Leflunomide Normon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Leflunomide Normon 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do 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, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Leflunomide Normon

3. How to take Leflunomide Normon

4. Possible adverse effects

5. How to store Leflunomide Normon

6. Contents of the pack and other information

1. What Leflunomida Normon is and what it is used for

Leflunomida Normon belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs).

Leflunomide is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.

Symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, and pain. Other systemic symptoms include loss of appetite, fever, lack of energy, and anemia (reduction in the number of red blood cells in the blood).

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

2. What you need to know before taking Leflunomida Normon

Do not take Leflunomida Normon

• if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin rashes, or blisters, e.g., Stevens-Johnson syndrome) or to any of the other components of this medicine (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 blood protein concentration (hypoproteinemia),
• if you have any condition affecting the immune system (e.g., AIDS),
• if you have any bone marrow disorder or if you have a reduced number of red or white blood cells or a reduced number of platelets,
• if you have a serious infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Leflunomida Normon

• 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 carry out tests to check whether you have tuberculosis,
  • if you are a man and wish to have children. Since it cannot be ruled out that leflunomide passes into semen, reliable contraceptive methods must be used during treatment with leflunomide. Men who wish to have children should consult their doctor, who may advise stopping leflunomide treatment and taking certain medications to rapidly and sufficiently eliminate leflunomide from the body. In this case, a blood test will be required to confirm that leflunomide has been sufficiently eliminated from your body, after which you should wait at least another 3 months before attempting to father a child,
  • if you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected,
  • if you are undergoing or have recently undergone major surgery, or if you still have an unhealed wound following surgery. Leflunomida Normon may impair wound healing.

Occasionally, leflunomide may cause certain problems in the blood, liver, lungs, or nerves in the arms or legs. It may also cause serious allergic reactions (including drug rash with eosinophilia and systemic symptoms [DRESS syndrome]) or increase the risk of developing a serious infection. For more information on these adverse effects, see section 4 (Possible side effects).

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

Your doctor will perform blood tests at regular intervals before and during treatment with leflunomide to monitor blood cells and liver function. Your doctor should also monitor your blood pressure regularly, as leflunomide may cause an increase in blood pressure.

Consult your doctor if you experience chronic diarrhea of unknown origin. You may need 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

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Taking Leflunomida Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription.

This is especially important if you are taking:

• other medicines for rheumatoid arthritis, such as antimalarials (e.g., chloroquine and hydroxychloroquine), intramuscular or oral gold salts, D-penicillamine, azathioprine, and other immunosuppressants (e.g., methotrexate), as these combinations are not recommended,
• warfarin (used as a blood anticoagulant), as monitoring is required to reduce the risk of adverse effects of this medicine,
• teriflunomide for multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer,
• duloxetine for depression, urinary incontinence, or diabetic kidney disease,
• alosetron for 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, "water pills"),
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
  • sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
  • a medicine called cholestyramine (used to lower high cholesterol) or activated charcoal, as these medicines may reduce the amount of Leflunomida Normon absorbed by the body.

If you are taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue taking them after starting treatment with Leflunomida Normon.

Vaccinations

Talk to 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 has ended.

Taking Leflunomida Normon with food, drink, and alcohol

This medicine may be taken with or without food.

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

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking leflunomide, there is an increased risk of having a baby with serious birth defects. Women of childbearing potential must not take Leflunomida Normon unless using reliable contraceptive measures.

Inform your doctor if you plan to become pregnant after stopping treatment with Leflunomida Normon, as it is necessary to ensure that no residual leflunomide remains in your body before conception. Elimination of the drug 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 Leflunomida Normon from the body.

In any case, before becoming pregnant, you must have a blood test to confirm that Leflunomida Normon has been sufficiently eliminated from your body. After this test, you should wait at least 1 month before becoming pregnant.

For more information about laboratory tests, contact your doctor.

If you suspect you may be pregnant during treatment with Leflunomida Normon or within two years after treatment, you must contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may recommend starting treatment with certain medications to rapidly and sufficiently eliminate Leflunomida Normon from your body, thereby reducing the risk to your baby.

Do not take Leflunomida Normon while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

This medicine may cause dizziness, which could affect your ability to concentrate and react. If this occurs, do not drive or operate machinery.

Leflunomida Normon contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Leflunomida Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you have any doubts.

The usual starting dose of leflunomide is one 100 mg tablet once daily for the first three days. After this, most people require a maintenance dose of:

• For rheumatoid arthritis: 10 mg or 20 mg of leflunomide once daily, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg of leflunomide once daily.

Swallow the tablet whole 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 experience further improvement after 4 to 6 months of treatment. Generally, leflunomide should be taken for long periods of time.

If you take more Leflunomida Normon than you should

If you take more leflunomide than you should, consult your doctor or any other healthcare provider. If possible, bring the tablets or the package to show the doctor.

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

If you forget to take Leflunomida Normon

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

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

4. Possible adverse effects

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

Tell your doctor immediately and stop taking Leflunomide Normon:

• 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 rashes or mouth ulcers, as these may indicate serious reactions which in some cases can be fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Tell your doctor immediately if you experience:

• pallor, tiredness, or bruising, as these may indicate blood problems due to an imbalance in the different types of cells that make up the blood,
• tiredness, abdominal pain, or jaundice (yellowing of the eyes or skin), as these may indicate serious problems such as liver failure, which could be fatal,
• any signs of infection such as fever, sore throat, or cough, as this medicine may increase the risk of developing serious infections, which could be fatal,
• cough or breathing problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness, or pain in the hands or feet, as this may indicate nerve problems (peripheral neuropathy).

Frequent adverse reactions (may affect up to 1 in 10 patients)

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

• mild allergic reactions,

• loss of appetite, weight loss (usually insignificant),

• fatigue (asthenia),

• headache, dizziness,

• abnormal skin sensations such as tingling (paraesthesia),

• mild increase in blood pressure,

• colitis,

• diarrhoea,

• nausea, vomiting,

• mouth inflammation, mouth ulcers,

  • abdominal pain,
  • increased results in certain liver function tests,

• increased hair loss,

• eczema, dry skin, skin rash, and itching (pruritus),

  • tendinitis (pain caused by inflammation of the membrane surrounding tendons, usually in the feet or hands),
    • increased levels of certain enzymes in the blood (creatine phosphokinase),
    • nerve problems in the arms or legs (peripheral neuropathy).

Uncommon adverse reactions (may affect up to 1 in 100 patients)

• decrease in the number of red blood cells (anaemia) and platelets (thrombocytopenia),
• low blood potassium levels,
• anxiety,
• taste disturbances,
• skin rash (urticaria),
  • tendon rupture,
  • increased levels of blood fats (cholesterol and triglycerides),
    • low blood phosphate levels.

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

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

Very rare adverse reactions (may affect up to 1 in 10,000 patients)

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

Other adverse effects may also occur, with unknown frequency, such as renal failure, decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (this effect is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by skin rash/erythema in areas of skin exposed to light), psoriasis (new onset or worsening), DRESS syndrome, and skin ulcer (a round, open sore in the skin through which underlying tissues may be visible), which may occur with unknown frequency.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Leflunomide Normon

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Leflunomida Normon

• The active substance is leflunomide. Each film-coated tablet contains 20 mg of leflunomide.
• The other components (excipients) are: lactose monohydrate, corn starch, crospovidone, povidone, colloidal silicon dioxide, magnesium stearate, titanium dioxide (E-171), hypromellose, polyethylene glycol 6000, and yellow iron oxide (E-172).

Appearance of the medicine and contents of the pack

This medicine is presented as film-coated tablets. The tablets are yellow, round, biconvex, and marked with "LF20" on one side.

The tablets are packed in blisters.

Pack sizes of 30 or 100 tablets are available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: September 2025

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