Leflunomide Sandoz

Leaflet attached to the packaging: patient information

Leflunomide Sandoz, 20 mg, film-coated tablets

Leflunomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 those not listed in this leaflet, please tell your 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 pack and other information

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

Leflunomide Sandoz belongs to a group of medicines called antirheumatic 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 include 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 scaly skin (skin lesions).

2. Important information before taking Leflunomide Sandoz

When not to take Leflunomide Sandoz

if you have ever had an allergic reaction to 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 if you are allergic to teriflunomide (used to treat multiple sclerosis);
if you have liver function disorders;
if you have moderate to severe kidney function disorders;
if you have significantly reduced blood protein levels (hypoproteinemia);
if you have any immune system disorders (e.g., AIDS);
if you have bone marrow disorders or a low red blood cell, white blood cell, or platelet count;
if you have a severe infection;
if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Before taking Leflunomide Sandoz, discuss with your doctor, pharmacist, or nurse if:
you have ever had interstitial lung disease (pulmonary fibrosis);
you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may order tests to determine if you have tuberculosis.
you are a man and plan to father a child. It cannot be excluded 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 prescribing appropriate medications 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 this time.
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 or have had major surgery, or if you still have an unhealed postoperative wound. Leflunomide Sandoz may interfere with wound healing.
Leflunomide Sandoz may occasionally 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 regularly during treatment, your doctor will order blood tests to check your blood count and liver function. Your doctor will also recommend regular blood pressure checks, as Leflunomide Sandoz may increase blood pressure.
If you experience chronic diarrhea of unknown cause, you should contact your doctor. Your doctor may order additional tests to determine the diagnosis.
You should inform your doctor if you 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 given intramuscularly or orally, D-penicillamine, 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 your condition to reduce the risk of side 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 muscle relaxant);
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 you are taking nonsteroidal anti-inflammatory medicines (NSAIDs) and (or) corticosteroids, you may continue to take them after starting treatment with Leflunomide Sandoz.

Vaccinations

If you are planning to be vaccinated, you should consult your doctor. Some vaccines should not be used during or for some time after 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 during treatment with Leflunomide Sandoz may increase the risk of liver damage.

Pregnancy, breastfeeding, and fertility

Do nottake Leflunomide Sandoz if you are or may be pregnant.
If you are pregnant or become pregnant during treatment with Leflunomide Sandoz, the risk of serious 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 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 medications that accelerate the removal of Leflunomide Sandoz from the body.
In any case, appropriate blood tests should be performed to ensure that Leflunomide Sandoz has been effectively removed from the body. After this time, you should wait at least one month before planning a pregnancy.
Your doctor will provide further information on blood tests.
If you suspect that you have become pregnant while taking Leflunomide Sandoz or within 2 years of stopping it, you must immediatelycontact your doctor and have a pregnancy test. If the test result confirms pregnancy, your doctor may advise treatment with certain medications 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 you experience dizziness, do not drive or operate machinery.

Leflunomide Sandoz contains lactose, lecithin (derived from soy), and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine should not be used by patients who are allergic to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Leflunomide Sandoz

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The usual starting dose of Leflunomide Sandoz is 100 mg once daily for the first three days. After this time, the following doses are usually taken:
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.
Swallow the tablet whole, with a large amount of water.
A noticeable improvement in your condition may occur after about 4 weeks of treatment or later.
Some patients 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

If you take more Leflunomide Sandoz than you should, contact your doctor or seek medical advice. If possible, take the tablets or packaging with you to show the doctor.

Missing a dose of Leflunomide Sandoz

If you miss 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 on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Leflunomide Sandoz can cause side effects, although not everybody gets them.
Immediatelytell your doctor and stop taking Leflunomide Sandoz if you:
feel weakness, dizziness, or have difficulty breathing, as these may be symptoms of a severe allergic reaction,
develop a skin rashor mouth ulcers, as these may indicate severe, potentially life-threatening reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS), see section 2.
Immediatelytell your doctor if you experience:
pale skin, feeling tiredor a tendency to bruise, as these may be symptoms of blood disorders, caused by an imbalance between different types of blood cells in the blood,
feeling tired, abdominal painor 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 this medicine 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 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),
weakness (asthenia),
headache, 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, eczema, pruritus,
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 affect up to 1 in 100 people):
decrease in red blood cell count (anemia) and decrease in platelet count (thrombocytopenia),
decrease in blood potassium levels,
restlessness,
taste disorders,
hives,
tendon rupture,
increased blood lipid levels (cholesterol and triglycerides),
decrease in blood phosphate levels.
Rare side effects(may affect up to 1 in 1,000 people):
increase in eosinophil count in the blood, mild decrease in white blood cell count (leukopenia), decrease in all blood cell counts (pancytopenia),
significant increase in blood pressure,
lung inflammation (interstitial lung disease),
increase in some liver function parameters, which may indicate the development of severe disorders, such as hepatitis and jaundice,
severe infections called sepsis, which can be life-threatening,
increase in the 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 certain white blood cell counts (agranulocytosis),
severe and potentially severe allergic reactions,
blood vessel inflammation (including vasculitis with skin necrosis),
pancreatitis,
severe liver damage, such as liver failure or necrosis, which can be life-threatening,
severe, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Other side effects, such as kidney failure, decreased blood uric acid levels, pulmonary hypertension, male infertility (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 the underlying tissues are visible) may occur with an unknown frequency.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 bottle and carton after EXP. The expiry date refers to the last day of the month.
The batch number on the packaging is marked as "Lot".
Keep the bottle tightly closed to protect from moisture.
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 Sandoz contains

The active substance is leflunomide. One film-coated tablet contains 20 mg of leflunomide.
The other ingredients are: lactose monohydrate, hypromellose, ascorbic acid, sodium lauryl sulfate, magnesium stearate
Coating: lecithin (from soy), polyvinyl alcohol, talc, titanium dioxide (E171), xanthan gum.
Leflunomide Sandoz contains lactose and lecithin (see section 2).

What Leflunomide Sandoz looks like and contents of the pack

White or almost white, round, biconvex film-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 packed in HDPE bottles with a PP cap containing a desiccant (white silica gel). The packs contain 30 and 100 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster, Germany

For more information on this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:09/2024
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