Package Insert: Information for the Patient

Leflunomida Aurovitas 20 mg Film-Coated Tablets

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

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Leflunomida Aurovitas belongs to a group of medications known as anti-rheumatic medications. It contains leflunomida as the active ingredient.

Leflunomida Aurovitas 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, 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 plaques, and scaly skin (skin lesions).

Do not take Leflunomida Aurovitas:

• if you have ever had a severe allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin rash, or blisters, such as Stevens-Johnson syndrome) or to any of the other components of this medication (listed in section 6), or if you are allergic to teriflunomide (used in the treatment of multiple sclerosis),
• if you have any liver problems,
• if you have moderate to severe kidney problems,
• if you have a severe decrease in the concentration of proteins in the blood (hypoproteinemia),
• if you have any condition that affects the immune system (for example, HIV/AIDS),
• if you have any bone marrow problems or if you have a reduced number of red or white blood cells in the blood or a reduced number of platelets,
• if you have a severe infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Leflunomida Aurovitas.

• If you have ever had lung inflammation (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 see if you have tuberculosis.
• If you are a male and wish to have children. As leflunomide may pass into semen, reliable contraceptive methods should be used during treatment with leflunomide. Males who wish to have children should contact their doctor, who may advise them to interrupt treatment with leflunomide and take certain medications to quickly and sufficiently eliminate leflunomide from their body. In this case, a blood test will be necessary to ensure that leflunomide has been eliminated sufficiently from their body, and then they should wait at least 3 months before attempting to have children.
• If a specific blood test (calcium level) is planned. 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 rash with eosinophilia and systemic symptoms [DRESS syndrome]), or increase the risk of a severe infection. For more information on these adverse effects, see section 4 (Possible adverse effects).

DRESS syndrome initially appears with symptoms similar to the flu and a skin rash on the face, followed by a widespread skin rash with fever, elevated liver enzymes in the blood, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Your doctor will perform regular blood tests, before and during treatment with leflunomide, to monitor blood cells and the liver. Your doctor should 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.

Consult your doctor if you develop skin ulcers during treatment with leflunomide (see also section 4).

Children and adolescents

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

Other medications and Leflunomida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription.

This is especially important if you are taking:

• other medications for rheumatoid arthritis, such as antimalarials (e.g., chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive medications (e.g., methotrexate), as the use of these combinations is not recommended
• warfarin and other oral medications used to thin the blood, as a control is necessary to reduce the risk of adverse effects of this medication
• teriflunomide for multiple sclerosis
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence, or renal insufficiency in diabetics
• alosetron for the control of severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, diuretic pills)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (high cholesterol)
• sulfasalazine for inflammatory bowel disease or for rheumatoid arthritis
• 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.

If you are taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, 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 being treated with leflunomide or for a certain period of time after treatment is completed.

Taking leflunomida Aurovitas with food, drinks, and alcohol

Leflunomide can be taken with or without food.

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

Pregnancy and lactation

Do not take leflunomide if you are or think you may bepregnant.

If you are pregnant or become pregnant while taking leflunomide, the risk of having a child with severe malformations increases. Women of childbearing age should not take leflunomide without using reliable contraceptive methods.

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 becoming pregnant. The elimination of the medication from the body may take up to 2 years. This time period may 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 should be performed before becoming pregnant to confirm that leflunomide has been sufficiently eliminated from your body, and once this test has been performed, 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 2 years after treatment, you should 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.

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

Driving and operating machines

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

Leflunomida Aurovitas contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Leflunomida Aurovitas 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose of leflunomida is 100 mg once a day for the first three days.

After that, most people need a dose of:

• For rheumatoid arthritis: 10 mg 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 plenty ofwater.

You may take 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.

Leflunomida is usually taken for prolonged periods of time.

If you take more Leflunomida Aurovitas than you should

If you have taken moreleflunomidathan you should, inform your doctor immediately or contact the nearest hospital's emergency service. If possible, bring the medication or the box with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Leflunomida Aurovitas

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 doses.

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

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

Inform your doctorimmediatelyand stop taking leflunomida:

• if you feelweak, dizzy or lightheaded, or havedifficulty breathing, because these can be symptoms of a severe allergic reaction,
• if you developskin rashesormouth ulcers, because it may indicate severe reactions that in some cases can be fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug eruption with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform your doctorimmediatelyif you experience:

• pallor, fatigueorbruising, because it may indicate blood problems caused by an imbalance of 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 as liver failure, which could be fatal,
• any symptom ofinfectionsuch asfever, sore throatorcough, because this medicine may increase the risk of severe infections, which could be fatal,
• coughorrespiratory problemssince these may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness or pain in the hands or feet, because it may indicate nerve problems (peripheral neuropathy).

Frequent side effects (may affect up to 1 in 10 patients)

• mild decrease in the number of white blood cells in the blood (leucopenia),
• 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,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth, mouth ulcers,
• abdominal pain,
• increase in liver test results that may lead to serious situations such as hepatitis and jaundice,
• increase in hair loss,
• eczema, dry skin, skin rash and itching (pruritus),
• tendinitis (pain caused by inflammation of the membrane surrounding the tendons of, usually, the feet or hands),
• increase in levels of certain enzymes in the blood (creatine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Rare side effects (may affect up to 1 in 100 patients)

• decrease in the number of red blood cells in the blood (anemia) and platelets (thrombocytopenia),
• decrease in potassium levels in the blood,
• anxiety,
• alterations in taste,
• skin rash (urticaria),
• tendon rupture,
• increase in levels of fat in the blood (cholesterol and triglycerides),
• decrease in levels of phosphate in the blood.

Very rare side effects (may affect up to 1 in 1,000 patients)

• increase in the number of blood cells called eosinophils (eosinophilia); mild decrease in the number of white blood cells in the blood (leucopenia); and decrease in the number of all blood cells (pancytopenia),
• severe increase in blood pressure,
• inflammation of the lung (interstitial lung disease),
• increase in values of some liver tests that may lead to serious situations such as hepatitis and jaundice,
• severe infections known as sepsis, which can be fatal,
• increase in levels of certain enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 patients)

• significant decrease in the number of certain white blood cells in the blood (agranulocytosis),
• severe allergic reactions and potentially severe allergic reactions,
• inflammation of small blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• severe liver damage such as liver failure or necrosis that can be fatal,
• severe reactions that can sometimes be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects may also occur, with unknown frequency, such as kidney failure, decrease in uric acid levels in the blood, pulmonary hypertension, male infertility (this effect is reversible once treatment with this medicine is discontinued), cutaneous lupus (characterized by skin rash/erythema in exposed skin areas), psoriasis (new or worsening), DRESS syndrome, and skin ulcers (open, round ulcer in the skin through which underlying tissues can be seen),may occur with an unknown frequency.

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 it 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 packaging and blister after CAD. The expiration date is the last day of the month indicated.

For Alu-Alu Blister:Store below 30°C.

For PVC/PVdC Alu Blister:Store below 25°C.

For HDPE Bottle:This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Leflunomide Aurovitas 20 mg

NCore of the tablet:lactose monohydrate, pregelatinized starch (cornstarch), povidone (K-30), anhydrous colloidal silica, crospovidone (type B), magnesium stearate.

Coating of the tablet:polyvinyl alcohol, talc (E553b), titanium dioxide (E171),monocaprilocaprato of glycerol, sodium lauryl sulfate, yellow iron oxide (E172).

Appearance of the product and contents of the package

Coated tablet.

Leflunomide Aurovitas 20 mg coated tablets EFG:[Size: approximately 7.2 mm]

Coated tablets of yellow to light yellow color, round, biconvex,with the mark “LF” on one face and “20” on the other.

Leflunomide Aurovitas 20 mg coated tablets EFG are available in blister packs and HDPE bottles.

Package sizes:

Blister pack:10, 15, 30, 60, 90 and 100coated tablets.

HDPE bottles:30 coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D, 5th floor

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon,

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany:Leflunomid PUREN 20 mg Filmtabletten

Belgium:Leflunomide AB 20 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Denmark:Leflunomid Aurobindo

Spain:Leflunomide Aurovitas 20 mg coated tablets

France:Leflunomide Arrow 20 mg, coated tablet

Italy:Leflunomide Aurobindo

Netherlands:Leflunomide Aurobindo 20 mg, filmomhulde tabletten

Poland:Leflunomide Aurovitas

Portugal:Leflunomida Generis

Romania:Leflunomida Aurobindo 20 mg coated tablets

Date of the last review of this leaflet:August 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/