LEFLUNOMID 20 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Leflunomid Bluefish, 20 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Leflunomid Bluefish and what is it used for
4. Important information before taking Leflunomid Bluefish
   1. When not to take Leflunomid Bluefish
   2. Warnings and precautions
   3. Children and adolescents
   4. Leflunomid Bluefish and other medicines
   5. Vaccinations
   6. Leflunomid Bluefish with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Leflunomid Bluefish contains lactose
   10. Leflunomid Bluefish contains sodium
   11. Leflunomid Bluefish contains soya lecithin
5. How to take Leflunomid Bluefish
   1. Taking a higher dose of Leflunomid Bluefish than recommended
   2. Missing a dose of Leflunomid Bluefish
6. Possible side effects
   1. Frequent (may affect up to 1 in 10 patients)
   2. Uncommon (may affect up to 1 in 100 patients)
   3. Rare (may affect up to 1 in 1000 patients)
   4. Very rare (may affect up to 1 in 10,000 patients)
   5. Reporting side effects
7. How to store Leflunomid Bluefish
8. Contents of the pack and other information
   1. What Leflunomid Bluefish contains
   2. What Leflunomid Bluefish looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Leflunomid Bluefish, 20 mg, coated tablets

leflunomid

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 a specific person. 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 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 Leflunomid Bluefish and what is it used for
• 2. Important information before taking Leflunomid Bluefish
• 3. How to take Leflunomid Bluefish
• 4. Possible side effects
• 5. How to store Leflunomid Bluefish
• 6. Contents of the pack and other information

1. What is Leflunomid Bluefish and what is it used for

Leflunomid Bluefish belongs to a group of anti-rheumatic medicines. It contains the active substance leflunomid.
Leflunomid Bluefish is used in adult patients to treat 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, loss of energy, and anemia (low red blood cell count).
The symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and redness and scaling of the skin (skin lesions).

2. Important information before taking Leflunomid Bluefish

When not to take Leflunomid Bluefish

• if the patient has ever had an allergic reactionto leflunomid (especially severe skin reactions, often with accompanying fever, joint pain, red spots, or blisters on the skin, 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 an 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 disease that reduces the body's immune defense (e.g., AIDS),
• if the patient has bone marrow disorders or if the number of red, white, or platelet blood cells is significantly reduced,
• if the patient has a severe infection,
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.

Warnings and precautions

Before starting treatment with Leflunomid Bluefish, the patient should consult their doctor, pharmacist, or nurse

• -if the patient has ever had pneumonia(interstitial lung disease).
• if the patient has ever had tuberculosisor if they have had contact with someone who has had tuberculosis in the past. The doctor may recommend screening tests to check if the patient has tuberculosis.
• if the patient is a manwho plans to become a father. Because it cannot be excluded that Leflunomid Bluefish passes into semen and may affect the fetus, patients taking Leflunomid Bluefish should use effective contraception. A man planning to become a father should contact his doctor, who may advise stopping Leflunomid Bluefish and recommending drugs that accelerate the elimination of Leflunomid Bluefish from the body. Effective elimination of the medicine must be confirmed by appropriate blood tests, and the decision to become a father can be made no earlier than 3 months after that.
• if the patient is to undergo a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.
• if the patient is to undergo or has recently undergone major surgery, or if the patient still has an unhealed postoperative wound. Leflunomid Bluefish may interfere with wound healing.

Leflunomid Bluefish may sometimes cause blood count disorders, liver or lung problems, or nerve problems 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 serious infections.
For more information, see section 4 (Possible side effects).
DRESS initially manifests as flu-like symptoms and a rash on the face, followed by a rash covering other areas of the body and a high temperature, elevated liver enzyme levels visible in blood tests, and an increase in the number of certain white blood cells (eosinophilia) and lymph node enlargement.
Before starting treatment with Leflunomid Bluefish, and during treatment, the attending physician should order regular blood tests to monitor the blood count and liver function. Blood pressure should also be monitored regularly, as Leflunomid Bluefish may cause an increase in blood pressure.
The patient should inform their doctor if they experience unexplained persistent diarrhea. The doctor may perform additional tests to rule out other conditions.
The patient should inform their doctor if they experience skin ulcers during treatment with Leflunomid Bluefish (see section 4).

Children and adolescents

Leflunomid Bluefish is not recommended for use in children and adolescents under 18 years of age.

Leflunomid Bluefish and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available 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 used intramuscularly or orally,

D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g., methotrexate), as these combinations are not recommended,

• warfarin and other oral medicines used to reduce blood clotting, as patient monitoring is necessary to reduce the risk of adverse reactions to this medicine,
• teriflunomide, used to treat multiple sclerosis,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone used to treat diabetes,
• daunorubicin, doxorubicin, paclitaxel, or topotecan used to treat cancer,
• duloxetine used to treat depression, urinary incontinence, or diabetic neuropathy,
• alosetron used to treat irritable bowel syndrome,
• theophylline used to treat asthma,
• tizanidine, a muscle relaxant,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin used to treat infections,
• indomethacin, ketoprofen used to treat pain or inflammation,
• furosemide used to treat heart disease (diuretic),
• zidovudine used to treat HIV infections,
• rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat hypercholesterolemia (high cholesterol),
• sulfasalazine used to treat inflammatory bowel disease and rheumatoid arthritis,
• cholestyramine (used to treat elevated lipid levels in the blood) and activated charcoal, these medicines may reduce the binding of Leflunomid Bluefish to proteins and thereby reduce its effect.

A patient taking non-steroidal anti-inflammatory drugs(NSAIDs) and/or corticosteroidsmay continue treatment with these medicines after starting Leflunomid Bluefish.

Vaccinations

In case of planned vaccinations, the patient should consult their doctor. If Leflunomid Bluefish is being taken, and for some time after stopping treatment with this medicine, the patient should not be vaccinated.

Leflunomid Bluefish with food, drink, and alcohol

Leflunomid Bluefish can be taken with or without food.
It is not recommended to consume alcoholic beverages during treatment with Leflunomid Bluefish. Drinking alcohol during treatment with Leflunomid Bluefish may increase the risk of liver damage.

Pregnancy and breastfeeding

Do not takeLeflunomid Bluefish if the patient is pregnantor suspects she may be pregnant. If a woman becomes pregnant or plans to become pregnant while taking Leflunomid Bluefish, the risk of serious birth defects in the child increases. Leflunomid Bluefish should not be taken by women of childbearing age unless they use effective contraception.
The patient should tell their doctor if they plan to become pregnant after stopping treatment with Leflunomid Bluefish, to ensure that Leflunomid Bluefish has been completely eliminated from the body before becoming pregnant. The elimination time may be up to 2 years. However, this time can be shortened to a few weeks by taking medicines that accelerate the elimination of Leflunomid Bluefish from the body.
In any case, the patient should undergo appropriate blood tests to ensure that the elimination of the medicine was effective enough. After obtaining a normal test result, the patient should wait at least one month before trying to become pregnant.
To obtain more information about the laboratory test, the patient should consult their doctor.
If the patient suspects she may be pregnant while taking Leflunomid Bluefish or if it has not been more than 2 years since stopping treatment, she should immediatelycontact her doctor to undergo pregnancy tests. If the test results confirm pregnancy, the doctor may recommend taking medicines that quickly and effectively eliminate Leflunomid Bluefish from the body, which may reduce the risk to the fetus.
Do nottake Leflunomid Bluefish during breastfeeding, as leflunomid passes into breast milk.

Driving and using machines

Leflunomid Bluefish may cause dizziness, which can affect concentration and reaction speed. The patient should not drive or operate machinery if such effects occur.

Leflunomid Bluefish contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Leflunomid Bluefish contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 20 mg tablet, which means the medicine is considered "sodium-free".

Leflunomid Bluefish contains soya lecithin

Do not take if the patient is hypersensitive to peanuts or soy.

3. How to take Leflunomid Bluefish

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Usually, the initial dose of Leflunomid Bluefish is 100 mg of leflunomid once a day, taken for the first three days. From the fourth day, in most patients, effective doses are:

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

The tablet should be swallowed whole, with a large amount of water.
A noticeable improvement in health may occur after 4 weeks of treatment. Some patients may experience further improvement after 4 to 6 months of treatment.
Leflunomid Bluefish is usually taken for a long time.

Taking a higher dose of Leflunomid Bluefish than recommended

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

Missing a dose of Leflunomid Bluefish

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

4. Possible side effects

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

• weakness, mild pain, and dizziness or breathing problemsoccur, as these may be symptoms of a severe allergic reaction,
• a skin rashor mouth ulcersappear, which may indicate severe, potentially life-threatening reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms - DRESS), see section 2.

The patient should immediatelyinform their doctor if they experience:

• pale skin, feeling tired, increased susceptibility to infections, or bruises, which may indicate blood count disorders caused by an imbalance of different types of blood cells,
• feeling tired, abdominal pain, or jaundice(yellowing of the eyes or skin), which may indicate serious liver diseases, such as liver failure, which can be life-threatening,
• infection symptoms, such as fever, sore throat, or cough, as this medicine may increase the risk of serious, life-threatening infections,
• coughor breathing problems, which may indicate lung disease (interstitial lung disease or pulmonary hypertension),
• numbness, weakness, or painin the hands or feet, which may indicate nerve problems (peripheral neuropathy).

Frequent (may affect up to 1 in 10 patients)

• mild decrease in white blood cell count (leukopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually slight),
• weakness (asthenia),
• pain and dizziness,
• abnormal sensations, such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• mouth ulcers or oral ulcers,
• abdominal pain,
• increase in some liver function parameters,
• increased hair loss,
• rash, dry skin, redness, and itching of the skin,
• tendinitis (pain caused by tendon inflammation, usually in the feet and hands),
• increase in the activity of some enzymes in the blood (creatine kinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Uncommon (may affect up to 1 in 100 patients)

• decrease in red blood cell count (anemia) and decrease in platelet count (thrombocytopenia),
• decrease in blood potassium levels,
• restlessness,
• taste disorders,
• hives (urticaria),
• tendon rupture,
• increase in blood lipid levels (cholesterol and triglycerides),
• decrease in blood phosphate levels.

Rare (may affect up to 1 in 1000 patients)

• increase in blood eosinophil count, called eosinophilia, mild decrease in white blood cell count (leukopenia), decrease in all blood cell counts (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• severe increase in some liver function parameters, which may lead to serious 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 (may affect up to 1 in 10,000 patients)

• significant decrease in the number of certain white blood cells (agranulocytosis),
• severe and potentially severe allergic reactions,
• blood vessel inflammation (vasculitis, 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, infertility in men (reversible after stopping treatment with this medicine), cutaneous lupus (characterized by a rash/redness on sun-exposed skin areas), psoriasis (newly diagnosed or worsening symptoms), DRESS, and skin ulcers (a round, open wound in the skin, through which underlying tissues are visible), may also occur with an unknown frequency.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-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, more information can be gathered on the safety of the medicine.

5. How to store Leflunomid Bluefish

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the label and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
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 pack and other information

What Leflunomid Bluefish contains

• The active substance is leflunomid. One coated tablet contains 20 mg of leflunomid.
• The other ingredients of the medicine are: Tablet core: lactose monohydrate, hydroxypropylcellulose (low-substituted), acetic acid, sodium lauryl sulfate, and magnesium stearate. Tablet coating: lecithin (soy), polyvinyl alcohol, talc, titanium dioxide (E 171), and xanthan gum.

What Leflunomid Bluefish looks like and contents of the pack

Leflunomid Bluefish 20 mg coated tablets are white or almost white, round, approximately 8 mm in diameter, with a dividing line on one side. The tablet can be divided into equal doses.
The coated tablets are packaged in bottles.
Pack sizes: 30 coated tablets.

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:September 2024