LEFLUNOMIDE AUROVITAS 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Leflunomide Aurovitas 20 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 package leaflet. See section 4.

Contents of the package leaflet:

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

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

Leflunomide Aurovitas belongs to a group of medications called antirheumatic medications. It contains leflunomide as the active ingredient.

Leflunomide 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 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 taking Leflunomide Aurovitas

Do not take Leflunomide Aurovitas:

• if you have ever had an allergic reactionto leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin, or blisters, e.g., 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 to treat multiple sclerosis),
• if you have any liver problems,
• if you have kidney problemsof moderate to severe degree,
• if you have a severe decrease in blood protein levels(hypoproteinemia),
• if you have any immune system problems(e.g., AIDS),
• if you have any bone marrow problemsor if you have a reduced number of red or white blood cells or platelets in your blood,
• 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 Leflunomide Aurovitas.

• If you have ever had lung inflammation(interstitial lung disease).
• If you have ever had tuberculosisor if you 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 maleand wish to have children. As it cannot be excluded that leflunomide passes into semen, reliable contraceptive methods should be used during treatment with leflunomide. Men who wish to have children should contact their doctor, who may advise them to discontinue treatment with leflunomide and take certain medications to rapidly and sufficiently eliminate leflunomide from their body. In this case, a blood test will be necessary to ensure that leflunomide has been sufficiently eliminated from the body, and then 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 interfere with 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 syndrome]) or increase the risk of serious infections. For more information on these side effects, see section 4 (Possible side effects).

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

Your doctor will perform blood testsat regular intervals, before and during treatment with leflunomide, to monitor blood cells and liver function. 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. You may need to undergo additional tests 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 Leflunomide Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, 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 by intramuscular or oral route, D-penicillamine, azathioprine, and other immunosuppressive medications (e.g., methotrexate), as these combinations are not recommended
• warfarin and other oral medications used to thin the blood, as monitoring 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 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, water pills)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or 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 non-steroidal anti-inflammatory medication(NSAIDs) 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 being treated with leflunomide or for a certain period after treatment.

Taking Leflunomide 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. Alcohol consumption during treatment with leflunomide may increase the risk of liver damage.

Pregnancy and breastfeeding

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 reliable contraceptive measures.

Inform your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that no leflunomide remains in your body before becoming pregnant. The elimination of the medication from the body may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications that accelerate the elimination of leflunomide from the body.

In any case, before becoming pregnant, a blood test must be performed to confirm that leflunomide has been sufficiently eliminated from the 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 following 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 rapidly and sufficiently eliminate leflunomide from your body, thereby reducing the risk to your child.

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

Driving and using machines

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

Leflunomide Aurovitas contains sodium.

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

Leflunomide 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.

3. How to take Leflunomide Aurovitas

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

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

After this, most people need a dose of:

• For rheumatoid arthritis: 10 mg 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.

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

Leflunomide should generally be taken for extended periods.

If you take more Leflunomide Aurovitas than you should

If you have taken more leflunomide than you should, inform your doctor immediately or contact the emergency department of the nearest hospital. If possible, bring the medication or the package with you to show the doctor.

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

If you forget to take Leflunomide Aurovitas

If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Inform your doctor immediatelyand stop taking leflunomide:

• if you feel weak, dizzy, or lightheaded, or have difficulty breathing, as these may be symptoms of a severe allergic reaction,
• if you develop skin rashesor mouth ulcers, as these may indicate severe reactions that can sometimes be life-threatening (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform 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 failure, which can be life-threatening,
• any symptoms of infectionsuch as fever, sore throat, or cough, as this medication may increase the risk of serious infections, which can be life-threatening,
• 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).

Common 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,
• mouth inflammation, mouth ulcers,
• abdominal pain,
• increase in liver test results,
• increase in hair loss,
• eczema, dry skin, skin rash, and itching (pruritus),
• tendinitis (pain caused by inflammation of the membrane surrounding the tendons, usually in the feet or hands),
• increase in certain enzyme levels in the blood (creatine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

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

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

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,
• lung inflammation (interstitial lung disease),
• increase in liver test values, which can lead to serious conditions such as hepatitis and jaundice,
• serious infections, known as sepsis, which can be life-threatening,
• increase in certain enzyme levels 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, which can be life-threatening,
• severe reactions that can sometimes be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects may also occur, with an 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 medication is stopped), cutaneous lupus (characterized by skin rash/erythema in sun-exposed areas), psoriasis (new or worsening), DRESS syndrome, and skin ulcers (round, open sore in the skin through which underlying tissues can be seen), may occur with an unknown frequency.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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 Aurovitas

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 packaging and blister after CAD. The expiry 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 medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Leflunomida Aurovitas 20 mg

• The active ingredient is leflunomide. Each tablet contains 20 mg of leflunomide.
• The other ingredients are:

Tablet core:lactose monohydrate, pregelatinized starch (corn starch), povidone (K-30), colloidal anhydrous silica, crospovidone (type B), magnesium stearate.

Tablet coating:polyvinyl alcohol, talc (E553b), titanium dioxide (E171), glycerol monocaprylate, sodium lauryl sulfate, yellow iron oxide (E172).

Appearance of the product and package contents

Film-coated tablet.

Leflunomida Aurovitas 20 mg film-coated tablets EFG:[Size: approximately 7.2 mm]

Yellow to light yellow, round, biconvex film-coated tablets, with the mark “LF” on one face and “20” on the other.

Leflunomida Aurovitas 20 mg film-coated tablets EFG are available in blister packs and HDPE bottles.

Package sizes:

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

HDPE bottles: 30 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

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

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon,

France

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

Germany: Leflunomid PUREN 20 mg Filmtabletten

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

Denmark: Leflunomid Aurobindo

Spain: Leflunomida Aurovitas 20 mg comprimidos recubiertos con película EFG

France: Leflunomide Arrow 20 mg, comprimé pelliculé

Italy: Leflunomide Aurobindo

Netherlands: Leflunomide Aurobindo 20 mg, filmomhulde tabletten

Poland: Leflunomide Aurovitas

Portugal: Leflunomida Generis

Romania: Leflunomida Aurobindo 20 mg comprimate filmate

Date of the last revision of this leaflet:August 2024

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