Eltrombopag Accord

Package leaflet: Information for the patient

Eltrombopag Accord 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet

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

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

Eltrombopag Accord 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 Accord 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 spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.

• Eltrombopag Accord may also be used to treat low platelet counts ( thrombocytopenia ) in patients with hepatitis C virus (HCV) if they have experienced problems due to adverse reactions during interferon therapy. Many people with hepatitis C have low platelet counts not only as a result of the disease itself but also due to certain antiviral medicines used to treat it. Taking Eltrombopag may make it easier for you to complete a full course of antiviral treatment (peginterferon and ribavirin).

2. What you need to know before taking Eltrombopag Accord

Do not take Eltrombopag Accord

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 under ‘What Eltrombopag Accord contains’). Check with your doctor if you think this applies to you.

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

• 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 Accord 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 clots are common in your family. You may be at increased risk of blood clot formation:
  • if you are elderly
  • if you have been bedridden for a long time
  • if you have cancer
  • if you are taking oral contraceptives for birth control or hormone replacement therapy
  • if you have recently undergone surgery or suffered physical trauma
  • if you are very overweight (obese)
  • if you are a smoker
  • 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 Accord unless your doctor considers that the expected benefits outweigh the risks of blood clot formation.
• 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 Accord. If you have MDS and take Eltrombopag Accord, your MDS may worsen. Inform your doctor if any of these apply to you.

Eye examination
Your doctor will recommend regular checks 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 blood tests
Before starting Eltrombopag Accord, your doctor will perform blood tests to monitor your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag Accord may alter blood test results, which could indicate liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatment in combination with Eltrombopag Accord 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 Accord and during treatment. You may need to stop taking Eltrombopag Accord if levels of these enzymes rise too much, or if physical 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 Accord, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored, and your doctor will advise you on appropriate precautions.
A very high platelet count may increase the risk of blood clot formation. However, blood clots can also form when platelet count is normal or even low. Your doctor will adjust your dose of Eltrombopag Accord to ensure that your platelet count does not increase 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 pain, abdominal swelling, blood in the stool
Bone marrow monitoring
In people who may have bone marrow problems, medicines such as Eltrombopag Accord 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 Accord.
Monitoring for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Eltrombopag Accord, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Eltrombopag Accord.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Accord and may perform an electrocardiogram (ECG).
Elderly people (65 years and older)
There is limited data on the use of Eltrombopag Accord in patients aged 65 years and older. Exercise caution when taking Eltrombopag Accord if you are aged 65 years or older.
Children and adolescents
Eltrombopag Accord 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.
Other medicines and Eltrombopag Accord
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 common medicines interact with Eltrombopag Accord – 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)
• statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplants and immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc 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 Accord, or you may need to have your dose adjusted, or the timing of administration 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 Accord.
Eltrombopag Accord with food and drink
Do not take Eltrombopag Accord with beverages or dairy products such as milk or cheese, 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 Accord if you are pregnant unless specifically recommended by your doctor. The effects of Eltrombopag Accord during pregnancy are unknown.

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

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

3. How to take Eltrombopag Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Accord unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Accord, you will be under the care of a doctor experienced in treating your condition.

How much to take

For ITP

Adults and children (6 to 17 years of age) – the recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Accord 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 of age) – the recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Accord daily.

For Hepatitis C

Adults – the recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Accord daily. If you are of East or Southeast Asian origin, you will start with the same dose of 25 mg.

Eltrombopag Accord may take 1 to 2 weeks to take effect. Based on your response to Eltrombopag Accord, your doctor may recommend adjusting your daily dose.

How to take the tablets

Swallow the tablet whole with some water.

When to take it

Make sure that-

• during the 4 hours before taking Eltrombopag Accord
• and during the 2 hours after taking Eltrombopag Accord

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based smoothies, milk-containing drinks, yoghurt, or cream
• antacids, a type of medicine used 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 into your body.

Take Eltrombopag Accord
For 4 hours before ... and for 2 hours after
taking
Eltrombopag…
NO dairy products, antacids, or
mineral supplements
For further advice on suitable foods and drinks, consult your doctor.
If you take more Eltrombopag Accord than you should
Contact your doctor or pharmacist immediately. If possible, show them the pack 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 Accord
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Accord in a single day.
If you stop taking Eltrombopag Accord
Do not stop taking Eltrombopag Accord 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 doubts 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 everyone gets them.
Symptoms requiring attention: consult a doctor
People taking Eltrombopag Accord for ITP or 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 Accord could 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 acute chest pain or rapid breathing
• abdominal pain (stomach pain), abdominal swelling, blood in the stool.

Liver problems
Eltrombopag Accord may cause changes detectable in blood tests that could 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 have any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine that is unusually dark in colour
  Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks of stopping Eltrombopag Accord, platelet counts usually decrease to the level they were before starting Eltrombopag Accord. 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 Accord.
Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Accord.
Some people have gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and Eltrombopag Accord. Symptoms include:

• 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 treatment with Eltrombopag Accord in adult patients with ITP:
Very common side effects
These may affect more than 1 in 10 people:

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

Very common side effects that may be evident from blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

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

• muscle pain, muscle spasms, 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
• herpes labialis (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, pricking, or numbness, commonly known as "pins and needles"
• decreased skin sensitivity
• feeling of drowsiness
• earache
• pain, swelling, and tenderness in one of the legs (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood from a broken blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormalities in liver function
• skin disorders including excessive sweating, itchy irregular rash, red spots, changes in skin appearance
• hair loss
• urine that appears foamy, frothy, or fizzy (signs of protein in the urine)
• high temperature, feeling hot
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (dizziness)
• gas/bloating due to digestion

Common side effects that may be evident from blood tests:

• decrease in red blood cell count (anaemia)
• decrease in platelet count (thrombocytopenia)
• decrease in white blood cell count
• decrease in haemoglobin levels
• increase in eosinophils
• increase in white blood cell count (leucocytosis)
• increase in uric acid levels
• decrease in potassium levels
• increase in creatinine levels
• increase in alkaline phosphatase levels
• increase in liver enzymes (aspartate aminotransferase (AST))
• increase in blood bilirubin (a substance produced by the liver)
• increase in 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 failure, especially if accompanied by acute chest pain and/or rapid breathing, which may be a sign of 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 caused by blockage of the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could be signs of blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which could be signs of 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 colour, heart rhythm disorders (QT prolongation), which could be signs of a heart or blood vessel disorder
• blood clot
• redness
• painful swelling of joints due to uric acid (gout)
• lack of interest, mood changes, crying that is difficult to stop or occurs unexpectedly
• 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's lens (cataract), retinal bleeding, dry eyes
• problems with nose, throat, and sinuses, breathing problems during sleep
• mouth and throat blisters/ulcers
• 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, feeling of anxiety
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• sensation of a foreign body
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweat
• feeling of general malaise
• skin infection
• skin changes including skin discolouration, peeling, redness, itching, and sweating
• muscle weakness
• cancer of the rectum and colon

Uncommon side effects that may be evident from laboratory tests:

• changes in the shape of red blood cells
• presence of abnormal white blood cell development, which may indicate certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increase in myelocytes
• increase in band neutrophils
• increase in blood urea
• increase in protein levels in urine
• increase in albumin levels in blood
• increase in total protein levels
• decrease in albumin levels in blood
• increase in urine pH
• increase in haemoglobin level

The following side effects have been reported in association with treatment with Eltrombopag Accord in paediatric patients (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 airways, 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 treatment with Eltrombopag Accord 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 of weakness
• flu-like illness
• swelling of hands or feet
• chills

Very common side effects that may be evident from blood tests:

• decrease in red blood cell count (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 disturbances, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes
• decreased brain function following liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye problems including clouding of the eye's lens (cataract), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
• retinal bleeding
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat, and discomfort when swallowing
• digestive system problems including vomiting, stomach ache, indigestion, constipation, stomach swelling, 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 airways, common cold (upper respiratory tract infection), inflammation of the mucosa lining the bronchi
• depression, anxiety, sleep disturbances, nervousness

Common side effects that may be evident from blood tests:

• increased blood sugar (glucose)
• reduced white blood cell count
• reduced neutrophil count
• reduced albumin in blood
• reduced haemoglobin level
• increased bilirubin (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
• mouth blisters/ulcers, 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
• decrease in red blood cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported in association with treatment with Eltrombopag 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 up to 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 that may be evident from 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
• feeling of general malaise
• eye problems including vision problems, blurred vision, clouding of the eye's lens (cataract), spots or deposits in the eye (vitreous floaters), 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 swelling, 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 caused by 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 that may be evident from blood tests:

• increased enzymes due to muscle injury (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increase in bilirubin in blood (a substance produced by the liver)
• decrease in white blood cell count

Side effects with unknown frequency
Frequency cannot be estimated 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Accord

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

What Eltrombopag Accord contains
12.5 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.
25 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
50 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
75 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other excipients are: mannitol, povidone, microcrystalline cellulose, sodium starch glycolate,
magnesium stearate, isomalt (E 953), calcium silicate, hypromellose, titanium dioxide (E171), triacetin,
iron oxide red (E172) and iron oxide yellow (E172) [except for the 75 mg tablet].

Description of the appearance of Eltrombopag Accord and contents of the pack
Eltrombopag Accord 12.5 mg film-coated tablets
Round, biconvex, film-coated tablet, orange to brown in colour, marked with "I" on one side, approximately 5.5 mm in diameter.
Eltrombopag Accord 25 mg film-coated tablets
Round, biconvex, film-coated tablet, dark pink in colour, marked with "II" on one side, approximately 8 mm in diameter.
Eltrombopag Accord 50 mg film-coated tablets
Round, biconvex, film-coated tablet, pink in colour, marked with "III" on one side, approximately 10 mm in diameter.
Eltrombopag Accord 75 mg film-coated tablets
Round, biconvex, film-coated tablet, red to brown in colour, marked with "IV" on one side, approximately 12 mm in diameter.

Supplied in aluminium blisters (OPA/Alu/PVC-Alu) in packs containing 14 or 28 tablets, and multiple packs containing 84 (3 packs of 28) tablets, or in perforated aluminium blisters (OPA/Alu/PVC-Alu) in a carton containing 14 x 1 or 28 x 1 tablets and multiple packs containing 84 x 1 (3 packs of 28 x 1) tablets.
The multiple pack containing 84 (3 packs of 28) and 84 x 1 (3 packs of 28 x 1) tablets is not applicable for the 12.5 mg dosage strength.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice, Poland
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.