LEFLUNOMIDE STADA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Leflunomide Stada 10 mg film-coated tablets EFG

Leflunomide Stada 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

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 taking Leflunomide Stada

Do not take Leflunomide Stada

• 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 or pharmacist before starting to take Leflunomide Stada:

• if you have ever had lung inflammation(interstitial lung disease).
• if you have ever had tuberculosis or have been in contact with someone who has or has had tuberculosis. Your doctor may perform tests to determine 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 this medication. Men who wish to have children should contact their doctor, who will 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 need to undergo a specific blood test(calcium levels). False low 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 blood, liver, lung, or nerve problems in the arms or legs. It may also cause severe allergic reactions (including a drug reaction with eosinophilia and systemic symptoms [DRESS]) or increase the risk of serious infections. For more information on these side effects, see section 4 (Possible side effects). In DRESS, initial symptoms of a flu-like nature and facial rash appear, which spread along with elevated temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia) and inflamed lymph nodes.

Your doctor will perform blood testsat regular intervals, before and during treatment with leflunomide, to monitor your blood cells and 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. 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 Stada is not recommended for use in children and adolescents under 18 years of age.

Other medications and Leflunomide Stada

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 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 as blood anticoagulants, 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 Stada absorbed by the body.

If you are taking a non-steroidal anti-inflammatorymedication (NSAIDs) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomide Stada.

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 Stada with food, drinks, and alcohol

Leflunomide Stada can be taken with or without food.

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

Pregnancy and breastfeeding

Do nottake Leflunomide Stada 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 severe birth defects increases. Women of childbearing age should not take leflunomide without using effective 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 is performed, 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 following treatment, you should immediatelycontact your doctor for a pregnancy test. If the test confirms you are pregnant, your doctor may suggest starting treatment with certain medications to rapidly and sufficiently eliminate leflunomide from your body, thereby reducing the risk to your child.

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

Driving and using machines

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

Leflunomide Stada contains lactose

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

3. How to take Leflunomide Stada

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The initial dose of leflunomide is usually 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 before you start to notice an improvement in your condition. Some patients may even notice a new improvement after 4 or 6 months of treatment. In general, leflunomide should be taken for extended periods of time.

If you take more Leflunomide Stada than you should

If you take more Leflunomide Stada than you should, consult your doctor or any other healthcare service. If possible, bring the tablets or the package 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 taken.

If you forget to take Leflunomide Stada

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 forgotten doses.

If you have any other questions 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.

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 serious reactions that can be life-threatening (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Inform your doctor immediatelyif you experience:

• pale skin, fatigue, or increased tendency to bruise, 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 problemsas 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 people)

• mild decrease in the number of white blood cells in the blood (leukopenia),
• 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 people)

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

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

• increase in the number of red blood cells or eosinophils in the blood, mild decrease in the number of white blood cells in the blood (leukopenia), 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 be symptoms of serious conditions such as hepatitis and jaundice,
• severe 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 people)

• significant decrease in the number of certain white blood cells in the blood (agranulocytosis),
• severe allergic reactions and potentially severe allergic reactions,
• inflammation of 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 skin reactions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. 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 Stada

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 carton after CAD. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 Stada

• The active ingredient is leflunomida.

Leflunomida Stada 10 mg film-coated tablets EFG:

One film-coated tablet contains 10 mg of leflunomida.

Leflunomida Stada 20 mg film-coated tablets EFG:

One film-coated tablet contains 20 mg of leflunomida.

• The other ingredients are: corn starch, povidone (E1201), crospovidone (E1202), colloidal anhydrous silica, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the coating.

Leflunomida Stada 20 mg film-coated tablets contain additionally yellow iron oxide (E172)

Appearance and Package Contents of the Product

Leflunomida Stada 10 mg are white to off-white, round, and biconvex film-coated tablets.

Leflunomida Stada 20 mg are yellow, round, and biconvex film-coated tablets.

The tablets are packaged in blisters.

Leflunomida Stada is available in packages containing 30, 90, 100, 150, and 200 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH,

Muthgasse 36,

1190 Vienna,

Austria

or

Eurogenerics N.V.,

Heizel Esplanade B22,

B-1020 Brussels,

Belgium

or

Centrafarm Services B.V.,

Van de Reijtstraat 31-E,

4814 NE Breda,

Netherlands

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

AT Leflunomid STADA 10 mg/20 mg Filmtabletten

BE Leflunomide EG 10 mg/20 mg filmomhulde tabletten

ES Leflunomida STADA 10 mg/20 mg comprimidos recubiertos con película EFG

FI Leflunomide STADA 10 mg/20 mg kalvopäällysteiset tabletit

FR Leflunomide EG 10 mg/20 mg, comprimés pelliculés

LU Leflunomide EG 10 mg/20 mg comprimés pelliculés

NL Leflunomide CF 10 mg/20 mg filmomhulde tabletten

Date of last revision of this leaflet:March 2025

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/

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