Leflunomide aurovitas

Package leaflet: Information for the user

Leflunomide Aurovitas, 10 mg, coated tablets
Leflunomide Aurovitas, 15 mg, coated tablets
Leflunomide Aurovitas, 20 mg, coated tablets
Leflunomide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Leflunomide Aurovitas is and what it is used for
2. What you need to know 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 Leflunomide Aurovitas is and what it is used for

Leflunomide Aurovitas belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.
Leflunomide Aurovitas 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 anaemia (lack of red blood cells).
Symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and patches of red, flaking skin (skin lesions).

2. Important information before using Leflunomide Aurovitas

When not to use Leflunomide Aurovitas

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

Warnings and precautions
Before starting treatment with Leflunomide Aurovitas, consult a doctor,
pharmacist, or nurse

• if the patient has ever had lung inflammation (interstitial lung disease).
• if the patient has ever had tuberculosis or has been in contact with someone who has or had tuberculosis. The doctor may recommend tests to check for tuberculosis.
• if the patient is a man planning to father a child. Since it cannot be ruled out that leflunomide passes into semen, effective contraception should be used during treatment with Leflunomide Aurovitas. Men planning to father a child should consult their doctor, who may recommend discontinuing Leflunomide Aurovitas and prescribe appropriate medication to rapidly and effectively eliminate the drug from the body. A blood test will then be required to confirm that Leflunomide Aurovitas has been effectively eliminated from the body, and a decision about fathering a child should not be made until at least 3 months after this point.
• if the patient is to undergo or has undergone a specific blood test (calcium level measurement). Calcium test results may be falsely low.
• if the patient is to undergo or has undergone major surgery, or still has an unhealed surgical wound. Leflunomide Aurovitas may impair wound healing.

Leflunomide may sometimes cause problems with blood, liver, lungs, or nerves 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 syndrome initially presents with flu-like symptoms and a facial rash, followed by widespread rash, high fever, elevated liver enzymes in blood tests, increased white blood cell count (eosinophilia), and enlarged lymph nodes.
The doctor will perform blood tests at regular intervals before and during treatment with Leflunomide Aurovitas to monitor blood cells and liver function. The doctor will also regularly monitor blood pressure, as leflunomide may cause an increase.
Inform the doctor if unexplained chronic diarrhoea occurs. The doctor may perform additional tests for differential diagnosis.
Inform the doctor if skin ulceration occurs 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 the patient is currently taking or has recently taken, including medicines obtained without a prescription.
This is particularly important if the patient is taking:

• other medicines used for rheumatoid arthritis, such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold preparations, D-penicillamine, azathioprine, or other immunosuppressive medicines (e.g. methotrexate), as such combinations are not recommended,
• warfarin and other oral anticoagulants (blood thinners), as patient monitoring is necessary to reduce the risk of adverse effects,
• teriflunomide used in the treatment of multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone used in the treatment of diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan used in cancer treatment,
• duloxetine used to treat depression, urinary incontinence, or kidney disease in patients with diabetes,
• alosetron used to treat acute diarrhoea,
• theophylline used to treat asthma,
• tizanidine, a muscle relaxant,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), or ciprofloxacin used to treat infections,
• indometacin, ketoprofen used to treat pain or inflammatory conditions,
• furosemide used to treat heart conditions (a diuretic, water tablet),
• zidovudine used to treat HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat hypercholesterolaemia (high cholesterol levels),
• sulfasalazine used to treat inflammatory bowel disease and rheumatoid arthritis,
• a medicine called cholestyramine (used to lower high cholesterol levels) or activated charcoal, as these medicines may reduce the amount of Leflunomide Aurovitas absorbed by the body.

If the patient is taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids,
treatment with these medicines may be continued after starting Leflunomide Aurovitas.

Vaccinations
If planning vaccinations, consult your doctor. Certain vaccinations should not be given during treatment with Leflunomide Aurovitas or for some time after treatment has ended.

Leflunomide Aurovitas with food, drink and alcohol
Leflunomide Aurovitas may be taken with or without food.
Alcohol consumption is not recommended during treatment with Leflunomide Aurovitas. Drinking alcohol during treatment may increase the risk of liver damage.

Pregnancy, breastfeeding and fertility
Do not take Leflunomide Aurovitas if the patient is pregnant or suspects she may be pregnant. If a woman becomes pregnant or plans to become pregnant while taking Leflunomide Aurovitas, there is an increased risk of severe birth defects in the child. Women of childbearing potential must not use Leflunomide Aurovitas unless they are using effective contraception.
Inform the doctor if a woman plans to become pregnant after stopping treatment with Leflunomide Aurovitas, as it is essential to ensure that all traces of the medicine have been eliminated from the body before attempting pregnancy. This may take up to 2 years. This period can be shortened to a few weeks by taking medicines that accelerate the elimination of Leflunomide Aurovitas from the body.
In all cases, blood testing must confirm that Leflunomide Aurovitas has been sufficiently eliminated from the body, and at least one additional month should be waited before attempting pregnancy.
For further information on laboratory tests, consult the doctor.
Immediate medical advice and pregnancy testing are recommended if pregnancy is suspected in a woman treated with Leflunomide Aurovitas or if less than 2 years have passed since stopping treatment. If the test confirms pregnancy, the doctor may recommend treatment with certain medicines to rapidly and adequately eliminate Leflunomide Aurovitas from the body, as this may reduce the risk to the unborn child.

Breastfeeding
Leflunomide Aurovitas must not be used during breastfeeding, as leflunomide passes into breast milk.

Driving and operating machinery
Leflunomide may cause dizziness, which may impair concentration and reaction speed. If such symptoms occur, do not drive or operate machinery.

Leflunomide Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Leflunomide Aurovitas contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Leflunomide Aurovitas

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The usual starting dose of Leflunomide Aurovitas is 100 mg once daily for the first three days.
Afterwards, most patients require a dose of:

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

The tablet should be swallowed whole with a large amount of water.
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 more than the recommended dose of Leflunomide Aurovitas
If more than the recommended dose of Leflunomide Aurovitas is taken, contact a doctor or seek
medical advice immediately. If possible, bring the tablets or the pack to show the doctor.
Missing a dose of Leflunomide Aurovitas
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed dose.
If there are further questions about the use of this medicine, consult a doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately inform your doctor and stop taking Leflunomide Aurovitas:

• if the patient experiences weakness, a feeling of emptiness in the head or dizziness, or breathing problems, as these may be symptoms of a severe allergic reaction,
• if the patient develops a skin rash or mouth ulceration, as these may indicate serious, sometimes 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 must immediately inform your doctor if any of the following occur:

• pallor, feeling of fatigue, or bruising, as these may indicate blood disorders caused by an imbalance in different types of blood-forming cells,
• feeling of fatigue, abdominal pain, or jaundice (yellowing of the eyes or skin), as these may indicate serious conditions such as liver failure, which may lead to death,
• any signs of infection such as fever, sore throat, or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
• cough or breathing problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension, or lung nodule),
• unusual tingling, weakness, or pain in the hands or feet, which may indicate nerve problems (peripheral neuropathy).

Common adverse reactions (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 mild),
• fatigue (asthenia),
• headaches and dizziness,
• unusual sensory sensations such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulceration,
• abdominal pain,
• increased levels of certain liver function parameters,
• increased hair loss,
• eczema, dry skin, rash, and itching,
• tendonitis (pain caused by inflammation of the membrane surrounding tendons, usually in the hands and feet),
• increased activity of certain enzymes in the blood (creatine phosphokinase),
• nerve problems in the hands or feet (peripheral neuropathy).

Uncommon adverse reactions (may affect 1 in 100 people)

• decreased number of red blood cells (anemia) and decreased platelet count (thrombocytopenia),
• decreased potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (hives),
• tendon rupture,
• increased levels of blood lipids (cholesterol and triglycerides),
• decreased levels of phosphates in the blood.

Rare adverse reactions (may affect 1 in 1,000 people)

• increased number of white blood cells called eosinophils (eosinophilia), mild decrease in white blood cell count (leukopenia), and decrease in all types of blood cells (pancytopenia),
• marked increase in blood pressure,
• lung inflammation (interstitial lung disease),
• serious increase in certain liver function parameters, potentially leading to severe disorders such as hepatitis and jaundice,
• serious infections called sepsis, which may be life-threatening,
• increased activity of certain enzymes in the blood (lactate dehydrogenase).

Very rare adverse reactions (may affect 1 in 10,000 people)

• marked decrease in certain white blood cells (agranulocytosis),
• severe and potentially life-threatening allergic reactions,
• vasculitis (inflammation of blood vessels, including necrotizing vasculitis of the skin),
• pancreatitis,
• severe liver damage, such as liver failure or liver necrosis, which may result in death,
• severe, sometimes life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other adverse reactions such as kidney failure, decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (reversible after discontinuation of treatment with this medicine), cutaneous lupus erythematosus (characterized by rash/erythema in skin areas exposed to light), psoriasis (new onset or worsening of symptoms), DRESS, and skin ulceration (round, open skin ulcers revealing subcutaneous tissue) may also occur with unknown frequency.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
Adverse reactions 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 stated on the carton, blister, or bottle
after: EXP. The expiry date refers to the last day of the stated month.
PA/Aluminium/PVC foil blisters: Store below 30°C.
Clear PVC/PVDC/Aluminium foil blisters (only for 15 mg and 20 mg): Store below 25°C.
HDPE bottle: No special requirements for storage of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Leflunomide Aurovitas contains

• The active substance 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 are:
  Tablet core: lactose monohydrate, pregelatinized starch (corn), povidone (K-30), colloidal anhydrous silica, crospovidone (Type B), magnesium stearate

Tablet coating: polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), glycerol monokaprylocapronate, sodium lauryl sulphate, iron oxide yellow (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: approx. 7.2 mm]
White to off-white, round, biconvex film-coated tablet, embossed with "LF" on one side and "10" on the other side.

Leflunomide Aurovitas 15 mg film-coated tablets: [Size: approx. 7.2 mm]
White to off-white, round, biconvex film-coated tablet, embossed with "LF" on one side and "15" on the other side.

Leflunomide Aurovitas 20 mg film-coated tablets: [Size: approx. 7.2 mm]
Light yellow to yellow, round, biconvex film-coated tablet, embossed with "LF" on one side and "20" on the other side.

Leflunomide Aurovitas film-coated tablets are available in blister packs and HDPE bottles.
Pack sizes:
Blister packs: 10, 15, 30, 60, 90 and 100 film-coated tablets.
HDPE bottle: 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Belgium: Leflunomide AB 10 mg/20 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
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
Spain: Leflunomida Aurovitas 10 mg/20 mg comprimidos recubiertos con película EFG