LEFLUNOMID 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Leflunomid Egis, 10 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Leflunomid Egis and what is it used for
4. Important information before taking Leflunomid Egis
   1. When not to take Leflunomid Egis
   2. Warnings and precautions
   3. Children and adolescents
   4. Leflunomid Egis is not recommended for use in children and adolescents under 18 years of age.
   5. Leflunomid Egis and other medicines
   6. Vaccinations
   7. Leflunomid Egis with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Leflunomid Egis contains lactose
5. How to take Leflunomid Egis
   1. Taking a higher dose of Leflunomid Egis than recommended
   2. Missing a dose of Leflunomid Egis
6. Possible side effects
   1. Frequent side effects (may affect up to 1 in 10 people)
   2. Uncommon side effects (may affect up to 1 in 100 people)
   3. Rare side effects (may affect up to 1 in 1,000 people)
   4. Very rare side effects (may affect up to 1 in 10,000 people)
   5. Reporting side effects
7. How to store Leflunomid Egis
8. Contents of the pack and other information
   1. What Leflunomid Egis contains
   2. What Leflunomid Egis looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the package leaflet: 05.08.2024

Package Leaflet: Information for the Patient

Leflunomid Egis, 10 mg, Film-Coated Tablets

Leflunomide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Leflunomid Egis and what is it used for
• 2. Important information before taking Leflunomid Egis
• 3. How to take Leflunomid Egis
• 4. Possible side effects
• 5. How to store Leflunomid Egis
• 6. Contents of the pack and other information

1. What is Leflunomid Egis and what is it used for

Leflunomid Egis belongs to a group of medicines called antirheumatic medicines.
It contains the active substance leflunomide.
Leflunomid Egis is used in adult patients to treat 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 (low red blood cell count).
The symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and redness and scaling of the skin (skin lesions).

2. Important information before taking Leflunomid Egis

When not to take Leflunomid Egis

• if you have ever had an allergic reactionto leflunomide (especially severe skin reaction, often with accompanying 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 liver function disorders,
• if you have moderate to severe kidney function disorders,
• if you have significantly reduced blood protein levels(hypoproteinemia),
• if you have any underlying diseases that affect the immune system(e.g., AIDS),
• if you have bone marrow disordersor if you have a reduced number of red blood cells, white blood cells, or platelets,
• if you have a severe infection,
• if you are pregnantor think you may be pregnant, or are breastfeeding.

Warnings and precautions

Before starting treatment with Leflunomid Egis, consult your doctor, pharmacist, or nurse:

• if you have ever had pulmonary fibrosis(interstitial lung disease).
• if you have ever had tuberculosisor have been in close contact with someone who has or has had tuberculosis. Your doctor may recommend tests to determine if you have tuberculosis.
• if you are a maleplanning to father a child. Leflunomid may be present in semen, so male patients taking Leflunomid Egis should use effective contraception. Men planning to father a child should consult their doctor, who may advise stopping Leflunomid Egis and prescribing medication to quickly and effectively remove Leflunomid Egis from the body. Effective removal of leflunomide must be confirmed by blood tests, and the decision to conceive can be made no earlier than 3 months after that.
• if you are going to have a specific blood test (calcium level measurement). The results of the calcium level test may be falsely lowered.
• if you are going to have a major surgery or have an unhealed postoperative wound. Leflunomid Egis may interfere with wound healing.

Leflunomid Egis may cause blood, liver, lung, or nerve disorders. It may also cause severe allergic reactions (including drug rash with eosinophilia and systemic symptoms - DRESS) or increase the risk of severe infections. For more information, see section 4 (Possible side effects).
DRESS syndrome is characterized by initial flu-like symptoms and a rash on the face, followed by the spread of the rash to other areas of the body, high fever, increased liver enzyme activity in blood tests, and an increase in the number of a certain type of white blood cell (eosinophilia) and lymph node enlargement.
Before starting treatment with Leflunomid Egis, and during treatment, your doctor will recommend regular blood tests to monitor your blood cell count and liver function. You should also have your blood pressure checked regularly, as leflunomide may cause an increase in blood pressure.
If you experience persistent diarrhea of unknown cause, inform your doctor, who may prescribe additional tests to determine the diagnosis.
If you experience skin ulcers during treatment with Leflunomid Egis (see also section 4), inform your doctor.

Children and adolescents

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

Leflunomid Egis and other medicines

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.
This is especially important if you are taking:

• other medicines used to treat rheumatoid arthritis, such as antimalarial drugs (e.g., chloroquine and hydroxychloroquine), gold preparations administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive drugs (e.g., methotrexate), as these combinations are not recommended
• warfarin and other oral anticoagulants, as it is necessary to monitor your condition to reduce the risk of side effects of this medicine
• teriflunomide (a medicine used to treat multiple sclerosis)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone (medicines used to treat diabetes)
• daunorubicin, doxorubicin, paclitaxel, or topotecan (anticancer medicines) duloxetine (a medicine used to treat depression, urinary incontinence, or diabetic neuropathy)
• alosetron (a medicine used to treat severe diarrhea)
• theophylline (a medicine used to treat asthma)
• tizanidine (a muscle relaxant)
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin (medicines used to treat infections)
• indomethacin, ketoprofen (medicines used to treat pain or inflammation)
• furosemide (a diuretic used to treat heart disease)
• zidovudine (a medicine used to treat HIV infection)
• rosuvastatin, simvastatin, atorvastatin, pravastatin (medicines used to treat high cholesterol)
• sulfasalazine (a medicine used to treat inflammatory bowel disease or rheumatoid arthritis)
• cholestyramine (used to treat high cholesterol) or activated charcoal, as they may reduce the absorption of leflunomide.

If you are taking non-steroidal anti-inflammatory drugs(NSAIDs) and (or) corticosteroids, you may continue to take them after starting Leflunomid Egis.

Vaccinations

If you are planning to be vaccinated, consult your doctor. Some vaccines should not be taken during or for some time after treatment with Leflunomid Egis.

Leflunomid Egis with food, drink, and alcohol

Leflunomid Egis can be taken with or without food.
During treatment with leflunomide, it is not recommended to consume alcoholic beverages. Drinking alcohol during treatment with Leflunomid Egis may increase the risk of liver damage.

Pregnancy and breastfeeding

Do not takeLeflunomid Egis if you are pregnantor think you may be pregnant.
If you are pregnant or become pregnant during treatment with leflunomide, the risk of severe birth defects in the child increases. Women of childbearing age must not take Leflunomid Egis unless they use effective contraception.
If a woman plans to become pregnant after stopping treatment with Leflunomid Egis, she should inform her doctor, as it is necessary to ensure that leflunomide has been completely removed from the body before attempting to conceive. After stopping treatment with Leflunomid Egis, wait 2 years, which can be shortened to a few weeks by taking medication to accelerate the removal of leflunomide from the body.
In any case, appropriate blood tests must be performed to ensure that leflunomide has been effectively removed from the body. After obtaining a normal blood test result, wait at least one month before planned conception.
To obtain more information about the laboratory test, consult your doctor.
If you suspect you have become pregnant while taking leflunomide or within two years of stopping treatment, you must immediatelyinform your doctor and have a pregnancy test.
If the test result confirms pregnancy, your doctor may recommend treatment with certain medicines to quickly and effectively remove leflunomide from the body, which may reduce the risk to the child.
Do not takeLeflunomid Egis while breastfeeding, as leflunomide passes into human milk.

Driving and using machines

Leflunomid Egis may cause dizziness, which can impair concentration and reaction speed. You should not drive or operate machinery if you experience such symptoms.

Leflunomid Egis contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Leflunomid Egis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the initial dose of Leflunomid Egis is 100 mg once daily for the first three days. After this time, the following doses are usually taken:

• for the treatment of rheumatoid arthritis: 10 or 20 mg of Leflunomid Egis once daily, depending on the severity of the disease.
• for the treatment of psoriatic arthritis: 20 mg of Leflunomid Egis once daily.

Swallow the tablet whole, with a large amount of water.
A noticeable improvement in your condition may occur after about 4 weeks of treatment or later.
Some patients experience further improvement after 4 to 6 months of treatment.
Leflunomid Egis is usually taken for a long time.

Taking a higher dose of Leflunomid Egis than recommended

If you take more Leflunomid Egis than you should, contact your doctor or seek other medical advice. If possible, take the tablets or packaging with you to show the doctor.

Missing a dose of Leflunomid Egis

If you miss 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 taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Leflunomid Egis can cause side effects, although not everybody gets them.
Immediately informyour doctor and stop taking Leflunomid Egis if you:

• feel weakness, dizziness, or have difficulty breathing, as these may be symptoms of a severe allergic reaction,
• develop a skin rashor mouth ulcers, as this may indicate severe, potentially life-threatening reactions (e.g., Stevens-Johnson syndrome,

toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms - DRESS), see section 2.
Immediately informyour doctor if you experience:

• pale skin, feeling tired, tendency to bruise, as these may be symptoms of blood disorders,
• feeling tired, abdominal pain, or jaundice(yellowing of the eyes or skin), as these may indicate severe disorders, such as liver failure, which can be life-threatening,
• infection symptoms such as fever, sore throat, or cough, as this medicine may increase the risk of severe, potentially life-threatening infections,
• coughor difficulty breathingthat may indicate lung disease (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness, or pain in the hands or feet, as these symptoms may indicate nerve disorders (peripheral neuropathy).

Frequent side effects (may affect up to 1 in 10 people)

• mild decrease in white blood cell count (leukopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually slight),
• weakness (asthenia),
• headache, dizziness,
• unusual sensations, such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation or ulcers of the mouth,
• abdominal pain,
• increased values of some liver function test parameters,
• excessive hair loss,
• rash, dry skin, skin lesions, itching,
• tendinitis (pain caused by inflammation of the tendon sheath, usually in the feet or hands),
• increased activity of some enzymes in the blood (creatine kinase),
• nerve disorders in the hands or feet (peripheral neuropathy).

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

• decrease in red blood cell count (anemia) and decrease in platelet count (thrombocytopenia),
• decrease in potassium levels in the blood,
• restlessness,
• taste disorders,
• hives (urticaria),
• tendon rupture,
• increased lipid levels in the blood (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 eosinophils (eosinophilia), mild decrease in white blood cell count (leukopenia), and decrease in all types of blood cells (pancytopenia),
• significant increase in blood pressure,
• pulmonary fibrosis (interstitial lung disease),
• increased liver function test parameters, which may indicate severe disorders such as hepatitis and jaundice,
• severe infections called sepsis, which can be life-threatening,
• increased activity of some 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 (agranulocytosis),
• severe and potentially life-threatening allergic reactions,
• inflammation of small blood vessels (including vasculitis with skin necrosis),
• pancreatitis,
• severe liver damage, such as liver failure or necrosis, which can be life-threatening,
• severe, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as kidney failure, decreased uric acid levels in the blood, pulmonary hypertension, male infertility (reversible after stopping treatment with this medicine), cutaneous lupus erythematosus (characterized by a rash/erythema on sun-exposed skin areas), psoriasis (occurring for the first time or worsening of existing disease), DRESS, and skin ulcers (a round, open sore in the skin, with visible subcutaneous tissue) may also occur with an unknown frequency.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leflunomid Egis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Leflunomid Egis contains

• The active substance of Leflunomid Egis is leflunomide. One film-coated tablet contains 10 mg of leflunomide.
• The other ingredients are: Core

Microcrystalline cellulose (type 102), corn starch, povidone K 30, crospovidone, colloidal anhydrous silica, magnesium stearate, lactose monohydrate.
Coating
Opadry II White OY-LS-28908 containingtitanium dioxide (E171), lactose monohydrate, hypromellose 15cP, hypromellose 3cP, hypromellose 50cP, macrogol 4000.

What Leflunomid Egis looks like and contents of the pack

Leflunomid Egis, 10 mg, are white, round, biconvex film-coated tablets with a diameter of about 6.1 mm.
The medicine is packaged in a cardboard box containing blisters of OPA/Aluminum/PVC/Aluminum foil.
Pack sizes: 30, 60, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

PHARMATHEN S.A.
Dervenakion 6
Pallini 15351
Attiki, Greece
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Ellas, Greece
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

Date of last revision of the package leaflet: 05.08.2024