Leflunomid Bluefish

Leaflet attached to the packaging: information for the user

Leflunomid Bluefish, 10 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 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, tell your 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 you have 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), peanuts, or soy, or 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 disease,
• if you have moderate to severe kidney disease,
• if you have significantly reduced blood protein levels(hypoproteinemia),
• if you have any immune system disorder(e.g., AIDS),
• if you have bone marrow disordersor if your red blood cell, white blood cell, or platelet count is significantly reduced,
• if you have a severe infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Before starting to take Leflunomid Bluefish, tell your doctor, pharmacist, or nurse

• -if you have ever had interstitial lung disease(a disease that affects the lungs),
• if you have ever had tuberculosisor have been in contact with someone who has had tuberculosis in the past. Your doctor may recommend screening tests to check if you have tuberculosis,
• if you are a malewho plans to father a child. 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 father a child should contact his doctor, who may advise stopping Leflunomid Bluefish and recommending a medicine that accelerates the elimination of Leflunomid Bluefish from the body. Effective elimination of the medicine must be confirmed by appropriate blood tests, and the decision to father a child can be made no earlier than 3 months after that time,
• if 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 major surgery or have recently had major surgery, or if you still have an unhealed post-operative wound. Leflunomid Bluefish may interfere with wound healing.

Leflunomid Bluefish may sometimes cause blood disorders, liver or lung problems, or nerve problems in the hands or feet. It may also cause serious allergic reactions (including drug rash with eosinophilia and systemic symptoms - DRESS) or increase the risk of serious infections.
See section 4 (Possible side effects) for more information.
DRESS initially presents 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 increased number of certain white blood cells (eosinophilia) and swollen lymph nodes.
Before starting treatment with Leflunomid Bluefish, and during treatment, your doctor should regularly order blood teststo monitor your blood cell count and liver function. You should also have your blood pressure checked regularly, as Leflunomid Bluefish may cause an increase in blood pressure.
Tell your doctor if you experience unexplained persistent diarrhea. Your doctor may perform additional tests to rule out other conditions.
Tell your doctor if you experience skin ulcers during treatment with Leflunomid Bluefish (see section 4).

Children and adolescents

Leflunomid Bluefish should not be used in children and adolescents under 18 years of age.

Leflunomid Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to 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 by injection or orally,

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 monitoring is required to reduce the risk of side effects of 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 (a diuretic),
• zidovudine used to treat HIV infections,
• rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat high cholesterol,
• sulfasalazine used to treat inflammatory bowel disease and rheumatoid arthritis,
• cholestyramine (used to treat high blood lipid levels) and activated charcoal, as these medicines may reduce the binding of Leflunomid Bluefish to proteins and thus 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

If you are planning to have vaccinations, consult your doctor. If you are taking Leflunomid Bluefish, and for a certain period after stopping treatment with this medicine, you should not have live vaccinations.

Leflunomid Bluefish with food, drink, and alcohol

Leflunomid Bluefish can be taken with or without food.
It is not recommended to drink alcohol 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 you are pregnantor think you may be pregnant. If you become pregnant or plan to become pregnant after stopping treatment with Leflunomid Bluefish, you must ensure that Leflunomid Bluefish has been completely eliminated from your 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, you should have appropriate blood tests to ensure that the elimination of the medicine was effective enough. After obtaining a normal test result, you should wait at least one month before trying to become pregnant.
To get more information about the laboratory test, consult your doctor.
If you think you may be pregnant during treatment with Leflunomid Bluefish or if it has been less than 2 years since you stopped treatment, you should immediatelycontact your doctor to have pregnancy tests done. If the test results confirm pregnancy, your 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 while breastfeeding, as leflunomid passes into breast milk.

Driving and using machines

Leflunomid Bluefish may cause dizziness, which may affect your ability to concentrate and react. You should not drive or operate machinery if you experience such effects.

Leflunomid Bluefish contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

Leflunomid Bluefish contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 mg tablet, which means the medicine is considered "sodium-free".

Leflunomid Bluefish contains soy lecithin

Do not take if you are hypersensitive to peanuts or soy.

3. How to take Leflunomid Bluefish

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Usually, the initial dose of Leflunomid Bluefish is 100 mg of leflunomid once daily for the first three days. From the fourth day, the following doses are effective for most patients:

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

Swallow the tablet whole, with a large amount of water.
A noticeable improvement in your condition 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

If you take more Leflunomid Bluefish 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 Leflunomid Bluefish

If you miss a dose, take it as soon as you remember, unless it is close to the 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 taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Leflunomid Bluefish can cause side effects, although not everybody gets them.
You should immediatelytell your doctor and stop taking Leflunomid Bluefish if:

• you experience weakness, mild pain, and dizziness or breathing problems, as these may be symptoms of a serious allergic reaction,
• you develop a skin rashor mouth ulcers, which may indicate serious, 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.

You should immediatelytell your doctor if you experience:

• pale skin, feeling tired, increased risk of infections, or bruising, which may indicate blood 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 disease, including 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 serious, potentially 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).

Common (may affect up to 1 in 10 people)

• mild reduction in white blood cell count (leukopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually mild),
• 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 inflammation of the tendon sheath, 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 people)

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

Rare (may affect up to 1 in 1,000 people)

• increase in eosinophil count in the blood, called eosinophilia, mild reduction in white blood cell count (leukopenia), reduction in all blood cell counts (pancytopenia),
• severe increase in blood pressure,
• interstitial lung disease (a disease that affects the lungs),
• severe increase in some liver function parameters, which may lead to serious disorders, such as hepatitis and jaundice,
• severe infections called sepsis, which may lead to death,
• increase in the activity of some enzymes in the blood (lactate dehydrogenase).

Very rare (may affect up to 1 in 10,000 people)

• significant reduction in the count of certain white blood cells (agranulocytosis),
• severe and potentially severe allergic reactions,
• vasculitis (inflammation of blood vessels, including vasculitis with skin necrosis),
• pancreatitis,
• severe liver damage, such as liver failure or necrosis, which may lead to death,
• severe, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects, such as kidney failure, reduced uric acid levels in the blood, 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Leflunomid Bluefish

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
Store 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 Leflunomid Bluefish contains

• The active substance is leflunomid. One coated tablet contains 10 mg of leflunomid.
• The other ingredients of the medicine are: Tablet core: lactose monohydrate, hydroxypropylcellulose (low-substituted), succinic 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 10 mg coated tablets are white or almost white, round, and approximately 6 mm in diameter.
The coated tablets are packed 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