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 someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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. This medicine 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 previously been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.
• Primary immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after 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 experienced difficulties due to side effects during interferon-based therapy. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of certain antiviral medications used in treatment. Taking Eltrombopag Stada may help patients complete full antiviral treatment (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 believes 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 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 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 determines 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.

Ophthalmological examination
The doctor will recommend regular monitoring to detect cataracts. If the patient does not undergo routine eye examinations, the doctor should order regular eye exams. 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 blood tests are required
Before starting Eltrombopag Stada, the doctor will perform blood tests to assess blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests to evaluate liver function
Eltrombopag may cause blood test results indicating liver damage—elevated levels of certain liver enzymes, particularly alanine aminotransferase and aspartate aminotransferase, and increased bilirubin levels. If the patient is receiving interferon-based therapy concurrently with Eltrombopag Stada for thrombocytopenia associated with hepatitis C, certain liver conditions may worsen.
Before starting Eltrombopag Stada and periodically during treatment, the patient will undergo blood tests to assess liver function. 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 of platelet count
If the patient stops taking Eltrombopag Stada, low platelet counts may recur within a few days. Platelet counts will be monitored, and the doctor will discuss appropriate precautions with the patient.
Very high platelet counts may increase the risk of blood clots. However, blood clots may also occur even when platelet counts are 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 clots:

• 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

Bone marrow examinations
In patients with bone marrow disorders, drugs 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 therapy 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 evaluate the patient’s heart during treatment with Eltrombopag Stada and may perform an electrocardiogram (ECG).
Elderly patients (aged 65 years and above)
Limited data are available on the use of eltrombopag in patients aged 65 years and older. Caution should be exercised when administering Eltrombopag Stada to 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 counts due to hepatitis C virus infection.
Eltrombopag Stada and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans 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)
• statins, cholesterol-lowering medicines
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplantation or immune 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 to treat cancer
  Consult the doctor if the patient is taking any of the medicines listed above. Some of these should not be taken during treatment with Eltrombopag Stada; others may require dose adjustments or appropriate timing of administration. The doctor will review the patient’s current medications and recommend changes if necessary.

If the patient is taking anticoagulant medicines, there is an increased risk of bleeding. 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 concurrent treatment with Eltrombopag Stada.
Taking Eltrombopag Stada with food and drink
Eltrombopag Stada must not be taken with dairy products or dairy-based beverages, as the calcium in dairy products affects drug absorption. 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.
• An appropriate contraceptive method should 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 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 take Eltrombopag Stada

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
you should 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 managing the
condition 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
begin with the same 25 mg dose.

The effect of Eltrombopag Stada may begin after 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 – you do 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, or 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’s
packaging or this leaflet.

Your condition will be monitored for any adverse effects, and appropriate treatment will be
started 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
you to stop 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 how to use this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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, 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 may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon side effect and may occur in up to 1 in 100 patients.

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

• swelling, pain, warmth, redness or tenderness to pressure 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 could 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 function disorders 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. 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.
In some patients, gastrointestinal bleeding may occur after discontinuation of peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry stools (change in stool colour is an uncommon side effect, which may affect 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 side effects have been reported as associated with treatment with
Eltrombopag Stada in adult patients with primary immune thrombocytopenia:
Very common side effects
May occur in more than 1 in 10 patients:

• cold
• nausea
• diarrhoea
• cough
• nose, sinus, throat and upper respiratory tract infection (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 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

• flu

• cold sores

• pneumonia

• irritation and inflammation (swelling) of sinuses

• inflammation (swelling) and infection of tonsils

• lung, sinus, nose and throat infection

• gingivitis (inflammation of gum tissue)

• 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

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

• watery nasal discharge

• toothache

• abdominal pain

• abnormal liver function

• skin disorders including: excessive sweating, raised itchy rash, red spots, skin appearance changes

• hair loss

• foamy urine with presence of air bubbles (symptoms of protein in urine)

• high body temperature, feeling hot

• chest pain

• feeling of weakness

• sleep difficulties, depression

• migraine

• impaired vision

• sensation of spinning (dizziness)

• flatulence

Common side effects that may be detected in blood tests:

• decreased number of red blood cells (anaemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin concentration
• increased 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 no more than 1 in 100 patients:

• allergic reaction

• interruption of blood flow to part of the heart

• sudden shortness of breath, especially combined 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 bile duct 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 colouration, 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

• nose, throat and sinus disorders, 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

• bleeding from the anus, 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 heat, restlessness

• redness or swelling around a wound

• bleeding around a catheter (if present) through the skin

• sensation of foreign body

• kidney disorders including: kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine

• cold sweats

• general malaise

• skin infection

• skin disorders, including skin discolouration, peeling, redness, itching and sweating

• muscle weakness

• anal and colorectal 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 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 side effects have been reported as associated with treatment with
Eltrombopag Stada 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:

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

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

The following side effects have been reported as associated with treatment with
eltrombopag in combination with peginterferon and ribavirin in patients with HCV:
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 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 in the mouth, 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 opacity (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, flu, cold sores, sore throat and discomfort when swallowing
• gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, abdominal distension, taste disturbances, haemorrhoids, stomach pain or discomfort, vascular swelling and bleeding in the oesophagus
• toothache
• liver problems including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (see above "Liver function disorders" in section 4)
• skin disorders including: rash, dry skin, skin eruptions, 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
• nose, sinus, throat and upper respiratory tract infection, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common side effects that may be detected in blood tests:

• increased blood glucose (sugar) concentration
• decreased white blood cell count
• 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 side effects
May occur in no 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 colour changes, peeling, redness, itching, skin lesions and night sweats
• blood clots in the vein carrying blood to the liver (possible liver and (or) gastrointestinal damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at injection site, chest discomfort
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported as associated with treatment with
Eltrombopag Stada 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 and feet)
• dizziness
• feeling of extreme fatigue
• fever
• chills
• itchy eyes
• mouth blisters
• bleeding gums
• abdominal pain
• muscle cramps

Very common side effects that may manifest in blood test results

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

Common side effects
May occur in no more than 1 in 10 patients.

• anxiety
• depression
• feeling cold
• general malaise
• eye disorders, including vision disturbances, blurred vision, lens opacity (cataract), spots or deposits in the eye (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 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 lower limbs due to fluid accumulation
• abnormal urine colour
• interruption of blood flow to the spleen (splenic infarction)
• catarrh

Common side effects 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 sugar concentration (hypoglycaemia)
• increased bilirubin concentration in blood (a substance produced by the liver)
• decreased white blood cell count

Side effects with unknown frequency
Frequency cannot be estimated from available data

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

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
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 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
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, iron oxide yellow (E 172), iron oxide red (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, iron oxide red (E 172)

What Eltrombopag Stada looks like and contents of the pack
Eltrombopag Stada 25 mg, coated tablets
White to pale yellow, round, biconvex, film-coated tablets with a breakline on one side, dark red to brown at the breaking point.

Eltrombopag Stada 50 mg, coated tablets
Brown, round, biconvex, film-coated tablets with a breakline on one side, dark red to brown at the breaking point.

Eltrombopag Stada 75 mg, coated tablets
Pink, round, biconvex, film-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 on 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