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 all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Eltrombopag Stada is and what it is used for
2. What you need to know 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 to treat a blood clotting disorder called primary immune thrombocytopenia (ITP), in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that have not worked.
• Primary immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with ITP are at increased risk of bleeding. Symptoms that patients with ITP may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after cuts 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 difficulties due to side effects during antiviral treatment with interferon. 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. Important 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 may 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 counts, 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 immobile 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 suffered trauma
  • if the patient is significantly overweight (obese)
  • 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 Stada unless the doctor determines that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the eye's lens)
• if the patient has other blood disorders, such as myelodysplastic syndrome (myelodysplastic syndrome, MDS). Before starting Eltrombopag 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.

Ophthalmological examination
The doctor will recommend regular eye examinations to detect cataracts. If the patient does not routinely undergo ophthalmological examinations, the doctor should arrange for regular check-ups. Examinations may also detect any bleeding in or around the retina (the light-sensitive layer at the back of the eye).
Regular tests are required
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 assessing 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 increases in platelet count.

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

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

Bone marrow examinations
In patients with bone marrow disorders, medicines such as eltrombopag may worsen these conditions. Changes in the bone marrow may manifest as abnormal blood test results. The doctor may recommend 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 stomach or intestinal bleeding after stopping Eltrombopag Stada treatment.
Heart examinations
The doctor may consider it necessary to examine the patient’s heart during treatment with Eltrombopag Stada and may perform an electrocardiogram (ECG).
Elderly patients (aged 65 years and above)
There is limited data on the use of eltrombopag in patients aged 65 years and above. Caution should be exercised when using Eltrombopag Stada in patients aged 65 years and above.
Children and adolescents
Eltrombopag Stada is not recommended for children under 1 year of age with immune thrombocytopenia. It is also not recommended for patients under 18 years of age with low platelet count due to hepatitis C virus infection.
Eltrombopag Stada and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use, including over-the-counter medicines and vitamins.
Some commonly used medicines interact with Eltrombopag Stada – including both prescription and non-prescription medicines, as well as mineral supplements. These include:

• acid-reducing medicines used to treat indigestion, heartburn, stomach ulcers (see also “ When to take the medicine ” in section 3)
• medicines called 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 immune system 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 cancer treatment. Consult your doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during Eltrombopag Stada treatment; others may require dose adjustments or appropriate timing of administration. 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, doses of these medicines may be reduced or their use discontinued during concomitant treatment with Eltrombopag Stada.
Taking Eltrombopag Stada with food and drink
Do not take Eltrombopag Stada 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 specifically recommends it.
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.
• While taking Eltrombopag Stada, use an appropriate method of contraception to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Stada.

Do not breastfeed while taking Eltrombopag Stada. It is not known 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 may impair 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 use Eltrombopag Stada

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
the doctor or pharmacist. Do not change the dose or dosing regimen of Eltrombopag Stada unless
instructed by the doctor or pharmacist. While taking Eltrombopag Stada, the patient will remain
under the care of a physician experienced in the treatment of the disease the patient has.

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 once daily.
Patients of East Asian/Southeast Asian origin may require initiation of treatment with a
lower 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 once daily.

In chronic hepatitis C

Adults – the recommended starting dose in chronic hepatitis C is one 25 mg tablet of
Eltrombopag Stada once daily. In 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 the patient's
response to treatment with Eltrombopag Stada, the doctor may adjust the daily dose.

How to take the tablets

The tablets should be swallowed 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 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 Stada.

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

Taking more than the recommended dose of Eltrombopag Stada

Contact the doctor or pharmacist immediately. If possible, show them the medicine packaging or this leaflet.

The patient's condition will be monitored for any adverse effects, and appropriate treatment will be initiated promptly.

If a dose of Eltrombopag Stada is missed

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

Stopping treatment with Eltrombopag Stada

Do not stop taking Eltrombopag Stada without consulting the doctor. If the 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 there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to watch for: seek medical advice
In patients taking Eltrombopag Stada for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse reactions may occur. It is important to inform your doctor
if any of these symptoms occur.
Increased risk of 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 pain (stomach), 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 tell your doctor immediately.

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. A low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor the patient’s platelet count for at least 4 weeks after stopping Eltrombopag 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, 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 treatment with
Eltrombopag Stada in adult patients with primary immune thrombocytopenia:
Very common adverse reactions
May occur in more than 1 in 10 patients:

• common cold
• nausea
• diarrhoea
• cough
• infection of 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 sinuses
• inflammation (swelling) and infection of tonsils
• infection of lungs, sinuses, nose and throat
• gingivitis (inflammation of gum tissue)
• loss of appetite
• tingling, pricking or numbness sensation
• reduced skin sensitivity
• drowsiness
• ear pain
• pain, swelling and tenderness in one leg (usually calf with warm skin at 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 changes 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 heat
• 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 number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin concentration
• increased eosinophil count
• increased number of white blood cells (leucocytosis)
• 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, especially 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 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, heart rhythm disorders (QT interval prolongation), which may indicate cardiovascular 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 opacity (cataract), retinal haemorrhage, dry eyes
• disorders of nose, throat and sinuses, sleep breathing disorders
• mouth and throat blisters or ulcers
• loss of appetite
• gastrointestinal disorders including frequent bowel movements, food poisoning, blood in stool, bloody vomiting
• bleeding from anus, change in stool colour, abdominal distension, constipation
• mouth disorders, including dry or painful mouth, tongue pain, bleeding gums, mouth discomfort
• sunburn
• feeling of heat, restlessness
• redness or swelling at wound site
• bleeding around catheter (if present) into 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 changes including: skin discolouration, peeling, redness, itching and sweating
• muscle weakness
• cancer of rectum and colon

Uncommon adverse reactions that may be detected in laboratory tests:

• changes in shape of red blood cells
• presence of developing white blood cells, which may indicate certain diseases
• increased 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 nose, sinuses, throat and upper respiratory tract, common 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
• 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 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 oral cavity, toothache
• weight loss
• sleep disturbances, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory problems, mood changes
• impaired brain function due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• visual disturbances, including: lens opacity (cataract), dry eye syndrome, small yellow deposits in retina, yellowing of sclera
• 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 oesophagus
• toothache
• liver problems including: liver tumour, yellowing of sclera or skin (jaundice), drug-induced liver injury (see above "Liver function disorders" in section 4)
• skin changes including: rash, dry 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 body or limbs causing swelling
• infection of nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of mucous lining of bronchi
• depression, anxiety, sleep disturbances, 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
• heart rhythm disorders (QT interval prolongation)
• gastroenteritis (stomach flu), sore throat
• mouth blisters or ulcers, gastritis
• skin changes including: colour change, 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
• 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 no more than 1 in 10 patients.

• anxiety
• depression
• feeling of cold
• general malaise
• eye disorders, including vision disturbances, blurred vision, lens opacity (cataract), spots or deposits in eye (floaters), dry eye, itchy eye, yellowing of sclera or skin
• nosebleeds
• gastrointestinal disorders, including: difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain or discomfort, abdominal distension, gas in gastrointestinal tract, constipation, intestinal peristalsis disorders which may cause constipation, bloating, diarrhoea and (or) 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 lower limbs due to fluid accumulation
• abnormal urine colour
• interruption of blood supply to spleen (splenic infarction)
• catarrh

Common adverse reactions that may be detected in blood test results

• increased enzyme activity due to muscle breakdown (creatine phosphokinase)
• 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 available data

• skin depigmentation
• darkening of 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 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 instructions 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 packaging 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
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
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
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 blister packs containing 14, 28 or 84 coated tablets, or in unit dose blister packs 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 about 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 European Economic Area countries 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