LEFLUNOMIDE NORMON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Leflunomide Normon 10 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, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness 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 Normon and what is it used for
2. What you need to know before taking Leflunomide Normon
3. How to take Leflunomide Normon
4. Possible side effects
5. Storage of Leflunomide Normon

1. Package Contents and Additional Information

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

Leflunomide Normon belongs to a group of medications called antirheumatic medications.

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 Normon

Do not take Leflunomide Normon

• 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 Normon

• 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 their 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 Normon may interfere with wound healing.

Occasionally, leflunomide may cause some blood, liver, lung, or nerve problems in the arms or legs. It may also cause some severe allergic reactions (including drug rash 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).

DRESS 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.

Inform your doctor if you develop a skin ulcer during treatment with leflunomide (see section 4).

Children and Adolescents

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

Using Leflunomide Normon with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 (used as a blood anticoagulant), 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 Normon 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 Normon.

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 Normon with Food, Drink, and Alcohol

This medication 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 not take this medication 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 Normon without using reliable contraceptive methods.

Inform your doctor if you plan to become pregnant after stopping treatment with Leflunomide Normon, 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 Normon from the body.

In any case, before becoming pregnant, a blood test will be necessary to confirm that Leflunomide Normon 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 Normon 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 Normon from your body, thereby reducing the risk to your child.

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

Driving and Using Machines

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

Leflunomide Normoncontains 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 Normon

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

The initial dose of leflunomide is usually one 100 mg tablet per 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 prolonged periods of time.

If you take moreLeflunomide Normonthan you should

If you take more leflunomide than you should, consult your doctor or any other healthcare service. If possible, bring the tablets or the box 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 takeLeflunomide 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 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 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 rashesor mouth ulcers, as these may indicate severe reactions that can be life-threatening (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS]), see section 2.

Inform your doctor immediatelyif you experience:

• pale skin, fatigue, or bruising, 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).

Frequent Adverse Reactions (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 Adverse Reactions (may affect up to 1 in 100 patients)

• 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 blood fat levels (cholesterol and triglycerides),
  • • decrease in phosphate levels in the blood.

Rare Adverse Reactions (may affect up to 1 in 1,000 patients)

• increase in the number of eosinophils (a type of white blood cell) in the blood, 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,
    • • severe infections known as sepsis, which can be life-threatening,
      • • increase in certain enzyme levels in the blood (lactate dehydrogenase).

Very Rare Adverse Reactions (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 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 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 areas of the skin exposed to light), 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 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 national reporting system included in the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Leflunomida Normon

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

Store below 30 ºC.

Do not use this medicine after the expiration date that appears on the packaging after Exp. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Leflunomida Normon

• The active ingredient is leflunomide. Each film-coated tablet contains 10 mg of leflunomide.
• The other components (excipients) are: lactose monohydrate, cornstarch, crospovidone, povidone, colloidal silica, magnesium stearate, titanium dioxide (E-171), hypromellose, and macrogol 6000.

Appearance of the Product and Package Contents

This medicine is presented in the form of film-coated tablets. They are white or almost white, round, biconvex tablets marked with "LF10" on one side.

The tablets are packaged in blisters.

Packages of 30 tablets are available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Leaflet:August 2024

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