LEFLUNOMIDE CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

leflunomide cinfa 20 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is leflunomide cinfa and what is it used for
2. What you need to know before you take leflunomide cinfa
3. How to take leflunomide cinfa
4. Possible side effects
5. Storage of leflunomide cinfa
6. Contents of the pack and other information

1. What is leflunomide cinfa and what is it used for

leflunomide cinfa belongs to a group of medicines called antirheumatic medicines. It contains leflunomide as the active substance.

leflunomide cinfa 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 you take leflunomida cinfa

Do not take leflunomida cinfa

• if you are allergic to 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 ingredients of this medicine (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 the blood,
• if you have a severe infection,
• if you are pregnant, think you may be pregnant or are breast-feeding.
• This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.

Warnings and precautions

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

• if you have ever had lung inflammation (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 male and 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 stop 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 sufficiently eliminated from the body and then they should wait at least 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 may impair 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 syndrome]), or increase the risk of serious infections. For more information on these side effects, see section 4 (Possible side effects).

DRESS syndrome initially appears with symptoms similar to those of the flu and a skin rash on the face and then 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.

Children and adolescents

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

Other medicines and leflunomida cinfa

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

This is especially important if you are taking:

• other medicines for rheumatoid arthritissuch as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts by intramuscular or oral route, D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g. methotrexate), as the use of these combinations is not recommended.
• warfarin (used as a blood anticoagulant), as monitoring is necessary 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 kidney failure 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 high cholesterol
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a medicine called cholestyramine(used to reduce high cholesterol) or activated charcoal, as these medicines may reduce the amount of leflunomide absorbed by the body.

If you are taking a non-steroidal anti-inflammatory medicine(NSAIDs) and/or corticosteroids, you may continue taking them after starting treatment with leflunomide.

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines may not be given while you are being treated with leflunomide or for a certain period after stopping treatment.

Taking leflunomida 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. Alcohol consumption during treatment with leflunomide may increase the risk of liver damage.

Pregnancy and breast-feeding

Do nottake leflunomide if you are or think you may be pregnant. If you are pregnant or become pregnant while taking leflunomide, there is an increased risk of having a child with serious birth defects. Women of childbearing age must not take leflunomide without using reliable contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that there are no remaining amounts of leflunomide in your body before becoming pregnant. The elimination of the medicine from the body may take up to 2 years. This time period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of leflunomide from the body.

In any case, before becoming pregnant, a blood test must be performed to confirm that leflunomide has been sufficiently eliminated from the 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 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 medicines to quickly and sufficiently eliminate leflunomide from your body, thereby reducing the risk to your child.

Do nottake this medicine while breast-feeding, as leflunomide passes into breast milk.

Driving and using machines

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

leflunomida cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

leflunomida cinfa contains sodium.

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

3. How to take leflunomida cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

After this, most people need a 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.

Swallowthe tablet wholeand with plenty of water.

The tablet can be divided into equal doses.

It may take about 4 weeks or even longer before you start to feel 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 more leflunomida cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take leflunomida cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyand stop taking leflunomide:

• if you feel weak, dizzy, or lightheaded, or have difficulty breathing, as these can be symptoms of a severe allergic reaction,
• if you get skin rashesor mouth ulcers, as these may indicate severe reactions that can sometimes be life-threatening (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 immediatelyif you experience:

• pale skin, tiredness, or bruising, as these may indicate blood problems caused by 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 can be life-threatening,
• any symptoms of infectionsuch as fever, sore throat, or cough, as this medicine 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).

Common side effects (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,
• 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 levels of certain enzymes in the blood (creatine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

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

Rare side effects (may affect up to 1 in 1,000 people)

• increase in the number of blood cells called 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,
• lung inflammation (interstitial lung disease),
• increase in liver test values that can lead to serious conditions such as hepatitis and jaundice,
• severe infections known as sepsis, which can be life-threatening,
• increase in levels of certain enzymes in the blood (lactate dehydrogenase).

Very rare side effects (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, which can be life-threatening,
• severe reactions that can sometimes 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 after stopping treatment with this medicine), cutaneous lupus (characterized by skin rash/erythema in sun-exposed areas), psoriasis (new or worsening), and DRESS syndrome may occur with an unknown frequency.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Leflunomide Cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Validity period after opening: 200 days.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Leflunomide Cinfa

• The active ingredient is leflunomide. Each tablet contains 20 mg of leflunomide.
• The other components are:

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

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

Appearance of the Product and Package Contents

White or off-white, cylindrical, biconvex, coated tablets with a score on one side.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster Germany

Date of the Last Revision of this Leaflet:September 2024

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

You can access detailed and updated information about this medication 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/80685/P_80685.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80685/P_80685.html