Lefluartil 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lefluartil 20 mg film-coated tablets EFG

Leflunomide

Read all of 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, and you should not give it to others, 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 Lefluartil is and what it is used for
2. What you need to know before taking Lefluartil
3. How to take Lefluartil
4. Possible side effects
5. How to store Lefluartil
6. Contents of the pack and other information

1. What Lefluartil 20 mg is and what it is used for

Lefluartil belongs to a group of medicines known as antirheumatic agents.

Lefluartil 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 taking Lefluartil

Do not take Lefluartil

• if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction; these serious reactions are usually accompanied by fever, joint pain, red skin rashes, or blisters, e.g., Stevens-Johnson syndrome) or to any of the other components of Lefluartil,
• 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 a condition affecting your immune system (e.g., AIDS),
• if you have a problem with your bone marrow or if you have a low number of red or white blood cells or a low platelet count,
• if you have a serious infection,
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Lefluartil:

• 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 check whether you have tuberculosis,
• if you are a man and wish to father a child. Since it cannot be ruled out that Lefluartil passes into semen, reliable contraceptive methods must be used during treatment with Lefluartil.

Men who wish to father a child should contact their doctor, who may advise stopping treatment with Lefluartil and taking certain medications to rapidly and sufficiently eliminate Lefluartil from the body. In this case, a blood test will be required to confirm that Lefluartil has been sufficiently eliminated from your body. Afterward, you must wait at least another 3 months before attempting to father a child.

• if you are scheduled to have a specific blood test (calcium level). 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 surgical wound. Lefluartil may impair wound healing.

Occasionally, Lefluartil may cause certain problems with the blood, liver, lungs, or nerves in the arms or legs. It may also cause some 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 about 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 cells (eosinophilia), and enlarged lymph nodes.

Your doctor will perform blood tests at regular intervals before and during treatment with Lefluartil to monitor blood cells and liver function. Your doctor should also monitor your blood pressure regularly, as Lefluartil may cause an increase in blood pressure.

Contact 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 Lefluartil (see section 4).

Use in children:

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

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those 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), intramuscular or oral gold salts, D-penicillamine, azathioprine, or 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,
• 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 medicine called cholestyramine (used to lower high cholesterol) or activated charcoal, as these medicines may reduce the amount of Lefluartil absorbed by the body.

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

Vaccinations

Talk to your doctor if you need to be vaccinated. Some vaccines should not be administered while you are being treated with Lefluartil or for a certain time after treatment has ended.

Taking Lefluartil with food and drink

Lefluartil may be taken with or without food.

Alcohol consumption is not recommended during treatment with Lefluartil. Drinking alcohol while taking Lefluartil may increase the risk of liver damage.

Pregnancy and breastfeeding

Do not take Lefluartil if you are or think you may be pregnant. Women of childbearing potential must not take Lefluartil unless using effective contraception.

Inform your doctor if you plan to become pregnant after stopping treatment with Lefluartil, as it is essential to ensure that no residual Lefluartil remains in your body before conception. Elimination of the drug 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 Lefluartil from the body. In any case, before becoming pregnant, you must have a blood test to confirm that Lefluartil has been sufficiently eliminated from your body. After this test, you must wait at least 1 month before attempting to become pregnant.

For more information about laboratory tests, contact your doctor.

If you suspect you may be pregnant during treatment with Lefluartil or within 2 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 medications to accelerate the elimination of Lefluartil from your body, thereby reducing the risk to your baby.

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

Driving and using machines

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

Important information about some of the components of Lefluartil

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

3. How to take Lefluartil 20 mg

Always take Lefluartil exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.

The usual initial dose of Lefluartil 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 Lefluartil once daily, depending on the
  severity of the disease.

Swallow the tablet whole with plenty of water.

• For psoriatic arthritis: 20 mg of Lefluartil once daily.

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 to 6 months of treatment. Generally, Lefluartil should be taken for long periods of time.

If you take more Lefluartil than you should

If you take more Lefluartil than prescribed, consult your doctor or another healthcare provider immediately. If possible, bring the tablets or the package to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lefluartil

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 missed dose.

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

4. Possible adverse effects

Like all medicines, Lefluartil can cause adverse effects, although not everyone experiences them.

Inform your doctor immediately and stop taking Lefluartil:

• 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 that can sometimes be fatal (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Inform your doctor immediately if you experience:

• pallor, fatigue, or increased tendency to bruise, 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 problems such as liver failure, which could be fatal,
• any signs of infection such as fever, sore throat, or cough, because Lefluartil may increase the risk of serious infections, which could be fatal,
• cough or breathing difficulties, because these may indicate lung inflammation (interstitial lung disease) or pulmonary hypertension.

Frequent adverse reactions (affects between 1 and 10 out of every 100 people)

• mild decrease in white blood cells (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,
• diarrhoea,
• nausea, vomiting,
• inflammation of the mouth, mouth ulcers,
• abdominal pain,
• increased results in certain liver function tests,
• increased hair loss,
• eczema, dry skin, skin rash, and itching (pruritus),
• tendinitis (pain due to inflammation of the membrane surrounding tendons, usually in the feet or hands),
• increased levels of certain enzymes in the blood (creatine phosphokinase),
• colitis.

Uncommon adverse reactions (affects between 1 and 10 out of every 1,000 people)

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

Rare adverse reactions (affects between 1 and 10 out of every 10,000 people)

• increase in red blood cells or eosinophils (eosinophilia), mild decrease in white blood cells (leucopenia), and decrease in all blood cells (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased liver test values that may indicate 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 reactions (affects fewer than 1 out of every 10,000 people)

• severe decrease in certain white blood cells (agranulocytosis),
• severe allergic reactions and potentially serious allergic reactions,
• inflammation of small blood vessels (vasculitis, including cutaneous necrotizing vasculitis),
• nerve problems in the arms and legs (peripheral neuropathies),
• inflammation of the pancreas (pancreatitis),
• severe liver damage such as liver failure or necrosis, which may be fatal,
• severe skin reactions that may be fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other adverse reactions such as renal failure, decreased blood uric acid levels, pulmonary hypertension, and male infertility (this effect is reversible once treatment with Lefluartil is discontinued) may occur with unknown frequency.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Lefluartil 20 mg film-coated tablets EFG

Keep out of the reach and sight of children.

Do not use Lefluartil tablets after the expiry date shown on the packaging. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lefluartil 20 mg film-coated tablets EFG

• The active substance is leflunomide. Each film-coated tablet contains 20 mg of leflunomide.

• The other components are: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (corn starch 1500), povidone (E1201), crospovidone (E1202), colloidal anhydrous silica, magnesium stearate (E470b) in the tablet core, and titanium dioxide (E171), lactose monohydrate, hypromellose 15 cP (E464), macrogol 4000, hypromellose 3 cP (E464), and hypromellose 50 cP (E464) in the coating.

Appearance of the product and contents of the pack

Lefluartil is presented as yellow, round, biconvex film-coated tablets.

The tablets are packed in blisters of 30 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ARAFARMA GROUP, S.A.
C/ Fray Gabriel de San Antonio, 6-10
Pol.Ind. del Henares
19180 Marchamalo (Guadalajara), Spain

Date of the most recent review of this leaflet:
July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/