LEFLUNOMIDE VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Leflunomide Viatris 10 mg film-coated tablets EFG

Read the entire summary carefully before starting to take this medication, as it contains important information for you.

• Keep this summary, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this summary. See section 4.

Summary of Product Characteristics

1. What is Leflunomide Viatris and what is it used for
2. What you need to know before taking Leflunomide Viatris
3. How to take Leflunomide Viatris
4. Possible side effects
5. Storage of Leflunomide Viatris
6. Package contents and additional information

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

Leflunomide belongs to a group of medications called antirheumatic medications. 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 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 taking 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, such as Stevens-Johnson syndrome), to a medication called teriflunomide (related to leflunomide), or to any of the other components of this medication (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 blood protein levels(hypoproteinemia).
• If you have any problem that affects your immune system(such as AIDS).
• If you have any problem in your bone marrow, or if you have a reduced 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 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

Consult 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 want to have children, as leflunomide may pass into the semen, reliable contraceptive methods should be used during treatment with leflunomide. To reduce any possible risk, men who want 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 the body. Then, a blood test will be necessary to ensure that leflunomide has been eliminated sufficiently from the 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 Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or increase the risk of serious infections. For more information on this, see section 4 "Possible side effects".

DRESS is initially manifested with symptoms similar to the flu and facial rash. Then, the rash spreads with elevated body temperature, increased blood levels of liver enzymes and a type of white blood cell (eosinophilia), and increased lymph node size.

Your doctor will perform blood testsat regular intervals, before and during treatment with this medication, 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.

Consult your doctor if you experience chronic diarrhea of unknown origin. You may need to undergo 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 medications

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

This is especially important if you are taking:

• Other medications for rheumatoid arthritis, such as antimalarials (e.g., chloroquine and hydroxychloroquine), gold salts by intramuscular or oral route, D-penicillamine, azathioprine, tumor necrosis factor alpha inhibitors (e.g., adalimumab, infliximab), and other immunosuppressive agents (e.g., methotrexate), as these combinations are not recommended.
• A medication called cholestyramine (used to reduce high cholesterol) or activated charcoal, as these medications may reduce the amount of leflunomide absorbed by the body.
• A medication called teriflunomide (used to treat multiple sclerosis).
• Warfarinand other oral medications used to thin the blood, as monitoring is necessary to reduce the risk of adverse effects of this medication.
• 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 severe diarrhea.
• 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 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-inflammatory drug (NSAID)and/or corticosteroids, you may continue taking them after starting treatment with leflunomide.

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines cannot be administered while you are taking this medication, nor for a certain period after stopping treatment.

Taking Leflunomide Viatris with alcohol

It is not recommended to consume alcohol during treatment with this medication. 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, the risk of having a child with serious birth defects increases. Women of childbearing age should 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 medication 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 you may be pregnant during treatment with leflunomide or in the 2 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, thereby reducing the risk to your child.

Breastfeeding

Do nottake this medication 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Leflunomide Viatris

Always follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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 per day, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg of leflunomide per day.

Swallowthe tablet wholeand with plenty of water. Leflunomide Viatris can be taken with or without food.

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

Generally, you should take this medication for extended periods.

If you take more Leflunomide Viatris than you should

If you take more Leflunomide Viatris than you should, consult your doctor or any other medical advisor. If possible, bring the tablets or the box to show the 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 medication and the amount ingested), or go to the nearest hospital. Bring the package and 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 the next dose. Do not take a double dose to make up for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor immediatelyand stop taking Leflunomide Viatris:

• If you feel weak, dizzy, or lightheaded, or have difficulty breathing(including itching with or without rash, swelling of 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 be life-threatening (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS), see section 2.

Tell your doctor immediatelyif you experience:

• Pale skin, 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 can be life-threatening.
• 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 medication may increase the risk of serious infections, including sepsis (rare), which can be life-threatening.
• Inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis).
• Coughor respiratory problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension).
• Numbness, 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 pancreatitis (inflammation of the pancreas).
• Severe pain on one or both sides of the back; sudden, severe 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 while urinating; fever, nausea, vomiting; rash; weight gain; these could be signs of kidney failure.
• Lupus-like skin rash (characterized by skin rash/erythema in sun-exposed areas).
• Colitis (causing persistent diarrhea without apparent cause).

Other side effects:

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

Unknown frequency (cannot be estimated from available data)

Other side effects that may also occur are decreased uric acid levels in the blood, pulmonary hypertension, male infertility (which is reversible after stopping treatment with this medication), psoriasis (new or worsening), and skin ulcers (open sores in the skin that can show underlying tissues).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this summary. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Leflunomida Viatris

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 blister or bottle and on the carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 10 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), lactose monohydrate, hypromellose (E-464), and macrogol in the coating.

Appearance of the Product and Package Contents

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

Package sizes of 30 and 100 film-coated tablets.

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 10 mg Filmtabletten

Spain Leflunomida Viatris 10 mg film-coated tablets EFG

France LEFLUNOMIDE MYLAN 10 mg film-coated tablet

Netherlands Leflunomide Mylan 10 mg, film-coated tablets

Italy LEFLUNOMIDE MYLAN

United Kingdom Leflunomide Mylan 10 mg film-coated tablets

Date of the last revision of this leaflet:September 2024

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