Patient Information Leaflet

Leflunomid Bluefish 20 mg film-coated tablets
leflunomide
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

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 get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Leflunomid Bluefish is and what it is used for
What you need to know before you take Leflunomid Bluefish
How to take Leflunomid Bluefish
Possible side effects
How to store Leflunomid Bluefish
Contents of the pack and other information

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

Leflunomid Bluefish belongs to a group of medicines called disease-modifying antirheumatic drugs (DMARDs). It contains the active substance leflunomide.
Leflunomid Bluefish is used in adult patients for the treatment of active rheumatoid arthritis or active psoriatic arthritis.
Symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, and pain. Other symptoms affecting the whole body include loss of appetite, fever, fatigue, and anaemia (low red blood cell count).
Symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, as well as red, scaly skin lesions (skin changes).

2. Important information before using Leflunomid Bluefish

When not to use Leflunomid Bluefish

if the patient has ever had an allergic reaction to leflunomide (especially severe skin reactions, often accompanied by fever, joint pain, red spots or blisters on the skin, e.g. Stevens-Johnson syndrome), to peanuts or soya, or to any of the other ingredients of this medicine (listed in section 6), or if allergic to teriflunomide (used in the treatment of multiple sclerosis),
if the patient has impaired liver function,
if the patient has moderate to severe impairment of kidney function,
if the patient has a significant decrease in blood protein levels (hypoproteinemia),
if the patient has any disease that reduces the body's immunity (e.g. AIDS),
if the patient has bone marrow disorders or significantly reduced numbers 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 Leflunomid Bluefish, consult your doctor,
pharmacist, or nurse

if the patient has ever had pneumonia (interstitial lung disease).
if the patient has ever had tuberculosis or has been in contact with someone who has or had tuberculosis in the past. The doctor may recommend screening tests to check whether the patient has tuberculosis.
if the patient is a man who plans to father a child. Since it cannot be ruled out that Leflunomid Bluefish passes into semen and may affect the unborn child, male patients taking Leflunomid Bluefish should use effective contraception. A man planning to father a child should contact his doctor, who may advise discontinuing Leflunomid Bluefish and prescribe medicines to accelerate 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 should not be made earlier than 3 months after this point.
if the patient is to undergo a specific blood test (calcium level measurement). Results of calcium level tests may be falsely low.
if the patient is to undergo or has recently undergone major surgery, or if the patient still has an unhealed surgical wound. Leflunomid Bluefish may impair wound healing.

Leflunomid Bluefish may occasionally cause blood count abnormalities, liver or lung function disorders,
or problems with nerves 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.
For more information on this, see section 4 (Possible side effects).
DRESS initially presents as flu-like symptoms and a rash on the face, followed by a rash spreading to other parts of the body, high fever, elevated liver enzymes (seen in blood tests), increased numbers of certain white blood cells (eosinophilia), and enlarged lymph nodes.
Before starting treatment with Leflunomid Bluefish and during treatment, your doctor should order regular blood tests to monitor blood counts and liver function. Blood pressure should also be monitored regularly, as Leflunomid Bluefish may increase it.
Inform your doctor if unexplained chronic diarrhoea occurs. Your doctor may perform additional tests for differential diagnosis.
Inform your doctor if skin ulceration occurs 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This includes medicines available without a prescription.
This is particularly important if the patient is taking:

other medicines used for rheumatoid arthritis, such as antimalarial drugs (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold preparations,
D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g. methotrexate), as such combinations are not recommended,
warfarin and other oral medicines used to reduce blood clotting, as patient monitoring is required to reduce the risk of adverse effects of this medicine,
teriflunomide, used in the treatment of multiple sclerosis,
repaglinide, pioglitazone, nateglinide, or rosiglitazone used in the treatment of diabetes,
daunorubicin, doxorubicin, paclitaxel, or topotecan used in cancer treatment,
duloxetine used in the treatment of depression, urinary incontinence, or kidney disease in diabetic patients,
alosetron used in the treatment of acute diarrhoea,
theophylline used in the treatment of asthma,
tizanidine, a muscle relaxant,
oral contraceptive medicines (containing ethinylestradiol and levonorgestrel),
cefaclor, benzylpenicillin (penicillin G), ciprofloxacin used in the treatment of infections,
indometacin, ketoprofen used in the treatment of pain or inflammation,
furosemide used in the treatment of heart disease (a diuretic),
zidovudine used in the treatment of HIV infections,
rosuvastatin, simvastatin, atorvastatin, pravastatin used in the treatment of hypercholesterolaemia (high cholesterol levels),
sulfasalazine used in the treatment of inflammatory bowel disease and rheumatoid arthritis,
cholestyramine (used in the treatment of elevated serum lipid levels) and activated charcoal, which may reduce the binding of Leflunomid Bluefish to proteins and thereby reduce its effectiveness.

Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids may continue treatment with these medicines after starting Leflunomid Bluefish.
Vaccinations
If planning vaccinations, consult your doctor. Do not receive vaccinations while taking Leflunomid Bluefish and for some time after stopping treatment with this medicine.
Leflunomid Bluefish with food, drink and alcohol
Leflunomid Bluefish can be taken with or without food.
Alcoholic beverages are not recommended during treatment with Leflunomid Bluefish. Drinking alcohol during therapy with Leflunomid Bluefish may increase the risk of liver damage.
Pregnancy and breastfeeding
Do not use Leflunomid Bluefish if the patient is pregnant or suspects she may be pregnant. If a woman becomes pregnant while taking Leflunomid Bluefish or plans to become pregnant during treatment, there is an increased risk of severe congenital malformations in the child. Leflunomid Bluefish must not be used in women of childbearing potential unless they are using effective contraception.
Inform your treating doctor if a woman plans to become pregnant after completing treatment with Leflunomid Bluefish, to ensure that Leflunomid Bluefish has been completely eliminated from the body before conception. The elimination period may take up to 2 years. However, this time can be shortened to several weeks by taking medicines that accelerate the elimination of Leflunomid Bluefish from the body.
In all cases, appropriate blood tests should be performed to confirm that elimination of the medicine has been sufficiently effective. After obtaining normal results, wait at least one month before attempting pregnancy.
For more information about the laboratory test, consult your treating doctor.
If a patient suspects she may be pregnant while being treated with Leflunomid Bluefish or if less than 2 years have passed since stopping treatment, she should immediately contact her doctor to undergo pregnancy testing. If test results confirm pregnancy, the doctor may recommend treatment with medicines that rapidly and effectively eliminate Leflunomid Bluefish from the body, which may reduce the risk to the fetus.
Do not use Leflunomid Bluefish during breastfeeding, as leflunomide passes into breast milk.
Driving and using machines
Leflunomid Bluefish may cause dizziness, which may impair concentration and reaction speed. Patients must not drive or operate machinery if such effects occur.
Leflunomid Bluefish contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Leflunomid Bluefish contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 20 mg tablet, meaning the medicine is considered "sodium-free".
Leflunomid Bluefish contains soya lecithin
Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Leflunomid Bluefish
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual initial dose of Leflunomid Bluefish is 100 mg of leflunomide once daily for the first three days. From the fourth day onwards, effective doses for most patients are:

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.

The tablet should be swallowed whole with a large amount of water.
Noticeable improvement in health may occur after 4 weeks of starting treatment. Some patients experience further improvement after 4 to 6 months of treatment.
Leflunomid Bluefish is usually taken for a long period.
Taking more Leflunomid Bluefish than prescribed
If more than the prescribed dose of Leflunomid Bluefish is taken, contact your doctor or seek medical advice immediately. If possible, bring the tablets or packaging to show the doctor.
Missing a dose of Leflunomid Bluefish
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor and stop taking Leflunomid Bluefish if:

you experience weakness, mild pain and dizziness, or breathing difficulties, as these may be symptoms of a serious allergic reaction,
you develop a skin rash or mouth ulcers, which may indicate serious, 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 immediately inform your doctor if:

pallor, feeling of fatigue, increased susceptibility to infections, or bruising occur, which may indicate blood disorders caused by imbalance in various types of blood cells,
feeling of fatigue, abdominal pain, or jaundice (yellowing of the eyes or skin) occur, which may indicate serious liver diseases, such as liver failure, which can lead to death,
signs of infection, such as fever, sore throat, or cough, as this medicine may increase the risk of serious, potentially life-threatening infections,
cough or breathing difficulties occur, which may indicate lung disease (interstitial lung disease or pulmonary hypertension),
unusual tingling, weakness, or pain in hands or feet, which may indicate nerve problems (peripheral neuropathy).

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

decrease in red blood cells (anemia) and decrease in platelets (thrombocytopenia),
decreased potassium levels in blood,
anxiety,
taste disturbances,
urticaria (hives),
tendon rupture,
increased lipid levels in blood (cholesterol and triglycerides),
decreased phosphate levels in blood.

Rare (may affect up to 1 in 1000 patients)

increased number of eosinophils in blood, called eosinophilia, mild decrease in white blood cells (leukopenia), decrease in all types of blood cells (pancytopenia),
severe increase in blood pressure,
lung inflammation (interstitial lung disease),
severe increase in liver function parameters, which may lead to serious disorders such as hepatitis and jaundice,
severe infections called sepsis, which may lead to death,
increased activity of certain enzymes in blood (lactate dehydrogenase).

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

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

Other adverse reactions, such as kidney failure, decreased uric acid levels in blood, pulmonary hypertension, male infertility (reversible after discontinuation of this medicine), cutaneous lupus erythematosus (characterized by rash/redness on skin areas exposed to light), psoriasis (new onset or worsening of symptoms), DRESS, and skin ulceration (a round, open wound in the skin through which subcutaneous tissues are visible), may also occur with unknown frequency.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Leflunomid Bluefish
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater 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 Leflunomid Bluefish contains

The active substance is leflunomide. One coated tablet contains 20 mg of leflunomide.
The other ingredients are:
Tablet core: monohydrate lactose, hydroxypropylcellulose (low substituted), tartaric 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 break line on one side. The tablet can be divided into equal doses.
Coated tablets are packed in bottles.
Pack size: 30 coated tablets.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Germany	Leflunomid Bluefish 20 mg Filmtabletten
Poland	Leflunomid Bluefish
Sweden	Leflunomid Bluefish 20 mg filmdragerade tabletter