Eltrombopag Zentiva 50 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Eltrombopag Zentiva 25 mg film-coated tablets EFG

Eltrombopag Zentiva 50 mg film-coated tablets EFG

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

Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

What Eltrombopag Zentiva is and what it is used for
What you need to know before taking Eltrombopag Zentiva
How to take Eltrombopag Zentiva
Possible side effects
How to store Eltrombopag Zentiva
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 is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already received other treatments (corticosteroids or immunoglobulins) that have not worked.

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 experience include petechiae (small, flat, red, pinpoint spots under the skin), bruising, nosebleeds, bleeding gums, and inability to control bleeding if they are cut or injured.

Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced problems with adverse effects during interferon-based treatment. Many people with hepatitis C have low platelet counts, not only as a result of the disease itself, but also due to some of the antiviral medications used to treat it. Taking eltrombopag may help you complete a full course of antiviral therapy (pegylated interferon and ribavirin).

2. What you need to 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).

Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor or pharmacist before taking eltrombopag:

if you have liver problems. People who have low platelet counts and advanced chronic liver disease (long-standing) are at higher risk of experiencing adverse effects, including potentially life-threatening liver damage and 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 veins or arteries, or if you know that blood clots are common in your family.

The risk of developing a blood clot may be higher in the following circumstances:

if you are elderly
if you have had to stay in bed for a long time
if you have cancer
if you are taking contraceptive pills or hormone replacement therapy
if you have recently undergone surgery or suffered physical injury
if you are significantly overweight (obesity)
if you smoke
if you have advanced chronic liver disease.

If any of these apply to you, inform your doctor before starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of developing 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 check that you do not have this blood disorder before starting eltrombopag. If you have MDS and take this medicine, your MDS may worsen.

Inform your doctor if any of these situations apply to you.

Eye examinations

Your doctor will recommend that you have an examination to check for cataracts. If you do not have routine eye examinations, your doctor should schedule regular eye check-ups. You may also be examined 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, your doctor will perform blood tests to check your blood cells, including platelets. These tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Eltrombopag may cause changes in blood test results that could indicate liver damage: an increase in certain liver enzymes, especially bilirubin and alanine/aspartate aminotransferases. If you are taking interferon-based treatments together with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests to check liver function before starting eltrombopag and regularly during treatment. You may need to stop taking eltrombopag if levels of these markers rise too much or if you develop other signs of liver damage.

Read the information “Liver problems” in section 4 of this leaflet.

Blood tests for platelet count

If you stop taking eltrombopag, your platelet count is likely to decrease again within a few days. Platelet levels will be monitored and your doctor will advise you on appropriate precautions.

Very high platelet levels may increase the risk of blood clot formation. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust the dose of eltrombopag to ensure that your platelet count does not increase too much.

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

swelling, pain, or tenderness in a leg
sudden shortness of breath, especially with sharp chest pain or rapid breathing
abdominal pain, enlarged abdomen, blood in stools.

Tests to examine your bone marrow

In people with bone marrow problems, medicines like eltrombopag could worsen these issues. Signs of changes in the bone marrow may appear as abnormal results in blood tests. Your doctor may also perform tests to directly assess your bone marrow during treatment with eltrombopag.

Monitoring for gastrointestinal bleeding

If you are taking interferon-based treatments together with eltrombopag, you will be monitored for any signs of bleeding in the stomach or intestines after stopping this medicine.

Heart monitoring

Your doctor may consider it necessary to monitor your heart during treatment with eltrombopag and may perform an electrocardiogram (ECG).

Elderly people (65 years and older)

There is limited data on the use of eltrombopag in patients aged 65 years or older. Caution should be exercised when using eltrombopag in patients aged 65 years or older.

Children and adolescents

Eltrombopag is not recommended for children under 1 year of age with ITP. It is also not recommended for patients under 18 years of age with low platelet counts due to hepatitis C.

Other medicines and Eltrombopag Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and vitamins.

Some commonly used medicines may 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 used to treat HIV infection, such as lopinavir and/or ritonavir
cyclosporine used in organ transplantation or 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.

Consult your doctor if you are taking any of these medicines. Some should not be taken with eltrombopag, or you may need to have your dose adjusted or change the timing of administration. Your doctor will review your current medications and suggest suitable alternatives if necessary.

If you are also taking medicines to prevent blood clot formation, there is an increased risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine, you may need to reduce the dose or stop taking them while on eltrombopag.

Taking Eltrombopag Zentiva with food and drinks

Do not take eltrombopag with food or dairy drinks, as the calcium in dairy products affects the absorption of the medicine. For more information, see “When to take it” in section 3.

Pregnancy and breastfeeding

Do not use eltrombopag 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 plan to become pregnant.
Use a reliable method of contraception while taking eltrombopag to prevent pregnancy.
If you become pregnant during treatment with eltrombopag, inform your doctor immediately.

Do not breastfeed while taking eltrombopag. 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 may cause dizziness and other adverse effects that may reduce your alertness.

Do not drive or operate machinery unless you are certain that eltrombopag does not affect you.

Eltrombopag Zentiva contains isomalt and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him 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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Do not change the dose or timing of eltrombopag administration unless your doctor or pharmacist tells you to. While you are taking eltrombopag, you will be under the care of a specialist doctor managing your condition.

How much to take

For ITP

Adults and children (6 to 17 years): the usual starting dose for ITP is one 50 mg eltrombopag tablet 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 usual starting dose for ITP is one 25 mg eltrombopag tablet daily.

For hepatitis C

Adults: the usual starting dose for hepatitis C is one 25 mg eltrombopag tablet daily.

If you are of East or Southeast Asian origin, you will start with the same 25 mg dose.

Eltrombopag may take 1 to 2 weeks to take effect. Depending on your response to eltrombopag, 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
and during the 2 hours after taking eltrombopag

you do not consume any of the following:

dairy products such as cheese, butter, yoghurt, or ice cream
milk or milkshakes, drinks containing milk, yoghurt, or cream
antacids, a type of medicine used for indigestion and stomach acidity
certain mineral and vitamin supplements, including iron, calcium, magnesium, aluminium, selenium, and zinc.

If you do, the medicine will not be properly absorbed into your body.

Clock showing 4 hours before and 2 hours after

For more information about suitable foods and drinks, speak with your doctor.

If you take more Eltrombopag Zentiva 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 will receive appropriate treatment immediately.

In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Eltrombopag Zentiva

Take your next dose at the usual time. Do not take more than one dose of eltrombopag in a day.

If you stop taking Eltrombopag Zentiva

Do not stop taking eltrombopag without consulting your doctor. If your doctor advises you to stop treatment, your platelet levels will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms requiring attention: consult a doctor

People who take eltrombopag for ITP or for low platelet count due to hepatitis C may develop signs related to potentially serious adverse effects. It is important to inform a doctor if you experience any of these symptoms.

Increased risk of thrombosis

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

Seek immediate medical help if you experience signs and symptoms of thrombosis, such as:

swelling, pain, warmth, redness, or tenderness in one leg
sudden difficulty breathing, especially along with sharp chest pain or rapid breathing
abdominal pain, enlarged abdomen, blood in the stool.

Liver problems

Eltrombopag may cause changes detectable in blood tests, which could indicate liver damage. Liver problems (increased liver enzymes seen 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)
unusually dark-colored urine

Inform your doctor immediately.

Bleeding or bruising after stopping treatment

Within two weeks after stopping eltrombopag, your platelet count in the blood will generally return to the level it was at before starting eltrombopag. A decrease in platelet levels may increase the risk of bleeding or bruising. Your doctor will monitor your platelet levels for at least 4 weeks after you stop taking this medicine.

Inform your doctor if you experience bleeding or bruising after stopping treatment with eltrombopag.

Some people experience gastrointestinal bleeding after stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

black, tarry stools (discolored stools are an uncommon adverse effect that may affect up to 1 in 100 people)
blood in the stool
vomiting blood or material that looks like coffee grounds

Inform your doctor immediately if you experience any of these symptoms.

The following adverse effects have been reported with eltrombopag treatment in adult patients with ITP:

Very common adverse effects (may affect more than 1 in 10 people)

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

Very common adverse effects that may appear in blood tests:

increased liver enzymes (alanine aminotransferase (ALT))

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

flu (influenza), cold sores, pneumonia, irritation and inflammation (swelling) of the sinuses, inflammation (swelling) and infection of the tonsils, lung, sinus, nose and throat infection, gum inflammation, sore throat and difficulty swallowing
loss of appetite
difficulty sleeping, depression
decreased skin sensitivity, tingling, itching or numbness, commonly referred to as "pins and needles", drowsiness, migraine
eye problems including abnormal eye tests, dry eyes, eye pain and blurred vision, decreased vision
ear pain, sensation of spinning (vertigo)
pain, swelling and tenderness in one of your legs (usually the calf) with warm skin in the affected area (signs of a deep vein thrombosis), localized swelling filled with blood from a ruptured blood vessel (haematoma), hot flushes
runny nose
mouth problems including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, digestive gas
abnormal liver function
skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance, hair loss
muscle pain, muscle spasm, muscle weakness, bone pain
foamy or bubbly-looking urine (signs of protein in the urine)
heavy menstrual period
high temperature, feeling of warmth, chest pain, feeling of weakness

Common adverse effects that may appear in blood tests:

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

Uncommon adverse effects (may affect up to 1 in 100 people)

skin infection
rectal and colon cancer
allergic reaction
loss of appetite, joint pain and swelling caused by uric acid (gout)
lack of interest, mood changes, uncontrollable or unexpected crying
problems with balance, speech and nerve function, tremors, 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, cloudy lens (cataracts), retinal bleeding, dry eyes
faster heartbeat, irregular heartbeat, bluish skin colouration, heart rhythm disturbances (prolongation of QT interval) which could indicate a disorder related to the heart and blood vessels, interruption of blood supply to part of the heart
possible pain, swelling and/or redness around a vein, which could indicate a blood clot in a vein, blood clot, hot flushes
sudden difficulty breathing, especially when accompanied by sharp chest pain and/or rapid breathing, which could indicate a blood clot in the lungs (see "Increased risk of thrombosis" above in section 4), loss of function in part of the lung due to blockage in the pulmonary artery, problems with nose, throat and sinuses, breathing problems during sleep
mouth problems including dry or irritated mouth, tongue pain, bleeding gums, mouth discomfort, blisters/sores in the mouth and throat, digestive system problems including frequent bowel movements, food poisoning, blood in the stool, vomiting blood, rectal bleeding, changes in stool colour, abdominal distension, constipation
yellowish skin colouring and/or abdominal pain which could indicate bile duct obstruction, kidney injury, liver damage due to inflammation (see "Liver problems" above in section 4), drug-induced liver damage
pain or abnormal sensations in the skin, skin changes including skin discoloration, peeling, redness, itching and sweating, cold sweats
muscle weakness
kidney problems, including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
feeling of warmth, anxiety, bleeding around a catheter (if present) on the skin, redness or inflammation around a wound, general malaise, sensation of a foreign body
sunburn

Uncommon adverse effects that may appear in laboratory tests:

changes in red blood cell shape, decrease in red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia), increase in myelocytes, increase in neutrophil bands, presence of immature white blood cells which may indicate certain diseases, increase in platelets, increase in haemoglobin level
decreased calcium levels
increased blood urea, increased protein levels in urine
increased blood albumin levels, increased total protein levels, decreased blood albumin levels, increased urine pH

The following additional adverse effects have been reported with eltrombopag treatment in children (1 to 17 years) with ITP:

If these adverse effects become severe, inform your doctor, pharmacist, or nurse.

Very common adverse effects (may affect more than 1 in 10 children)

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

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

difficulty sleeping (insomnia)
itching, nasal discharge or congestion, throat irritation, runny nose, nasal congestion and sneezing, pain in the nose and throat
toothache, mouth disorders including dryness, mouth irritation, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse effects have been reported with eltrombopag treatment in combination with peginterferon and ribavirin in patients with HCV:

Very common adverse effects (may affect more than 1 in 10 people)

loss of appetite
headache
cough
feeling unwell (nausea), diarrhoea
itching, swelling in hands or feet, unusual hair loss
muscle pain, muscle weakness
fever, feeling of tiredness, flu-like malaise, feeling of weakness, chills

Very common adverse effects that may appear in blood tests:

decrease in red blood cells (anaemia)

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

urinary tract infection, infection of the nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi, nasal inflammation, throat and mouth inflammation, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache, flu, cold sores
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
eye problems including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellowish discoloration of the white part of the eye, retinal bleeding
sensation of spinning (vertigo)
rapid or irregular heartbeat (palpitations)
difficulty breathing, cough with phlegm, runny nose, throat irritation and discomfort when swallowing
digestive system problems including vomiting, stomach pain, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, inflammation and bleeding of blood vessels in the throat (oesophagus), toothache
liver problems including liver tumours, yellowish discoloration of the whites of the eyes or skin (jaundice), drug-induced liver injury (see "Liver problems" above in 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 (arms, legs, hands or feet), muscle spasms
irritability, general malaise, skin reactions such as redness, swelling and pain at injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
depression, anxiety, difficulty sleeping, nervousness
fever, headache

Common adverse effects that may appear in blood tests:

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

Uncommon adverse effects (may affect up to 1 in 100 people)

stomach flu (gastroenteritis), sore throat
decrease in red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
confusion, agitation
blisters/sores in the mouth, stomach inflammation
blood clots in a vein leading to the liver (possible liver and/or digestive system damage), liver failure
skin changes including colour changes, peeling, redness, itching, lesions and night sweats
abnormal blood clotting in small blood vessels with kidney failure, pain when urinating
skin rash, bruising at injection site, chest discomfort
heart rhythm disturbances (prolongation of QT interval)

The following adverse effects have been reported with eltrombopag treatment in patients with severe aplastic anaemia (SAA):

If these adverse effects become severe, inform your doctor, pharmacist, or nurse.

Very common adverse effects (may affect more than 1 in 10 people)

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

Very common adverse effects that may appear in blood tests:

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

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

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

Common adverse effects that may appear in blood tests:

decreased white blood cell levels
iron accumulation in the body (iron overload), decreased blood sugar levels (hypoglycaemia)
increased blood bilirubin levels (a substance produced by the liver)
increased enzyme levels due to muscle breakdown (creatine phosphokinase)

Adverse effects of unknown frequency (frequency cannot be estimated from available data)

drug-induced liver damage
skin discoloration, skin darkening

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the outer carton following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eltrombopag Zentiva

The active substance is eltrombopag olamine.

Eltrombopag Zentiva 25 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Eltrombopag Zentiva 50 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

The other components are: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethyl starch, magnesium stearate (tablet core); hypromellose, titanium dioxide (E171), red iron oxide (E 172), triacetin (tablet coating).
The film-coated tablets of Eltrombopag Zentiva 25 mg and 50 mg also contain yellow iron oxide (E172).

Nature of the product and pack sizes

Eltrombopag Zentiva 25 mg are film-coated, biconvex, round, dark pink tablets, with "II" engraved on one side and a diameter of approximately 8 mm.

Eltrombopag Zentiva 50 mg are film-coated, biconvex, round, pink tablets, with "III" engraved on one side and a diameter of approximately 10 mm.

Eltrombopag Zentiva 25 mg and 50 mg are available in packs containing 14, 28 or 84 film-coated tablets in blisters, or in packs containing 14x1, 28x1 or 84x1 film-coated tablets in unit dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer

Synthon B.V.

Microweg 22

6545 CM Nijmegen

The Netherlands

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat

Barcelona

Spain

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Germany	Eltrombopag Zentiva 25 mg Film-coated tablets Eltrombopag Zentiva 50 mg Film-coated tablets
Denmark	Eltrombopag Zentiva
Spain	Eltrombopag Zentiva 25 mg film-coated tablets EFG Eltrombopag Zentiva 50 mg film-coated tablets EFG
Estonia	Eltrombopag Zentiva
France	Eltrombopag Zentiva 25 mg, film-coated tablets Eltrombopag Zentiva 50 mg, film-coated tablets
Italy	Eltrombopag Zentiva
Lithuania	Eltrombopag Zentiva 25 mg film-coated tablets
Norway	Eltrombopag Zentiva
Netherlands	Eltrombopag Zentiva 25 mg, film-coated tablets Eltrombopag Zentiva 50 mg, film-coated tablets
Poland	Eltrombopag Zentiva
Portugal	Eltrombopag Zentiva
Sweden	Eltrombopag Zentiva

Date of the most recent review of this leaflet: May 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/