Eltrombopag Zentiva

Patient Information Leaflet: Information for the User

Eltrombopag Zentiva 25 mg film-coated tablets, 50 mg film-coated tablets

Generic medicine
Please 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 they have the same symptoms as yours, because 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.
• The information in this leaflet is intended for you or for the child, but only the term "you" will be used throughout the text.

Contents of this leaflet

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

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

Eltrombopag Zentiva 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 Zentiva is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already been treated with 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, bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.
Eltrombopag Zentiva may also be used to treat low platelet count (thrombocytopenia) in patients with hepatitis C virus (HCV) infection, if they 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 Zentiva may make it easier for you to complete a full course of antiviral treatment (pegylated interferon and ribavirin).

2. What you should know before taking Eltrombopag Zentiva

Do not take Eltrombopag Zentiva

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

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

• 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 this medicine outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in your veins or arteries, or if you know that blood clots are common in your family. You may be at increased risk of developing blood clots if:
• you are elderly
• you have had to stay in bed for a long time
• you have a tumour
• you are taking contraceptive pills or hormone replacement therapy
• you have recently undergone surgery or suffered physical trauma
• you are very overweight (obese)
• you are a smoker
• you have advanced chronic liver disease
  If any of these apply to you, inform your doctor before starting treatment. You must not take Eltrombopag Zentiva 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 Zentiva. If you have MDS and take this medicine, 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 routinely have eye examinations, your doctor will arrange regular eye exams. You may also be monitored for any bleeding in the retina or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular tests
Before starting Eltrombopag Zentiva, your doctor will carry out 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 the results of blood tests, which could be signs of liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate aminotransferase. If you are receiving interferon-based treatments in combination with Eltrombopag Zentiva 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 Zentiva and during treatment. You may need to stop taking Eltrombopag Zentiva if levels of these substances become too high, or if physical signs of liver damage appear.
Please read the information ‘Liver problems’ in section 4 of this leaflet.
Blood tests for platelet count
If you stop taking Eltrombopag Zentiva, 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 occur with normal or even low platelet counts. Your doctor will adjust your dose of Eltrombopag Zentiva 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 shortness of breath, especially 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 like Eltrombopag Zentiva could worsen these issues. 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 Zentiva.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Eltrombopag Zentiva, you will be monitored for any signs of bleeding in your stomach or intestines after stopping this medicine.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Zentiva 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 Zentiva if you are aged 65 or older.
Children and adolescents
Eltrombopag is not recommended in children under 1 year of age with ITP. It is also not recommended in people under 18 years of age with low platelet count due to hepatitis C.
Other medicines and Eltrombopag Zentiva
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 – 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 transplant patients 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 Zentiva, or you may need to adjust your dose, 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 alternatives.
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 Zentiva.
Eltrombopag Zentiva with food and drink
Do not take Eltrombopag Zentiva with beverages or products derived from milk and 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 Zentiva during pregnancy unless specifically recommended by your doctor. The effect of eltrombopag during pregnancy is unknown.

• Inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.
• Use a reliable method of contraception while taking Eltrombopag Zentiva to prevent pregnancy.
• If you become pregnant while being treated with Eltrombopag Zentiva, inform your doctor immediately.

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

3. How to take Eltrombopag Zentiva

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 Zentiva unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Zentiva, 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 of age) – The recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Zentiva daily. If you are of East or Southeast Asian origin, you may need to start at 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 Zentiva daily.

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

Eltrombopag Zentiva may take 1 to 2 weeks to start working. Depending on your response to Eltrombopag Zentiva, your doctor may recommend adjusting the 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 Zentiva
• and during the 2 hours after taking Eltrombopag Zentiva

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based milkshakes, milk-containing beverages, 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.

For further advice on suitable foods and drinks, please consult your doctor.

If you take more Eltrombopag Zentiva 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 treated appropriately without delay.

If you forget to take Eltrombopag Zentiva
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Zentiva in a day.

If you stop taking Eltrombopag Zentiva
Do not stop taking Eltrombopag Zentiva 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, ask 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 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.
Higher risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as Eltrombopag Zentiva 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 Zentiva may cause changes detectable in blood tests, which could indicate liver damage. Liver problems (elevated 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 Zentiva, platelet counts usually decrease to the level they were before starting Eltrombopag Zentiva. 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 this medicine.
Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Zentiva.
Some people have experienced gastrointestinal bleeding after stopping treatment with

• 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
adults with ITP:
Very common side effects (may affect more than 1 in 10 people)

• common cold
• feeling unwell (nausea)
• diarrhoea
• cough
• nasal, sinus, throat and upper respiratory tract infection (upper respiratory tract infection)
• back pain

Very common side effects detectable in blood tests:

• increase in the liver enzyme alanine aminotransferase (ALT)

Common side effects (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
• 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 pain on pressure 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 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, abnormal liver function
• skin changes including excessive sweating, irregular itchy rash, red spots, changes in skin appearance
• hair loss
• foamy, frothy, or fizzy-looking urine (signs of protein in the urine)
• elevated temperature, feeling hot
• chest pain
• feeling weak
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (dizziness)
• gas/bloating due to digestion

Common side effects detectable in blood tests:

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

Uncommon side effects (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 'Higher 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, liver damage due to inflammation (see 'Liver problems' at the beginning of section 4), or drug-induced liver damage
• rapid heartbeat, irregular heartbeat, bluish skin colouration, heart rhythm disorders (QT prolongation), which could indicate cardiovascular disorders
• blood clot
• redness
• painful swelling of the joints caused by uric acid (gout)
• lack of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech and nerve function problems, 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
• mouth and throat blisters/ulcers
• digestive system problems including frequent bowel movements, food poisoning, blood in the stool, vomiting 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 sensation
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in the urine
• cold sweat
• feeling of general 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 development of white blood cells that may indicate certain diseases
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (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 the urine
• increase in albumin levels in the blood
• increase in total protein levels
• decrease in albumin levels in the blood
• increase in urine pH, increase in haemoglobin level

The following side effects have been reported in association with eltrombopag treatment 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 (may affect more than 1 in 10 children)

• nasal, sinus, throat and upper airway infection, common cold (upper respiratory tract infection)
• diarrhoea
• abdominal pain
• cough
• high temperature
• feeling unwell (nausea)

Common side effects (may affect up to 1 in 10 children)

• difficulty sleeping (insomnia)
• toothache
• nose and throat pain
• 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 (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:

• decrease in the number of red blood cells (anaemia)

Common side effects (may affect up to 1 in 10 people)

• urinary tract infections
• inflammation of the nose, throat and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, 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
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat, 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
• 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, pain in extremities (arms, legs, hands or feet), muscle spasms
• irritability, general feeling of malaise, skin reaction such as redness, swelling and pain at the injection site, chest pain and discomfort, fluid accumulation in the body or extremities causing swelling
• nasal, sinus, throat and upper airway infection, common cold (upper respiratory tract infection), inflammation of the mucous membrane 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 in the blood
• reduced haemoglobin level
• increased bilirubin (a substance produced by the liver)
• changes in enzymes controlling blood clotting
  Uncommon side effects (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), liver failure
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at injection site, chest discomfort
• decrease in the number of red blood cells (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 eltrombopag treatment in
patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects (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, feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• mouth blisters
• abdominal pain
• muscle spasms

Very common side effects detectable in blood tests:

• abnormal changes in bone marrow cells
• increase in the liver enzyme aspartate aminotransferase (AST)

Common side effects (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 (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
• bleeding gums
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the 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)
• decrease in blood sugar levels (hypoglycaemia)
• increase in bilirubin in the blood (a substance produced by the liver)
• reduction in the number of white blood cells

Side effects with unknown frequency (frequency cannot be estimated from the available data)

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

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 .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following "Exp". The
expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 Zentiva contains

• The active substance is eltrombopag olamine. Eltrombopag Zentiva 25 mg: each film-coated tablet contains eltrombopag olamine equivalent to

Eltrombopag Zentiva 50 mg: each film-coated tablet contains eltrombopag olamine equivalent to

• The other ingredients are: microcrystalline cellulose, mannitol, povidone, isomalt (E953), calcium silicate, sodium starch glycolate, magnesium stearate (tablet core); hypromellose, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), triacetin (coating).

Description of the appearance of Eltrombopag Zentiva and package contents
Eltrombopag Zentiva 25 mg are dark pink, round, biconvex film-coated tablets, engraved with “II” on one side and with a diameter of approximately 8 mm.
Eltrombopag Zentiva 50 mg are pink, round, biconvex film-coated tablets, engraved with “III” on one side and with a diameter of approximately 10 mm.
Eltrombopag Zentiva 25 mg and 50 mg is available in boxes containing 14, 28 or 84 film-coated tablets in blisters, or boxes containing 14x1, 28x1 or 84x1 film-coated tablets in unit-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer(s)
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat
Barcelona
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark, Estonia, France, Germany, Italy, Lithuania, The Netherlands, Norway, Poland, Portugal, Spain, Sweden: Eltrombopag Zentiva