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 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet contents:

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. It 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 over 1 year of age 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), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut 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 side effects during interferon treatment. Many people with hepatitis C have low platelet counts not only because of the disease itself, but also due to certain antiviral medicines used in treatment. Taking Eltrombopag Vipharm may help patients complete full antiviral therapy (pegylated interferon and ribavirin).

2. Important information before using Eltrombopag Vipharm

When not to use Eltrombopag Vipharm

• if the patient is allergic to eltrombopag or to 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/or advanced (chronic) liver disease are at increased 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 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
  • if the patient has advanced chronic liver disease
    Inform the doctor before starting treatment if any of the above conditions apply. Do not take Eltrombopag Vipharm 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 (MDS). Before starting Eltrombopag Vipharm, the doctor will perform tests to rule out this condition. If the patient has MDS, treatment with Eltrombopag Vipharm may worsen the condition. Inform the doctor if any of the above situations apply.

Ophthalmological examination
The treating doctor will recommend regular eye examinations to detect cataracts. If the patient does not routinely undergo ophthalmological check-ups, the doctor should arrange regular eye exams. Examinations may also include assessment for any retinal bleeding (in the layer of light-sensitive cells at the back of the eye) or bleeding nearby.
Regular blood tests will be necessary
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 possible liver damage—elevated levels of certain liver enzymes, particularly bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST). If the patient is receiving interferon-based therapy in combination with Eltrombopag Vipharm for thrombocytopenia associated with hepatitis C, certain liver conditions may worsen.
Blood tests to assess liver function will be performed before starting Eltrombopag Vipharm and periodically during treatment. It may be necessary to discontinue Eltrombopag Vipharm if levels of these substances become too high or if other signs of liver damage occur.
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 counts may decrease again within a few days. Platelet counts 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 counts are normal or low. The treating doctor will adjust the dose of Eltrombopag Vipharm to prevent excessive increases in platelet count.

Seek immediate medical attention 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, drugs such as Eltrombopag Vipharm may worsen these conditions. Changes in bone marrow may be indicated by abnormal blood test results. The doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Vipharm.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon therapy in combination 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 and older)
Limited data are available on the use of eltrombopag in patients aged 65 years and older. Caution should be exercised when administering Eltrombopag Vipharm to 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 individuals under 18 years of age with thrombocytopenia due to chronic hepatitis C or severe aplastic anemia.
Eltrombopag Vipharm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter drugs and vitamins. This also includes herbal supplements and mineral preparations.
Some commonly used medicines interact with Eltrombopag Vipharm – including both prescription and over-the-counter medicines, as well as mineral supplements. These include:

• antacids used to treat indigestion, heartburn, stomach ulcers
• stomach (see also "When to take the medicine" in section 3)
• drugs known as statins, used to lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ 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)
• drugs such as methotrexate and topotecan, used in the treatment of cancer → Inform the doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during treatment with Eltrombopag Vipharm; for others, dose adjustments or changes in timing of administration may be required. The treating doctor will review all medications the patient is taking and recommend changes if necessary.

If the patient is taking anticoagulant (blood-thinning) medicines, 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-containing beverages, as the calcium in milk products interferes with drug absorption. For further information, see "When to take the medicine" in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag Vipharm during pregnancy, unless specifically advised by a doctor.
The effect of eltrombopag during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy.
• An effective method of contraception must be used during treatment with Eltrombopag Vipharm to prevent pregnancy.
• Inform the doctor immediately if the patient becomes pregnant while taking Eltrombopag Vipharm.

Breastfeeding must be avoided during treatment with Eltrombopag Vipharm. It is unknown whether eltrombopag passes into breast milk.
→ Inform the doctor if the patient is breastfeeding or planning to breastfeed.
Driving and operating machinery
Eltrombopag Vipharm may cause dizziness and other adverse effects that impair concentration.
→ Do not drive or operate machinery unless the patient is certain that these symptoms do not affect them.
Eltrombopag Vipharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Eltrombopag Vipharm

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 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 affecting the patient.

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 per day.
For patients of East Asian or South-East 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 per day.
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
per day. For patients of East Asian or South-East Asian origin, treatment should be initiated with
the same 25 mg dose.

The effect of Eltrombopag Vipharm may begin after 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
Ensure that:
→ within 4 hours before taking Eltrombopag Vipharm
→ and within 2 hours after taking Eltrombopag Vipharm
the patient does not consume the following foods:

• Dairy products, such as cheese, butter, yoghurt, ice cream
• Milk or beverages containing milk, yoghurt, or cream
• Antacids used to treat indigestion and heartburn
• Vitamin and mineral supplements containing iron, calcium, magnesium, aluminium, selenium, zinc

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

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

Taking more Eltrombopag Vipharm than prescribed
If more Eltrombopag Vipharm has been taken than prescribed, 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 to provide appropriate treatment without delay.

Missed 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 advises
stopping 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 using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will get them.

Symptoms to pay attention to: seek medical advice

In patients treated with Eltrombopag Vipharm for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe side effects 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 Vipharm may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon side effect and may affect up to 1 in 100 patients.

Seek immediate medical help if the patient experiences symptoms of a blood clot such as:

• 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 Vipharm 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 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 treatment with Eltrombopag Vipharm. 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 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 color is an uncommon side effect, 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 side effects have been reported in association with eltrombopag treatment in adult patients with primary immune thrombocytopenia:

Very common side effects

May occur in more than 1 in 10 patients:

• cold symptoms
• 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 the sinuses
• inflammation (swelling) and infection of the tonsils
• infection of the 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 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 of heat
• chest pain
• feeling of weakness
• difficulty sleeping, 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 eosinophil count
• increased white blood cell count (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 supply to part of the heart
• sudden shortness of breath, especially in combination with acute 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 liver damage due to inflammation (see “ Liver problems ” above in section 4)
• drug-induced liver damage
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT interval prolongation), which may indicate heart and blood vessel disorders
• 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, sleep breathing disorders
• blisters or ulcers in the mouth and throat
• loss of appetite
• gastrointestinal disorders including frequent defecation, food poisoning, blood in stool, bloody vomiting
• bleeding from the rectum, stool color change, abdominal distension, constipation
• mouth disorders, including dryness or pain in the 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 disorders, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects that may be detected in laboratory tests:

• changes in the shape of red blood cells
• presence of developing white blood cells, which may indicate certain diseases
• increased platelet count
• decreased calcium concentration
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• increased myelocyte count
• increased neutrophil band count
• 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 side effects have been reported in association with eltrombopag treatment in children (aged 1 to 17 years) with ITP:

If these side effects worsen, inform your doctor, pharmacist, or nurse.

Very common side effects

May occur in more than 1 in 10 children:

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

Common side effects

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 side effects have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with hepatitis C:

Very common side effects

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
• influenza-like illness
• swelling of hands or feet
• chills

Very common side effects that may be detected in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects

May occur in not more than 1 in 10 patients:

• urinary tract infections
• inflammation of nasal passages, throat, oral cavity, influenza-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
• 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 damage (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, 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 symptoms (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disorders, restlessness

Common side effects that may be detected in blood tests:

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

Uncommon side effects

May occur in not more than 1 in 100 patients:

• pain during urination
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters or ulcers in the mouth, gastritis
• skin disorders, including color changes, peeling, redness, itching, skin lesions, and night sweats
• blood clots in the vein bringing 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 side effects have been reported in association with eltrombopag treatment in patients with severe aplastic anaemia (SAA):

If these side effects worsen, inform your doctor, pharmacist, or nurse.

Very common side effects

May occur in more than 1 in 10 patients:

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

Very common side effects detectable in blood test results

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

Common side effects

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 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 distension, gas in the digestive tract, constipation, intestinal peristalsis disorders, which may cause constipation, bloating, diarrhoea and (or) the above-mentioned symptoms, stool color change
• 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 color
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects detectable 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

Side effects with unknown frequency

Frequency cannot be estimated from the available data:

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

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects 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 are 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 are white, round, biconvex film-coated tablets with "25" embossed on one side and smooth on the other.
Eltrombopag Vipharm 50 mg film-coated tablets are brown, round, biconvex film-coated tablets with "50" embossed on one side and smooth on the other.
Eltrombopag Vipharm 75 mg film-coated tablets are pink, round, biconvex film-coated tablets with "75" embossed on one side and smooth on the other.
The tablets are supplied in aluminum blisters packed in cardboard boxes containing 14, 28 or 48 film-coated tablets.
Not all pack sizes may be available in every 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 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