Leflunomide sandoz

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Leflunomide Sandoz (Leflunomide Sandoz)
20 mg, coated tablets
Leflunomidum
Leflunomide Sandoz and Leflunomide Sandoz are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 (a deficiency of red blood cells).
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 had an allergic reaction to leflunomide (especially severe skin reactions, often with fever, joint pain, red skin patches 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 in case of 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 been diagnosed with a significant decrease in blood protein levels (hypoproteinemia);
• if the patient has any disorders affecting the immune system (e.g. AIDS);
• if the patient has bone marrow function disorders or low levels 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 had close contact with someone who has or has 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 to father a child should contact their doctor, who may advise discontinuation of Leflunomide Sandoz and recommend appropriate medication to rapidly and effectively eliminate Leflunomide Sandoz 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 undergo a specific blood test (calcium level measurement). Calcium level test results may be falsely lowered.

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 rash with eosinophilia and systemic symptoms [DRESS]) or increase the risk of developing a serious infection. More information on this
can be found in section 4 („Possible side effects”).
DRESS initially presents with flu-like symptoms and a rash on the face, followed by spreading of the rash, high fever, increased liver enzyme activity and elevated levels of a certain type of white blood cells (eosinophilia) visible in blood tests, and enlarged lymph nodes.
Before starting treatment with Leflunomide Sandoz, and regularly during treatment, 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 it.
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 available without a prescription.
This is particularly important if the patient is taking:

• other medicines used to treat rheumatoid arthritis, such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold preparations, D-penicillamine, azathioprine, or other medicines that suppress immune system function (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 of these medicines;
• 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 used to reduce muscle stiffness);
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin (medicines used to treat infections);
• indometacin, 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 hypercholesterolemia - high cholesterol levels);
• sulfasalazine (a medicine used to treat inflammatory bowel disease or rheumatoid arthritis);
• cholestyramine (used to reduce 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, they may continue taking them after starting treatment with Leflunomide Sandoz.
Vaccinations
If the patient plans to be vaccinated, they should consult their doctor. Some vaccines should not be administered during or for a certain time after treatment with Leflunomide Sandoz.
Leflunomide Sandoz with food, drink and alcohol
Leflunomide Sandoz may be taken regardless 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 fertility
Do not use Leflunomide Sandoz if the patient is or may be pregnant.
If the patient is pregnant or becomes pregnant while taking Leflunomide Sandoz, the risk of severe congenital malformations in the child increases. 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 necessary 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 several weeks by taking medicines that accelerate the elimination of Leflunomide Sandoz from the body.
In any case, appropriate blood tests should be performed to confirm that Leflunomide Sandoz has been effectively eliminated 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 became 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 medicines 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 breast milk.
Driving and operating machinery
Leflunomide Sandoz may cause dizziness, impairing concentration and reaction speed. If dizziness occurs, do not drive or operate machinery.
Leflunomide Sandoz contains lactose, 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 by patients allergic to peanuts or soya.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine 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 have any doubts,
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, the following doses are generally 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 a higher than 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. If possible, take the tablets or the medicine package with you to show to the doctor.
Missing a dose of Leflunomide Sandoz
If you forget to take a dose, you should 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 doubts about 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 will get them.
You should inform your doctor immediately 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 a skin rash or oral ulceration, as these may indicate severe, 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.

You should promptly inform your doctor if the patient experiences:

• pallor, feeling tired or a tendency to develop bruising, as these may be symptoms of blood disorders caused by an imbalance between different types of blood cells,
• feeling tired, abdominal pain or jaundice (yellowing of the eyes or skin), as these may indicate severe disorders such as liver failure, sometimes leading to death,
• symptoms of infection, such as fever, sore throat or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
• 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 side effects (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 mild),
• 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 mucous membranes of the mouth,
• abdominal pain,
• increased values in some liver function tests,
• increased 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 blood enzymes (creatine kinase),
• nerve disorders in hands or feet (peripheral neuropathy).

Uncommon side effects (may occur in less than 1 in 100 people):

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

Rare side effects (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), decrease in all types of blood cells (pancytopenia),
• significant increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increased values of certain liver function parameters, which may indicate development of severe disorders such as hepatitis and jaundice,
• severe infections known as sepsis, which may result in death,
• increased activity of certain blood enzymes (lactate dehydrogenase).

Very rare side effects (may occur in less than 1 in 10,000 people):

• significant 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 side effects such as kidney failure, decreased uric acid levels in blood, pulmonary hypertension, male infertility (reversible after discontinuation of treatment with this medicine), cutaneous lupus erythematosus (characterized by rash and/or erythema in areas of skin 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 side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects 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 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Leflunomide Sandoz

• Keep this medicine out of the 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 the sewage system 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 Sandoz contains
The active substance is leflunomide. One 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 lactose and 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 screw cap containing a desiccant, placed in a cardboard box. The packaging contains 30 coated tablets.

For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Relabeled in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorization number in Romania, country of export: 8581/2016/05
Parallel import authorization number: 292/23