).

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

Vaccinations

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

Taking Leflunomida Viatris with alcohol

It is not recommended to drink alcohol during treatment with this medicine. Consuming alcohol while being treated with leflunomide may increase the risk of liver damage.

Pregnancy and breastfeeding

Pregnancy

Do not take leflunomide 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 child with serious birth defects. Women of childbearing potential must not take leflunomide unless they are using effective contraceptive measures.

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 attempting pregnancy. This may take up to 2 years. However, this period can be reduced to a few weeks by taking certain medications that accelerate the elimination of leflunomide from the body.

In any case, you must have a blood test to confirm that the drug has been sufficiently eliminated from your body, and you should wait at least 1 month before attempting to become pregnant.

For further information about laboratory testing, please contact your doctor.

If you suspect you may be pregnant during treatment with leflunomide or within two years after stopping treatment, you must contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may advise you to start treatment with certain medications to rapidly and sufficiently eliminate leflunomide from your body, thereby reducing the risk to your child.

Breastfeeding

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

Driving and operating machinery

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

Leflunomide Viatris contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Leflunomida Viatris

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

• For rheumatoid arthritis: 10 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. Leflunomida Viatris can be taken with or without food.

It may take about 4 weeks or 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, you will need to take this medicine for long periods of time.

If you take more Leflunomida Viatris than you should

If you take more Leflunomida Viatris than prescribed, consult your doctor or another medical advisor. If possible, bring the tablets or the packaging to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at phone number 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take the container and any remaining tablets with you.

You may experience any of the following symptoms: stomach pain, diarrhea, itching, and skin rash.

If you forget to take Leflunomida Viatris

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 dose.

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.

Inform your doctor immediately and stop taking Leflunomide Viatris:

• If you feel weak, dizzy, or short of breath, or have difficulty breathing (including itching with or without skin rash, swelling of the hands, feet, ankles, face, lips, mouth, or throat with difficulty swallowing), as these may be symptoms of a serious allergic reaction.
• If you develop skin rashes, inflammation, or mouth ulcers, as these may indicate serious allergic reactions, which in some cases can be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS); see section 2.

Inform your doctor immediately if you experience:

• Paleness, tiredness, or bruising, as 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), as these may indicate serious liver problems such as liver inflammation (hepatitis) or liver failure, which could be fatal.
• Any signs of infection such as fever, mouth ulcers (signs of agranulocytosis—marked decrease in certain white blood cells—very rare), sore throat, or cough, as this medicine may increase the risk of serious infections, including sepsis (rare), which could be fatal.
• Inflammation of blood vessels (vasculitis, including cutaneous necrotizing vasculitis).
• Cough or breathing problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension).
• Unusual tingling, weakness, or pain in the hands or feet, as this may indicate nerve problems (peripheral neuropathy).
• Loss of appetite; stomach pain; abdominal tenderness; feeling nauseous, generally accompanied by dizziness, vomiting, and fever; these could be signs of inflammation of the pancreas (pancreatitis).
• Severe pain on one or both sides of the back; sudden spasms with intense pain (usually starting in the back below the ribs, spreading around the abdomen, and sometimes to the groin and genital area); blood in the urine; nausea or vomiting; frequent need to urinate or a burning sensation during urination; fever, nausea, vomiting; rashes; weight gain; these could be signs of kidney failure.
• Cutaneous lupus (characterized by skin rash/erythema on areas of skin exposed to light).
• Colitis (causing persistent diarrhea without apparent cause).

Other adverse effects:

Common (may affect up to 1 in 10 people)

• Mild allergic reactions.
• Loss of appetite, weight loss (usually insignificant).
• Tiredness (asthenia).
• Headache, dizziness.
• Abnormal skin sensations such as tingling (paresthesia).
• Slight increase in blood pressure.
• Diarrhea.
• Nausea, vomiting.
• Abdominal pain.
• Increased values in certain liver function tests.
• Increased hair loss.
• Eczema, dry skin, skin rash, and itching.
• 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).

Uncommon (may affect up to 1 in 100 people)

• Decreased potassium levels in the blood.
• Anxiety.
• Taste disturbances.
• Hives (urticaria).
• Tendon rupture.
• Increased levels of fat in the blood (cholesterol and triglycerides).
• Decreased phosphate levels in the blood.

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

• Increase in the number of blood cells called eosinophils (eosinophilia).
• Severe increase in blood pressure.
• Increase in levels of certain enzymes in the blood (lactate dehydrogenase).

Not known (frequency cannot be estimated from available data)

Other adverse effects that may also occur include decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is reversible after stopping treatment with this medicine), psoriasis (new onset or worsening), and skin ulceration (a round, open sore in the skin through which underlying tissues can be seen).

Medicines such as leflunomide have been associated with an increased risk of developing cancers.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Leflunomide Viatris

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Viatris

• The active substance is leflunomide. One film-coated tablet contains 10 mg of leflunomide.
• The other components are microcrystalline cellulose, pregelatinized corn starch, povidone K30 (E-1201), crospovidone (E-1202), colloidal anhydrous silica, magnesium stearate (E-470b), and monohydrate lactose in the tablet core, as well as titanium dioxide (E-171), monohydrate lactose, hypromellose (E-464), and macrogol in the coating.

Appearance of the product and contents of the pack

Leflunomida Viatris are white, round, biconvex tablets with a diameter of approximately 6.1 mm. The product is packaged in a cardboard box containing blisters or a bottle with an integrated desiccant (white silica gel) or a desiccant sachet. Do not eat the desiccant.

Pack sizes of 30 and 100 film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Pharmathen S.A.
Dervenakion 6
15351 Pallini, Attiki
Greece

Or

Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

Or

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

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

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Leflunomid Mylan 10 mg Filmtabletten
Spain: Leflunomida Viatris 10 mg film-coated tablets EFG
France: LEFLUNOMIDE MYLAN 10 mg comprimé pelliculé
Netherlands: Leflunomide Mylan 10 mg, filmomhulde tabletten
Italy: LEFLUNOMIDE MYLAN
United Kingdom: Leflunomide Mylan 10 mg film-coated tablets

Date of the most recent revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/