Eltrombopag tzf

Poland
Brand name Eltrombopag tzf
Form tablets, film-coated
Active substance / Dosage
eltrombopag · 50 mg
Prescription type Prescription only – restricted use
ATC code
B02BX05
Registration number 100510570
Manufacturer Coripharma ehf.
Eltrombopag tzf tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Eltrombopag TZF, 25 mg, film-coated tablets
Eltrombopag TZF, 50 mg, film-coated tablets
Eltrombopag TZF, 75 mg, film-coated tablets
Eltrombopagum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

  • Keep this leaflet so that you can read it again if necessary.
  • If you have any further questions, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific patient only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

  1. What Eltrombopag TZF is and what it is used for
  2. Important information before taking Eltrombopag TZF
  3. How to take Eltrombopag TZF
  4. Possible side effects
  5. How to store Eltrombopag TZF
  6. Contents of the pack and other information

1. What Eltrombopag TZF is and what it is used for

Eltrombopag TZF contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to increase the number of platelets in the patient's blood. Platelets are blood components that help reduce the risk of bleeding or prevent it.

  • Eltrombopag TZF is used in the treatment of a blood clotting disorder called immune (primary) thrombocytopenia in patients over 1 year of age who have previously been treated with other medicines (corticosteroids or immunoglobulins) and for whom these treatments were ineffective.

Immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut or injury.

  • Eltrombopag TZF may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced difficulties due to adverse reactions during interferon-based therapy. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of certain antiviral medicines used in treatment. Taking Eltrombopag TZF may help patients complete full antiviral therapy (with peginterferon and ribavirin).

2. Important information before using Eltrombopag TZF

When not to use Eltrombopag TZF

  • if the patient is allergic to eltrombopag or any of the other ingredients of this

medicine (listed in section 6 under "What Eltrombopag TZF contains").
→ Consult a doctor if the patient believes they have the condition described
above.
Warnings and precautions
Before starting treatment with Eltrombopag TZF, discuss the following with your doctor:

  • if the patient has liver disease. Patients with low platelet counts and also advanced (chronic) liver disease are at greater risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag TZF outweigh the risks, the patient will be closely monitored during treatment;
  • if the patient has a risk of venous or arterial blood clots, or if there is a family history of blood clots. The risk of blood clots may be increased:
    • if the patient is elderly
    • if the patient has been immobilized for a prolonged period
    • if the patient has malignant cancer
    • if the patient is taking oral contraceptives or hormone replacement therapy
    • if the patient has recently undergone surgery or experienced trauma
    • if the patient is overweight
    • if the patient smokes tobacco
    • if the patient has advanced chronic liver disease → Inform the doctor before starting treatment if any of the above conditions apply to the patient. Do not take Eltrombopag TZF unless the doctor determines that the expected benefits outweigh the risk of blood clots.
  • if the patient has cataracts (clouding of the eye's lens)
  • if the patient has other blood disorders, such as myelodysplastic syndrome (Myelodysplastic Syndrome, MDS). Before starting Eltrombopag TZF, the doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag TZF, the MDS may worsen. → Inform the doctor if any of the above situations apply to the patient.

Ophthalmological examination
The treating doctor will recommend regular check-ups to detect cataracts. If the patient does not undergo routine eye examinations, the doctor should schedule regular eye exams. Examinations may also include assessment for any bleeding in the retina (the light-sensitive layer of cells at the back of the eye) or nearby areas.
Regular tests will be required
Before starting Eltrombopag TZF, the doctor will perform blood tests to evaluate blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests to monitor liver function
Eltrombopag TZF may cause blood test results indicating possible liver damage

  • increased activity of certain liver enzymes, particularly bilirubin, alanine aminotransferase, and aspartate aminotransferase. If the patient is receiving interferon-based therapy concurrently with Eltrombopag TZF for low platelet count associated with hepatitis C, certain liver conditions may worsen.

Before starting Eltrombopag TZF and periodically during treatment, blood tests assessing liver function will be performed. It may be necessary to discontinue Eltrombopag TZF if levels of these substances rise too high or if other signs of liver damage occur.
→ Refer to the information in section 4 of this leaflet, “ Liver disorders ”.
Monitoring platelet count
If the patient stops taking Eltrombopag TZF, a recurrence of low platelet count is likely within a few days. Platelet count will be monitored, and the treating doctor will discuss appropriate precautions with the patient.
A very high platelet count may increase the risk of blood clots. However, blood clots may also occur even when platelet count is normal or low. The treating doctor will adjust the dose of Eltrombopag TZF to prevent excessive increases in platelet count.

Triangular warning sign with a thick purple border and a red exclamation mark on a white background used to draw attention to important information

Seek immediate medical help if the patient experiences any of the following symptoms of blood clot:

  • swelling, pain, or tenderness in one leg
  • sudden shortness of breath, especially with sharp chest pain or rapid breathing
  • abdominal pain, abdominal swelling, blood in stool

Tests to evaluate bone marrow
In patients with bone marrow disorders, medicines such as Eltrombopag TZF may worsen these conditions. Changes in the bone marrow may show up as abnormal blood test results. The treating doctor may recommend direct bone marrow examinations during treatment with Eltrombopag TZF.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based therapy concurrently with Eltrombopag TZF, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag TZF treatment.
Heart examinations
The treating doctor may consider it necessary to evaluate the patient's heart during treatment with Eltrombopag TZF and may perform an electrocardiogram (ECG).
Elderly patients (65 years and older)
There are limited data on the use of Eltrombopag TZF in patients aged 65 years and older. Caution should be exercised when using Eltrombopag TZF in patients aged 65 years and older.
Children and adolescents
Eltrombopag TZF is not recommended for children under 1 year of age with immune thrombocytopenia. It is also not recommended for patients under 18 years of age with low platelet count due to hepatitis C virus or severe aplastic anaemia.
Eltrombopag TZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those planned for future use. This includes over-the-counter medicines and vitamins.
Some commonly used medicines interact with Eltrombopag TZF – including both prescription and non-prescription medicines, as well as mineral supplements. These include:

  • acid-reducing medicines used to treat indigestion, heartburn, stomach ulcers

(see also "When to take the medicine" in section 3)

  • medicines known as statins, used to lower cholesterol levels
  • certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
  • cyclosporine, used in transplantation or in autoimmune diseases
  • mineral products such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin and mineral supplements (see also "When to take the medicine" in section 3)
  • medicines such as methotrexate and topotecan, used in the treatment of cancer → Consult a doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during treatment with Eltrombopag TZF; others may require dose adjustments or appropriate timing of administration. The treating doctor will review all medicines the patient is taking and recommend changes if necessary.

If the patient is taking anticoagulant medicines to prevent blood clots, there is an increased risk of bleeding. The treating doctor will discuss this with the patient.
If the patient is taking corticosteroids, danazol, and/or azathioprine, doses of these medicines may be reduced or their use discontinued during concomitant treatment with Eltrombopag TZF.
Taking Eltrombopag TZF with food and drink
Eltrombopag TZF must not be taken with dairy products or dairy drinks, as the calcium in dairy products affects the absorption of the medicine. For further information, see "When to take the medicine" in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag TZF during pregnancy, unless the doctor specifically recommends it.
The effect of Eltrombopag TZF during pregnancy is unknown.

  • Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
  • An appropriate method of contraception must be used during treatment with Eltrombopag TZF to prevent pregnancy.
  • Inform the doctor if the patient becomes pregnant while taking Eltrombopag TZF.

Breastfeeding must not be performed during treatment with Eltrombopag TZF. It is not known whether Eltrombopag TZF passes into breast milk.
→ Inform the doctor if the patient is breastfeeding or plans to breastfeed.
Driving and operating machinery
Eltrombopag TZF may cause dizziness and other adverse effects that may impair attention.
→ Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.
Eltrombopag TZF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Eltrombopag TZF

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the
doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag TZF unless
instructed to do so by the doctor or pharmacist. While taking Eltrombopag TZF, the patient will
remain under the care of a doctor experienced in treating the condition the patient has.
How much medicine to take
In the case of primary immune thrombocytopenia
Adults and children (aged 6 to 17 years) – the usual starting dose in primary immune
thrombocytopenia is one 50 mg tablet of Eltrombopag TZF once daily.
Patients of East Asian or Southeast Asian origin may require a lower starting dose of 25 mg.
Children (aged 1 to 5 years) – the usual starting dose in primary immune thrombocytopenia is
one 25 mg tablet of Eltrombopag TZF once daily.
In the case of hepatitis C
Adults – the usual starting dose in hepatitis C is one 25 mg tablet of Eltrombopag TZF once
daily. For patients of East Asian or Southeast Asian origin, treatment should be initiated with
this same 25 mg dose.
The effect of Eltrombopag TZF may begin within 1 to 2 weeks. Depending on the patient's
response to treatment with Eltrombopag TZF, the doctor may adjust the daily dose.
How to take the tablets
The tablets should be swallowed whole with water.
When to take the medicine
Make sure that –

  • within 4 hours before taking Eltrombopag TZF
  • and within 2 hours after taking Eltrombopag TZF – the patient does not consume the following foods:
  • dairy products, such as cheese, butter, yogurt, ice cream
  • milk or beverages containing milk, yogurt, or cream
  • antacids used to treat indigestion and heartburn
  • vitamin and mineral supplements containing iron, calcium, magnesium, aluminium, selenium, or zinc

Failure to follow these instructions may result in inadequate absorption of Eltrombopag TZF.

Clock indicating 4 hours before and 2 hours after Revolade medication, with milk crossed out, tablets, and a note prohibiting dairy products, antacids, and supplements

Consult a doctor for further advice regarding suitable foods and drinks.
Taking more than the recommended dose of Eltrombopag TZF
Contact a doctor or pharmacist immediately. If possible, show them the medicine packaging or
this leaflet.
The patient's condition will be monitored to detect any adverse reactions and to initiate
appropriate treatment promptly.
Missing a dose of Eltrombopag TZF
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag TZF per day.
Stopping treatment with Eltrombopag TZF
Do not stop taking Eltrombopag TZF without consulting the doctor. If the doctor decides to
discontinue treatment, the patient's platelet count will be monitored weekly for four weeks. See
also "Bleeding or bruising after stopping treatment" in section 4.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Symptoms to watch for: seek medical advice
In patients treated with Eltrombopag TZF for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse reactions may occur. It is important to inform your doctor if any of these symptoms occur.
Increased risk of blood clots
Some patients may have an increased risk of blood clots, and medicines such as Eltrombopag TZF may increase this risk. Sudden blockage of a blood vessel by a blood clot is an uncommon adverse reaction and may occur in up to 1 in 100 patients.

Triangular warning sign with a thick purple border and a red exclamation mark on a white background inside a symbol

Seek immediate medical help if the patient experiences any of the following symptoms of a blood clot:

  • swelling, pain, warmth, redness or tenderness to pressure in one leg
  • sudden shortness of breath, especially with sharp chest pain or rapid breathing
  • abdominal (stomach) pain, abdominal swelling, blood in stool.

Liver problems
Eltrombopag TZF may cause changes detectable in blood tests, which may indicate liver damage. Liver disorders (increased liver enzyme activity in blood tests) are common and may affect up to 1 in 10 patients. Other liver problems are uncommon and may affect up to 1 in 100 patients.
If any of the following symptoms of liver problems occur:

  • yellowing of the skin or whites of the eyes (jaundice)
  • abnormally dark-coloured urine → inform your doctor immediately.

Bleeding or bruising after stopping treatment
Usually within two weeks of stopping Eltrombopag TZF, the patient's platelet count decreases to the level observed before starting Eltrombopag TZF. A low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor the patient's platelet count for at least 4 weeks after stopping Eltrombopag TZF.
Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag TZF.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag TZF. Symptoms include:

  • black, tarry stools (change in stool colour is an uncommon adverse reaction, which may affect up to 1 in 100 patients)
  • blood in stool
  • vomiting blood or coffee-ground-like material Inform your doctor immediately if any of these symptoms occur.

The following adverse reactions have been reported as associated with treatment with Eltrombopag TZF in adult patients with primary immune thrombocytopenia:
Very common adverse reactions
May occur in more than 1 in 10 patients:

  • cold
  • nausea
  • diarrhoea
  • cough
  • infection of the nose, sinuses, throat and upper respiratory tract (upper respiratory tract infection)
  • back pain

Very common adverse reactions that may be detected in blood tests:

  • increased liver enzyme activity (alanine aminotransferase (ALAT))

Common adverse reactions
May occur in not more than 1 in 10 patients:

  • muscle pain, muscle cramps, muscle weakness
  • bone pain
  • heavy menstrual bleeding
  • sore throat and discomfort when swallowing
  • eye disorders, including abnormal eye test results, dry eyes, eye pain and blurred vision
  • vomiting
  • flu
  • cold sores
  • pneumonia
  • irritation and inflammation (swelling) of sinuses
  • inflammation (swelling) and infection of tonsils
  • infection of lungs, sinuses, nose and throat
  • gingivitis
  • loss of appetite
  • tingling, pricking or numbness sensation
  • reduced skin sensation
  • drowsiness
  • ear pain
  • pain, swelling and tenderness in one leg (usually calf with warm skin in the affected area) (symptoms of deep vein thrombosis)
  • localized swelling filled with blood from a damaged blood vessel (haematoma)
  • hot flushes
  • mouth disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers
  • watery nasal discharge
  • toothache
  • abdominal pain
  • abnormal liver function
  • skin changes including: excessive sweating, raised itchy rash, red spots, skin appearance changes
  • excessive hair loss
  • foamy urine with presence of air bubbles (symptoms of protein in urine)
  • high body temperature, feeling of heat
  • chest pain
  • feeling of weakness
  • difficulty sleeping, depression
  • migraine
  • impaired vision
  • sensation of spinning (dizziness)
  • flatulence

Common adverse reactions that may be detected in blood tests:

  • decreased number of red blood cells (anaemia)
  • decreased number of platelets (thrombocytopenia)
  • decreased number of white blood cells
  • decreased haemoglobin concentration
  • increased number of eosinophils
  • increased number of white blood cells (leukocytosis)
  • increased uric acid concentration
  • decreased potassium concentration
  • increased creatinine concentration
  • increased alkaline phosphatase activity
  • increased liver enzyme activity (aspartate aminotransferase (AspAT))
  • increased bilirubin concentration in blood (a substance produced by the liver)
  • increased concentration of certain proteins

Uncommon adverse reactions
May occur in not more than 1 in 100 patients:

  • allergic reaction
  • interruption of blood flow to part of the heart
  • sudden shortness of breath, especially in combination with sharp chest pain and (or) rapid breathing, which may indicate a pulmonary embolism (see "Increased risk of blood clots" above in section 4)
  • loss of function in part of the lung due to blockage of the pulmonary artery
  • possible pain, swelling and (or) redness around a vein, which may indicate a blood clot
  • yellowing of the skin and (or) abdominal pain, which may indicate bile duct obstruction, liver disease or liver damage due to inflammation (see "Liver problems" above in section 4)
  • drug-induced liver injury
  • rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (prolonged QT interval), which may indicate heart and blood vessel problems
  • blood clot
  • redness
  • painful joint swelling due to uric acid (gout)
  • lack of interest, mood changes, crying that is difficult to control or occurs unexpectedly
  • balance, speech and nerve function disorders, tremors
  • painful or abnormal skin sensations
  • paralysis on one side of the body
  • migraine with aura
  • nerve damage
  • dilation or swelling of blood vessels causing headache
  • eye disorders, including excessive tearing, lens clouding (cataract), retinal haemorrhage, dry eyes
  • nose, throat and sinus disorders, breathing disorders during sleep
  • blisters or ulcers in the mouth and throat
  • loss of appetite
  • gastrointestinal disorders including frequent bowel movements, food poisoning, presence of blood in stool, bloody vomiting
  • bleeding from the rectum, change in stool colour, abdominal bloating, constipation
  • mouth disorders, including dry or painful mouth, tongue pain, bleeding gums, oral discomfort
  • sunburn
  • feeling of heat, feeling of unease
  • redness or swelling around a wound
  • bleeding around a catheter (if present) through the skin
  • sensation of a foreign body
  • kidney disorders including: kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
  • cold sweats
  • general malaise
  • skin infection
  • skin changes, including skin discoloration, peeling, redness, itching and sweating
  • muscle weakness
  • cancer of the rectum and colon

Uncommon adverse reactions that may be detected in laboratory tests:

  • changes in shape of red blood cells
  • presence of developing white blood cells, which may indicate certain diseases
  • increased number of platelets
  • decreased calcium concentration
  • decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
  • increased number of myelocytes
  • increased number of neutrophilic band granulocytes
  • increased blood urea concentration
  • increased protein concentration in urine
  • increased albumin concentration in blood
  • increased total protein concentration
  • decreased albumin concentration in blood
  • increased urine pH
  • increased haemoglobin concentration

The following additional adverse reactions have been reported as associated with treatment with Eltrombopag TZF in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, inform your treating doctor, pharmacist or nurse.
Very common adverse reactions
May occur in more than 1 in 10 children:

  • infection of the nose, sinuses, throat and upper respiratory tract, cold (upper respiratory tract infection)
  • diarrhoea
  • abdominal pain
  • cough
  • high body temperature
  • nausea

Common adverse reactions
May occur in not more than 1 in 10 children:

  • difficulty falling asleep (insomnia)
  • toothache
  • nasal and throat pain
  • itchy nose, runny nose or nasal congestion
  • sore throat, runny nose, nasal mucosa congestion and sneezing
  • mouth disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse reactions have been reported as associated with treatment with Eltrombopag TZF in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse reactions
May occur in more than 1 in 10 patients:

  • headache
  • loss of appetite
  • cough
  • nausea, diarrhoea
  • muscle pain, muscle weakness
  • itching
  • feeling of fatigue
  • fever
  • unusual hair loss
  • weakness
  • flu-like illness
  • swelling of hands or feet
  • chills

Very common adverse reactions that may be detected in blood tests:

  • decreased number of red blood cells (anaemia)

Common adverse reactions
May occur in not more than 1 in 10 patients:

  • urinary tract infections
  • inflammation of nasal passages, throat, oral cavity, flu-like symptoms, dry mouth, pain or inflammation of the oral cavity, toothache
  • weight loss
  • sleep disorders, abnormal drowsiness, depression, anxiety
  • dizziness, concentration and memory disturbances, mood changes
  • brain dysfunction due to liver damage
  • tingling or numbness in hands or feet
  • fever, headache
  • visual disturbances, including: lens clouding (cataract), dry eye syndrome, small yellow deposits on the retina, yellowing of the whites of the eyes
  • retinal haemorrhage
  • sensation of spinning (dizziness)
  • rapid or irregular heartbeat (palpitations), shortness of breath
  • cough with sputum, runny nose, flu, cold sores, sore throat and discomfort when swallowing
  • gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, abdominal bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, swelling and bleeding of blood vessels in the oesophagus
  • toothache
  • liver problems including: liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (see above "Liver problems" in section 4)
  • skin changes, including: rash, dry skin, skin eruptions, skin redness, itching, excessive sweating, skin growths, hair loss
  • joint pain, back pain, bone pain, limb pain (legs, arms, hands or feet), muscle cramps
  • irritability, general malaise, skin reaction such as redness or swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
  • infection of the nose, sinuses, throat and upper respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
  • depression, anxiety, sleep disorders, nervousness

Common adverse reactions that may be detected in blood tests:

  • increased blood glucose (sugar) concentration
  • decreased number of white blood cells
  • decreased number of neutrophils
  • decreased albumin concentration in blood
  • decreased haemoglobin concentration
  • increased bilirubin concentration in blood (a substance produced by the liver)
  • changes in enzymes controlling blood coagulation

Uncommon adverse reactions
May occur in not more than 1 in 100 patients:

  • pain during urination
  • heart rhythm disorders (prolonged QT interval)
  • stomach flu (gastroenteritis), sore throat
  • blisters or ulcers in the mouth, gastritis
  • skin changes, including colour change, peeling, redness, itching, skin disease and night sweats
  • blood clots in the vein carrying blood to the liver (possible liver and (or) gastrointestinal damage)
  • abnormal blood clotting in small blood vessels with kidney failure
  • rash, bruising at injection site, chest discomfort
  • decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
  • confusion, agitation
  • liver failure

The following adverse reactions have been reported as associated with eltrombopag treatment in patients with severe aplastic anaemia (SAA):
If these adverse reactions worsen, inform your treating doctor, pharmacist or nurse.
Very common adverse reactions
May occur in more than 1 in 10 patients:

  • cough
  • headache
  • mouth and throat pain
  • diarrhoea
  • nausea
  • joint pain
  • limb pain (arms, legs, hands and feet)
  • dizziness
  • feeling of extreme fatigue
  • fever
  • chills
  • itchy eyes
  • mouth blisters
  • bleeding gums
  • abdominal pain
  • muscle cramps

Very common adverse reactions that may manifest in blood test results

  • abnormal changes in bone marrow cells
  • increased liver enzyme activity (aspartate aminotransferase (AspAT))

Common adverse reactions
May occur in not more than 1 in 10 patients.

  • anxiety
  • depression
  • feeling of cold
  • general malaise
  • eye disorders, including vision disturbances, blurred vision, lens clouding (cataract), spots or deposits in the eye (floaters), dry eye, itchy eye, yellowing of the whites of the eyes or skin
  • nosebleeds
  • gastrointestinal disorders, including: difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain or discomfort, abdominal bloating, gas in the digestive tract, constipation, intestinal peristalsis disorders which may cause constipation, bloating, diarrhoea and (or) the above-mentioned symptoms, change in stool colour
  • fainting
  • skin disorders, including: small red or purple spots due to bleeding under the skin (petechiae), rash, itching, urticaria, skin changes
  • back pain
  • muscle pain
  • bone pain
  • weakness
  • swelling of lower limbs due to fluid accumulation
  • abnormal urine colour
  • interruption of blood flow to the spleen (splenic infarction)
  • runny nose

Common adverse reactions that may manifest in blood test results

  • increased enzyme activity due to muscle breakdown (creatine kinase)
  • iron accumulation in the body (iron overload)
  • decreased blood sugar concentration (hypoglycaemia)
  • increased bilirubin concentration in blood (a substance produced by the liver)
  • decreased number of white blood cells

Adverse reactions with unknown frequency
Frequency cannot be determined from available data

  • skin depigmentation
  • darker skin colouration
  • drug-induced liver injury

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eltrombopag TZF

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
No special storage instructions apply for this medicine.
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 package and other information

What Eltrombopag TZF contains
The active substance in Eltrombopag TZF is eltrombopag.
25 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
50 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
75 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
The other ingredients are: microcrystalline cellulose, mannitol, povidone K29/32, sodium carboxymethyl starch,
magnesium stearate, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), glycerol monocaprylocaprate, and sodium lauryl sulfate.
Eltrombopag TZF 50 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).
Eltrombopag TZF 75 mg film-coated tablets also contain iron oxide red (E172).

What Eltrombopag TZF looks like and contents of the pack
Eltrombopag TZF 25 mg film-coated tablets: white, round, biconvex film-coated tablets with the imprint “C21” on one side.
Eltrombopag TZF 50 mg film-coated tablets: beige, round, biconvex film-coated tablets with the imprint “C22” on one side.
Eltrombopag TZF 75 mg film-coated tablets: pink, round, biconvex film-coated tablets with the imprint “C23” on one side.
Eltrombopag TZF is supplied in blister packs made of Aluminium/PVC/Aluminium/OPA foil, packed in a cardboard box containing 14 or 28 film-coated tablets, and in multipacks containing 84 film-coated tablets (3 packs of 28).
Not all pack sizes may be available in all countries.

Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: (22) 811-18-14

Manufacturer
Coripharma ehf.
Reykjavikurvegur 78-80
220 Hafnarfjörður
Iceland