Eltrombopag msn

Package leaflet: Information for the user

Eltrombopag MSN, 25 mg, film-coated tablets
Eltrombopag MSN, 50 mg, film-coated tablets
Eltrombopag MSN, 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 adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Eltrombopag MSN 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 MSN is used in the treatment of a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have previously been treated with other medicines (corticosteroids or immunoglobulins) and for whom these treatments were ineffective.

ITP 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), subcutaneous bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut or injury.

• Eltrombopag MSN may also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced difficulties due to adverse reactions during interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of certain antiviral medicines used in treatment. Taking Eltrombopag MSN may help patients complete full antiviral therapy (pegylated interferon and ribavirin).

2. Important information before using Eltrombopag MSN

When not to use Eltrombopag MSN

• if the patient is allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 “What Eltrombopag MSN contains”). Consult a doctor if the patient thinks the situation described above applies.

Warnings and precautions
Before starting treatment with Eltrombopag MSN, discuss this with a doctor or pharmacist.

• if the patient has liver disease. Patients with low platelet counts, as well as those with advanced (chronic) liver disease, are at higher risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag MSN outweigh the risks, the patient will be closely monitored during treatment.
• if the patient is at risk of venous or arterial thrombosis, or if there is a family history of blood clots. The risk of thrombosis may be increased:
  • if the patient is elderly
  • if the patient has been immobilized for a prolonged period
  • if the patient has malignant neoplasm
  • if the patient is taking oral contraceptives or hormone replacement therapy
  • if the patient has recently undergone surgery or experienced trauma
  • if the patient is overweight
  • if the patient smokes tobacco
  • if the patient has advanced chronic liver disease
    Inform the doctor before starting treatment if any of the above situations apply to the patient. Do not take Eltrombopag MSN unless the doctor considers that the expected benefits outweigh the risk of thrombosis.
• 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 MSN, the doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag MSN, MDS may worsen. Inform the doctor if any of the above conditions apply to the patient.

Ophthalmological examination
The treating physician will recommend monitoring for cataracts. If the patient does not undergo routine ophthalmological examinations, the doctor should order regular checks. Monitoring may also include detection of any retinal haemorrhages (retina is the layer of light-sensitive cells located at the back of the eye) or haemorrhages nearby.
Regular blood tests will be necessary
Before starting Eltrombopag MSN, the doctor will perform blood tests to assess blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests to assess liver function
Eltrombopag MSN 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 MSN for low platelet count associated with hepatitis C, certain liver conditions may worsen.
Before starting Eltrombopag MSN and periodically during treatment, blood tests assessing liver function will be performed. It may be necessary to discontinue Eltrombopag MSN if levels of these substances rise too high or if other signs of liver damage occur.
Refer to the information in section 4 of this leaflet “ Liver function disorders ”.
Blood tests to monitor platelet count
If the patient stops taking Eltrombopag MSN, there is a likelihood of recurrence of low platelet count within a few days. Platelet count will be monitored, and the treating doctor will discuss appropriate precautions with the patient.
A very high platelet count may increase the risk of thrombosis. However, thrombosis may also occur even when platelet count is normal or low. The treating doctor will adjust the dose of Eltrombopag MSN to prevent excessive increases in platelet count.

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

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

Tests to assess bone marrow
In patients with bone marrow disorders, medicines such as Eltrombopag MSN may worsen these conditions. Changes in bone marrow may manifest as abnormal blood test results. The doctor may order direct bone marrow tests during treatment with Eltrombopag MSN.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based treatment concurrently with Eltrombopag MSN, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag MSN treatment.
Heart examinations
The doctor may consider it necessary to monitor the patient's heart function during treatment with Eltrombopag MSN and may perform an electrocardiogram (ECG).
Elderly patients (65 years of age and older)
There is limited data on the use of Eltrombopag MSN in patients aged 65 years and older. Exercise caution when using Eltrombopag MSN in patients aged 65 years and older.
Children and adolescents
Eltrombopag MSN is not recommended for children under 1 year of age with ITP. It is also not recommended for individuals under 18 years of age with low platelet count due to hepatitis C virus or severe aplastic anaemia.
Eltrombopag MSN and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes over-the-counter medicines and vitamins.
Some commonly used medicines interact with Eltrombopag MSN – including both prescription and non-prescription medicines, as well as mineral preparations. These include:

• acid-reducing medicines used to treat indigestion, heartburn, or stomach ulcers (see also “When to take the medicine” in section 3)
• medicines known as statins, lowering cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplantation or in autoimmune diseases
• mineral products such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin and mineral supplements (see also “When to take the medicine” in section 3)
• medicines such as methotrexate and topotecan, used in the treatment of cancer
  Consult the doctor if the patient is taking any of the medicines listed above. Some of these should not be used during treatment with Eltrombopag MSN; for others, dose adjustment or appropriate timing of administration may be required. The doctor will review all medicines taken by the patient and recommend changes in treatment 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, it may be necessary to reduce the doses of these medicines or discontinue them during concomitant use of Eltrombopag MSN.
Taking Eltrombopag MSN with food and drink
Eltrombopag MSN must not be taken with dairy products or dairy drinks, as the calcium present 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 MSN during pregnancy, unless the doctor specifically recommends it. The effect of using Eltrombopag MSN during pregnancy is unknown.

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

Do not breastfeed while taking Eltrombopag MSN. It is not known whether Eltrombopag MSN passes into human milk.
Inform the doctor if the patient is breastfeeding or planning to breastfeed.
Driving and operating machinery
Eltrombopag MSN 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 MSN contains sodium
This 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 MSN

This medicine should always be used exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag MSN unless instructed by a doctor or pharmacist. While taking Eltrombopag MSN, the patient will remain under the care of a doctor experienced in managing the condition from which the patient suffers.

How much medicine to take

Primary immune thrombocytopenia (ITP)

Adults and children (aged 6 to 17 years) – the usual starting dose in ITP is one 50 mg tablet of Eltrombopag MSN once daily. For patients of East Asian or Southeast Asian origin, treatment may need to be initiated at a lower dose of 25 mg.

Children (aged 1 to 5 years) – the usual starting dose in ITP is one 25 mg tablet of Eltrombopag MSN once daily.

Hepatitis C

Adults – the usual starting dose in hepatitis C is one 25 mg tablet of Eltrombopag MSN once daily. For patients of East Asian or Southeast Asian origin, treatment should be initiated at the same dose of 25 mg.

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

How to take the tablets

Swallow the tablets whole with water.

When to take the medicine

Make sure that during:

• 4 hours before taking Eltrombopag MSN
• and 2 hours after taking Eltrombopag MSN

the patient does not consume the following foods:

• Dairy products, such as cheese, butter, yogurt, ice cream
• Milk or milk-based shakes, milk-containing beverages, yogurts, or cream
• Acid-reducing medicines used to treat indigestion and heartburn
• certain vitamin and mineral supplements containing iron, calcium, magnesium, aluminum, selenium, or zinc

Failure to follow these instructions may result in inadequate absorption of Eltrombopag MSN by the body.

Taking Eltrombopag MSN

Talk to your doctor for more information about suitable foods and drinks.

Taking more Eltrombopag MSN than prescribed

Contact your doctor or pharmacist immediately. If possible, show them the medicine packaging or this leaflet. The patient's condition will be monitored to detect any adverse effects, and appropriate treatment will be initiated promptly.

Missing a dose of Eltrombopag MSN

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

Stopping Eltrombopag MSN

Do not stop taking Eltrombopag MSN without consulting your 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 you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Symptoms to be aware of: seek medical advice
In patients taking Eltrombopag MSN for the treatment of ITP or low platelet count associated with hepatitis C, symptoms of serious adverse reactions 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 MSN may worsen this risk. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may occur in up to 1 in 100 people.

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

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

Liver function disorders
Eltrombopag MSN 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 people. Other liver-related problems are uncommon and may affect up to 1 in 100 people.
If any of the following symptoms of liver dysfunction occur:

• yellowing of the skin or the 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 MSN, the patient's platelet count decreases to the level observed before starting Eltrombopag MSN. Low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after stopping Eltrombopag MSN.
Tell your doctor immediately if bruising or bleeding occurs after stopping Eltrombopag MSN.
Some patients may experience gastrointestinal bleeding after stopping peginterferon, ribavirin, and Eltrombopag MSN. Symptoms include:

• black, tarry stools (change in stool colour is an uncommon adverse effect, occurring in no more than 1 in 100 people)
• 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 in association with treatment with Eltrombopag MSN in adult patients with ITP:
Very common adverse reactions
May occur in more than 1 in 10 people:

• 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 people:

• 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, blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of sinuses
• inflammation (swelling) and infection of tonsils
• infection of lungs, sinuses, nose and throat
• gingivitis
• loss of appetite
• tingling, pricking or numbness sensation
• reduced skin sensation
• drowsiness
• ear pain
• pain, swelling and tenderness in one leg (usually calf) with warm skin at the affected site (symptoms of deep vein thrombosis)
• localized swelling filled with blood from a damaged blood vessel (haematoma)
• hot flushes
• mouth disorders, including dry mouth, mouth pain, sore tongue, 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 number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin concentration
• increased number of eosinophils
• increased number of white blood cells (leukocytosis)
• increased uric acid concentration
• decreased potassium concentration
• increased creatinine concentration
• increased alkaline phosphatase activity
• increased liver enzyme activity (aspartate aminotransferase, AspAT)
• increased bilirubin concentration in blood (a substance produced by the liver)
• increased concentration of certain proteins

Uncommon adverse reactions
May occur in no more than 1 in 100 people:

• allergic reaction
• interruption of blood supply 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 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, breathing disturbances during sleep
• 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, stool colour change, abdominal bloating, constipation
• mouth 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) through the skin
• sensation of foreign body
• kidney disorders including: nephritis, 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
• 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 number of myelocytes
• increased number of neutrophilic band granulocytes
• increased blood urea concentration
• increased protein concentration in urine
• increased albumin concentration in blood
• increased total protein concentration
• decreased albumin concentration in blood
• increased urine pH
• increased haemoglobin concentration

The following additional adverse reactions have been reported in association with treatment with Eltrombopag MSN in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, tell 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, 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
• oral disorders, including dry mouth, oral pain, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse reactions have been reported in association with treatment with Eltrombopag MSN in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse reactions
May occur in more than 1 in 10 people:

• headache
• loss of appetite
• cough
• nausea, diarrhoea
• muscle pain, muscle weakness
• itching
• feeling of fatigue
• fever
• unusual hair loss
• weakness
• flu-like illness
• swelling of hands or feet
• chills

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

• decreased number of red blood cells (anaemia)

Common adverse reactions
May occur in no more than 1 in 10 people:

• 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 disturbances, mood changes
• brain dysfunction due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye disorders, including: lens opacity (cataract), dry eye syndrome, small yellow deposits on retina, yellowing of the whites of the eyes or skin
• retinal haemorrhage
• sensation of spinning (dizziness)
• rapid or irregular heartbeat (palpitations), shortness of breath
• cough with sputum, runny nose, flu, cold sores, sore throat and discomfort when swallowing
• gastrointestinal disorders, including: vomiting, abdominal pain, indigestion, constipation, bloating, 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 disease (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 nose, sinuses, throat and upper respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the 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 number of neutrophilic granulocytes
• 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 people:

• pain during urination
• heart rhythm disorders (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 bringing blood to the liver (possible liver and (or) gastrointestinal damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at injection site, chest discomfort
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following adverse reactions have been reported in association with treatment with Eltrombopag MSN in patients with severe aplastic anaemia (SAA):
If these adverse reactions worsen, inform your treating doctor, pharmacist or nurse.
Very common adverse reactions
May occur in more than 1 in 10 people:

• cough
• headache
• mouth and throat pain
• diarrhoea
• nausea
• joint pain
• limb pain (arms, legs, hands and feet)
• dizziness
• feeling of extreme fatigue
• fever
• chills
• eye itching
• 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 people:

• anxiety
• depression
• feeling of cold
• general malaise
• eye disorders, including: vision disturbances, blurred vision, lens opacity (cataract), spots or deposits in the eye (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 bloating, gas in the digestive tract, constipation, intestinal peristalsis disorders which may cause constipation, bloating, diarrhoea and (or) the above-mentioned symptoms, stool colour change
• fainting
• skin disorders, including: small red or purple spots due to bleeding under the skin (petechiae), rash, itching, urticaria, skin changes
• back pain
• muscle pain
• bone pain
• weakness
• swelling of lower limbs due to fluid accumulation
• abnormal urine colour
• interruption of blood supply to the spleen (splenic infarction)
• watery nasal discharge

Common adverse reactions that may be detected in blood test results

• increased enzyme activity due to muscle breakdown (creatine kinase)
• iron accumulation in the body (iron overload)
• decreased blood sugar concentration (hypoglycaemia)
• increased bilirubin concentration in blood (a substance produced by the liver)
• decreased number of white blood cells

Adverse reactions with unknown frequency
Frequency cannot be estimated from the available data

• skin depigmentation
• darker skin pigmentation
• drug-induced liver injury

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Eltrombopag MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging 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 should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Eltrombopag MSN contains
The active substance is eltrombopag.
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.

The other ingredients are:
Tablet core: mannitol (E 421), povidone (E 1201), microcrystalline cellulose (E 460(i)), sodium carboxymethyl starch, magnesium stearate (E 470b).
Tablet coating:
[25 mg]: hypromellose (E 464), titanium dioxide (E 171), polyethylene glycol (E 1521), yellow iron oxide (E 172), red iron oxide (E 172).
[50 mg]: hypromellose (E 464), titanium dioxide (E 171), polyethylene glycol (E 1521), indigo carmine aluminium lake (E 132), yellow iron oxide (E 172).
[75 mg]: hypromellose (E 464), red iron oxide (E 172), polyethylene glycol (E 1521), titanium dioxide (E 171), black iron oxide (E 172), yellow iron oxide (E 172).

What Eltrombopag MSN looks like and contents of the pack
Eltrombopag MSN 25 mg film-coated tablets are light orange to orange, round, biconvex film-coated tablets with a diameter of approximately 7 mm, printed with "ME" on one side and "13" on the other.
Eltrombopag MSN 50 mg film-coated tablets are light blue to blue, round, biconvex film-coated tablets with a diameter of approximately 9 mm, printed with "ME" on one side and "14" on the other.
Eltrombopag MSN 75 mg film-coated tablets are brown, round, biconvex film-coated tablets with a diameter of approximately 10 mm, printed with "ME" on one side and "15" on the other.

The film-coated tablets are supplied in aluminium blisters packed in a cardboard box containing 14 or 28 film-coated tablets, and in multi-packs containing 84 film-coated tablets (3 packs of 28 film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
(company logo)

Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Eltrombopag MSN
Croatia: Eltrombopag MSN 25 mg filmom obložene
Eltrombopag MSN 50 mg filmom obložene
Eltrombopag MSN 75 mg filmom obložene
Slovenia: Eltrombopag MSN 25 mg filmsko obložene tablete
Eltrombopag MSN 50 mg filmsko obložene tablete
Eltrombopag MSN 75 mg filmsko obložene tablete
Romania: Eltrombopag MSN 25 mg comprimate filmate
Eltrombopag MSN 50 mg comprimate filmate
Eltrombopag MSN 75 mg comprimate filmate
Poland: Eltrombopag MSN
Bulgaria: Елтромбопаг MSN 25 mg филмирани таблетки
Елтромбопаг MSN 50 mg филмирани таблетки
Елтромбопаг MSN 75 mg филмирани таблетки
Estonia: Eltrombopag MSN
Hungary: Eltrombopag MSN 25 mg filmtabletta
Eltrombopag MSN 50 mg filmtabletta
Eltrombopag MSN 75 mg filmtabletta
Lithuania: Eltrombopag MSN 25 mg plėvele dengtos tabletės
Eltrombopag MSN 50 mg plėvele dengtos tabletės
Eltrombopag MSN 75 mg plėvele dengtos tabletės
Slovakia: Eltrombopag MSN