LEFLUNOMIDE VIATRIS 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Leflunomide Viatris 20 mg film-coated tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Leflunomide belongs to a group of medicines called antirheumatic medicines. Leflunomide is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.

The symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, and pain. Other symptoms that affect the whole body include loss of appetite, fever, lack of energy, and anemia (reduction in the number of red blood cells in the blood).

The symptoms of active psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, red-colored plaques, and scaly skin (skin lesions).

2. What you need to know before you take 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 spots on the skin, 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 kidney problemsof moderate or severe degree.
• If you have a severe decrease in the concentration of proteins in the blood(hypoproteinemia).
• If you have any problem that affects your immune system(for example, AIDS).
• If you have any problem in your bone marrow, or if you have a reduced number of red or white blood cells in your blood or a reduced number of platelets due to causes other than rheumatoid arthritis or psoriatic arthritis.
• If you have a severe infection.
• If you are pregnant, think you may be pregnant, or are breastfeeding.
• If you are a woman of childbearing age and do not use an effective contraceptive method.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take 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 if you have tuberculosis.
• If you are a man and wish to have children, since leflunomide may pass into the semen, reliable contraceptive methods should be used during treatment with leflunomide. To reduce any possible risk, men who wish to have children should contact their doctor, who will advise them to stop treatment with leflunomide and take certain medications that help eliminate leflunomide quickly and sufficiently from their body. Then, a blood test will be necessary to ensure that leflunomide has been eliminated sufficiently from their body, and after that, they should wait at least another 3 months before trying to have children.
• If you are scheduled to have a specific blood test(calcium level). A false decrease in calcium levels may be detected.
• If you are going to undergo 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 some problems in the blood, liver, lungs, or nerves of the arms or legs. It may also cause some severe allergic reactions (including Drug Rash with Eosinophilia and Systemic Symptoms [DRESS]) or increase the risk of having a severe infection. For more information on this, see section 4 "Possible side effects".

DRESS initially manifests with symptoms similar to the flu and facial rash. Then, the rash spreads with elevated body temperature, increased levels of liver enzymes and a type of white blood cells (eosinophilia) in the blood, and enlargement of lymph nodes.

Your doctor will perform blood testsat regular intervals, before and during treatment with this medicine, to monitor your blood cells and liver. Your doctor will also check your blood pressure regularly, as leflunomide may cause an increase in blood pressure.

Talk to your doctor if you experience chronic diarrhea of unknown origin. You may need to undergo additional tests to establish a differential diagnosis.

Tell 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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), gold salts by intramuscular or oral route, D-penicillamine, azathioprine, tumor necrosis factor alpha inhibitors (for example, adalimumab, infliximab), and other immunosuppressive agents (for example, methotrexate), as these combinations are 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).
• Warfarinand other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of adverse effects of 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 diarrhea.
• 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.
• Indomethacin, ketoprofen, for pain or inflammation.
• Furosemide, for heart disease (diuretic, water pills).
• Zidovudine, for HIV infection.
• Rosuvastatin, simvastatin, atorvastatin, pravastatin, for high cholesterol.
• Sulfasalazine, for inflammatory bowel disease or rheumatoid arthritis.
• Cimetidine (for excess stomach acid).

If you are already taking a non-steroidal anti-inflammatorymedicine (NSAIDs) 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 taking this medicine, or for a certain period after you finish treatment.

Taking Leflunomide Viatris with alcohol

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

Pregnancy and breastfeeding

Pregnancy

Do nottake 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 age must not take leflunomide without using effective contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that there are no remaining levels of leflunomide in your body before trying to become pregnant. This may take up to 2 years. It 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 will be necessary to confirm that the medicine has been eliminated sufficiently from your body, and you should wait at least 1 month before becoming pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you may be pregnant during treatment with leflunomide or in the two years after stopping treatment, you should immediatelycontact your doctor for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest that you start treatment with certain medications to quickly and sufficiently eliminate leflunomide from your body, and thus reduce the risk to your child.

Breastfeeding

Do nottake this medicine while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

Leflunomide may make you feel dizzy, which can affect your ability to concentrate and react. If this happens, do not drive or use machines.

Leflunomide Viatris contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Leflunomide Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended initial dose is one 100 mg leflunomide tablet per day for the first three days. After this, most people need a dose of:

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

Swallowthe tablet wholeand with plenty of water. Leflunomide Viatris can be taken with or without food. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

It may take about 4 weeks or more before you start to feel an improvement in your condition. Some patients may even notice a new improvement after 4 or 6 months of treatment.

In general, you should take this medicine for prolonged periods of time.

If you take more Leflunomide Viatris than you should

If you take more Leflunomide Viatris than you should, talk to your doctor or any other healthcare professional. If possible, take the tablets or the package to show them to the doctor.

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

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

If you forget to take Leflunomide 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 forgotten dose.

If you have any other 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 all people suffer from them.

Inform your doctor immediatelyand stop taking Leflunomida Viatris:

• If you feel weak, dizzy or faint, 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 severe allergic reaction.
• If you develop skin rashesor inflammationand mouth ulcers, as these may indicate severe allergic reactions that can sometimes be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS), see section 2.

Inform your doctor immediatelyif you experience:

• Pallor, fatigue, or bruises, as these may indicate blood problems caused by an imbalance in the different types of cells that make up the blood.
• Fatigue, abdominal pain, or jaundice(yellowing of the eyes or skin), as these may indicate serious problems such as liver inflammation (hepatitis) or liver failure, which could be fatal.
• Any symptoms of infectionsuch as fever, mouth ulcers(signs of agranulocytosis - a marked decrease in certain white blood cells - very rare), sore throat, or cough, as this medicine may increase the chances of developing serious infections, including sepsis (rare), which could be fatal.
• Inflammation of the blood vessels (vasculitis, including necrotizing cutaneous vasculitis).
• Coughor respiratory problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension).
• Unusual tingling, weakness, or pain in the hands or feet, as these may indicate nerve problems (peripheral neuropathy).
• Loss of appetite; abdominal pain; pain when touching the abdomen; feeling nauseous and, usually, dizzy, vomiting, and fever; these could be signs of pancreas inflammation (pancreatitis).
• Severe pain on one or both sides of the back; sudden spasms with severe pain (usually starting in the back below the ribs, spreading around the abdomen, and sometimes towards the groin and genital area); blood in the urine; nausea or vomiting; frequent need to urinate or burning sensation during urination; fever, nausea, vomiting; rashes; weight gain; these could be signs of kidney failure.
• Lupus-like skin rash (characterized by skin rash/erythema in areas of the skin exposed to light).
• Colitis (causing persistent diarrhea without apparent cause).

Other adverse effects:

Frequent (may affect up to 1 in 10 people)

• Mild allergic reactions.
• Loss of appetite, weight loss (usually insignificant).
• Fatigue (asthenia).
• Headache, dizziness.
• Abnormal sensations in the skin such as tingling (paresthesia).
• Mild increase in blood pressure.
• Diarrhea.
• Nausea, vomiting.
• Abdominal pain.
• Increased values of some liver tests.
• Increased hair loss.
• Eczema, dry skin, skin rash, and itching.
• Tendinitis (pain caused by inflammation of the membrane surrounding the tendons, usually in the feet or hands).
• Increased levels of certain enzymes in the blood (creatinine phosphokinase).

Uncommon (may affect up to 1 in 100 people)

• Decreased potassium levels in the blood.
• Anxiety.
• Taste disturbances.
• Hives (skin rash).
• 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)

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

Unknown frequency (cannot be estimated from the available data)

Other adverse effects that may also occur are decreased uric acid levels in the blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), psoriasis (new or worsening), and skin ulcers (round, open sores in the skin through which underlying tissues can be seen).

Medicines like leflunomide have been associated with an increased risk of developing cancer.

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 that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Leflunomida Viatris

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

Do not use this medicine after the expiration date stated on the blister or bottle and on the carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Leflunomida Viatris

• The active ingredient is leflunomide. One film-coated tablet contains 20 mg of leflunomide.
• The other ingredients are microcrystalline cellulose, pregelatinized corn starch, povidone K30 (E-1201), crospovidone (E-1202), anhydrous colloidal silica, magnesium stearate (E-470b), and lactose monohydrate in the tablet core, as well as titanium dioxide (E-171), hypromellose (E-464), macrogol, talc, and yellow iron oxide (E-172) in the coating.

Appearance of the product and package contents

Leflunomida Viatris are yellow, round, biconvex film-coated tablets with a score line on one side, approximately 8.1 mm in diameter. 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.

Package sizes of 30, 100, and 500 (only for the HDPE bottle) film-coated tablets.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Only some package sizes may 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized 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, film-coated tablet

Netherlands Leflunomide Mylan 20 mg, film-coated tablets

Italy LEFLUNOMIDE MYLAN

United Kingdom Leflunomide Mylan 20 mg film-coated tablets

Czech RepublicLeflugen 20 mg, film-coated tablets

Date of the last revision of this leaflet:September 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/