Package Leaflet: Information for the User

Leflunomide Cinfa 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

leflunomide cinfa belongs to a group of medicines called antirheumatic medicines. It containsleflunomide as the active ingredient.

leflunomide cinfa is used to treat adult patients with active rheumatoid arthritis or active psoriaticarthritis.

The symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, andpain. 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 plaques, and scaly skin (skin lesions).

Do not take leflunomide cinfa

• if you are allergic to leflunomide (especially a severe reaction in the skin, often accompanied by fever, joint pain, red patches on the skin, 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 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 the concentration of proteins in the blood (hypoproteinemia),
• if you have any condition that affects the immune system (for example, AIDS),
• if you have any problems with the bone marrow or if you have a reduced number of red or white blood cells in the 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.
• This medication contains soy lecithin. Do not use in case of allergy to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take leflunomide cinfa.

• if you have ever had inflammation of the lungs (interstitial lung disease).
• if you have ever had tuberculosis or 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 a male and wish to have children. As it cannot be ruled out that leflunomide may pass into the semen, reliable contraceptive methods should be used during treatment with leflunomide. Males who wish to have children should contact their doctor, who may advise them to interrupt treatment with leflunomide and take certain medications to quickly and sufficiently eliminate leflunomide from their body. In this case, a blood test will be necessary to ensure that leflunomide has been eliminated sufficiently from their body, and then they should wait at least 3 months before attempting to have children.
• if a specific blood test (calcium level) is planned. A false decrease in calcium levels may be detected.
• if you are to undergo or have recently undergone a major surgical procedure, or if you still have an open wound after a surgical procedure. Leflunomide may impair wound healing.

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

Your doctor will perform regular blood tests, before and during treatment with leflunomide, to monitor blood cells and the 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 undergo additional tests to establish a differential diagnosis.

Children and adolescents

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

Other medications and leflunomide cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes medications obtained without a prescription.

This is especially important if you are taking:

• other medications for rheumatoid arthritis, such as antimalarials (for example: chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive medications (for example: 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
• 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 the 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, pills to urinate)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (high cholesterol)
• sulfasalazine for inflammatory bowel disease or for rheumatoid arthritis
• a medication called cholestyramine (used to reduce high cholesterol) or activated charcoal, as these medications may reduce the amount of leflunomide 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 leflunomide.

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 of time after treatment is completed.

Taking leflunomide cinfa with food, drinks, and alcohol

Leflunomide can be taken with or without food.

It is not recommended to consume alcohol during treatment with leflunomide. Drinking alcohol 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 bepregnant.

If you are pregnant or become pregnant while taking leflunomide, the risk of having a child with severe malformations increases. Women of childbearing age should not take leflunomide without using reliable contraceptive methods.

Inform your doctor if you plan to become pregnant after interrupting treatment with leflunomide, as it is necessary to ensure that there are no remaining leflunomide residues in your body before becoming pregnant. The elimination of the medication from the body may take up to 2 years. This time interval may be reduced to a few weeks by taking certain medications that accelerate the elimination of leflunomide from the body.

In any case, a blood test should be performed before becoming pregnant to confirm that leflunomide 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 leflunomide 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 eliminate leflunomide from your body, and thus reduce the risk to your child.

Do not take this medication while breastfeeding,as leflunomide passes into breast milk.

Driving and operating machinery

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

Leflunomide cinfa contains 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.

Leflunomide cinfa containssodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The initial recommended dose of leflunomide is 100 mg once a day for the first three days.

After this, most people need a dose of:

Swallowthe tabletwholeand with plenty ofwater.

You may take up to 4 weeks or even longer to notice an improvement in your condition. Some patients may even notice a new improvement after 4 or 6 months of treatment.Generally, leflunomide should be taken for prolonged periods of time.

If you take more leflunomide cinfa than you should

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 take leflunomide cinfa

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next one. Do not take a double dose to compensate for the missed doses.

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

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

Inform your doctor immediately and stop taking leflunomida:

• 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 this may indicate severe reactions that in some cases can be fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform your doctor immediately if you experience:

• pale skin, fatigue or bruising, as this may indicate blood problems caused by a balance of different types of blood cells,
• fatigue, abdominal pain or jaundice (yellowing of the eyes or skin), as this may indicate severe problems such as liver failure, which could be fatal,
• any symptoms of infection such as fever, sore throat or cough, as this medicine may increase the risk of severe infections, which could be fatal,
• cough or respiratory problems, as this 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 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,
• inflammation of the mouth, mouth ulcers,
• abdominal pain,
• increase in liver test results that may lead to serious situations such as hepatitis and jaundice,
• 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).

Uncommon side effects (may affect up to 1 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.

Rare side effects (may affect up to 1 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 may lead to 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 side effects (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 small blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• pancreatitis,
• severe liver damage such as liver failure or necrosis that can be fatal,
• severe reactions that can sometimes 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 completed), cutaneous lupus (characterized by skin rash/erythema in exposed areas of the skin), psoriasis (new or worsening) and DRESS syndrome 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 Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special storage conditions.

Shelf life after opening: 100 days.

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.

Medications 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 leflunomide cinfa

-The active ingredient is leflunomide. Each tablet contains 10 mg of leflunomide.

-The other components are:

Ntablet core:monohydrate lactose, low-substituted hydroxypropyl cellulose, tartaric acid, sodium lauryl sulfate, and magnesium stearate.

Tablet coating:polyvinyl alcohol, titanium dioxide, talc, soy lecithin (E-322) (may contain soy oil), xanthan gum, and purified water.

Appearance of the product and contents of the packaging

White or off-white, cylindrical, biconvex, and coated tablets.

Rectangular HDPE bottle with a round polypropylene cap and a desiccant capsule. Each package contains 30 tablets.

Marketing authorization holder and responsible manufacturerand responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster Germany.

Last review date of this leaflet:September 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80684/P_80684.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80684/P_80684.html