Eltrombopag zentiva

Poland
Brand name Eltrombopag zentiva
Form tablets, film-coated
Active substance / Dosage
eltrombopag · 50 mg
Prescription type Prescription only – restricted use
ATC code
B02BX05
Registration number 100477074
Manufacturer Synthon B.V., Synthon Hispania S.L.
Eltrombopag zentiva tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Eltrombopag Zentiva, 25 mg, film-coated tablets
Eltrombopag Zentiva, 50 mg, film-coated tablets
eltrombopag
Please read all of this leaflet carefully before 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 or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  • The information in this leaflet refers to the patient or child, but throughout the text we will refer only to the patient.

Contents of the leaflet

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

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

Eltrombopag Zentiva contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. This medicine is used to increase the number of platelets in the patient's blood. Platelets are blood components that help reduce or prevent the risk of bleeding. Eltrombopag Zentiva is used to treat a blood clotting disorder called immune (primary) thrombocytopenia in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that 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 Zentiva may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have difficulties due to side effects during interferon treatment. 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 Zentiva may help patients complete a full course of antiviral therapy (peginterferon and ribavirin).

2. Important information before using Eltrombopag Zentiva

When not to use Eltrombopag Zentiva

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

(listed in section 6).
Please consult your doctor if you think you may be in the situation described above.
Warnings and precautions
Before starting treatment with Eltrombopag Zentiva, discuss the following with your doctor:

  • if the patient has impaired liver function. Patients with low platelet counts and also those with advanced chronic (long-term) liver disease are at increased risk of adverse reactions, including life-threatening liver damage and blood clots. If your doctor considers that the benefits of taking the medicine outweigh the risks, the patient will be closely monitored during treatment;
  • if the patient is at 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 immobile for a prolonged period
    • if the patient has a malignant tumour
    • if the patient is taking oral contraceptives or hormone replacement therapy
    • if the patient has recently undergone surgery or suffered physical trauma
    • if the patient is significantly overweight (obesity)
    • if the patient smokes
    • if the patient has advanced chronic liver disease Inform your doctor before starting treatment if any of the above conditions apply to you. Do not take Eltrombopag Zentiva unless your doctor considers that the expected benefits outweigh the risk of blood clots.
  • if the patient has cataracts (clouding of the eye lens)
  • if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Zentiva, your doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag Zentiva, MDS may worsen.

Please inform your doctor if any of the above situations apply to you.
Ophthalmological examination
Your doctor will recommend regular check-ups to detect cataracts. If the patient does not undergo routine ophthalmological examinations, the doctor should arrange regular eye examinations. Examinations may also include detection of any bleeding in or near the retina (the light-sensitive layer of cells at the back of the eye).
Regular monitoring tests are required
Before starting treatment with Eltrombopag Zentiva, your doctor will perform blood tests to assess blood cells, including platelets. These tests will be repeated periodically during treatment.
Liver function blood tests
Eltrombopag Zentiva may cause blood test results indicating liver damage – increased activity of certain liver enzymes, particularly bilirubin, alanine aminotransferase and aspartate aminotransferase. If the patient is receiving interferon-based treatment simultaneously with Eltrombopag Zentiva for low platelet count associated with hepatitis C, certain liver diseases may worsen.
Before starting treatment with Eltrombopag Zentiva and periodically during treatment, blood tests to assess liver function will be performed. It may be necessary to discontinue Eltrombopag Zentiva if levels of these substances rise too high or if other signs of liver damage occur.
Please refer to the information in section 4 of this leaflet regarding liver function disorders.
Monitoring of platelet count
If the patient stops taking Eltrombopag Zentiva, low platelet count may recur 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 when platelet count is normal or low. The treating doctor will adjust the dose of Eltrombopag Zentiva to prevent excessive increase in platelet count.
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 acute chest pain or rapid breathing
  • abdominal (stomach) pain, abdominal swelling, blood in stool

Bone marrow examinations
In patients with bone marrow disorders, medicines such as Eltrombopag Zentiva may worsen these conditions. Changes in the bone marrow may be indicated by abnormal blood test results. The treating doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Zentiva.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based treatment simultaneously with Eltrombopag Zentiva, they will be monitored for signs of stomach or intestinal bleeding after stopping Eltrombopag Zentiva treatment.
Heart examinations
The treating doctor may consider it necessary to perform heart examinations during treatment with Eltrombopag Zentiva, including electrocardiography (ECG).
Elderly patients (65 years of age and older)
Limited data are available on the use of eltrombopag in patients aged 65 years and older. Caution should be exercised when using Eltrombopag Zentiva in patients aged 65 years and older.
Children and adolescents
Eltrombopag is not recommended for children under 1 year of age with immune thrombocytopenia.
The medicine is also not recommended for patients under 18 years of age with low platelet count due to hepatitis C virus infection.
Eltrombopag Zentiva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription and vitamins.
Some commonly used medicines interact with eltrombopag – including both prescription and over-the-counter medicines, as well as mineral products. 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, which reduce cholesterol levels
  • certain medicines used to treat HIV infection such as lopinavir and (or) ritonavir
  • cyclosporine used in transplant patients 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 cancer treatment

Please consult your doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during treatment with Eltrombopag Zentiva; for others, dose adjustment or appropriate timing of administration may be required. The treating doctor will review all medicines the patient is taking and recommend changes to treatment if necessary.
If the patient is taking anticoagulant medicines to prevent blood clots, the risk of bleeding may be increased. The treating doctor will discuss this with the patient.
If the patient is taking corticosteroids, danazol and (or) azathioprine, the doses of these medicines may be reduced or their use discontinued during concomitant treatment with Eltrombopag Zentiva.
Taking Eltrombopag Zentiva with food and drink
Eltrombopag Zentiva must not be taken with dairy products or dairy drinks, as the calcium present 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 Zentiva during pregnancy unless your doctor specifically recommends it.
The effect of Eltrombopag Zentiva during pregnancy is unknown.

  • Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant.
  • While taking Eltrombopag Zentiva, use an appropriate method of contraception to prevent pregnancy.
  • Inform your doctor if you become pregnant while taking Eltrombopag Zentiva.

Breastfeeding must not be undertaken during treatment with Eltrombopag Zentiva. It is not known whether Eltrombopag Zentiva passes into breast milk.
Inform your doctor if you are breastfeeding or plan to breastfeed.
Driving and operating machinery
Eltrombopag Zentiva may cause dizziness and other adverse effects that reduce alertness.
Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.
Eltrombopag Zentiva contains isomalt and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Eltrombopag Zentiva

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Zentiva
unless instructed to do so by your doctor or pharmacist. While taking Eltrombopag Zentiva,
you will remain under the care of a doctor experienced in treating the condition from which you suffer.

How much medicine to take

In 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 Zentiva once daily.
Patients of East Asian or Southeast Asian origin may require a lower starting dose of 25 mg once daily.
Children (aged 1 to 5 years) – the usual starting dose in primary immune thrombocytopenia is one 25 mg tablet of Eltrombopag Zentiva once daily.

In chronic hepatitis C
Adults – the usual starting dose in chronic hepatitis C is one 25 mg tablet of Eltrombopag Zentiva once daily. Patients of East Asian or Southeast Asian origin should start treatment with the same 25 mg dose.

The effect of Eltrombopag Zentiva may begin within 1 to 2 weeks. Depending on the patient's response to treatment with Eltrombopag Zentiva, the doctor may adjust the daily dose.

How to take the tablets
The tablets should be swallowed whole with a small amount of water.

When to take the medicine
Make sure that:

  • for 4 hours before taking Eltrombopag Zentiva,
  • and for 2 hours after taking Eltrombopag Zentiva,
    the patient does not consume the following foods:
  • dairy products such as cheese, butter, yoghurt, ice cream
  • milk or milk-containing drinks, yoghurts 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 Zentiva.

Clock showing the time 4 hours before and 2 hours after taking Revolade, with crossed-out dairy products, antacids, and supplements

Consult your doctor for further information regarding suitable foods and drinks.

Taking more Eltrombopag Zentiva than prescribed
Contact your doctor or pharmacist immediately. If possible, show them the medicine pack or this leaflet.
The patient's condition will be monitored for any signs or symptoms of adverse reactions, and appropriate treatment will be initiated promptly.

If you miss a dose of Eltrombopag Zentiva
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Zentiva per day.

Stopping Eltrombopag Zentiva
Do not stop taking Eltrombopag Zentiva without consulting your doctor. If your doctor decides to discontinue treatment, your platelet count will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms to watch for: consult a doctor
In patients taking Eltrombopag Zentiva for the treatment of 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
Zentiva 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.
Seek immediate medical help if the patient experiences any of the following symptoms of a blood clot:

  • swelling, pain, warmth, redness, or tenderness 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 Zentiva 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 Zentiva, the patient's platelet count decreases to the level observed before starting Eltrombopag Zentiva. Low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after stopping Eltrombopag Zentiva.
Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag Zentiva.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and eltrombopag. 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 in association with treatment with
Eltrombopag Zentiva 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 detectable in blood tests:

  • increased activity of liver enzyme (alanine aminotransferase (AlAT))

Common adverse reactions (may occur in up to 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, blurred vision
  • vomiting
  • flu
  • cold sores
  • pneumonia
  • irritation and inflammation (swelling) of the sinuses
  • inflammation (swelling) and infection of the tonsils
  • infection of the lungs, sinuses, nose, and throat
  • gingivitis (inflammation of the gums)
  • loss of appetite
  • tingling, pricking, or numbness sensation
  • reduced skin sensitivity
  • somnolence (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 disorders including: excessive sweating, raised itchy rash, red spots, skin appearance changes
  • hair loss
  • foamy urine with presence of air bubbles (symptoms of protein in urine)
  • high body temperature, feeling of warmth
  • chest pain
  • feeling of weakness
  • sleep disturbances, depression
  • migraine
  • impaired vision
  • sensation of spinning (dizziness)
  • flatulence

Common adverse reactions detectable 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 eosinophilia
  • 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 up to 1 in 100 patients):

  • allergic reaction
  • interruption of blood flow to part of the heart
  • sudden shortness of breath, especially in combination with acute chest pain and/or rapid breathing, which may indicate pulmonary embolism (see "Increased risk of blood clots" above in section 4)
  • loss of function in part of the lung caused by blockage of the pulmonary artery
  • possible pain, swelling, and/or redness around a vein, which may indicate venous thrombosis
  • yellowing of the skin and/or abdominal pain, which may indicate bile duct obstruction, liver disease, or drug-induced liver injury (see "Liver problems" above in section 4)
  • drug-induced liver injury
  • rapid or irregular heartbeat, cyanosis (bluish skin), cardiac rhythm disorders (prolonged QT interval), which may indicate heart and blood vessel disorders
  • blood clot
  • redness
  • painful joint swelling caused by uric acid (gout)
  • lack of interest, mood changes, uncontrollable or unexpected crying
  • 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 opacity (cataract), retinal haemorrhage, dry eyes
  • nose, throat, and sinus disorders, sleep breathing disorders
  • blisters or ulcers in the mouth and throat
  • gastrointestinal disorders including frequent defecation, food poisoning, blood in stool, haematemesis (vomiting blood)
  • rectal bleeding, change in stool colour, abdominal distension, constipation
  • mouth disorders, including dry or painful mouth, tongue pain, bleeding gums, oral discomfort
  • sunburn
  • feeling of warmth, feeling of restlessness
  • redness or swelling around a wound
  • bleeding around a catheter (if present) into 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 disorders including: skin discoloration, peeling, redness, itching, and sweating
  • muscle weakness
  • rectal and colon cancer

Uncommon adverse reactions detectable in laboratory tests:

  • changes in the 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) caused by excessive destruction of red blood cells (haemolytic anaemia)
  • increased number of myelocytes
  • increased number of neutrophil band cells
  • 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 in association with eltrombopag
treatment in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, inform your 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 up to 1 in 10 children):

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

The following adverse reactions have been reported in association with eltrombopag
treatment 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 detectable in blood tests:

  • decreased number of red blood cells (anaemia)

Common adverse reactions (may occur in up to 1 in 10 patients):

  • urinary tract infections
  • inflammation of nasal passages, throat, oral cavity, flu-like symptoms, dry mouth, oral pain or inflammation, toothache
  • weight loss
  • sleep disorders, abnormal drowsiness, depression, anxiety
  • dizziness, concentration and memory disturbances, mood changes
  • impaired brain function due to liver damage
  • tingling or numbness in hands or feet
  • fever, headache
  • visual disturbances, including: lens opacity (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
  • productive cough, runny nose, flu, cold sores, sore throat, and discomfort when swallowing
  • gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, abdominal distension, taste disturbances, haemorrhoids, stomach pain or discomfort, vascular swelling and bleeding 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 disorders including: rash, dry skin, skin eruptions, skin redness, itching, excessive sweating, skin growths, hair loss
  • joint pain, back pain, bone pain, limb pain (arms, legs, hands or feet), muscle cramps
  • irritability, general malaise, skin reactions 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 detectable 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 up to 1 in 100 patients):

  • pain during urination
  • cardiac rhythm disorders (prolonged QT interval)
  • stomach flu (gastroenteritis), sore throat
  • blisters or ulcers in the mouth, gastritis
  • skin disorders including: colour change, peeling, redness, itching, skin lesions, 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) caused by excessive destruction of red blood cells (haemolytic anaemia)
  • confusion, agitation
  • liver failure

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

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

Very common adverse reactions detectable in blood test results:

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

Common adverse reactions (may occur in up to 1 in 10 patients):

  • anxiety
  • depression
  • feeling cold
  • general malaise
  • eye disorders, including vision disturbances, blurred vision, lens opacity (cataract), spots or deposits in the eye (vitreous opacities), dry eye, itchy eye, yellowing of the whites of the eyes or skin
  • nosebleeds
  • gastrointestinal disorders, including: difficulty swallowing, oral pain, tongue swelling, vomiting, loss of appetite, stomach pain or discomfort, abdominal distension, gas in the gastrointestinal 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 caused by bleeding into the skin (petechiae), rash, itching, urticaria, skin changes
  • bleeding from gums
  • 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)
  • catarrh

Common adverse reactions detectable in blood test results:

  • increased enzyme activity due to muscle breakdown (creatine kinase)
  • iron accumulation in the body (iron overload)
  • decreased blood glucose 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 estimated from available data)

  • skin depigmentation
  • darkening of the skin
  • drug-induced liver injury

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 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 or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Eltrombopag Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after:
EXP. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 Eltrombopag Zentiva contains
The active substance is eltrombopag olamine.
Eltrombopag Zentiva 25 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Eltrombopag Zentiva 50 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
The other ingredients are: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethyl starch, magnesium stearate (tablet core); hypromellose, titanium dioxide (E 171), iron oxide red (E 172) and iron oxide yellow (E 172), triacetin (tablet coating).

What Eltrombopag Zentiva looks like and contents of the pack
Eltrombopag Zentiva 25 mg, film-coated tablets
Dark pink, round, biconvex, film-coated tablets, embossed with "II" on one side, approximately 8 mm in diameter.
Eltrombopag Zentiva 50 mg, film-coated tablets
Pink, round, biconvex, film-coated tablets, embossed with "III" on one side, approximately 10 mm in diameter.
Eltrombopag Zentiva 25 mg and 50 mg are supplied in blister packs contained in cardboard cartons containing 14, 28 or 84 film-coated tablets, or in unit-dose blisters packed in a cardboard carton containing 1x14, 1x28, 1x84 film-coated tablets.
Not all pack sizes may be available in a given country.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10, Czech Republic

Manufacturer
Synthon Hispania S.L. Calle De Castelló 1
08830 Sant Boi De Llobregat Barcelona
Spain
Synthon B.V. Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark, Estonia, France, Germany, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Spain, Sweden: Eltrombopag Zentiva

To obtain more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00