Leflunomide Sandoz

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Leflunomide Sandoz(Leflunomide Sandoz)

20 mg, coated tablets

Leflunomide
Leflunomide Sandoz and Leflunomide Sandoz are different trade names for the same medicine.

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Leflunomide Sandoz and what is it 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 packaging and other information

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

Leflunomide Sandoz belongs to a group of anti-rheumatic medicines. It contains the active substance leflunomide.
Leflunomide Sandoz 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 are loss of appetite, fever, lack of energy, and anemia (low red blood cell count).
The symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and redness and flaking of the skin (skin lesions).

2. Important information before taking Leflunomide Sandoz

When not to take Leflunomide Sandoz

• if the patient has ever had an allergic reactionto leflunomide (especially severe skin reaction, often with fever, joint pain, red spots on the skin, or blisters (e.g., Stevens-Johnson syndrome), to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6) or in case of allergy to teriflunomide (used to treat multiple sclerosis);
• if the patient has liver function disorders;
• if the patient has moderate to severe kidney function disorders;
• if the patient has significantly reduced blood protein levels(hypoproteinemia);
• if the patient has any immune system disorders(e.g., AIDS);
• if the patient has bone marrow disordersor a low number of red blood cells, white blood cells, or platelets;
• if the patient has a severe infection;
• if the patient is pregnant, suspects she is pregnant, or is breastfeeding.

Warnings and precautions

Before starting to take Leflunomide Sandoz, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has ever had pulmonary fibrosis(interstitial lung disease);
• the patient has ever had tuberculosisor has been in close contact with someone who has or has had tuberculosis in the past. The doctor may order tests to determine if the patient has tuberculosis.
• the patient is a man and plans to father a child. It cannot be ruled out that Leflunomide Sandoz passes into semen, so during treatment with Leflunomide Sandoz, effective contraception should be used. Men planning to father a child should contact their doctor, who may advise stopping Leflunomide Sandoz and prescribe appropriate medication to quickly and effectively remove Leflunomide Sandoz from the body. Effective removal of Leflunomide Sandoz must be confirmed by appropriate blood tests. The decision to father a child can be made no earlier than 3 months after that.
• the patient is to undergo a specific blood test (calcium level measurement). The results of the calcium level measurement 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 reaction with eosinophilia and systemic symptoms [DRESS]) or increase the risk of developing a severe 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, then observes the spread of the rash, high fever, increased liver enzyme activity, and an increased number of a certain type of white blood cell (eosinophilia) visible in blood tests and lymph node enlargement.
Before starting Leflunomide Sandoz, and also regularly during treatment, the doctor will recommend blood teststo monitor the blood count and liver function. The doctor will also recommend regular blood pressure checks, as Leflunomide Sandoz may cause an increase in blood pressure.
If the patient experiences chronic diarrhea of unknown cause, they should consult their doctor. The doctor may order additional tests to determine the diagnosis.
The patient should inform their doctor if they experience skin ulcers during treatment with Leflunomide Sandoz (see section 4).

Children and adolescents

Leflunomide Sandoz should not be used in children and adolescents under 18 years of age.

Leflunomide Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. This includes medicines obtained without a prescription.
This is especially important if the patient is taking:

• other medicines used to treat rheumatoid arthritis, such as antimalarial medicines (e.g., chloroquine and hydroxychloroquine), gold preparations given intramuscularly or orally, D-penicillamine, and azathioprine, and other medicines that suppress the immune system (e.g., methotrexate), as their concurrent use with Leflunomide Sandoz is not recommended;
• warfarin and other oral anticoagulants, as it is necessary to monitor the patient's condition to reduce the risk of adverse effects of this medicine;
• 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 diabetic neuropathy);
• alosetron (a medicine used to treat severe diarrhea);
• theophylline (a medicine used to treat asthma);
• tizanidine (a medicine that reduces muscle tension);
• 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 disease)
• zidovudine (a medicine used to treat HIV infection)
• rosuvastatin, simvastatin, atorvastatin, pravastatin (medicines used to treat high cholesterol)
• sulfasalazine (a medicine used to treat inflammatory bowel disease or rheumatoid arthritis)
• cholestyramine (used to reduce high cholesterol) 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 to take 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 used during or for a certain period after stopping treatment with Leflunomide Sandoz.

Leflunomide Sandoz with food, drink, and alcohol

Leflunomide Sandoz can be taken with or without food.
During treatment with Leflunomide Sandoz, it is not recommended to drink alcohol, as consuming alcohol while taking Leflunomide Sandoz may increase the risk of liver damage.

Pregnancy, breastfeeding, and fertility

Do nottake Leflunomide Sandoz if the patient is or may be pregnant.
If the patient is pregnant or becomes pregnant during treatment with Leflunomide Sandoz, the risk of severe birth defects in the child increases. Women of childbearing age should not take Leflunomide Sandoz unless they use effective contraception.
Women planning to become pregnant after stopping treatment with Leflunomide Sandoz should inform their doctor, as it is necessary to ensure beforehand that no traces of Leflunomide Sandoz remain in the body. This may take up to 2 years, but this time can be shortened to a few weeks by taking medicines that accelerate the removal of Leflunomide Sandoz from the body.
In any case, appropriate blood tests must be performed to ensure that Leflunomide Sandoz has been effectively removed from the body. After that time, the patient should wait at least one month before planning a pregnancy.
The doctor will provide further information on blood tests.
If the patient suspects they have become pregnant while taking Leflunomide Sandoz or within 2 years of stopping it, they must immediatelycontact their doctor and have a pregnancy test. If the test result confirms pregnancy, the doctor may advise treatment with certain medicines to quickly and effectively remove Leflunomide Sandoz from the body, which may reduce the risk to the child.
Do nottake Leflunomide Sandoz while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

Leflunomide Sandoz may cause dizziness that impairs concentration and reaction speed. If the patient experiences dizziness, they should not drive or operate machinery.

Leflunomide Sandoz contains lactose, soy lecithin, and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine should not be used by patients allergic to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Leflunomide Sandoz

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Usually, the initial dose of Leflunomide Sandoz is 100 mg once a day for the first three days. After that, in most patients, the following doses are used:

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

The tablet should be swallowed whole, with a large amount of water.
A noticeable improvement in health may occur after about 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 time.

Taking a higher dose of Leflunomide Sandoz than recommended

In case of taking a higher dose of Leflunomide Sandoz than recommended, the patient should contact their doctor or seek medical advice. If possible, the patient should take the tablets or packaging of the medicine with them to show the doctor.

Missing a dose of Leflunomide Sandoz

If the patient forgets to take a dose, they should take it as soon as they remember, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Leflunomide Sandoz can cause side effects, although not everybody gets them.
The patient should immediatelyinform their doctor and stop taking Leflunomide Sandoz if:

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

The patient should immediatelyinform their doctor if they experience:

• pale skin, feeling tired, or a tendency to bruise, 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, which can be life-threatening,
• symptoms of infection, such as fever, sore throat, or cough, as Leflunomide Sandoz may increase the risk of severe, life-threatening infections,
• coughor difficulty breathing, as these may indicate lung disease (interstitial lung disease or pulmonary hypertension),
• unusual tingling, weakness, or pain in the hands or feet, as these 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 slight),
• weakness (asthenia),
• pains and dizziness,
• unusual sensations, such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation or ulcers of the mouth,
• abdominal pain,
• increased values of some liver function tests,
• increased hair loss,
• rash, dry skin, flushing, itching,
• tendinitis (pain caused by inflammation of the tendon sheath, usually in the feet or hands),
• increased activity of some enzymes in the blood (creatine kinase),
• nerve disorders in the 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),
• decrease in potassium levels in the blood,
• restlessness,
• taste disorders,
• hives,
• tendon rupture,
• increased lipid levels in the blood (cholesterol and triglycerides),
• decrease in phosphate levels in the blood.

Rare side effects(may occur in less than 1 in 1000 people):

• increase in eosinophil count in the blood (eosinophilia), mild decrease in white blood cell count (leukopenia), decrease in all types of blood cells (pancytopenia),
• significant increase in blood pressure,
• pulmonary fibrosis (interstitial lung disease),
• increased liver function test values, which may indicate the development of severe disorders, such as hepatitis and jaundice,
• severe infections called sepsis, which can be fatal,
• increased activity of some enzymes in the blood (lactate dehydrogenase).

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

• significant decrease in certain white blood cell counts (agranulocytosis),
• severe and potentially severe allergic reactions,
• vasculitis (including vasculitis with skin necrosis),
• pancreatitis,
• 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, infertility in men (reversible after stopping treatment with this medicine), cutaneous lupus erythematosus (characterized by a rash and/or redness on sun-exposed skin areas), psoriasis (occurring for the first time or worsening of existing disease), DRESS (drug reaction with eosinophilia and systemic symptoms), and skin ulcers (a round, open sore in the skin, through which underlying tissues are visible) may occur with an unknown frequency.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Leflunomide Sandoz

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Store the bottle tightly closed to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Leflunomide Sandoz contains

The active substance is leflunomide. One coated tablet contains 20 mg of leflunomide.
The other ingredients are: lactose monohydrate, hypromellose, 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 about 8 mm, with a dividing line on one side. The tablet can be divided into equal doses.
The tablets are packaged in an HDPE bottle with a PP cap containing a desiccant, in a cardboard box. The packaging contains 30 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Romanian marketing authorization number, country of export:8581/2016/05

Parallel import authorization number: 292/23

Date of leaflet approval: 18.12.2023