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Package Insert: Information for the Patient

Leflunomide Viatris 20 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Leflunomide Viatris

3. How to take Leflunomide Viatris

4. Possible side effects

5. Storage of Leflunomide Viatris

6. Contents of the pack and additional information

Leflunomida belongs to a group of medications known as disease-modifying antirheumatic drugs. Leflunomida 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 affecting the entire body include loss of appetite, fever, fatigue, and anemia (reduction in the number of red blood cells).

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

Do not take Leflunomida ViatrisViatris

• If you are allergic to leflunomide (especially a severe skin reaction, usually accompanied by fever, joint pain, red skin rash, or blisters, for example, Stevens-Johnson syndrome),a medication called teriflunomide (related to leflunomide)or to any of the other components of this medication (listed in section 6).
• If you have anyliver problems.
• If you havekidney problemsmoderate or severe.
• If you have a severe decrease in the concentration ofproteins in the blood(hypoproteinemia).
• If you have any condition that affects yourimmune system(for example, HIV/AIDS).
• If you have any problem with yourbone 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 aserious infection.
• If you arepregnant,think you may be pregnantor are breastfeeding.
• If you are a fertile woman and do not use an effective contraceptive method.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takeleflunomide:

• If you have ever hadinterstitial 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 male and wish to have children, as leflunomide may pass into the semen, you should use reliable contraceptive methods during treatment with leflunomide. To reduce any possible risk, males who wish to have children should contact their doctor, who will advise them to interrupt treatment with leflunomide and take certain medications that help to quickly and sufficiently eliminate leflunomide from their body. Then, a blood test will be performed to ensure that leflunomide has been eliminated sufficiently from their body, and they should wait at least 3 months before attempting 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 to undergo or have recently undergone a major surgical procedure, or if you still have an open wound after a surgical procedure. Leflunomide may impair wound healing.

Leflunomide may occasionally cause some problems in the blood, liver, lungs, or nerves in 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 a serious infection. For more information on this, see section 4 “Possible side effects”.

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

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

Consult your doctor if you experience chronic diarrhea of unknown origin. Additional tests may be performed 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).

Taking Leflunomida Viatris with other medications

Inform 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 forrheumatoid arthritis, such as antimalarials (for example, chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, tumor 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 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 for the treatment ofmultiple sclerosis).
• Warfarinand other oral medications, used to thinthe blood, asmonitoring is necessary to reduce the risk of adverse effectsof 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 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, urination pills).
• Zidovudine, for HIV infection.
• Rosuvastatin, simvastatin, atorvastatin, pravastatin, for high cholesterol.
• Sulfasalazine, for inflammatory bowel diseases or rheumatoid arthritis.
• Cimetidine (for excess acid in the stomach).

If you are already taking anonsteroidal anti-inflammatory drug (NSAID)and/orcorticosteroids, you may continue to take them after starting treatment with leflunomide.

Vaccinations

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

Taking Leflunomida 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 not take leflunomide if you are or think you may bepregnant.

Inform your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that there are no remaining leflunomide residues in your body before attempting 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 your body.

However, a blood test will be performed to confirm that the medication has been eliminated sufficiently from your body, and you should wait at least 1 month before attempting to become 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 2 years after stopping treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest that you start taking certain medications to quickly and sufficiently eliminate leflunomide from your body and thus reduce the risk to your child.

Breastfeeding

Do not take this medication while you arebreastfeeding,as leflunomide passes into breast milk.

Driving and operating machinery

Leflunomide may cause you to feel dizzy, which may affect your ability to concentrate and react. If this happens, do not drive or operate machinery.

Leflunomida Viatris contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

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

Swallowthe tabletwholeand with plentywater. Leflunomida Viatris can be taken with or without food. The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

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

Generally, you will need to take this medication for prolonged periods of time.

If you take moreLeflunomida Viatristhan you should

If you take more Leflunomida Viatris than you should, consult your doctor or seek medical advice. If possible, bring the tablets or the box to show the doctor.

In case of overdose or accidental ingestion, contactimmediatelyyour doctor or pharmacist, call the Toxicological Information Service, phone91 562 04 20(indicating the medication and the amount ingested) or go to the nearest hospital. Bring the packaging and any remaining tablets with you.

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

If you forgot to take Leflunomida Viatris

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next one. Do not take a double dose to make up for the missed dose.

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

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

Inform your doctorimmediatelyand stop taking Leflunomida Viatris:

• If you feelweak, dizzy or lightheaded or havedifficulty breathing(including itching with or without skin eruptions, swelling of the hands, feet, ankles, face, lips, mouth or throat with difficulty swallowing), because these can be symptoms of a severe allergic reaction.
• If you developskin eruptionsorinflammationandmouth ulcers, because it may indicate severe allergic reactions that in some cases can be fatal (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS), see section 2.

Inform your doctorimmediatelyif you experience:

• Pallor,fatigueorbruising, because it may indicate blood problems caused by a balance disorder in the different types of cells that make up the blood.
• Fatigue,abdominal painorjaundice(yellowing of the eyes or skin), because it may indicate serious problems such asinflammation of the liver (hepatitis) orliver insufficiency, which could be fatal.
• Any symptom ofinfectionsuch asfever,mouth ulcers(signs of agranulocytosis -marked decrease in some white blood cells- very rare),throat painorcough, because this medicine may increase the likelihood of developing severe infections, including sepsis (rare), which could be fatal.
• Swelling of blood vessels (vasculitis, including necrotizing cutaneous vasculitis).
• Coughorrespiratory problems, because it may indicate lung problems (interstitial lung diseaseor pulmonary hypertension).
• Unusual tingling, weakness or pain in the hands or feet, because it may indicate nerve problems (peripheral neuropathy).
• Loss of appetite; abdominal pain; abdominal tenderness; feeling nauseous and, usually, dizzy, vomiting and fever; these may be signs ofinflammation of the pancreas (pancreatitis).
• Intense pain on one or both sides of the back; sudden spasms with intense pain (usually starting in the lower back below the ribs, spreading to the abdomen and sometimes to the inguinal and genital areas); blood in the urine; nausea or vomiting; frequent need to urinate or burning sensation during urination; fever, nausea, vomiting; rashes; weight gain; these may be signs of kidney insufficiency.
• Cutaneous lupus (characterized by skin rash/erythema in exposed skin areas).
• Colitis (causing persistent diarrhea without apparent cause).

Other side 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 levels 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 of, usually, the feet or hands).
• Increased levels of certain enzymes in the blood (creatinine phosphokinase).

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

• Decreased levels of potassium in the blood.
• Anxiety.
• Alterations in taste.
• Urticaria (skin rash).
• Tendon rupture.
• Increased levels of fat in the blood (cholesterol and triglycerides).
• Decreased levels of phosphate in the blood.

Very rare (may affect up to 1 in 10,000 people)

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

Unknown (cannot be estimated from available data)

Other side effectsthat may also occur aredecreased levels of uric acid in the blood,pulmonary hypertension,male infertility (which is reversible once treatment with this medicine is completed), psoriasis (new or worsening) and skin ulcer (round, open sore in the skin through which underlying tissues can be seen).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack or bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Leflunomide Viatris Composition

• The active ingredient is leflunomida. A film-coated tablet contains 20 mg of leflunomida.
• The other components are microcrystalline cellulose, pregelatinized cornstarch, 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 packaging contents

Leflunomide Viatris are yellow, round, biconvex tablets with a notch on one side with 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.

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

The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyLeflunomid Mylan 20 mg Filmtabletten

SpainLeflunomida Viatris 20 mg film-coated tablets EFG

FranceLEFLUNOMIDE MYLAN 20 mg, coated tablet

NetherlandsLeflunomide Mylan 20 mg, filmomhulde tablets

ItalyLEFLUNOMIDE MYLAN

United KingdomLeflunomide Mylan 20 mg film-coated tablets

Czech RepublicLeflugen 20 mg, coated tablets

Last review date of this leaflet:September 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/