Eltrombopag Abdi

Patient Information Leaflet

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

eltrombopag
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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Eltrombopag Abdi 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 Abdi is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients (aged 1 year and older) 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 that patients with ITP may notice include petechiae (flat, round, red spots under the skin the size of a pinprick), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding from cuts or wounds.

• Eltrombopag Abdi may also be used to treat low platelet count (thrombocytopenia) in patients with hepatitis C virus (HCV) hepatitis who have experienced problems with adverse reactions during interferon therapy. 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 Abdi may make it easier for you to complete a full course of antiviral treatment (peginterferon and ribavirina).

2. What you need to know before taking Eltrombopag Abdi

Do not take Eltrombopag Abdi

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine

(listed in section 6 under ‘What Eltrombopag Abdi contains’).
➔ Check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor before taking Eltrombopag Abdi:

• if you have liver problems. People who have low platelet counts and advanced chronic (long-term) liver disease are at higher risk of experiencing adverse effects, including liver damage and life-threatening blood clots. If your doctor believes the benefits of taking Eltrombopag Abdi 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 increased risk of blood clot formation:
  • if you are elderly
  • if you have had to remain bedridden for a long time
  • if you have cancer
  • if you are taking oral contraceptives or hormone replacement therapy
  • if you have recently undergone 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 Abdi unless your doctor considers that the expected benefits outweigh the risk of blood clots.
• if you have cataracts (clouding of the eye's lens)
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to ensure you do not have this blood disorder before you start taking Eltrombopag Abdi. If you have MDS and take Eltrombopag Abdi, your MDS may worsen. ➔ Inform your doctor if any of these situations apply to you.

Eye examination
Your doctor will recommend regular check-ups for cataracts. If you do not have routine eye exams, your doctor will arrange regular monitoring. You may also be monitored for any signs of bleeding inside or around the retina (the layer of light-sensitive cells at the back of the eye).
Regular tests will be needed
Before starting Eltrombopag Abdi, your doctor will perform blood tests to monitor blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag Abdi may alter the results of blood tests that can indicate liver damage – such as increased levels of certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatment in combination with Eltrombopag Abdi for low platelet count due to hepatitis C, some liver problems may worsen.
Before starting Eltrombopag Abdi and at regular intervals during treatment, you will need blood tests to monitor liver function. You may need to stop taking Eltrombopag Abdi if levels of these enzymes rise too much, or if other physical signs of liver damage occur.
➔ Read the information ‘Liver problems’ in section 4 of this Leaflet.
Blood tests for platelet count
If you stop taking Eltrombopag Abdi, 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 clots. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust the dose of Eltrombopag Abdi 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 if accompanied by sharp chest pain or rapid breathing
• abdominal (stomach) pain, abdominal swelling, blood in stools

Tests to monitor bone marrow
In people with bone marrow problems, medicines such as Eltrombopag Abdi may worsen these conditions. Signs of bone marrow changes may appear as abnormalities in blood test results. Your doctor may perform tests to directly monitor your bone marrow during treatment with Eltrombopag Abdi.
Tests for gastrointestinal bleeding
If you are receiving interferon-based treatment in combination with Eltrombopag Abdi, you will be monitored for any signs of bleeding in the stomach or intestines after stopping Eltrombopag Abdi.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Abdi and may perform an electrocardiogram (ECG).
Elderly patients (65 years and over)
There is limited data on the use of Eltrombopag Abdi in patients aged 65 years and older. Caution is required when taking Eltrombopag Abdi if you are aged 65 or older.
Children and adolescents
Eltrombopag Abdi is not recommended in children under 1 year of age with ITP. It is also not recommended in individuals under 18 years of age with low platelet count due to hepatitis C or severe aplastic anemia.
Other medicines and Eltrombopag Abdi
Inform 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 Abdi – 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 for HIV infection, such as lopinavir and/or ritonavir

• cyclosporine, used in transplants or 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 Abdi, or you may need to adjust your dose or change the timing of administration. 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 Abdi.
  Eltrombopag Abdi with food and drinks
  Do not take Eltrombopag Abdi with dairy products or beverages containing 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 Abdi if you are pregnant unless specifically recommended by your doctor. The effect of Eltrombopag Abdi during pregnancy is unknown.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.

• Use a reliable method of contraception while taking Eltrombopag Abdi to prevent pregnancy.

• If you become pregnant during treatment with Eltrombopag Abdi, inform your doctor.

Do not breastfeed while taking Eltrombopag Abdi. It is not known whether Eltrombopag Abdi passes into breast milk.
➔ If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Eltrombopag Abdi may cause dizziness and other side effects that may reduce your ability to concentrate.
➔ Do not drive or operate machinery unless you are certain you are unaffected.
Eltrombopag Abdi 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 Abdi

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Abdi unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Abdi, you will be under the care of a doctor experienced in managing 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 Abdi 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 Abdi daily.

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

How to take the tablets
Swallow the tablet whole with some water.

When to take it
Make sure that –

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

Do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based shakes, drinks containing milk, 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 may not be properly absorbed into your body.

For further advice on suitable foods and drinks, please consult your doctor.
If you take more Eltrombopag Abdi 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 side effects and will receive appropriate treatment immediately.
If you forget to take Eltrombopag Abdi
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Abdi in a day.
If you stop taking Eltrombopag Abdi
Do not stop taking Eltrombopag Abdi without talking to your doctor. If your doctor advises you to stop treatment, your platelet count will be checked 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 everybody gets them.
Symptoms requiring attention: consult a doctor
People taking Eltrombopag Abdi for ITP or low platelet counts in the blood 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 Abdi 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 and 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), abdominal swelling, blood in the stool.

Liver problems
Eltrombopag Abdi may cause changes detectable in blood tests, which 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 Abdi, platelet counts in the blood usually decrease to the level they were before starting Eltrombopag Abdi. 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 stopping Eltrombopag Abdi.
➔ Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Abdi.
Some people have gastrointestinal bleeding after stopping treatment with peginterferon, ribavirin, and Eltrombopag Abdi. 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 Abdi 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 detected by blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

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

• muscle pain, muscle cramp, muscle weakness
• bone pain
• heavy menstrual period
• 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
• infection 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
• ear pain
• pain, swelling, and tightness 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 due to rupture of a blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormalities in liver function
• skin problems 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 weak
• sleep problems, depression
• migraine
• decreased vision
• feeling dizzy (vertigo)
• gas/bloating due to digestion

Common side effects that may be detected by 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 shortness of breath, especially if accompanied by sharp chest pain and/or rapid breathing, which could 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)
• liver damage due to medication
• increased heart rate, irregular heartbeat, bluish skin discolouration, heart rhythm disorders (QT prolongation), which could indicate heart and blood vessel problems
• blood clot
• redness
• painful swelling of joints due to uric acid (gout)
• loss of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech difficulties, nerve function issues, 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
• nose, throat, and sinus problems, breathing problems during sleep
• mouth and throat blisters/ulcers
• loss of appetite
• digestive 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, sore mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling of warmth, feeling anxious
• 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
• feeling of general discomfort
• 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 detected by laboratory tests:

• changes in the shape of red blood cells
• presence of abnormal white blood cell development, 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 treatment with
Eltrombopag Abdi 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, sore mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported in association with treatment with
Eltrombopag Abdi 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 that may be detected by blood tests:

• decreased number of red blood cells (anaemia)

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

• urinary tract infection
• inflammation of the nose, throat, and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention 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 pain when swallowing
• digestive problems, including vomiting, stomach ache, indigestion, constipation, stomach swelling, taste disturbances, haemorrhoids, pain/discomfort in the stomach, 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 damage (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, limb pain (in arms, legs, hands or feet), muscle cramps
• irritability, general feeling of discomfort, skin reaction such as redness, 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 mucous lining of the bronchi
• depression, anxiety, sleep disorders, nervousness

Common side effects that may be detected by blood tests:

• increased blood sugar (glucose)
• decreased number of white blood cells
• decreased number of neutrophils
• decreased albumin levels in blood
• decreased 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:

• painful urination
• heart rhythm disorders (QT interval prolongation)
• gastrointestinal 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
• 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 treatment with
Eltrombopag Abdi 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)
limb pain (arms, legs, hands, and feet)
dizziness
feeling very tired
fever
chills
itchy eyes
mouth blisters
bleeding gums
abdominal pain
muscle cramps
Very common side effects that may be detected by 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 discomfort
eye problems, including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eyes, eye itching, yellowing of the whites of the eyes or skin
nosebleeds
digestive problems, including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, stomach swelling, gas/bloating during digestion, constipation, intestinal motility disorders that may cause constipation, bloating, diarrhoea and/or the above-mentioned symptoms, change in stool colour
fainting
skin problems, including small red spots or purpura 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 detected by 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)
decreased white blood cell levels
Side effects with unknown frequency
Frequency cannot be estimated from the available data
change in skin colour
darkening of the skin
liver damage due to medication
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 helps provide more information on the safety of this medicine.

5. How to store Eltrombopag Abdi

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./EXP.
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 Abdi contains
25 mg film-coated tablets
50 mg film-coated tablets
75 mg film-coated tablets
The other ingredients are: hypromellose, macrogol/PEG, magnesium stearate, mannitol (E421), microcrystalline cellulose (Type 101), microcrystalline cellulose (Type 102), povidone (K30), sodium starch glycolate (Type A), titanium dioxide (E171).
Eltrombopag Abdi 25 mg and 50 mg film-coated tablets also contain yellow iron oxide (E172), red iron oxide (E172).
Eltrombopag Abdi 75 mg film-coated tablets also contain red iron oxide (E172).

Description of the appearance of Eltrombopag Abdi and contents of the pack
Eltrombopag Abdi 25 mg film-coated tablets (7.5 mm) are round, biconvex, brown, with "E1" engraved on one side and smooth on the other.
Eltrombopag Abdi 50 mg film-coated tablets (10.7 mm) are round, biconvex, brown, with "E2" engraved on one side and smooth on the other.
Eltrombopag Abdi 75 mg film-coated tablets (12.1 mm) are round, biconvex, reddish-brown, with "E3" engraved on one side and smooth on the other.
They are supplied in PVC/OPA/Al – aluminium blisters in packs containing 14 or 28 film-coated tablets and in a multiple pack containing 84 (3 packs of 28) film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturer
Flavine Pharma France
3 Voie d’Allemagne,
13127 Vitrolles
France
Interpharma Services Ltd.
43A Cherni Vrah Blvd.
1407 Sofia
Bulgaria
Pharmadox Healthcare Limited
KW20a Kordin Industrial Park
Paola PLA 3000,
Malta
Abdi Farma GmbH
Donnersbergstraße 1
64646 Heppenheim,
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names: