Leflunomide sandoz

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Leflunomide Sandoz, 20 mg, film-coated tablets
Leflunomidum
Leflunomide Sandoz and Leflunomidă Sandoz are different brand names of the same medicine.
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• 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 side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

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

Leflunomide Sandoz belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.
Leflunomide Sandoz 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 (low red blood cell count).
Symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, as well as redness and scaling of the skin (skin lesions).

2. Important information before using Leflunomide Sandoz

When not to use Leflunomide Sandoz

• if the patient has ever experienced an allergic reaction to leflunomide (especially severe skin reactions, often accompanied by fever, joint pain, red skin lesions or blisters (e.g. Stevens-Johnson syndrome)), to peanuts or soya, or to any of the other ingredients of this medicine (listed in section 6), or if the patient has a known allergy to teriflunomide (used in the treatment of multiple sclerosis);
• if the patient has liver function disorders;
• if the patient has moderate to severe kidney function disorders;
• if the patient has significant reduction in blood protein levels (hypoproteinaemia);
• if the patient has any disorders affecting the immune system (e.g. AIDS);
• if the patient has bone marrow dysfunction or low counts of red blood cells, white blood cells or platelets;
• if the patient has a serious infection;
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.

Warnings and precautions
Before starting treatment with Leflunomide Sandoz, discuss with your doctor,
pharmacist or nurse if:

• the patient has ever had pneumonia ( interstitial lung disease );
• the patient has ever had tuberculosis or has had close contact with someone who currently or previously had tuberculosis. The doctor may order tests to determine whether the patient has tuberculosis.
• the patient is a man planning to father a child. It cannot be ruled out that Leflunomide Sandoz passes into semen; therefore, effective contraception should be used during treatment with Leflunomide Sandoz. Men planning fatherhood should consult their doctor, who may advise discontinuation of Leflunomide Sandoz and recommend appropriate medications to rapidly and effectively eliminate the drug from the body. Effective elimination of Leflunomide Sandoz must be confirmed by appropriate blood tests. A decision about fatherhood should not be made earlier than 3 months after this point.
• the patient is due to have or has had a specific blood test (calcium level measurement). Calcium test results may be falsely low.
• if the patient is undergoing or has recently undergone major surgery, or still has an unhealed surgical wound. Leflunomide Sandoz may impair wound healing.

Leflunomide Sandoz may rarely cause blood, liver, lung or nerve disorders in the hands or feet. It may also cause severe allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]) or increase the risk of serious infections. More information on this can be found in section 4 („Possible side effects”).
DRESS initially presents with flu-like symptoms and a facial rash, followed by spreading rash, high fever, elevated liver enzymes and increased numbers of certain white blood cells (eosinophilia) in blood tests, as well as swollen lymph nodes.
Before starting treatment with Leflunomide Sandoz and regularly during therapy, the doctor will recommend blood tests to monitor blood counts and liver function. The doctor will also recommend regular monitoring of blood pressure, as Leflunomide Sandoz may increase blood pressure.
If the patient develops chronic diarrhoea of unknown cause, medical advice should be sought. The doctor may order additional tests to establish a diagnosis.
Inform the doctor if skin ulceration occurs during treatment with Leflunomide Sandoz (see section 4).
Children and adolescents
Leflunomide Sandoz is not recommended for use in children and adolescents under 18 years of age.
Leflunomide Sandoz and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes medicines obtained without a prescription.
This is particularly important if the patient is taking:

• other medicines used to treat rheumatoid arthritis, such as antimalarial drugs (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold preparations, D-penicillamine, azathioprine, or other immunosuppressive agents (e.g. methotrexate), as concomitant use with Leflunomide Sandoz is not recommended;
• warfarin or other oral anticoagulants, as patient monitoring is required to reduce the risk of adverse effects;
• 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 kidney disease in people with diabetes);
• alosetron (a medicine used to treat severe diarrhoea);
• theophylline (a medicine used to treat asthma);
• tizanidine (a medicine that reduces muscle stiffness);
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin (medicines used to treat infections);
• indomethacin, ketoprofen (medicines used to treat pain and inflammation);
• furosemide (a diuretic used to treat heart conditions);
• zidovudine (a medicine used to treat HIV infection);
• rosuvastatin, simvastatin, atorvastatin, pravastatin (medicines used to treat hypercholesterolaemia - high cholesterol levels);
• sulfasalazine (a medicine used to treat inflammatory bowel disease or rheumatoid arthritis);
• cholestyramine (used to lower high cholesterol levels) or activated charcoal, as they may reduce the absorption of Leflunomide Sandoz;

If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may continue to be used after starting treatment with Leflunomide Sandoz.
Vaccinations
If the patient plans to be vaccinated, they should consult their doctor. Certain vaccines should not be administered during or for some time after treatment with Leflunomide Sandoz.
Leflunomide Sandoz with food, drink and alcohol
Leflunomide Sandoz can be taken independently of meals.
During treatment with Leflunomide Sandoz, alcohol consumption is not recommended, as drinking alcohol while taking Leflunomide Sandoz may increase the risk of liver damage.
Pregnancy, breastfeeding and effects on fertility
Do not use Leflunomide Sandoz if the patient is pregnant or suspects she may be pregnant.
If the patient is pregnant or becomes pregnant while taking Leflunomide Sandoz, there is an increased risk of severe congenital malformations in the child. Women of childbearing potential must not take Leflunomide Sandoz unless they are using effective contraception.
Women planning pregnancy after stopping Leflunomide Sandoz should inform their doctor, as it is essential to ensure beforehand that no trace of Leflunomide Sandoz remains in the body. This may take up to 2 years, but the time can be reduced to a few weeks by taking medications that accelerate the elimination of Leflunomide Sandoz from the body.
In all cases, appropriate blood tests must be performed to confirm effective removal of Leflunomide Sandoz from the body. After this, at least one month should be waited before attempting pregnancy.
The doctor will provide further information regarding blood tests.
If the patient suspects she has become pregnant while taking Leflunomide Sandoz or within 2 years after stopping it, she must immediately contact her doctor and undergo a pregnancy test. If the test confirms pregnancy, the doctor may recommend treatment with specific medications to rapidly and effectively eliminate Leflunomide Sandoz from the body, which may reduce the risk to the unborn child.
Do not take Leflunomide Sandoz during breastfeeding, as leflunomide passes into human milk.
Driving and operating machinery
Leflunomide Sandoz may cause dizziness and impair concentration and reaction speed. If dizziness occurs, the patient should not drive or operate machinery.
Leflunomide Sandoz contains lactose monohydrate, soya lecithin and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine should not be used in patients allergic to peanuts or soya.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Leflunomide Sandoz

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The usual starting dose of Leflunomide Sandoz is 100 mg once daily for the first three days. After this period, in most patients the following doses are used:

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

The tablet should be swallowed whole with a large amount of water.
Noticeable improvement in health may occur after approximately 4 weeks of treatment or later.
Some patients may experience further improvement even after 4 to 6 months of treatment.
Leflunomide Sandoz is usually taken for a long period of time.
Taking more than the recommended dose of Leflunomide Sandoz
If you take more than the recommended dose of Leflunomide Sandoz, you should contact your doctor or seek medical advice immediately. If possible, bring the tablets or the medicine packaging with you to show the doctor.
Missing a dose of Leflunomide Sandoz
If you forget to take 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 the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Immediately inform your doctor and stop taking Leflunomide Sandoz if:

• the patient experiences weakness, dizziness or vertigo, or has difficulty breathing, as these may be symptoms of a severe allergic reaction,
• the patient develops skin rash or oral ulcers, as these may indicate serious, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Promptly inform your doctor if the patient experiences:

• pallor, feeling tired or tendency to develop bruising, as these may be symptoms of blood disorders caused by imbalance between different types of blood cells,
• feeling tired, abdominal pain or jaundice (yellowing of the eyes or skin), as these may indicate serious disorders such as liver failure, sometimes leading to death,
• signs of infection, such as fever, sore throat or cough, as this medicine may increase the risk of severe, potentially life-threatening infection,
• cough or difficulty breathing, as these may indicate lung disease (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness or pain in hands or feet, as these symptoms may indicate nerve disorders (peripheral neuropathy).

Common adverse reactions (may occur in less than 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 sensory sensations such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation or ulceration of the oral mucosa,
• abdominal pain,
• increased values in certain liver function tests,
• excessive hair loss,
• rash, dry skin, skin eruptions, itching,
• tendonitis (pain due to inflammation of the membrane surrounding tendons, usually in the area of feet or hands),
• increased activity of certain enzymes in blood (creatine kinase),
• nerve disorders in arms or legs (peripheral neuropathy).

Uncommon adverse reactions (may occur in less than 1 in 100 people):

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

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• increased number of eosinophils in blood (eosinophilia), mild decrease in white blood cell count (leukopenia), decreased number of all types of blood cells (pancytopenia),
• marked increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values of certain liver function parameters, which may indicate development of serious disorders such as hepatitis and jaundice,
• severe infections called sepsis, which may result in death,
• increased activity of certain enzymes in blood (lactate dehydrogenase).

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• marked decrease in certain white blood cells (agranulocytosis),
• severe and potentially severe allergic reactions,
• vasculitis (including cutaneous necrotizing vasculitis),
• pancreatitis,
• severe liver damage, such as liver failure or 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 renal failure, decreased uric acid levels in blood, pulmonary hypertension, male infertility (reversible after discontinuation of this medicine), cutaneous lupus erythematosus (characterized by rash and/or erythema in skin areas exposed to light), psoriasis (new onset or worsening of existing disease), DRESS (drug reaction with eosinophilia and systemic symptoms), and skin ulceration (a round, open wound in the skin through which subcutaneous tissues are visible) may occur with unknown frequency.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Leflunomide Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Store the bottle tightly closed to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Leflunomide Sandoz contains
The active substance is leflunomide. Each coated tablet contains 20 mg of leflunomide.
The other ingredients are: monohydrate lactose, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate, magnesium stearate.
Coating: soy lecithin, polyvinyl alcohol, talc, titanium dioxide (E 171), xanthan gum.
Leflunomide Sandoz contains monohydrate lactose and soy lecithin (more information in section 2).

What Leflunomide Sandoz looks like and contents of the pack
White or almost white, round, biconvex coated tablets with a diameter of approximately 8 mm, with a score line on one side. The tablet can be divided into equal doses.
The tablets are packed in HDPE bottles with a PP cap containing a desiccant, placed in a cardboard box. The pack contains 30 coated tablets.

For more detailed information, please contact the responsible party or parallel importer.

Responsible party in Romania, country of export:
Sandoz Pharmaceuticals S.R.L.
Calea Floreasca, nr 169A
Clădirea A, etaj 1, sector 1, 014459 Bucharest, Romania

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15, 48159 Münster, Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Authorization number in Romania, country of export: 8581/2016/05
Parallel import authorization number: 113/25