Leflunomide Aurovitas

Leaflet accompanying the packaging: information for the user

Leflunomide Aurovitas, 10 mg, film-coated tablets

Leflunomide Aurovitas, 15 mg, film-coated tablets

Leflunomide Aurovitas, 20 mg, film-coated tablets

Leflunomide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• 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 any not listed in this leaflet, please inform your 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 pack 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 you have 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 you are allergic to teriflunomide (used to treat multiple sclerosis),
• if you have liver function disorders,
• if you have moderate to severe kidney failure,
• if you have a very low level of protein in the blood(hypoproteinemia),
• if you have any immune system disorder(e.g., AIDS),
• if you have bone marrow disorders or if you have a low number of red or white blood cells, or a decreased platelet count,
• if you have severe infections,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Before starting to take Leflunomide Aurovitas, you should consult your doctor, pharmacist, or nurse

• -if you have ever had pneumonia(interstitial lung disease).
• if you have ever had tuberculosisor have had contact with someone with tuberculosis in the past. Your doctor may recommend tests to check for tuberculosis.
• if you are a maleplanning to father a child. Because it cannot be excluded that Leflunomide Aurovitas passes into semen, you should use effective contraception 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 you are going to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.
• if you are going to have a serious operation or have had a serious operation, or if you still have an unhealed post-operative 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 infections. For more information, see section 4 (Possible side effects).
DRESS is characterized by initial symptoms of flu-like symptoms and a rash on the face, followed by widespread rash with high fever, elevated liver enzymes visible in blood tests, and increased white blood cell count (eosinophilia) and swollen lymph nodes.
Your doctor will perform blood testsat regular intervals before and during treatment with Leflunomide Aurovitas to monitor blood cells and liver function. Your doctor will also regularly check your blood pressure, as Leflunomide Aurovitas may cause it to rise.
You should inform your doctor if you experience unexplained persistent diarrhea. Your doctor may perform additional tests to diagnose the condition.
You should inform your doctor if you experience skin ulcers 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 used 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 have vaccinations, you should 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, there is an increased risk of serious birth defects in the baby. Women of childbearing age should not take Leflunomide Aurovitas unless they use effective contraception.
You should inform your doctor if you plan to become pregnant after stopping treatment with Leflunomide Aurovitas, as you need to make sure that 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, you should 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 that 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 baby.
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 essentially 'sodium-free'.

Leflunomide Aurovitas contains lactose

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

3. How to take Leflunomide Aurovitas

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual starting dose of Leflunomide Aurovitas is 100 mg once daily for the first three days. Then, most patients need a dose of:

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

The tablet should be swallowed 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 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, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

• if you experience weakness, 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.

You should immediatelyinform your doctor if you experience:

• pale skin, feeling tiredor bruises, as these may indicate blood disorders caused by an imbalance in different types of blood cells,
• feeling tired, stomach painor jaundice(yellowing of the eyes or skin), as these may indicate serious conditions, such as liver failure, which can be fatal,
• any symptoms of infectionsuch as fever, sore throator 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 white blood cell count (leukopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually slight),
• fatigue (asthenia),
• headache and dizziness,
• unusual sensations such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• mouth ulcers or mouth sores,
• stomach 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 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 red blood cell count (anemia) and decrease in platelet count (thrombocytopenia),
• decrease in potassium level in the blood,
• restlessness,
• taste disorders,
• hives (urticaria),
• tendon rupture,
• increase in blood fat levels (cholesterol and triglycerides),
• decrease in phosphate level 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 white blood cell count (leukopenia), and decrease in all types of blood cells (pancytopenia),
• significant increase in blood pressure,
• lung inflammation (interstitial lung disease),
• serious increase in some liver function test parameters, which may lead to serious disorders, such as hepatitis and jaundice,
• serious infections called sepsis, which can be life-threatening,
• increase in 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),
• serious and potentially life-threatening allergic reactions,
• blood vessel inflammation (vasculitis, including necrotizing vasculitis of the skin),
• pancreatitis (inflammation of the pancreas),
• serious liver damage, such as liver failure or necrosis, which can be fatal,
• serious, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as kidney failure, decreased uric acid level in the blood, pulmonary hypertension, male infertility (reversible after stopping treatment with this medicine), cutaneous lupus erythematosus (characterized by a rash/skin redness in areas of the skin exposed to light), psoriasis (newly diagnosed or worsening of symptoms), DRESS, and skin ulcers (round, open skin ulcers, through which subcutaneous tissues are visible), may also occur with an unknown frequency.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of that 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 pack and other information

What Leflunomide Aurovitas contains

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

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

• The other ingredients of the medicine are: Tablet core:lactose monohydrate, maize starch, povidone (K-30), colloidal anhydrous silica, crospovidone (Type B), magnesium stearate

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

What Leflunomide Aurovitas looks like and contents of the pack

Film-coated tablet.
Leflunomide Aurovitas, 10 mg, film-coated tablets:[Size: approximately 7.2 mm]
White to off-white, round, biconvex film-coated tablet with engraved "LF" on one side and "10" on the other side.
Leflunomide Aurovitas, 15 mg, film-coated tablets:[Size: approximately 7.2 mm]
White to off-white, round, biconvex film-coated tablet with engraved "LF" on one side and "15" on the other side.
Leflunomide Aurovitas, 20 mg, film-coated tablets:[Size: approximately 7.2 mm]
Light yellow to yellow, round, biconvex film-coated tablet with engraved "LF" on one side and "20" on the other side.
Leflunomide Aurovitas, film-coated tablets are available in blisters and HDPE bottles.
Pack sizes:
Blisters: 10, 15, 30, 60, 90, and 100 film-coated tablets.
HDPE bottle: 30 film-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: medicalinformation@aurovitas.pl

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 filmomhulde tabletten/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