Leflunomid Egis

Leaflet attached to the packaging: patient information

Leflunomid Egis, 20 mg, film-coated tablets

Leflunomide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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.
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).
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 the patient has ever had an allergic reactionto leflunomide (especially a 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 in case of allergy to teriflunomide (used to treat multiple sclerosis),
• if the patient has liver function disorders,
• if the patient has moderate to severe kidney function disorders,
• if the patient has a significant decrease in blood protein levels(hypoproteinemia),
• if the patient has any underlying diseases that affect the immune system (e.g., AIDS),
• if the patient has bone marrow disordersor if the number of red blood cells, white blood cells, or platelets is decreased,
• if the patient has a severe infection,
• -if the patient is pregnantor suspects she is pregnant, or is breastfeeding.

Warnings and precautions

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

• if the patient has ever had pneumonia(interstitial lung disease).
• if the patient has ever had tuberculosisor has had close contact with someone who has or has had tuberculosis in the past. The doctor may recommend tests to determine if the patient has tuberculosis.
• if the patient is a maleplanning to become a father. It cannot be ruled out that leflunomide passes into semen, so patients taking Leflunomid Egis should use effective contraception. A man planning to become a father should contact his doctor, who may advise stopping Leflunomid Egis and prescribing appropriate medications to quickly and effectively remove Leflunomid Egis from the body. Effective removal of leflunomide must be confirmed by appropriate blood tests, and the decision to become a father can be made no earlier than 3 months after that.
• if the patient is to undergo a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.
• if the patient is to undergo or has undergone major surgery, or if they still have an unhealed postoperative wound. Leflunomid Egis may hinder wound healing.

Leflunomid Egis may cause blood disorders, liver function disorders, lung disorders, or nerve disorders in the hands or feet. It may also cause severe allergic reactions (including drug rash with eosinophilia and systemic symptoms - DRESS) or increase the risk of severe infection. For more information, see section 4 (Possible side effects).
DRESS 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 visible 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 its use, the doctor will recommend regular blood tests at regular intervals to monitor the blood cell count and liver function. It is also necessary to regularly monitor blood pressure, as leflunomide may cause its increase.
If chronic diarrhea of unknown cause occurs, the patient should inform their doctor. The doctor may order additional tests to determine the diagnosis.
If skin ulcers occur during treatment with Leflunomid Egis (see also section 4), the patient should inform their 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

Tell 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 medicines (e.g., chloroquine and hydroxychloroquine), gold preparations used intramuscularly or orally,

D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g., methotrexate), as such combinations are not recommended

• warfarin and other oral anticoagulants, as it is necessary to monitor the patient's condition to reduce the risk of adverse reactions to 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 hypercholesterolemia - high cholesterol levels)
• 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 the patient is taking non-steroidal anti-inflammatory drugs(NSAIDs) and/or corticosteroids, they may continue to take them after starting Leflunomid Egis.

Vaccinations

If the patient plans to be vaccinated, they should consult their 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 the patient is pregnant or becomes 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 beforehand, as it is necessary to ensure that leflunomide has been completely removed from the body before attempting to become pregnant. After stopping treatment with Leflunomid Egis, it is recommended to wait 2 years, which can be shortened to a few weeks by taking medications that 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, it is recommended to wait at least one month before planned pregnancy.
To obtain more information about the laboratory test, consult your doctor.
If the patient suspects they have become pregnant while taking leflunomide or within two years of stopping treatment, they must immediatelyinform their doctor and undergo a pregnancy test.
If the test result confirms pregnancy, the doctor may recommend treatment with certain medications to quickly and effectively remove leflunomide from the body, which may reduce the risk to the child.
Do nottake Leflunomid 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. The patient should not drive vehicles or operate machines if they experience such symptoms.

Leflunomid Egis contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult their 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, consult your doctor or pharmacist.
Usually, the initial dose of Leflunomid Egis is 100 mg once a day for the first three days. After this time, in most patients:

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

Swallow the tablet whole, with a large amount of water.
The dividing line on the tablet only makes it easier to break it, to make it easier to swallow.
A noticeable improvement in health 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 a higher dose of Leflunomid Egis than recommended is taken, consult a doctor or seek other medical advice. If possible, take the tablets or packaging of the medicine with you to show the doctor.

Missing a dose of Leflunomid Egis

If the patient forgets to take a dose, they should take it as soon as they remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult 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:

• the patient feels weakness, dizziness, or dizziness, or has difficulty breathing, as these may be symptoms of a severe allergic reaction,
• -the patient develops 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 the patient experiences:

• pale skin, feeling tired, tendency to bruise, as these may be symptoms of blood disorders,
• feeling tired, abdominal painor 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, life-threatening infection,
• 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 occur in 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 mucosa,
• abdominal pain,
• increased values of some liver function test parameters,
• increased hair loss,
• rash, dry skin, scaling, 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 occur in 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 occur in 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,
• pneumonia (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 occur in 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, infertility in men (reversible after stopping treatment with this medicine), cutaneous lupus (characterized by a rash/rash on sun-exposed skin areas), psoriasis (occurring for the first time or worsening of existing disease), DRESS, and skin ulcers (a round, open wound in the skin, through which subcutaneous tissues are visible), may also occur with an unknown frequency.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help gather 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.
Blister packs: no special storage precautions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. 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 20 mg of leflunomide.
• Other ingredients are: CoreMicrocrystalline cellulose (type 102), cornstarch, povidone K 30, crospovidone, colloidal anhydrous silica, magnesium stearate, lactose monohydrate. CoatingOpadry OY-SR-6497 with the composition: titanium dioxide (E171), talc, hypromellose 15cP, macrogol 6000, yellow iron oxide (E172).

What Leflunomid Egis looks like and contents of the pack

Leflunomid Egis, 20 mg are yellow, round, biconvex film-coated tablets, with a dividing line on one side, with a diameter of about 8.1 mm.
The medicine is packed in a cardboard box containing blister packs of aluminum/PVC film.
Pack sizes: 14, 28, 30, 56, 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, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: 05.08.2024