Package Insert: Information for the Patient

Leflunomida Normon 10 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms of disease 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.

6. Contents of the pack and additional information

Leflunomida Normon belongs to a group of medications known as anti-rheumatic medications.

Leflunomida 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).

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

Do not take Leflunomida Normon

• if you have ever had an allergic reaction to leflunomida (especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches, or blisters, such as Stevens-Johnson syndrome) or to any of the other components of this medication (listed in section 6), or if you are allergic to teriflunomida (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 the concentration of proteins in your blood (hypoproteinemia),
• if you have any condition that affects your immune system (for example, HIV/AIDS),
• if you have any problems with your bone marrow or if you have a reduced number of red or white blood cells in your blood or a reduced number of platelets,
• 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 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 perform tests to see if you have tuberculosis,
• if you are a male and wish to have children. As leflunomida may pass into semen, reliable contraceptive methods should be used during treatment with leflunomida. Males who wish to have children should contact their doctor, who may advise them to stop treatment with leflunomida and take certain medications to quickly and sufficiently remove leflunomida from their body. In this case, a blood test will be performed to ensure that leflunomida has been removed sufficiently from their body, and they should wait at least 3 months before trying to have children,
• if a specific blood test (calcium level) is planned. A false decrease in calcium levels may be detected,
• if you are scheduled to undergo or have recently undergone a major surgical procedure, or if you still have an open wound after a surgical procedure. Leflunomida Normon may impair wound healing.

Occasionally, leflunomida may cause some problems in the blood, liver, lungs, or nerves in 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 a severe infection. For more information on these adverse effects, see section 4 (Possible adverse effects).

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

Your doctor will perform regular blood tests, 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.

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 leflunomida (see section 4).

Children and adolescents

This medication is not recommended for children or adolescents under 18 years old.

Use of Leflunomida Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive medications (e.g., methotrexate), as these combinations are not recommended,
• warfarin (used as an anticoagulant), 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, diuretics),

-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 charcoalas these medications may reduce the amount of Leflunomida Normon absorbed by the body.

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

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines cannot be administered while you are being treated with leflunomida or for a certain period after treatment is completed.

Taking Leflunomida Normon with food, drink, or alcohol

This medication can be taken with or without food.

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

Pregnancy and breastfeeding

Do not takethis medication if you are or think you may bepregnant. If you are pregnant or become pregnant while taking leflunomida, there is an increased risk of having a child with severe malformations.Women of childbearing age should not take Leflunomida Normon without using reliable contraceptive methods.

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

In any case, a blood test should be performed before becoming pregnant to confirm that Leflunomida 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 Leflunomida Normon or in the 2 years after treatment, you should 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 remove leflunomida from your body, and thus reduce the risk to your child.

Do not takeLeflunomida Normon while breastfeeding, asleflunomida passes into breast milk.

Driving and operating machinery

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

Leflunomida Normon contains lactose.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Take this medication exactly as your doctor or pharmacist has told you. Consult with your doctor or pharmacist if you have any doubts.

The usual initial dose of leflunomida is 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 not notice an improvement in your condition for 4 weeks or even longer. Some patients may even notice a new improvement after 4 or 6 months of treatment. Leflunomida is usually taken for prolonged periods of time.

If you take moreLeflunomida Normonthan you should

If you take more leflunomida than you should, consult with 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeLeflunomida Normon

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, pharmacist, or nurse.

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

Inform your doctorimmediatelyand stop taking Leflunomida Normon:

• if you feelweak, dizzy or lightheaded, or havedifficulty breathing, as these may be symptoms of a severe allergic reaction,
• if you developskin rashesormouth ulcers,as this may indicate severe reactions that can be fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug eruption with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform your doctorimmediatelyif you experience:

• pallor,fatigueorbruising,as this may indicate blood problems caused by an imbalance of the different types of blood cells,
• fatigue,abdominal painorjaundice(yellowing of the eyes or skin), as this may indicate serious problems such as liver failure, which could be fatal,
• any symptoms ofinfectionsuch asfever, sore throat or cough, as this medicine may increase the risk of serious infections, which could be fatal,
• coughorrespiratory 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 side effects (may affect up to one 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,
• inflammation of the mouth, mouth ulcers,
• • abdominal pain,
  • increase in liver test results,

• 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 (creatine phosphokinase),
    • nerve problems in the arms or legs (peripheral neuropathy).

Rare side effects (may affect up to one in 100 patients)

• 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 phosphate in the blood.

Very rare side effects (may affect up to one in 1,000 patients)

• increase in the number of eosinophils in the blood (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 results that can lead to serious conditions 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 side effects (may affect up to one 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),
• pancreatitis,
• severe liver damage such as liver failure or necrosis that can be fatal,
• severe skin reactions that can be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side 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.

Store below30 °C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Leflunomida Normon

• The active ingredient is leflunomida. Each film-coated tablet contains 10 mg of leflunomida.
• 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 content of the packaging

This medication is presented in the form of film-coated tablets. They are white or almost white, round, biconvex, and marked with “LF10” on one of the faces.

The tablets are packaged in blisters.

They are available in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:August 2024

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