10 mg, 20 mg film-coated tablets
leflunomide

What Leflunomide Bluefish is and what it is used for

Leflunomide Bluefish belongs to a group of medicines called anti-rheumatic medicines. It contains the active substance leflunomide.

Leflunomide Bluefish is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.

Symptoms of rheumatoid arthritis include inflammation of the joints, swelling, difficulty moving, and pain. Other symptoms that can affect the whole body include decreased appetite, fever, decreased energy, and anemia (lack of red blood cells ).

Symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty moving and pain, and red and scaly patches on the skin (skin damage).

Leflunomide contained in Leflunomide Bluefish may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions

What you need to know before you take Leflunomide Bluefish

Do not take Leflunomide Bluefish:

  • if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin or blisters [eg Stevens-Johnson syndrome ]), soy, peanuts or any of the other ingredients thereof medicines (listed in section 6)
  • if you have liver problems ,
  • if you have moderate to severe renal impairment ,
  • if you have a sharp drop in your blood protein (egg white) concentration (hypoproteinemia),
  • if you suffer from a disease that weakens your immune system (ex AIDS ),
  • if you have impaired bone marrow function or if the number of red or white blood cells or
  • the number of platelets is low,
  • if you suffer from a serious infection ,
  • if you are pregnant , think you may be pregnant or breast-feeding.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Leflunomide Bluefish:

  • if you have ever had interstitial lung disease .
  • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may take samples to see if you have tuberculosis .
  • if you are a man and want to have children. As it can not be ruled out that Leflunomide Bluefish passes into the semen, a reliable contraceptive should be used during treatment with Leflunomide Bluefish. Men wishing to have children should contact their doctor who may advise them to discontinue treatment with Leflunomide Bluefish and take certain medications to quickly remove Leflunomide Bluefish from the body. A blood test will confirm that Leflunomide Bluefish has been adequately excreted. After that, you should wait at least another 3 months before trying to have children
  • if you are going to take a specific blood test (calcium level). Measurements can show falsely low calcium levels.

Leflunomide Bluefish can sometimes affect your blood, your liver, your lungs, or the nerves in your arms or legs. It can also cause severe allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or increase the risk of developing serious infections. For further information, see section 4 (Possible side effects ).

DRESS initially appears with flu-like symptoms and rashes on the face, followed by widespread rashes and high fever, increased liver enzyme levels seen in blood tests, and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes.

Your doctor will regularly take blood samples, before and during treatment with Leflunomide Bluefish to check your blood and your liver. Your doctor will also regularly check your blood pressure as Leflunomide Bluefish may cause high blood pressure.

Tell your doctor if you have diarrhea that lasts for a long time for no particular reason. Your doctor may need to perform additional tests to find out what this is causing.

Children and young people

Leflunomide Bluefish is not recommended for use in children and adolescents below 18 years.

Other medicines and Leflunomide Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are using:

  • other drugs for rheumatoid arthritis such as antimalarial drugs (eg chloroquine and hydroxychloroquine); intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (eg methotrexate) as these combinations are not recommended.
  • warfarin and other oral blood thinners, as monitoring is necessary to reduce the risk of side effects of this medicine
  • teriflunomide in multiple sclerosis
  • repaglinide, pioglitazone, nateglinide or rosiglitazone in diabetes
  • daunorubicin, doxorubicin, paclitaxel or topotecan in cancer
  • duloxetine for depression, urinary incontinence or kidney disease in diabetics
  • alosetron in the treatment of severe diarrhea
  • theophylline in asthma
  • tizanidine, a muscle relaxant
  • birth control pills (containing ethinyl estradiol and levonorgestrel)
  • cefaclor, benzylpenicillin ( penicillin G), ciprofloxacin in case of infection are
  • indomethacin, ketoprofen for pain or inflammation
  • furosemide for heart disease (diuretic, diuretic)
  • zidovudine, HIV – infection
  • rosuvastatin, simvastatin , atorvastatin, pravastatin for hypercholesterolemia (high cholesterol )
  • sulfasalazine in inflammatory bowel disease or rheumatoid arthritis
  • a drug called cholestyramine (used to treat increased blood fat levels) or activated charcoal as these drugs can reduce the body’s uptake of Leflunomide Bluefish.

If you are already taking non-steroidal anti-inflammatory drugs ( NSAIDs ) and/or corticosteroids, you can continue to take them after starting treatment with Leflunomide Bluefish.

Vaccinations

If you need to be vaccinated, ask your doctor for advice. Some vaccines should not be given during treatment with Leflunomide Bluefish, and for a period after stopping treatment.

Leflunomide Bluefish with food, drink and alcohol

Leflunomide Bluefish can be taken independently of food intake.

Alcohol consumption is not recommended during treatment with Leflunomide Bluefish. Consumption of alcohol during treatment may increase the risk of liver damage.

Pregnancy, breastfeeding and fertility

Do not use Leflunomide Bluefish if you are or think you may be pregnant. If you are pregnant or become pregnant while taking Leflunomide Bluefish, the risk of having a baby with severe birth defects increases. Women of childbearing potential should not use Leflunomide Bluefish without the use of a reliable contraceptive.

Tell your doctor if you are planning to become pregnant after stopping treatment with Leflunomide Bluefish as you need to make sure that Leflunomide Bluefish is completely excreted from your body before attempting to conceive. This can take up to 2 years, but this period can be shortened to a few weeks if you take special medicines that accelerate the excretion of Leflunomide Bluefish from your body. In both cases, a blood test should confirm that Leflunomide Bluefish has been adequately excreted from your body. After that, you have to wait at least another month before you get pregnant.

For further information on laboratory tests, please contact your doctor.

If you suspect that you are pregnant during treatment with Leflunomide Bluefish or for the next two years after stopping treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with specific drugs to quickly remove Leflunomide Bluefish from your body as this may reduce the risk to your baby.

Do not use Leflunomide Bluefish if you are breastfeeding as Leflunomide Bluefish may be excreted in human milk.

Driving and using machines

Leflunomide Bluefish may cause dizziness which may impair your ability to concentrate and react. If you feel affected, do not drive or operate machinery.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Leflunomide Bluefish contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Leflunomide Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 10 mg and 20 mg tablet,

ie is almost “sodium-free”.

Leflunomide Bluefish contains soybean lecithin

If you are allergic to peanuts or soy, do not use this medicine.

How to take Leflunomide Bluefish

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual starting dose is 100 mg Leflunomide Bluefish once a day for the first three days. Then, most people need:

  • In rheumatoid arthritis: 10 or 20 mg Leflunomide Bluefish once a day, depending on the severity of the disease.
  • For psoriatic arthritis: 20 mg Leflunomide Bluefish once daily.

Swallow the tablet whole with plenty of water.

It may take about 4 weeks or longer before you feel an improvement in your condition. Some patients may even feel further improvement after 4 to 6 months of treatment.

Treatment with Leflunomide Bluefish usually takes longer periods.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately and stop using Leflunomide Bluefish:

  • if you feel weak , dizzy or have difficulty breathing , as this may be a symptom of a severe allergic reaction .
  • if you get a skin rash or mucous membrane damage in the mouth , as these may be symptoms of severe, sometimes life-threatening, reactions (eg Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]). See section 2.

Contact your doctor immediately if you experience:

  • pallor , fatigue or increased tendency to bruise , as this may indicate blood disease caused by an imbalance between different types of blood cells in the blood.
  • fatigue , abdominal pain or jaundice (yellowing of the eyes and skin), as this may indicate serious conditions such as liver problems which can be life threatening.
  • Symptoms of infection such as fever, sore throat or cough , as this medicine may increase the risk of serious infection which can be life threatening.
  • cough or difficulty breathing as this may indicate lung problems (interstitial lung disease or pulmonary hypertension ).
  • unusual tingling , weakness or pain in your hands or feet as these may indicate problems with your nerves ( peripheral neuropathy ).

Common side effects (may affect more than 1 user in 10)

  • a marginal decrease in the number of white blood cells ( leukopenia ),
  • mild allergic reactions,
  • loss of appetite, weight loss (usually insignificant),
  • fatigue ( asthenia ),
  • headache, dizziness,
  • abnormal skin sensations such as tingling ( paresthesia ),
  • problems with nerves in arms and legs ( peripheral neuropathy )
  • slightly increased blood pressure ,
  • diarrhea,
  • nausea, vomiting,
  • inflammation of the mouth or affected oral mucosa,
  • abdominal pain,
  • colitis (intestinal inflammation),
  • increase in certain liver values,
  •  hair loss,
  • eczema , dry skin, rash and itching ,
  • tendonitis (pain caused by inflammation of the membrane surrounding the tendon, usually in the feet or hands),
  • an increase in certain blood enzymes (creatine kinase).

Uncommon side effects (may affect up to 1 in 100 people)

  • a decrease in the number of red blood cells ( anemia ) and a decrease in the number of platelets ( thrombocytopenia ),
  • a decrease in potassium levels in the blood,
  • anxiety,
  • taste changes,
  • hives,
  • tendon rupture,
  • an increase in blood fat levels ( cholesterol and triglycerides ),
  • a decrease in the level of phosphate in the blood.

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

  • increase in the number of eosinophilic blood cells ( eosinophilia ); a slight decrease in the number of white blood cells ( leukopenia ); and a decrease in the number of blood cells (pancytopenia),
  • sharply increased blood pressure ,
  • inflammation of the lungs (interstitial lung disease),
  • an increase in certain liver values ​​that can develop into serious conditions such as hepatitis and jaundice,
  • severe infection , so-called sepsis , which can be life-threatening,
  • an increase in certain enzymes in the blood ( lactate dehydrogenase ).

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

  • a marked decrease in certain white blood cells ( agranulocytosis ),
  • severe and possibly severe allergic reactions,
  • inflammation of the small blood vessels ( vasculitis , including cutaneous necrotizing vasculitis ),
  • inflammation of the pancreas ( pancreatitis ),
  • severe liver damage such as liver failure or necrosis , which can be fatal,
  • severe, sometimes life-threatening, reactions ( Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme).

Other side effects such as kidney failure, a decrease in uric acid in the blood, pulmonary hypertension, male infertility (this side effect returns when treatment with this drug is stopped), cutaneous lupus (characterized by rash/redness on exposed skin areas), and psoriasis (new or aggravated) may also occur with unknown frequency.

How to store Leflunomide Bluefish

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Close the jar tightly. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Content declaration

The active substance is leflunomide.

  • 1 film-coated tablet contains 10 mg or 20 mg leflunomide.

Other ingredients are:

Tablet core: lactose monohydrate, hydroxypropyl cellulose, (5.0 – 16.0% hydroxypropoxy groups), tartaric acid, sodium lauryl sulfate, and magnesium stearate.

Tablet cover: soybean lecithin, poly (vinyl alcohol), talc (E 553b), titanium dioxide (E171), and xanthan gum.

What the medicine looks like and contents of the pack

Leflunomide Bluefish 10 mg film-coated tablets are white to off-white, round, about 6 mm in diameter.

Leflunomide Bluefish 20 mg film-coated tablets are white to off-white, round, with a diameter of about 8 mm and with a break notch on one side. The tablet can be divided into two parts.

The film-coated tablets are packaged in cans.

The packs are available in 10, 20, 28, 30, 42, 50, 56, 60, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB  

Box 49013

100 28 Stockholm

Manufacturer

Bluefish Pharmaceuticals AB 

Gävlegatan 22

113 30 Stockholm

Haupt Pharma Münster GmbH,

Schleebrüggenkamp 15,

48159 Münster, Germany

This medicinal product is authorized under the European Economic Area under the names:

Germany Leflunomide Bluefish 10 mg Film TabletLeflunomide Bluefish 20 mg mg Film tablets
Poland Leflunomide Bluefish, 10 mg, powlekane tabletsLeflunomide Bluefish, 20 mg, powlekane tablets
Sweden Leflunomide Bluefish

Muhammad Nadeem

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