Lefluartil 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lefluartil 10 mg film-coated tablets EFG

Leflunomide

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, consult 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 10 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 moving, and pain. Other systemic symptoms include loss of appetite, fever, fatigue, and anemia (reduction in the number of red blood cells in the blood).

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 starting 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 spots on the skin, 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 reduction 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 have low levels 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 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 have children. Since it cannot be ruled out that Lefluartil passes into semen, reliable contraceptive methods should be used during treatment with Lefluartil.

Men who wish to have children 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 ensure that Lefluartil has been sufficiently eliminated from your body, and you should then wait at least another 3 months before attempting to have children.

• if you are scheduled to have or have recently undergone a major surgical procedure, or if you still have an unhealed wound following surgery. Lefluartil may impair wound healing.
• if you are due to have a specific blood test (calcium level). A falsely low calcium level may be detected.

Occasionally, Lefluartil may cause certain problems with the 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 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 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 regular blood tests 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.

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 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, have recently taken, or might take 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), 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,
• 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, nor for a certain period after stopping treatment.

Taking Lefluartil with food and drinks

Lefluartil may be taken with or without food.

Alcohol consumption is not recommended during treatment with Lefluartil. Drinking alcohol during
treatment with 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 contraceptive measures.

Inform your doctor if you plan to become pregnant after stopping treatment with Lefluartil,
as it is necessary to ensure that no residual Lefluartil remains in your body before becoming pregnant. 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, and after this test, you should wait at least 1 month before attempting to become pregnant.

For more information about laboratory tests, contact your doctor.

If you suspect you might 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 child.

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 him before taking this medicine.

3. How to take Lefluartil

Always take Lefluartil exactly as your doctor has instructed you. Consult your doctor or
pharmacist if you have any doubts.

The usual starting 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.

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

Swallow the tablet whole with plenty of water.

It may take about 4 weeks, or even longer, before you start to notice 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 you should, consult your doctor or any other healthcare professional. 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: 91 562 04 20, stating 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 a missed dose.

If you have any further questions about the use of this product, 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, as these may be symptoms of a severe allergic reaction,
• if you develop skin rashes or mouth ulcers, as these may indicate serious reactions that in some cases can 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, as these may indicate blood disorders caused by an imbalance in the different types of blood cells,
• fatigue, abdominal pain, or jaundice (yellowing of the skin or eyes), as 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, as Lefluartil may increase the risk of developing serious infections, which could be fatal,
• cough or breathing difficulties, as these may indicate lung inflammation (interstitial lung disease) or pulmonary hypertension.

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

• 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,
• 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 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 in every 1,000 people)

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

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

• increase in the number of blood cells known as red blood cells or eosinophils (eosinophilia), mild decrease in white blood cell count (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 in every 10,000 people)

• significant 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),
• nerve problems in 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 levels of uric acid in blood, pulmonary hypertension, 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 10 mg film-coated tablets EFG

Keep out of the reach and sight of children.

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

Store in the original packaging.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lefluartil 10 mg film-coated tablets EFG

• The active substance is leflunomide. Each film-coated tablet contains 10 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 pack contents

Lefluartil is presented as white, 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/