ELTROMBOPAG EG

Patient Information Leaflet

Eltrombopag EG 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Eltrombopag EG contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to help increase the number of platelets in the blood.
Platelets are blood cells that help reduce or prevent bleeding.

• Eltrombopag EG is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients (over 1 year of age) who have already taken other medicines (corticosteroids or immunoglobulins) that were not effective.
• ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms in patients with ITP may include petechiae (small flat red round spots on the skin), bruising, nosebleeds (epistaxis), bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.
• Eltrombopag EG may also be used to treat low platelet counts (thrombocytopenia) in adult patients with hepatitis C virus (HCV) if they have experienced problems due to adverse reactions during interferon treatment. Many people with hepatitis C have a low platelet count not only as a result of the disease itself but also due to certain antiviral medicines used to treat it. Taking Eltrombopag EG may make it easier for you to complete a full course of antiviral therapy (pegylated interferon and ribavirin).
• Eltrombopag EG may also be used to treat adult patients with low blood cell counts due to severe aplastic anaemia (SAA). SAA is a disease in which the bone marrow is damaged, leading to a deficiency of red blood cells (anaemia), white blood cells (leucopenia), and platelets (thrombocytopenia).

2. What you need to know before taking Eltrombopag EG

DO NOT take Eltrombopag EG

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6). - Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking Eltrombopag EG:

• if you have liver problems. People who have a low platelet count and advanced chronic (long-term) liver disease are at higher risk of experiencing side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking Eltrombopag EG outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in veins or arteries, or if you know that blood clotting is common in your family. You may be at higher risk of developing blood clots:
• as you get older
• if you have had to stay in bed for a long time
• if you have cancer
• if you are taking birth control pills or hormone replacement therapy
• if you have recently had surgery or suffered physical trauma
• if you are very overweight (obese)
• if you smoke
• if you have advanced chronic liver disease  If any of these apply to you, inform your doctor before starting treatment. You must not take Eltrombopag EG unless your doctor considers that the expected benefits outweigh the risk of blood clots.
• if you suffer from cataracts (clouding of the eye's lens)
• if you suffer from another blood disorder, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check that you do not have this blood disorder before you start taking Eltrombopag EG.
• If you have MDS and take Eltrombopag EG, your MDS may worsen.  Inform your doctor if any of these apply to you.

Eye examinations
Your doctor will recommend regular check-ups for cataracts. If you do not have routine eye examinations, your doctor will schedule regular eye exams. You may also be monitored for any bleeding in or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular monitoring
Before starting Eltrombopag EG, your doctor will perform blood tests to check your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag may alter blood test results, which could be signs of liver damage:

• an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate aminotransferase. If you are receiving interferon treatment in combination with Eltrombopag EG for low platelet count due to hepatitis C, some liver problems may worsen.

You will need blood tests to monitor liver function before starting Eltrombopag EG and at regular intervals during treatment. You may need to stop taking Eltrombopag EG if levels of these substances rise too much, or if other signs of liver damage appear.
 Read the information ‘ Liver problems’ in section 4 of this Leaflet.
Blood tests for platelet count
If you stop taking Eltrombopag EG, your platelet count is likely to drop again within a few days. Your platelet count will be monitored, and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clots. However, blood clots can also form when the platelet count is normal or even low. Your doctor will adjust the dose of Eltrombopag EG to ensure that your platelet count does not rise too much.

Seek immediate medical help if you experience any of the following signs indicating a blood clot:

• swelling, pain, or tenderness in one leg
• sudden onset of breathlessness, especially together with sharp chest pain or rapid breathing
• abdominal (stomach) pain, abdominal swelling, blood in stools

Tests to monitor bone marrow
In people who may have bone marrow problems, medicines such as eltrombopag could worsen these issues. Signs of bone marrow abnormalities may appear as abnormalities in blood test results.
Your doctor may perform tests to directly monitor your bone marrow during treatment with Eltrombopag EG.
Monitoring for gastrointestinal bleeding
If you are treated with interferon-containing medicines in combination with Eltrombopag EG, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Eltrombopag EG.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag EG and may perform an electrocardiogram (ECG).
Elderly people (65 years and over)
There is limited data on the use of eltrombopag in patients aged 65 years and older. Exercise caution when taking Eltrombopag EG if you are aged 65 years or older.
Children and adolescents
Eltrombopag EG is not recommended for children under 1 year of age with ITP. It is also not recommended for people under 18 years of age with low platelet count due to hepatitis C or severe aplastic anaemia.
Other medicines and Eltrombopag EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines taken without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag EG – including prescription and over-the-counter medicines and minerals. These include:

• antacids used to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it’ in section 3)
• medicines called statins, used to lower cholesterol
• some medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine used in transplantation and immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be found in vitamin and mineral supplements (see also “When to take it” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer  Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Eltrombopag EG, or you may need a dose adjustment, or the timing of administration may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, suggest appropriate substitutions.

There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol and/or azathioprine, you may need to take a lower dose or stop taking them while on Eltrombopag EG.
Eltrombopag EG with food and drink
Do not take Eltrombopag EG with food or drinks containing milk, as the calcium in dairy products affects the absorption of the medicine. For further information, see ‘When to take it’ in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag EG during pregnancy unless specifically recommended by your doctor.
The effect of eltrombopag during pregnancy is not known.

• Inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy.
• Use a reliable method of contraception while taking Eltrombopag EG to prevent pregnancy.
• If you become pregnant during treatment with Eltrombopag EG, inform your doctor.

Do not breastfeed while taking Eltrombopag EG. It is not known whether eltrombopag passes into breast milk.
 If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Eltrombopag EG may cause dizziness and other side effects that may reduce your attention.
 Do not drive or operate machinery unless you are sure you are not affected.
Eltrombopag EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Eltrombopag EG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag EG unless your
doctor or pharmacist advises you to do so. While taking Eltrombopag EG, you will be under the care
of a doctor experienced in the treatment of your condition.
How much to take
For ITP
Adults and children (6 to 17 years) – the recommended starting dose for ITP is one 50 mg tablet
of Eltrombopag EG daily. If you are of East or Southeast Asian origin, you may need to start with
a lower dose of 25 mg.
Children (1 to 5 years) – the recommended starting dose for ITP is one 25 mg tablet of
Eltrombopag EG daily.
For Hepatitis C
Adults – the recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag EG
daily. If you are of East or Southeast Asian origin, you will start with the same dose of 25 mg.
For SAA
Adults – the recommended starting dose for SAA is one 50 mg tablet of Eltrombopag EG
daily. If you are of East or Southeast Asian origin, you may need to start with a lower dose of
25 mg.
Eltrombopag EG may take 1 to 2 weeks to take effect. Based on your response to Eltrombopag
EG, your doctor may recommend adjusting the daily dose.
How to take the tablets
Swallow the tablet whole with some water.
Only for Eltrombopag EG 25 mg and 50 mg film-coated tablets:
The tablet may be divided into equal doses.
When to take it
Make sure that

• in the 4 hours before taking Eltrombopag EG
• and in the 2 hours after taking Eltrombopag EG

you do not consume any of the following:

• dairy products such as cheese, butter, yoghurt, or ice cream
• milk or milk-based shakes , milk-containing drinks, yoghurt, or cream
• antacids , a type of medicine for indigestion and heartburn
• certain vitamin and mineral supplements including iron, calcium, magnesium, aluminium, selenium, and zinc.

If you do, the medicine will not be properly absorbed by your body.
NO dairy products, antacids, or mineral supplements!

For further advice on suitable foods and drinks, consult your doctor.
If you take more Eltrombopag EG than you should
Contact your doctor or pharmacist immediately. If possible, show them the packaging or this
leaflet. You will be monitored for any signs or symptoms of adverse effects and treated appropriately without delay.
If you forget to take Eltrombopag EG
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag EG in a day.
If you stop taking Eltrombopag EG
Do not stop taking Eltrombopag EG without talking to 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Symptoms requiring attention: consult a doctor
People taking Eltrombopag EG for ITP or for low platelet count due to hepatitis C may develop signs of potentially serious side effects. It is important to inform your doctor if you experience any of these symptoms.

Increased risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as eltrombopag may worsen this problem. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs or symptoms of a blood clot, such as:

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

Liver problems
Eltrombopag may cause changes detectable in blood tests, which may indicate liver damage. Liver problems (increased liver enzymes detected in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.
If you experience any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• unusually dark-coloured urine
  ⇒ Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks after stopping Eltrombopag EG, platelet counts usually decrease to the level they were before starting Eltrombopag EG. A lower platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Eltrombopag EG.
⇒ Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag EG.
Some people have experienced gastrointestinal bleeding after stopping treatment:

• dark stools (change in stool colour is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or material resembling coffee grounds
  ⇒ Inform your doctor immediately if you experience any of these symptoms.

The following side effects have been reported in association with eltrombopag treatment in adult patients with ITP:
Very common side effects
These may affect more than 1 in 10 people:

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

Very common side effects detectable in blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

Common side effects
These may affect up to 1 in 10 people:

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstrual periods
• sore throat and pain when swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain, blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils
• infections of the lungs, sinuses, nose, and throat
• inflammation of the gum tissue
• loss of appetite
• sensation of tingling, prickling, or numbness, commonly known as "pins and needles"
• decreased skin sensitivity
• feeling drowsy
• earache
• pain, swelling, and tenderness in one leg (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood from a rupture in a blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function abnormalities
• skin problems including excessive sweating, itchy irregular rash, red spots, skin appearance changes
• hair loss
• foamy, frothy, or fizzy-looking urine (signs of protein in the urine)
• high temperature, feeling hot
• chest pain
• feeling weak
• sleep problems, depression
• migraine
• decreased vision
• feeling dizzy (vertigo)
• gas/bloating due to digestion

Common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leucocytosis)
• increased levels of uric acid
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase (AST))
• increased bilirubin in the blood (a substance produced by the liver)
• increased levels of certain proteins

Uncommon side effects
These may affect up to 1 in 100 people:

• allergic reaction
• interruption of blood flow to part of the heart
• sudden breathing difficulty, especially if accompanied by sharp chest pain and/or rapid breathing, which may indicate a blood clot in the lungs (see 'Increased risk of blood clots' at the beginning of 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 could indicate blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which could indicate bile duct obstruction, liver injury, or liver damage due to inflammation (see 'Liver problems' at the beginning of section 4)
• drug-induced liver injury
• rapid heartbeat, irregular heartbeat, bluish skin colouration, heart rhythm disorders (QT prolongation), which could indicate cardiovascular disorders
• blood clot
• redness
• painful joint swelling due to uric acid (gout)
• loss of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech and nervous system disorders, tremor
• 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 problems including increased tear production, clouding of the eye lens (cataract), retinal bleeding, dry eyes
• problems with nose, throat, and sinuses, breathing problems during sleep
• blisters/ulcers in the mouth and throat
• loss of appetite
• digestive system problems including frequent bowel movements, food poisoning, blood in the stool, vomiting with blood
• bleeding from the rectum, change in stool colour, abdominal swelling, constipation
• mouth problems including dry mouth, painful mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling hot, anxiety
• redness or swelling around a wound
• bleeding around a skin catheter (if present)
• sensation of a foreign body
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweat
• general feeling of malaise
• skin infection
• skin changes including skin discolouration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects detectable in laboratory tests:

• changes in the shape of red blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increased number of myelocytes
• increased band neutrophils
• increased blood urea levels
• increased protein levels in urine
• increased albumin levels in blood
• increased total protein levels
• decreased albumin levels in blood
• increased urine pH
• increased haemoglobin levels

The following additional side effects have been reported in association with eltrombopag treatment in children (aged 1 to 17 years) with ITP:
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect more than 1 in 10 children:

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

Common side effects
These may affect up to 1 in 10 children:

• difficulty sleeping (insomnia)
• toothache
• pain in nose and throat
• itchy nose, runny or blocked nose
• sore throat, runny nose, nasal congestion, and sneezing
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with HCV:
Very common side effects
These may affect more than 1 in 10 people:

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

Very common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects
These may affect up to 1 in 10 people:

• urinary tract infections
• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory problems, mood changes
• decreased brain function due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye problems including clouding of the eye lens (cataract), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
• retinal bleeding
• feeling dizzy (vertigo)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat, and swallowing discomfort
• digestive system problems including vomiting, stomach ache, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels 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 'Liver problems' at the beginning of section 4)
• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands, or feet), muscle spasms
• irritability, general feeling of malaise, skin reaction such as redness or swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or extremities causing swelling
• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucosa lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common side effects detectable in blood tests:

• increased blood sugar (glucose)
• reduced number of white blood cells
• reduced number of neutrophils
• reduced albumin levels in blood
• reduced haemoglobin levels
• increased bilirubin in blood (a substance produced by the liver)
• changes in enzymes controlling blood clotting

Uncommon side effects
These may affect up to 1 in 100 people:

• pain during urination
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters/ulcers in the mouth, stomach inflammation
• skin changes including colour changes, peeling, redness, itching, lesions, and night sweats
• blood clots in a liver vein (possible liver and/or digestive system 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 in association with eltrombopag treatment in patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect more than 1 in 10 people:

• cough
• headache
• mouth and throat pain
• diarrhoea
• feeling unwell (nausea)
• joint pain (arthralgia)
• pain in extremities (arms, legs, hands, and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• mouth blisters
• bleeding gums
• abdominal pain
• muscle spasms

Very common side effects detectable in blood tests:

• abnormal changes in bone marrow cells
• increased liver enzyme levels (aspartate aminotransferase (AST))

Common side effects
These may affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (floaters in the vitreous), dry eyes, itchy eyes, yellowing of the skin or whites of the eyes
• nosebleeds
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach ache/discomfort, stomach bloating, gas during digestion, constipation, intestinal motility disorder that may cause constipation, bloating, diarrhoea, and/or the above-mentioned symptoms, change in stool colour
• fainting
• skin problems including small red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of lower limbs due to fluid accumulation
• abnormally coloured urine
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects detectable in blood tests:

• increased enzymes due to muscle injury (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decreased blood sugar levels (hypoglycaemia)
• increased bilirubin in blood (a substance produced by the liver)
• reduced number of white blood cells

Side effects with unknown frequency
Frequency cannot be determined from the available data:

• skin discolouration
• dark skin
• drug-induced liver injury

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Eltrombopag EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

The active substance is eltrombopag (as eltrombopag olamine).
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

Eltrombopag EG 25 mg film-coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (Type A), magnesium stearate.
Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc.

Eltrombopag EG 50 mg film-coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (Type A), magnesium stearate.
Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).

Eltrombopag EG 75 mg film-coated tablets
Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch (Type A), magnesium stearate.
Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).

Description of the appearance of Eltrombopag EG and pack contents
Eltrombopag EG 25 mg film-coated tablets
Film-coated tablets, white to pale yellow, round, biconvex, with a break line on one side, showing a dark red to brown colour when broken.

Eltrombopag EG 50 mg film-coated tablets
Film-coated tablets, brown, round, biconvex, with a break line on one side, showing a dark red to brown colour when broken.

Eltrombopag EG 75 mg film-coated tablets
Film-coated tablets, pink, round, biconvex.

Eltrombopag EG is available in blisters containing 14, 28 or 84 film-coated tablets, or in divisible unit-dose blisters containing 14x1, 28x1 or 84x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Stada Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel 61118 – Germany
Stada Arzneimittel GmbH, Muthgasse 36/2, Vienna 1190 – Austria
Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, E91 D768 – Ireland

This medicinal product is authorised in the European Economic Area countries under the following names:
AT Eltrombopag STADA 25 mg/50 mg/75 mg Filmtabletten
CY Eltrombopag/STADA
DE Eltrombopag AL 25 mg/50 mg/75 mg Filmtabletten
DK Eltrombopag STADA
EE Eltrombopag STADA
EL Eltrombopag/STADA
ES ELTROMBOPAG STADA 25 mg/50 mg/75 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
FI Eltrombopag STADA 25 mg/50 mg/75 mg kalvopäällysteiset tabletit
FR ELTROMBOPAG EG 25 mg/50 mg/75 mg, comprimé pelliculé
HU Eltrombopag Stada 25 mg/50 mg/75 mg filmtabletta
HR Eltrombopag STADA 25 mg/50 mg/75 mg filmom obložene tablete
IE Eltrombopag Clonmel 25 mg/50 mg/75 mg film-coated tablets
IS Eltrombopag STADA 25 mg/50 mg/75 mg filmuhúðaðar töflur
IT Eltrombopag EG
LT Eltrombopag STADA 25 mg/50 mg/75 mg plėvele dengtos tabletės
LV Eltrombopag STADA 25 mg/50 mg/75 mg apvalkotās tablets
MT Eltrombopag Clonmel 25 mg/50 mg/75 mg film-coated tablets
NL Eltrombopag STADA 25 mg/50 mg/75 mg filmomhulde tabletten
NO Eltrombopag STADA
PL Eltrombopag Stada
RO Eltrombopag Stada 25 mg/50 mg/75 mg comprimate filmate
SK Eltrombopag STADA 25 mg/50 mg/75 mg filmom obalené tablety
SI Eltrombopag STADA 25 mg/50 mg/75 mg filmsko obložene tablete
SE Eltrombopag STADA 25 mg/50 mg/75 mg filmdragerade tabletter