Leflunomide Viatris 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Leflunomide Viatris 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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. 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 Leflunomida Viatris

Do not take Leflunomida Viatris

• If you are allergic to leflunomide (especially a severe skin reaction, usually accompanied by fever, joint pain, red skin rashes, 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 problem with your bone marrow, 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 for 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 should be used during treatment with leflunomide. To reduce any potential risk, men who wish to father a child should contact their doctor, who will advise them to stop 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, and you must wait at least 3 additional months before attempting to father a child.
• If you are scheduled for a specific blood test (calcium level). 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 problems in 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, see section 4, “Possible side effects”.

DRESS initially presents with flu-like symptoms and facial rash. This is followed by a spreading rash, elevated body temperature, increased blood levels of liver enzymes and a type of white blood cell (eosinophilia), and enlarged lymph nodes.

Your doctor will perform blood tests regularly, 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 need 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

The use of leflunomide is not recommended 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 (e.g., chloroquine and hydroxychloroquine), intramuscular or oral gold salts, D-penicillamine, azathioprine, tumour necrosis factor alpha inhibitors (e.g., adalimumab, infliximab), and other immunosuppressive agents (e.g., methotrexate), as use of these combinations is not recommended.
• A medicine called cholestyramine (used to lower 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 anticoagulant 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 (e.g., ethinylestradiol and levonorgestrel).
• Rifampicin (used in the treatment of tuberculosis).
• Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, for infections.
• Indomethacin, 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 leflunomida.

Vaccinations

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

Taking Leflunomida Viatris with alcohol

It is not recommended to drink alcohol during treatment with this medicine. Consuming alcohol while taking 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 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 remnants of leflunomide remain 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, a blood test must be performed to confirm that the drug has been sufficiently eliminated from your body, and you must wait at least 1 month before attempting pregnancy.

For more information about laboratory tests, 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 the test confirms pregnancy, your doctor may recommend starting treatment with certain medications to rapidly and adequately eliminate leflunomide from your body, thereby reducing the risk to your child.

Breastfeeding

Do not take this medication 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 use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial 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 may be taken with or without food. The tablet's notch is intended solely for ease of splitting and swallowing, and must not be used to divide the tablet into equal doses.

It may take about 4 weeks or 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, 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 you should, consult your doctor or another medical professional. If possible, bring the tablets or the packaging to show your doctor.

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

Tell 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 or inflammation and 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.

Tell 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 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, and generally 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 burning sensation during urination; fever, nausea, vomiting; rash; 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 levels in certain liver function tests.
• Increased hair loss.
• Eczema, dry skin, skin rash, and itching.
• Tendinitis (pain caused by 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 levels of potassium in the blood.
• Anxiety.
• Taste disturbances.
• Hives (urticaria).
• Tendon rupture.
• Increased levels of fats in the blood (cholesterol and triglycerides).
• Decreased levels of phosphate in the blood.

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

• Increased number of a type of blood cell called eosinophils (eosinophilia).
• Severe increase in blood pressure.
• Increased levels of certain enzymes in the blood (lactate dehydrogenase).

Not known (frequency cannot be estimated from available data)

Other possible adverse effects 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 cutaneous ulceration (an open, round 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Viatris

Keep this medicine out of sight and reach of children.

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

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If in doubt, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. 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 20 mg of leflunomide.
• The other components are microcrystalline cellulose, pregelatinized corn starch, povidone K30 (E-1201), crospovidone (E-1202), anhydrous colloidal silica, magnesium stearate (E-470b) and monohydrate lactose in the tablet core, and titanium dioxide (E-171), hypromellose (E-464), macrogol, talc and yellow iron oxide (E-172) in the coating.

Appearance of the product and contents of the pack

Leflunomida Viatris are yellow, round, biconvex film-coated tablets with a score line on one side and a diameter of approximately 8.1 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, 100 and 500 (only for the HDPE bottle) film-coated tablets.

The score line is intended solely to facilitate breaking the tablet and swallowing, but not for dividing into equal doses.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Authorisation Holder:

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

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

Germany Leflunomid Mylan 20 mg Filmtabletten
Spain Leflunomida Viatris 20 mg film-coated tablets EFG
France LEFLUNOMIDE MYLAN 20 mg, comprimé pelliculé
Netherlands Leflunomide Mylan 20 mg, filmomhulde tabletten
Italy LEFLUNOMIDE MYLAN
United Kingdom Leflunomide Mylan 20 mg film-coated tablets
Czech Republic Leflugen 20 mg, potahované tablety

Date of the latest 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 of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/