Package Insert: Information for the Patient

Leflunomida Stada 10 mg Film-Coated Tablets

Leflunomida Stada 20 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine because 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 for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Leflunomida Stada belongs to a group of medicines known as anti-rheumatic medicines. 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 affecting 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 patches, and scaly skin (skin lesions).

Do not take Leflunomida Stada

• if you have ever experienced an allergic reactionto leflunomida(especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches, or blisters, e.g., Stevens-Johnson syndrome) or to any of the other components of this medication (listed in section 6),

• if you are allergic to a medication called teriflunomida (which is related to leflunomida and may be used to treat multiple sclerosis),

• if you have anyliver problems,
• if you havekidney problemsof moderate to severe degree,
• if you have a severe decrease in the concentration ofproteins in the blood(hypoproteinemia),
• if you have any condition that affects yourimmune system(e.g., AIDS),
• if you have any problems with yourbone marrowor if you have a reduced number of red or white blood cells in your blood or a reduced number of platelets,
• if you have aserious infection,

• if you arepregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Leflunomida Stada, especially:

• if you have ever hadinterstitial 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 amaleand wish to have children. As leflunomida may pass into the semen, reliable contraceptive methods should be used during treatment with this medication. Males who wish to have children should contact their doctor, who will advise them to interrupt treatment with leflunomida and take certain medications to quickly and sufficiently eliminate leflunomida from their body. In this case, a blood test will be necessary to ensure that leflunomida has been eliminated sufficiently from their body, and then they should wait at least 3 months before attempting to have children.
• if you are to undergo a specific blood test (calcium levels). False low calcium levels may be detected.
• if you are to undergo or have recently undergone major surgery, or if you still have an open wound after surgery. Leflunomida may impair wound healing.

Consult your doctor if you experience chronic diarrhea of unknown origin. You may undergo additional tests to establish a differential diagnosis.

Leflunomida 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 a pharmacological reaction with eosinophilia and systemic symptoms (DRESS)), or increase the risk of a serious infection. For more information on these adverse effects, see section 4 (Possible adverse effects). In DRESS, initially, symptoms of a flu-like illness and facial rash appear, accompanied by high temperature, elevated liver enzymes in blood tests, and increased eosinophils, and swollen lymph nodes.

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

Children and adolescents

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

Other medications and Leflunomida Stada

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

This is especially important if you are taking:

• other medications forrheumatoid arthritissuch as antimalarials (e.g., chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive agents (e.g., methotrexate), as the use of these combinations is not recommended.
• warfarin and other oral medications used as anticoagulants, as a control is necessary to reduce the risk of adverse effects of this medication
• teriflunomida 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 control
• 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, urination 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 Leflunomida Stada absorbed by the body.

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

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines cannot be administered while you are being treated with leflunomidaor for a certain period after treatment has ended.

Taking Leflunomida Stada with food, drinks, and alcohol

Leflunomida Stada can be taken with or without food.

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

Pregnancy and lactation

Do not take Leflunomida Stada if you are or think you may bepregnant.Leflunomida Stada increases the risk of having a child with severe malformations. Women of childbearing age should not take leflunomida without using effective contraceptive methods.

Inform your doctor if you plan to become pregnant after interrupting treatment with leflunomida, as it is necessary to ensure that there are no remaining leflunomida 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 leflunomida from the body. In any case, a blood test will be necessary to confirm that leflunomida has been eliminated sufficiently 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 leflunomida or in the 2 years after 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 leflunomida from your body, and thus reduce the risk to your child.

Do not take leflunomidawhile breastfeeding, as leflunomida passes into breast milk.

Driving and operating machinery

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

Leflunomida Stada 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 again with your doctor or pharmacist.

The usual initial dose of leflunomidais one 100 mg tablet 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 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 up to 4 weeks or even more time to notice an improvement in your condition. Some patients may even notice a new improvement after 4 or 6 months of treatment. Generally, leflunomidashould be taken for prolonged periods of time.

If you take more Leflunomida Stada than you should

If you take more Leflunomida Stada than you should, consult with your doctor or any other healthcare service. If possible, bring the tablets or the box to show them to your 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 taken.

If you forgot to take Leflunomida Stada

If you forgot to take a dose, take it as soon as you remember, unless 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:

• if you feelweak, dizzy or lightheaded, or havedifficulty breathing, because these may be symptoms of a severe allergic reaction,

• if you developskin rashesormouth ulcers, because it may indicate serious reactions that in some cases can be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pharmacological reaction with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform your doctorimmediatelyif you experience:

• pallor,fatigue, or increased tendency to sufferbruising, 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 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 problemsbecause it 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 adverse reactions (may affect up to 1 in 10 people)

• 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,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth, mouth ulcers,
• abdominal pain,
• increase in liver test results that may be symptoms of 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 (creatinine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy),

• colitis.

Less frequent adverse reactions (may affect up to 1 in 100 people)

• 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 phosphorus in the blood.

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

• increase in the number of blood cells called red blood cells or 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 be symptoms of 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 adverse reactions (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 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 skin reactions that can be fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other adverse reactions 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 completed), lupus skin (characterized by skin rash/erythema in exposed skin areas), psoriasis (new or worsening) and DRESS syndrome may occur with unknown frequency.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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 after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

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. By doing so, you will help protect the environment.

Leflunomide Stada Composition

• The active ingredient is leflunomide.

Leflunomide Stada 10 mg film-coated tablets:

One film-coated tablet contains 10 mg of leflunomide.

Leflunomide Stada 20 mg film-coated tablets:

One film-coated tablet contains 20 mg of leflunomide.

• The other components are: maize starch, povidone (E1201), crospovidone (E1202), anhydrous colloidal 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.

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

Appearance of the product and contents of the package

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

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

The tablets are packaged in blisters.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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 medicinal product is authorized in the member states of theEuropean Economic Areaunder the following nameswith the following names:

ATLeflunomid STADA 10 mg/20 mg Filmtabletten

BELeflunomide EG 10 mg/20 mg filmomhulde tabletten

ESLeflunomide STADA 10 mg/20 mg comprimidos recubiertos con película EFG

FILeflunomide STADA 10 mg/20 mg kalvopäällysteiset tabletit

FRLeflunomide EG 10 mg/20 mg, comprimés pelliculés

LULeflunomide EG 10 mg/20 mg comprimés pelliculés

NLLeflunomide CF 10 mg/20 mg filmomhulde tabletten

Last review date of this leaflet:January 2025

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

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