Eltrombopag vipharm

Package leaflet: Information for the user

Eltrombopag Vipharm, 12.5 mg, film-coated tablets
Eltrombopag Vipharm, 25 mg, film-coated tablets
Eltrombopag Vipharm, 50 mg, film-coated tablets
Eltrombopag Vipharm, 75 mg, film-coated tablets
Eltrombopagum

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 a specific person only. Do not give it 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Eltrombopag Vipharm 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 Vipharm is used to treat a blood clotting disorder called immune (primary) thrombocytopenia in patients aged over 1 year who have previously 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 higher risk of bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), subcutaneous bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after cuts or injury.

• Eltrombopag Vipharm 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 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 Vipharm may help patients complete full antiviral therapy (with peginterferon and ribavirin).

2. Important information before using Eltrombopag Vipharm

When not to use Eltrombopag Vipharm

• if the patient is allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6). → Consult a doctor if the patient thinks they are experiencing the condition described above.

Warnings and precautions
Before starting treatment with Eltrombopag Vipharm, 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 higher risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag Vipharm 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 immobilized for a prolonged period
  • if the patient has a malignant tumor
  • if the patient is taking oral contraceptives or hormone replacement therapy
  • if the patient has recently undergone surgery or suffered trauma
  • if the patient is overweight
  • if the patient smokes
  • 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 Vipharm unless the doctor considers 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 (MDS). Before starting Eltrombopag Vipharm, the doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag Vipharm, 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 routinely undergo ophthalmological examinations, the doctor should order regular tests. Monitoring may also include detection of any bleeding in or around the retina (the light-sensitive layer at the back of the eye).
Regular blood tests will be required
Before starting Eltrombopag Vipharm, the doctor will perform blood tests to evaluate blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests to assess liver function
Eltrombopag Vipharm may cause blood test results indicating liver damage—elevated levels of certain liver enzymes, particularly bilirubin, alanine aminotransferase, and aspartate aminotransferase. If the patient is receiving interferon-based treatment concurrently with Eltrombopag Vipharm for low platelet count associated with hepatitis C, certain liver conditions may worsen.
Before starting Eltrombopag Vipharm and periodically during treatment, blood tests to assess liver function will be performed. It may be necessary to discontinue Eltrombopag Vipharm 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 “Liver disorders”.
Blood tests to monitor platelet count
If the patient stops taking Eltrombopag Vipharm, platelet count may decrease again within a few days. Platelet count will be monitored, and the 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 Vipharm to prevent excessive increases in platelet count.

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

• swelling, pain, 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

Tests to assess bone marrow
In patients with bone marrow disorders, medicines such as Eltrombopag Vipharm may worsen these conditions. Changes in bone marrow may manifest as abnormal blood test results. The doctor may order direct bone marrow examinations during treatment with Eltrombopag Vipharm.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon therapy concurrently with Eltrombopag Vipharm, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag Vipharm treatment.
Heart examinations
The treating doctor may consider the need for cardiac evaluation during treatment with Eltrombopag Vipharm and may perform an electrocardiogram (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 Vipharm in patients aged 65 years and older.
Children and adolescents
Eltrombopag Vipharm 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 viral hepatitis C or severe aplastic anemia.
Eltrombopag Vipharm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes over-the-counter medicines and vitamins.
Some commonly used medicines interact with Eltrombopag Vipharm – including both prescription and non-prescription medicines and mineral supplements. These include:

• antacids used to treat indigestion, heartburn, stomach ulcers
• stomach (see also “When to take the medicine” in section 3)
• medicines known as statins, lowering cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or 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 → Inform the doctor if the patient is taking any of the medicines listed above. Some of these should not be used during treatment with Eltrombopag Vipharm; others may require dose adjustments or appropriate timing adjustments for administration. The treating doctor will review all medicines the patient is taking and recommend changes in 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, doses of these medicines may be reduced or their use discontinued during concomitant treatment with Eltrombopag Vipharm.
Taking Eltrombopag Vipharm with food and drink
Eltrombopag Vipharm 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 Vipharm during pregnancy, unless the doctor specifically recommends it.
The effect of eltrombopag used during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
• While taking Eltrombopag Vipharm, an appropriate method of contraception should be used to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Vipharm.

Do not breastfeed while taking Eltrombopag Vipharm. It is unknown whether eltrombopag passes into breast milk.
→ Inform the doctor if the patient is breastfeeding or plans to breastfeed.
Driving and operating machinery
Eltrombopag Vipharm may cause dizziness and other adverse effects that may impair attention and concentration.
→ Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.

Eltrombopag Vipharm contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to use Eltrombopag Vipharm

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Vipharm unless instructed by your doctor or pharmacist. While taking Eltrombopag Vipharm, the patient will remain under the care of a doctor experienced in treating the condition the patient has.

How much medicine to take

Immune thrombocytopenic purpura (ITP)
Adults and children (aged 6 to 17 years) – the usual starting dose in immune thrombocytopenic purpura is one 50 mg tablet of Eltrombopag Vipharm once daily.
In patients of East Asian or Southeast Asian origin, it may be necessary to start treatment with a lower dose of 25 mg.
Children (aged 1 to 5 years) – the usual starting dose in immune thrombocytopenic purpura is one 25 mg tablet of Eltrombopag Vipharm once daily. Other pharmaceutical forms may be more suitable for administration to this patient group.

Chronic hepatitis C
Adults – the usual starting dose in chronic hepatitis C is one 25 mg tablet of Eltrombopag Vipharm once daily. In patients of East Asian or Southeast Asian origin, treatment should be initiated with the same 25 mg dose.

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

How to take the tablets
The tablets should be swallowed whole with water.

When to take the medicine
Make sure that:
→ 4 hours before taking Eltrombopag Vipharm
→ and 2 hours after taking Eltrombopag Vipharm
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 Vipharm.

Talk to your doctor for further advice on suitable foods and drinks.

Taking more than the recommended dose of Eltrombopag Vipharm
If more than the recommended dose of Eltrombopag Vipharm has been taken, contact your doctor or pharmacist immediately. If possible, show the medicine packaging or leaflet. The patient's condition will be monitored to detect any adverse effects and initiate appropriate treatment without delay.

Missing a dose of Eltrombopag Vipharm
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Vipharm per day.

Stopping Eltrombopag Vipharm
Do not stop taking Eltrombopag Vipharm without first consulting your doctor. If your 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 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: see a doctor
Patients taking Eltrombopag Vipharm for the treatment of primary immune thrombocytopenia or low platelet count associated with hepatitis C may experience symptoms of severe adverse reactions. 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 Vipharm may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon side effect 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 sudden chest pain or rapid breathing
• abdominal (stomach) pain, abdominal swelling, blood in stool.

Liver problems
Eltrombopag Vipharm may cause changes detectable in blood tests, which may indicate liver damage. Liver problems (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 urine seek immediate medical advice.

Bleeding or bruising after stopping treatment
Usually within two weeks of stopping Eltrombopag Vipharm, the patient's platelet count decreases to the level observed before starting Eltrombopag Vipharm. 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 Vipharm.
Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag Vipharm.
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 Tell your doctor immediately if any of these symptoms occur.

The following adverse reactions have been reported as associated with eltrombopag treatment in
adult patients with primary immune thrombocytopenia:
Very common side effects
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 side effects that may be detected in blood tests:

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

Common side effects
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
• lung, sinus, nose and throat infections
• gingivitis
• loss of appetite
• tingling, pricking or numbness sensations
• reduced skin sensation
• drowsiness
• ear pain
• pain, swelling and tenderness in one leg (usually calf with warm skin at the affected site) (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
• excessive hair loss
• foamy urine with presence of air bubbles (symptoms of protein in urine)
• high body temperature, feeling hot
• chest pain
• feeling weak
• sleep difficulties, depression
• migraine
• impaired vision
• sensation of spinning (dizziness)
• flatulence

Common side effects 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 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 side effects
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, particularly in combination with sudden 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 biliary obstruction, liver disease or drug-induced liver injury (see “ Liver problems ” above in section 4)
• drug-induced liver injury
• rapid heartbeat, irregular heartbeat, bluish skin colouration, heart rhythm disorders (prolonged QT interval), which may indicate cardiovascular disorders
• blood clot
• redness
• painful joint swelling due to 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 clouding (cataract), retinal haemorrhage, dry eyes
• nose, throat and sinus disorders, sleep breathing disorders
• mouth and throat blisters or ulcers
• loss of appetite
• gastrointestinal disorders including frequent defecation, food poisoning, blood in stool, bloody vomiting
• rectal bleeding, stool colour change, 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 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 discolouration, peeling, redness, itching and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects 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 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 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 mucosal 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 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 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
• impaired brain function 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 sclera
• 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 bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, vascular swelling and bleeding in the oesophagus
• toothache
• liver problems including liver tumour, yellowing of the sclera 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 (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 disorders, including discolouration, 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) due to excessive destruction of red blood cells (haemolytic anaemia)
• disorientation, 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 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 be detected 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 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 sclera 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 motility 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 under the skin (petechiae), rash, itching, urticaria, skin lesions
• 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 be detected 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 estimated from the available data

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 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 this medicine.

5. How to store Eltrombopag Vipharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister. The expiry date refers to the last day of the stated month.
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 protect the environment.
Eltrombopag Vipharm 12.5 mg and 25 mg film-coated tablets do not require any special storage conditions.
Eltrombopag Vipharm 50 mg and 75 mg film-coated tablets do not require any special storage conditions; store in the original packaging to protect from light.

6. Contents of the pack and other information

What Eltrombopag Vipharm contains
The active substance in Eltrombopag Vipharm is eltrombopag.
12.5 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg
of 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: mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethyl starch,
magnesium stearate, titanium dioxide (E171), hypromellose (E464), macrogol (E1521).
Eltrombopag Vipharm 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Eltrombopag Vipharm 50 mg film-coated tablets also contain iron oxide red (E172) and
iron oxide yellow (E172).
Eltrombopag Vipharm 75 mg film-coated tablets also contain iron oxide red (E172) and
iron oxide black (E172).
What Eltrombopag Vipharm looks like and contents of the pack
Eltrombopag Vipharm 12.5 mg film-coated tablets, white, round, biconvex film-coated tablets
with "12.5" embossed on one side and smooth on the other.
Eltrombopag Vipharm 25 mg film-coated tablets, white, round, biconvex
with "25" embossed on one side and smooth on the other.
Eltrombopag Vipharm 50 mg film-coated tablets, brown, round, biconvex
with "50" embossed on one side and smooth on the other.
Eltrombopag Vipharm 75 mg film-coated tablets, pink, round, biconvex
with "75" embossed on one side and smooth on the other.
The tablets are supplied in aluminium blisters packed in cardboard boxes containing
14, 28 or 48 film-coated tablets.
Not all pack sizes may be available in a given country.
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland
e-mail: [email protected]
Manufacturer
Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini
Greece
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Denmark: Eltrombopag Vipharm
Czech Republic: Eltrombopag Vipharm
Hungary: Eltrombopag Vipharm 12.5 mg, 25 mg, 50 mg, 75 mg filmtabletta
Poland: Eltrombopag Vipharm
Slovakia: Eltrombopag Vipharm 12.5 mg, 25 mg, 50 mg, 75 mg filmom obalené tablety