Leflunomide CINFA 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

leflunomida cinfa 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

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

Symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty in movement, 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 in movement, pain, and red, scaly skin plaques (skin lesions).

2. What you need to know before starting to take leflunomide cinfa

Do not take leflunomide cinfa

• if you are allergic to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin spots, 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 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 levels (hypoproteinemia),
• if you have any disorder affecting the immune system, (e.g., AIDS),
• if you have any bone marrow disorder or have low levels of red or white blood cells or platelets in your blood,
• if you have a serious infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.
• This medicine contains soya lecithin. It should not be used if you are allergic to peanuts or soya.

Warnings and precautions

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

• 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 father a child. 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 father a child should contact their doctor, who may advise stopping leflunomide treatment and taking certain medicines to rapidly and sufficiently eliminate leflunomide from the body. In this case, a blood test will be necessary to confirm that leflunomide has been sufficiently eliminated from your body, and after this, you must wait at least another 3 months before attempting to father a child.
• if you are scheduled for a specific blood test (calcium levels). A false decrease in calcium levels may be detected.
• if you are scheduled for 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 certain problems with 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 cell (eosinophilia), and enlarged lymph nodes.

Your doctor will perform blood tests regularly, 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.

Children and adolescents

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

Other medicines and leflunomide cinfa

Inform 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), gold salts administered intramuscularly or orally, 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
• indometacin, 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 leflunomide absorbed by the body.

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

Vaccinations

Talk to your doctor if you need to be vaccinated. Some vaccines should not be administered while you are being treated with leflunomide, nor for a certain period after treatment has ended.

Taking leflunomide cinfa with food, drinks and alcohol

Leflunomide 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 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 potential must not take leflunomide unless using reliable contraception.

Inform your doctor if you plan to become pregnant after stopping treatment with leflunomide, as it is necessary to ensure that no traces of leflunomide remain in your body before becoming pregnant. Elimination of the medicine from the body may take up to 2 years. This time period may 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, you must have a blood test to confirm that leflunomide has been sufficiently eliminated from your body, and after this test, you must wait at least 1 month before becoming pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you might be pregnant during treatment with leflunomide or within two years after treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may recommend starting treatment with certain medicines to rapidly and sufficiently eliminate leflunomide from your body, thereby reducing the risk to your child.

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

Driving and using machines

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

leflunomide cinfa contains lactose.

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

leflunomide cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take leflunomide cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

After this, most people require 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.

Swallow the tablet whole and 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 or 6 months of treatment. Generally, leflunomide should be taken for long 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take leflunomide cinfa

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 forgotten doses.

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:

• if you feel weak, dizzy, or short of breath, because these may be symptoms of a severe allergic reaction,
• if you develop skin rashes or mouth ulcers, because 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, fatigue, or bruising, because these may indicate blood problems caused by an imbalance in the different types of blood cells,
• fatigue, abdominal pain, or jaundice (yellowing of the eyes or skin), because these may indicate serious liver problems such as liver failure, which could be fatal,
• any signs of infection such as fever, sore throat, or cough, because 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, because this may indicate nerve problems (peripheral neuropathy).

Common adverse effects (may affect up to 1 in 10 patients)

• mild decrease in white blood cell count (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 effects (may affect up to 1 in 100 patients)

• decrease in red blood cell count (anaemia) and platelets (thrombocytopenia),
• decreased blood potassium levels,
• anxiety,
• taste disturbances,
• skin rash (urticaria),
• tendon rupture,
• increased levels of fat in the blood (cholesterol and triglycerides),
• decreased blood phosphate levels.

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

• increased number of a type of white blood cells called eosinophils (eosinophilia), mild decrease in white blood cell count (leucopenia), and decrease in all blood cells (pancytopenia),
• marked increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values 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 effects (may affect up to 1 in 10,000 patients)

• severe decrease in certain white blood cells (agranulocytosis),
• severe allergic reactions and potentially severe allergic reactions,
• inflammation of small 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,
• serious reactions which sometimes 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 blood uric acid levels, pulmonary hypertension, male infertility (this effect is reversible once treatment with this medicine is discontinued), cutaneous lupus (characterized by skin rash/erythema in skin areas exposed to light), psoriasis (new onset or worsening), and DRESS syndrome, which may occur with unknown frequency.

Reporting of adverse effects

If you experience any type of 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 Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of leflunomide cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Shelf life after first opening: 100 days.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of leflunomide cinfa

• The active substance is leflunomide. Each tablet contains 10 mg of leflunomide.
• The other components are:

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

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

Appearance of the medicine and contents of the pack

White or almost white, cylindrical, biconvex, coated tablets.

Rectangular HDPE bottle with a round polypropylene cap and a desiccant cap. Each pack 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 most recent review of this leaflet: September 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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