Eltrombopag stada

Package leaflet: Information for the patient

Eltrombopag Stada, 25 mg, film-coated tablets
Eltrombopag Stada, 50 mg, film-coated tablets
Eltrombopag Stada, 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 individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents:

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

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

Eltrombopag Stada 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 cells that help reduce or prevent the risk of bleeding.

• Eltrombopag Stada is used in the treatment of a blood clotting disorder called primary immune thrombocytopenia (ITP), in patients over 1 year of age who have previously been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.
• Primary immune thrombocytopenia is caused by a low number of platelets in the blood (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 Stada may also be used to treat low platelet counts (thrombocytopenia) in adults with chronic hepatitis C virus (HCV) infection who have experienced difficulties due to side effects 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 Stada may help patients complete a full course of antiviral therapy (pegylated interferon and ribavirin).

2. Information before using Eltrombopag Stada

When NOT to use Eltrombopag Stada

• 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 have the condition
described above.
Warnings and precautions
Before starting treatment with Eltrombopag Stada, discuss the following with your doctor:

• if the patient has liver disease. Patients with low platelet count, as well as those with 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 Stada 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 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 has significant overweight (obesity)
  • 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 Stada unless the 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 Eltrombopag Stada, the doctor will perform tests to rule out this condition.
• If the patient has MDS and is taking Eltrombopag Stada, MDS may worsen. Inform the doctor if any of the above situations apply to the patient.

Ophthalmological examination
The doctor will recommend monitoring for cataracts. If the patient does not undergo routine eye
examinations, the doctor should prescribe regular check-ups. Monitoring may also include
detection of any bleeding in the retina (the light-sensitive layer at the back of the eye) or nearby
areas.
Regular tests will be necessary
Before starting Eltrombopag Stada, 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 may cause blood test results indicating liver damage – increased activity of certain
liver enzymes, particularly alanine aminotransferase and aspartate aminotransferase, and
increased bilirubin levels. If the patient is receiving interferon-based treatment concurrently
with Eltrombopag Stada for low platelet count associated with hepatitis C, certain liver conditions
may worsen.
Before starting Eltrombopag Stada and periodically during treatment, blood tests to assess liver
function will be performed. It may be necessary to discontinue Eltrombopag Stada 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 function disorders ”.
Monitoring platelet count
If the patient stops taking Eltrombopag Stada, low platelet count may recur 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 even when platelet count is normal or low. The doctor will adjust the dose of Eltrombopag
Stada 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 sharp 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 may worsen these
conditions. Changes in the bone marrow may be indicated by abnormal blood test results. The
doctor may order direct bone marrow examinations during treatment with Eltrombopag Stada.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based treatment concurrently with Eltrombopag Stada, they
will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag
Stada.
Heart examinations
The doctor may consider it necessary to monitor the patient’s heart during treatment with
Eltrombopag Stada and may perform an electrocardiogram (ECG).
Elderly patients (aged 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 using Eltrombopag Stada in patients aged 65 years and older.
Children and adolescents
Eltrombopag Stada 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 Stada 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 they plan to take. This includes over-the-counter medicines and
vitamins.
Some commonly used medicines interact with Eltrombopag Stada – including both prescription
and over-the-counter medicines, as well as mineral supplements. These include:

• medicines that neutralize stomach acid used to treat indigestion, heartburn, stomach ulcers (see also “ When to take the medicine ” in section 3)
• medicines called statins, used to lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplantation or in immunological disorders
• mineral products such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be components of vitamin and mineral supplements (see also “ When to take the medicine ” in section 3)
• medicines such as methotrexate and topotecan, used in the treatment of cancer. Consult a doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during treatment with Eltrombopag Stada; for others, dose adjustment or appropriate timing of administration may be required. The doctor will review all medicines the patient is taking and recommend changes if necessary.

If the patient is taking anticoagulant medicines, the risk of bleeding may be increased. The 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 Stada.
Taking Eltrombopag Stada with food and drink
Eltrombopag Stada 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 Stada during pregnancy, unless the doctor advises otherwise.
The effect of eltrombopag used during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy.
• An appropriate contraceptive method must be used during treatment with Eltrombopag Stada to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Stada.

Do not breastfeed while taking Eltrombopag Stada. 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 Stada may cause dizziness and other adverse effects that reduce attention.
Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.
Eltrombopag Stada 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 take Eltrombopag Stada

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 Stada unless
your doctor or pharmacist advises you to do so. While taking Eltrombopag Stada, you will remain under
the care of a doctor experienced in the treatment of the disease you have.

How much medicine to take

In primary immune thrombocytopenia

Adults and children (aged 6 to 17 years) – the recommended starting dose in primary
immune thrombocytopenia is one 50 mg tablet of Eltrombopag Stada per day.
Patients of East Asian/Southeast Asian origin may require a lower starting dose of 25 mg.

Children (aged 1 to 5 years) – the recommended starting dose in primary immune
thrombocytopenia is one 25 mg tablet of Eltrombopag Stada per day.

In chronic hepatitis C

Adults – the recommended starting dose in chronic hepatitis C is one 25 mg tablet of
Eltrombopag Stada per day. For patients of East Asian/Southeast Asian origin, treatment should
be initiated with the same 25 mg dose.

The effect of Eltrombopag Stada may begin within 1 to 2 weeks. Depending on your response to
treatment with Eltrombopag Stada, your doctor may adjust your daily dose.

How to take the tablets

Swallow the tablets whole with water.

Eltrombopag Stada 25 mg and 50 mg film-coated tablets:
The tablet may be divided into equal doses.

When to take the medicine

Make sure that –

• within 4 hours before taking Eltrombopag Stada
• and within 2 hours after taking Eltrombopag Stada – the patient does not consume the following foods:
• dairy products, such as cheese, butter, yoghurt, ice cream
• milk or drinks 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 Stada.

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

Taking more Eltrombopag Stada than prescribed

Contact your doctor or pharmacist immediately. If possible, show them the medicine packaging or this leaflet.
Your condition will be monitored for any adverse effects, and appropriate treatment will be given without delay.

If you miss a dose of Eltrombopag Stada

Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Stada per day.

Stopping Eltrombopag Stada

Do not stop taking Eltrombopag Stada without consulting your doctor. If your doctor advises stopping
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 using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of: seek medical advice
In patients taking Eltrombopag Stada for primary immune thrombocytopenia or low platelet count associated with hepatitis C, severe adverse reactions may occur. It is important to inform your doctor
if any of these symptoms occur.
Increased risk of thrombosis
Some patients may have an increased risk of blood clots, and medicines such as eltrombopag may increase this risk. Sudden blockage of a blood vessel by a 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 symptoms of
thrombosis 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 function disorders
Eltrombopag may cause changes detectable in blood tests, which may indicate liver damage. Liver function abnormalities (increased liver enzyme activity in blood tests) are common and may affect up to 1 in 10 patients. Other liver-related problems are uncommon and may affect up to 1 in 100 patients.
If any of the following symptoms of liver dysfunction occur:

• yellowing of the skin or whites of the eyes (jaundice)
• abnormally dark-coloured urine seek immediate medical advice.

Bleeding or bruising after stopping treatment
Usually, within two weeks of stopping Eltrombopag Stada, the patient's platelet count decreases to the level observed before starting Eltrombopag Stada. 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 Stada.
Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag Stada.
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, affecting up to 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material Seek immediate medical advice if any of these symptoms occur.

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

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

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

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

Common adverse reactions
May occur in no 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

• influenza

• 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 gum tissue)

• loss of appetite

• tingling, pricking, or numbness sensations

• reduced skin sensitivity

• drowsiness

• ear pain

• pain, swelling, and tenderness in one leg (usually the calf, with skin warmth at the affected site) (symptoms of deep vein thrombosis)

• localized swelling filled with blood from a damaged blood vessel (haematoma)

• hot flushes

• oral disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers

• watery nasal discharge

• toothache

• abdominal pain

• abnormal liver function

• skin reactions 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 that may be detected in blood tests:

• decreased number of red blood cells (anaemia)
• decreased platelet count (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 adverse reactions
May occur in no more than 1 in 100 patients:

• allergic reaction
• interruption of blood supply to part of the heart
• sudden shortness of breath, particularly with sharp chest pain and (or) rapid breathing, which may indicate pulmonary embolism (see Increased risk of thrombosis 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 venous thrombosis
• yellowing of the skin and (or) abdominal pain, which may indicate biliary obstruction, liver disease, or drug-induced liver injury (see Liver function disorders above in section 4)
• drug-induced liver injury
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, cardiac arrhythmias (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, 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 opacification (cataract), retinal haemorrhage, dry eyes
• disorders of the nose, throat, and sinuses, sleep breathing disorders
• blisters or ulcers in the mouth and throat
• loss of appetite
• gastrointestinal disorders including frequent bowel movements, food poisoning, blood in stool, bloody vomiting
• rectal bleeding, change in stool colour, abdominal distension, constipation
• oral disorders, including dryness or pain in the mouth, tongue pain, bleeding gums, oral discomfort
• sunburn
• feeling of warmth, 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 reactions, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon adverse reactions 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 band neutrophil 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 adverse reactions have been reported as associated with treatment
with Eltrombopag Stada 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 no more than 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 mucosal congestion, and sneezing
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse reactions have been reported as associated with treatment
with eltrombopag in combination with peginterferon and ribavirin in patients with HCV:
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
• influenza-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 no 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, difficulty concentrating and memory problems, mood changes
• brain dysfunction due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• visual disturbances, including: lens opacification (cataract), dry eye syndrome, small yellow deposits in 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, influenza, 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 function disorders in section 4)
• skin reactions 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 neutrophil count
• 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 no more than 1 in 100 patients:

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

The following adverse reactions have been reported as associated with treatment with
Eltrombopag Stada 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
• eye itching
• mouth blisters
• bleeding gums
• abdominal pain
• muscle cramps

Very common adverse reactions that may manifest in blood test results

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

Common adverse reactions
May occur in no more than 1 in 10 patients.

• anxiety
• depression
• feeling of cold
• general malaise
• eye disorders, including vision disturbances, blurred vision, lens opacification (cataract), eye spots or deposits (floaters), dry eye, eye itching, 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 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 due to bleeding under the skin (petechiae), rash, itching, urticaria, skin lesions
• back pain
• muscle pain
• bone pain
• weakness
• swelling of the lower limbs due to fluid accumulation
• abnormal urine colour
• interruption of blood supply to the spleen (splenic infarction)
• catarrh

Common adverse reactions that may manifest in blood test results

• increased enzyme activity due to muscle breakdown (creatine kinase)
• iron accumulation in the body (iron overload)
• decreased blood 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 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eltrombopag Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

The active substance is eltrombopag (in the form of eltrombopag olamine).
Each coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Each coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
Each coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

Eltrombopag Stada 25 mg, coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (type A), magnesium stearate
Tablet coating
Polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc

Eltrombopag Stada 50 mg, coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (type A), magnesium stearate
Tablet coating
Polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172)

Eltrombopag Stada 75 mg, coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (type A), magnesium stearate
Tablet coating
Polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, red iron oxide (E 172)

What Eltrombopag Stada looks like and contents of the pack
Eltrombopag Stada 25 mg, coated tablets
White to pale yellow, round, biconvex coated tablets with a score line on one side, dark red to brown at the break.

Eltrombopag Stada 50 mg, coated tablets
Brown, round, biconvex coated tablets with a score line on one side, dark red to brown at the break.

Eltrombopag Stada 75 mg, coated tablets
Pink, round, biconvex coated tablets.

Eltrombopag Stada is available in blisters containing 14, 28 or 84 coated tablets or in unit dose blisters containing 14 x 1, 28 x 1 or 84 x 1 coated tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Ltd.
Waterford Road
E91 D768 County Tipperary, Clonmel
Ireland

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the countries of the European Economic Area under the following names:
Austria, Croatia, Cyprus, Denmark, Estonia, Eltrombopag STADA
Finland, Greece, Spain, Netherlands,
Iceland, Lithuania, Latvia, Norway, Sweden,
Slovakia, Slovenia

Poland, Romania, Hungary Eltrombopag Stada
Germany Eltrombopag AL
France, Italy Eltrombopag EG
Ireland, Malta Eltrombopag Clonmel