LEFLUNOMIDE 20 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Leflunomide Aurovitas, 10 mg, coated tablets
3. Leflunomide Aurovitas, 15 mg, coated tablets
4. Leflunomide Aurovitas, 20 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Leflunomide Aurovitas and what is it used for
6. Important information before taking Leflunomide Aurovitas
   1. When not to take Leflunomide Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Leflunomide Aurovitas is not recommended for use in children and adolescents under 18 years of age.
   5. Leflunomide Aurovitas and other medicines
   6. Vaccinations
   7. Leflunomide Aurovitas with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Leflunomide Aurovitas contains sodium
   11. Leflunomide Aurovitas contains lactose
7. How to take Leflunomide Aurovitas
   1. Taking a higher dose of Leflunomide Aurovitas than recommended
   2. Missing a dose of Leflunomide Aurovitas
8. Possible side effects
   1. Common 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
9. How to store Leflunomide Aurovitas
10. Contents of the packaging and other information
    1. What Leflunomide Aurovitas contains
    2. What Leflunomide Aurovitas looks like and contents of the pack
    3. Marketing authorization holder and manufacturer/importer
    4. Marketing authorization holder:
    5. Manufacturer/Importer:
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: 08/2024

Leaflet attached to the packaging: information for the user

Leflunomide Aurovitas, 10 mg, coated tablets

Leflunomide Aurovitas, 15 mg, coated tablets

Leflunomide Aurovitas, 20 mg, 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 or pharmacist.
• 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 any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Leflunomide Aurovitas and what is it used for

Leflunomide Aurovitas belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.
Leflunomide Aurovitas is used to treat adult patients with 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, loss of energy, and anemia (lack of red blood cells).
The symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and patches of red, scaly skin (skin lesions).

2. Important information before taking Leflunomide Aurovitas

When not to take Leflunomide Aurovitas

• if the patient has ever had an allergic reactionto leflunomide (especially severe skin reaction, often accompanied by fever, joint pain, red spots on the skin, or blisters, e.g., Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6) or if the patient is allergic to teriflunomide (used to treat multiple sclerosis),
• if the patient has liver function disorders,
• if the patient has moderate to severe kidney failure,
• if the patient has a very low level of protein in the blood(hypoproteinemia),
• if the patient has any immune system disorder(e.g., AIDS),
• if the patient has bone marrow function disorders or if the patient has a low number of red or white blood cells, or a decreased number of platelets,
• if the patient has severe infections,
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.

Warnings and precautions

Before starting to take Leflunomide Aurovitas, 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 contact with a person with tuberculosis in the past. The doctor may recommend tests to check for tuberculosis.
• if the patient is maleand plans to father a child. Because it cannot be excluded that Leflunomide Aurovitas passes into semen, effective contraception should be used during treatment with Leflunomide Aurovitas. Men planning to father a child should contact their doctor, who may recommend stopping Leflunomide Aurovitas and recommend appropriate medication to quickly and effectively remove Leflunomide Aurovitas from the body. Then, a blood test will be necessary to ensure that Leflunomide Aurovitas has been effectively removed from the body, and the decision to father a child 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 the patient still has an unhealed postoperative wound. Leflunomide Aurovitas may hinder wound healing.

Leflunomide Aurovitas may sometimes cause blood, liver, lung, or nerve problems in the hands or feet. It may also cause serious allergic reactions (including drug rash with eosinophilia and systemic symptoms, DRESS) or increase the risk of serious infection. For more information, see section 4 (Possible side effects).
DRESS is characterized by initial symptoms of a flu-like illness and a rash on the face, followed by a widespread rash with a high temperature, elevated liver enzymes visible in blood tests, and an increased number of white blood cells (eosinophilia) and enlarged lymph nodes.
The doctor will perform blood testsat regular intervals before and during treatment with Leflunomide Aurovitas to monitor blood cells and liver function. The doctor will also regularly check blood pressure, as Leflunomide Aurovitas may cause it to rise.
Notify the doctor if unexplained chronic diarrhea occurs. The doctor may perform additional tests to diagnose the condition.
Notify the doctor if skin ulcers occur during treatment with Leflunomide Aurovitas (see section 4).

Children and adolescents

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

Leflunomide Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This includes medicines 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 administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g., methotrexate), as these combinations are not recommended

if you are taking a non-steroidal anti-inflammatory drug(NSAID) and/or corticosteroidsyou may continue treatment with these medicines after starting Leflunomide Aurovitas.

Vaccinations

If you are planning to be vaccinated, consult your doctor. Some vaccinations should not be given while taking Leflunomide Aurovitas and for some time after stopping treatment.

Leflunomide Aurovitas with food, drink, and alcohol

Leflunomide Aurovitas can be taken with or without food.
It is not recommended to drink alcohol while taking Leflunomide Aurovitas. Drinking alcohol during treatment with Leflunomide Aurovitas may increase the risk of liver damage.

Pregnancy, breastfeeding, and fertility

Do not takeLeflunomide Aurovitas if you are pregnantor think you may be pregnant. If you become pregnant while taking Leflunomide Aurovitas or plan to become pregnant, the risk of serious birth defects in the child increases. Women of childbearing age should not take Leflunomide Aurovitas unless they use effective contraception.
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide Aurovitas, as you need to make sure all amounts of Leflunomide Aurovitas have been removed from your body before trying to become pregnant. This may take up to 2 years.
This time can be shortened to a few weeks by taking medicines that speed up the removal of Leflunomide Aurovitas from the body.
In any case, you should confirm with a blood test that Leflunomide Aurovitas has been sufficiently removed from your body and then wait at least another month before becoming pregnant.
For further information on laboratory tests, consult your doctor.
It is recommended to immediatelyinform your doctor and have pregnancy tests done if you suspect you are pregnant while taking Leflunomide Aurovitas or if it has not been 2 years since you stopped treatment. If the test confirms you are pregnant, your doctor may suggest treatment with certain medicines to quickly and sufficiently remove Leflunomide Aurovitas from your body, as this may reduce the risk to the child.
Do not breastfeedwhile taking Leflunomide Aurovitas, as leflunomide passes into breast milk.

Driving and using machines

Leflunomide Aurovitas may cause dizziness, which can impair your ability to concentrate and react. If you experience symptoms, do not drive or operate machinery.

Leflunomide Aurovitas contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Leflunomide Aurovitas contains lactose

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

3. How to take Leflunomide Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The usual starting dose of Leflunomide Aurovitas is 100 mg once a day for the first three days. Then, most patients need a dose of:

• In rheumatoid arthritis: 10 or 20 mg of Leflunomide Aurovitas once a day, depending on the severity of the disease.
• In psoriatic arthritis: 20 mg of Leflunomide Aurovitas once a day.

Swallow the tablet whole, with a large amount of water.
A noticeable improvement in health may occur after 4 weeks or more from the start of treatment. Some patients may experience further improvement after 4 to 6 months of treatment.
Leflunomide Aurovitas is intended for long-term use.

Taking a higher dose of Leflunomide Aurovitas than recommended

If you take more Leflunomide Aurovitas 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 Leflunomide Aurovitas

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 on the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediatelytell your doctor and stop taking Leflunomide Aurovitas:

• if you experience weakness, a feeling of emptiness in the head, and dizziness or breathing problems, as these may be symptoms of a severe allergic reaction,

if you experience skin rashor mouth ulcers, as these 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.

Immediatelytell your doctor if you experience:

• pale skin, feeling tired, or bruises, as these may indicate blood disorders caused by an imbalance in different types of blood cells,
• feeling tired, abdominal pain, or jaundice(yellowing of the eyes or skin), as these may indicate serious conditions, such as liver failure, which can be fatal,
• any symptoms of infection, such as fever, sore throat, or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
• coughor breathing problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness, or pain in the hands or feet, which may indicate nerve problems (peripheral neuropathy).

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

• mild decrease in the number of white blood cells (leukopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually minor),
• fatigue (asthenia),
• headaches and dizziness,
• unusual sensations such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• mouth ulcers or oral ulcers,
• abdominal pain,
• increase in some liver function test parameters,
• increased hair loss,
• eczema, dry skin, rash, and itching,
• tendinitis (pain caused by inflammation of the tendon sheath, usually in the feet and hands),
• increase in the activity of some enzymes in the blood (creatine phosphokinase),
• nerve problems in the hands or feet (peripheral neuropathy).

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

• decrease in the number of red blood cells (anemia) and decrease in the number of platelets (thrombocytopenia),
• decrease in potassium levels in the blood,
• restlessness,
• taste disorders,
• hives (urticaria),
• tendon rupture,
• increase in blood fat levels (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 blood cells called eosinophils (eosinophilia), mild decrease in the number of white blood cells (leukopenia), and decrease in the number of all types of blood cells (pancytopenia),
• significant increase in blood pressure,
• pneumonia (interstitial lung disease),
• severe increase in some liver function test parameters, which can lead to serious disorders, such as hepatitis and jaundice,
• severe infections called sepsis, which can be life-threatening,
• increase in the 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,
• vasculitis (inflammation of blood vessels, including necrotizing vasculitis of the skin),
• pancreatitis (inflammation of the pancreas),
• severe liver damage, such as liver failure or necrosis, which can be fatal,
• 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 (transient after stopping treatment with this medicine), cutaneous lupus erythematosus (characterized by a rash/erythema on skin areas exposed to light), psoriasis (newly diagnosed or worsening of symptoms), DRESS, and skin ulcers (round, open sores on the skin, through which underlying tissues are visible), may also occur with an unknown frequency.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Leflunomide Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after: EXP. The expiry date refers to the last day of the month.
PA/Aluminum/PVC blisters:Store in a temperature below 30°C.
Transparent PVC/PVDC/Aluminum blisters (only for 15 mg and 20 mg):Store in a temperature below 25°C.
HDPE bottle:No special storage precautions are required.
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 packaging and other information

What Leflunomide Aurovitas contains

• The active substance of Leflunomide Aurovitas is leflunomide. Each coated tablet contains 10 mg of leflunomide.

Each coated tablet contains 15 mg of leflunomide.
Each coated tablet contains 20 mg of leflunomide.

• The other ingredients of the medicine are: Tablet core:lactose monohydrate, cornstarch, povidone (K-30), colloidal silicon dioxide, crospovidone (Type B), magnesium stearate

Coating:polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), glycerol monicaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E 172) (only for 20 mg)

What Leflunomide Aurovitas looks like and contents of the pack

Coated tablet.
Leflunomide Aurovitas, 10 mg, coated tablets:[Size: approximately 7.2 mm]
White to off-white, round, biconvex coated tablet with engraved "LF" on one side and "10" on the other side.
Leflunomide Aurovitas, 15 mg, coated tablets:[Size: approximately 7.2 mm]
White to off-white, round, biconvex coated tablet with engraved "LF" on one side and "15" on the other side.
Leflunomide Aurovitas, 20 mg, coated tablets:[Size: approximately 7.2 mm]
Light yellow to yellow, round, biconvex coated tablet with engraved "LF" on one side and "20" on the other side.
Leflunomide Aurovitas, coated tablets are available in blisters and HDPE bottles.
Pack sizes:
Blisters: 10, 15, 30, 60, 90, and 100 coated tablets.
HDPE bottle: 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Leflunomide AB 10 mg/20 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Denmark:
Leflunomid Aurobindo
France:
Leflunomide Arrow 10 mg/20 mg, comprimé pelliculé
Germany:
Leflunomid PUREN 10 mg/15 mg/20 mg Filmtabletten
Italy:
Leflunomide Aurobindo
Netherlands:
Leflunomide Aurobindo 10 mg/20 mg, filmomhulde tabletten
Poland:
Leflunomide Aurovitas
Portugal:
Leflunomida Generis
Romania:
Leflunomidă Aurobindo 10 mg/20 mg comprimate filmate
Spain:
Leflunomida Aurovitas 10 mg/20 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 08/2024