ELTROMBOPAG 50 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. What is Eltrombopag Vivanta and what is it used for
3. What you need to know before you take Eltrombopag Vivanta
4. How to take Eltrombopag Vivanta
5. Possible Adverse Effects
6. Storage of Eltrombopag Vivanta
7. Package contents and additional information

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Vivanta 25 mg film-coated tablets EFG

Eltrombopag Vivanta 50 mg film-coated tablets EFG

Eltrombopag Vivanta 75 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

• Eltrombopag is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already taken other medicines (corticosteroids or immunoglobulins) that have not worked.

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have a higher risk of bleeding. Symptoms that patients with ITP may notice are petechiae (small, round, flat red spots under the skin), bruises, nosebleeds, bleeding gums, and inability to stop bleeding if cut or injured.

• Eltrombopag may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in case they have had problems with the side effects of interferon treatment. Many people with hepatitis C have low platelet counts, not only due to the disease but also due to the antiviral treatments used to treat it. Taking this medicine may help you complete the cycle with antivirals (peginterferon and ribavirin).

2. What you need to know before you take Eltrombopag Vivanta

Do not take Eltrombopag Vivanta

• to eltrombopag or any of the other ingredients of this medicine

(including those listed in section 6 under the heading "Composition of Eltrombopag Vivanta").

Consult your doctorif you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take Eltrombopag Vivanta:

• . People who have a low platelet count as well as advanced chronic liver disease (long-standing) are at higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of eltrombopag outweighs the risks, you will be closely monitored during treatment.
• in your veins or arteries, or if you know that blood clots are common in your family.

The risk of having a blood clot may be higherin the following circumstances:

Tell your doctorif you are in any of these situations. You should not take this medicine unless your doctor considers that the expected benefit outweighs the risk of having blood clots.

• (the lens of the eye becomes cloudy).
• , such as myelodysplastic syndrome (MDS). Before starting to take this medicine, your doctor will perform tests to check that you do not have this disease. If you have MDS and take eltrombopag, MDS may worsen.

Tell your doctorif you are in any of these situations.

Eye exams

Your doctor will recommend that you have an eye exam to check for cataracts. If you do not have regular eye exams, your doctor will ask you to have one. They should also check your retina (the light-sensitive layer at the back of the eye) for bleeding in the retina or around it.

You will need to have regular blood tests

Before you start taking eltrombopag, your doctor will perform a blood test 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 your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, base treatment along with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting to take eltrombopag and frequently while taking it to check your liver function. You may need to stop taking eltrombopag if the levels of these markers increase too much or if you have any other sign of liver damage.

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

Blood tests for platelet count

If you stop taking this medicine, it is likely that, within a few days, you will have low platelet counts again (thrombocytopenia). Your platelet counts will be monitored and your doctor will advise you on what precautions to take.

Very high platelet counts may increase the risk of blood clots. However, blood clots can also form with normal or even low platelet counts. Your doctor will adjust the dose of this medicine to ensure that your platelet count does not become too high.

Seek medical help immediatelyif you have any of these signs of a blood clot:

• swelling, painor tenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by sharp chest pain or rapid breathing
• abdominal pain(stomach), enlarged abdomen, blood in the stool.

Tests to examine your bone marrow

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

Review of gastrointestinal bleeding

If you are taking interferon, base treatment along with eltrombopag, you will be monitored for signs of bleeding in your stomach or intestine after you stop taking eltrombopag.

Heart monitoring

Your doctor may consider, if necessary, monitoring your heart while you are taking eltrombopag using an electrocardiogram.

Older people (65 years and over)

There is limited data on the use of eltrombopag in patients aged 65 years or over. If you are 65 or over, you should be cautious when using this medicine.

Children and adolescents

This medicine is not recommended for use in children under 1 year of age with ITP. It is also not recommended in children under 18 years of age with low platelet counts due to hepatitis C or severe aplastic anemia.

Other medicines and Eltrombopag Vivanta

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

Some common medicines may interact with eltrombopag(including prescription medicines, over-the-counter medicines, and minerals). These include:

• antacids for indigestion, heartburn, or stomach ulcers
• (see also section 3 "When to take it").
• statins, to lower cholesterol
• some medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in transplantsor immune system diseases
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be present in vitamin and mineral supplements(see also section 3 "When to take it").
• medicines such as methotrexate and topotecan, used to treat cancer

Consult your doctorif you are taking any of these medicines. Some should not be taken with eltrombopag; it may be necessary to adjust the dose or change the times when you take them. Your doctor will review the medicines you are taking and recommend alternatives if necessary.

If you are also taking medicines to prevent blood clots, there is a higher risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol,and/or azathioprinewith this medicine, it may be necessary to reduce the dose or stop treatment with these medicines.

Taking Eltrombopag Vivanta with food and drinks

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

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnantunless your doctor specifically recommends it. The effect of eltrombopag during pregnancy is not known.

• Tell your doctor if you are pregnant,think you may be pregnant, or plan to become pregnant.
• Use a reliable contraceptive methodto prevent pregnancy while taking this medicine.
• If you become pregnant during treatmentwith eltrombopag, tell your doctor.

Do not breastfeed while taking eltrombopag. It is not known if eltrombopag passes into breast milk.

If you are breastfeedingor plan to breastfeed, tell your doctor.

Driving and using machines

Eltrombopag may cause dizzinessand have other side effects that may make you less alert.

Do not drive or use machinesunless you are sure that eltrombopag does not affect you.

Eltrombopag Vivanta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Eltrombopag Vivanta

Follow exactly the instructions for taking this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again. Do not change the dose or treatment schedule with eltrombopag unless your doctor or pharmacist advises you to do so. While taking eltrombopag, you will be under the supervision of a specialist doctor with experience in treating 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 tabletof eltrombopag per day. If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25 mg.

Children(1 to 5 years) - the usual starting dose for ITP is one 25 mg tabletof eltrombopag per day.

For Hepatitis C

Adults- the usual starting dose for hepatitis C is one 25 mg tabletof eltrombopag per day. If you are of East or Southeast Asian descent, start treatment with the same dose of 25 mg.

This medicine may take 1 to 2 weeks to work. Depending on your response to eltrombopag, your doctor may recommend changing your daily dose.

How to take the tablets

Swallow the tablet whole, with water

When to take it

Make sure that -

• in the 4 hours beforetaking eltrombopag
• and in the 2 hours aftertaking eltrombopag

you do notconsume any of the following:

• dairy productssuch as cheese, butter, yogurt, or ice cream
• milk or milkshakes, milk-based drinks, yogurt, or cream
• antacids, a type of medicine for indigestion and heartburn
• certain vitamin and mineral supplements, including iron, calcium, magnesium, aluminum, selenium, and zinc.

If you do, your body may not absorb the medicine properly.

For more information on what foods and drinks are suitable, consult your doctor.

If you take more Eltrombopag Vivanta than you should

Consult your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for signs or symptoms of side effects and given immediate treatment if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eltrombopag Vivanta

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

If you stop taking Eltrombopag Vivanta

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Symptoms to which you need to pay attention: consult your doctor

People taking this medicine for both ITP and low platelet counts associated with hepatitis C may exhibit signs related to possible serious adverse effects. It is essential that you inform your doctor if you develop symptoms.

Increased Risk of Thrombosis

Some people may have a higher risk of having a thrombus, and medicines like eltrombopag may worsen this problem. The sudden blockage of a blood vessel by a thrombus is a rare adverse effect that can affect up to 1 in 100 people.

Seek medical help immediately if you experience signs or symptoms of thrombosis, such as:

• swelling, pain, heat, redness, orsensitivity in one leg
• sudden difficulty breathing, exceptionally accompanied by acute chest pain or agitated breathing.
• abdominal pain (stomach), ,enlarged abdomen, blood in your stool.

Liver Problems

Eltrombopag may cause changes that appear in blood tests, which can be signs of liver damage. Liver problems (increased liver enzymes in blood tests) are frequent and can affect up to 1 in 10 people. Other liver problems are rare and can affect up to 1 in 100 people.

If you have any signs of liver problems:

• yellowish coloron the skin or in the white area of the eyes (jaundice)
• dark-colored urineunusual.

contact your doctor immediately

Bleeding or Hematoma after Treatment Discontinuation

Two weeks after discontinuing treatment with eltrombopag, your platelet levels will normally drop to levels similar to those before starting eltrombopag. A decrease in platelet levels can increase the risk of bleeding or hematoma. Your doctor will check your platelet levels for at least 4 weeks after discontinuing treatment with eltrombopag.

Contact your doctorif you experience bleeding or hematoma when stopping eltrombopag.

Some people have bleeding in the digestive systemafter stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tar-like stools (stool discoloration is a rare adverse effect that can affect up to 1 in 100 people).
• blood in the stool
• vomiting blood or something that looks like coffee grounds

Contact your doctor immediatelyif you experience any of these symptoms.

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

Very Common Adverse Effects

May affect more than 1 in 10people

• Common cold
• feeling of dizziness (nausea)
• diarrhea
• cough
• infection of the nose, nasal sinuses, throat, and respiratory tract (upper respiratory tract infection)
• back pain

Very Common Adverse Effects that may appear in Blood Tests:

• increase in liver enzymes (alanine aminotransferase (ALT))

Common Adverse Effects

May affect up to 1 in 10people

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstruation
• irritation of the throat and difficulty swallowing
• eye problems including abnormal eye tests, dry eye, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• inflammation of the gums
• loss of appetite
• feeling of tingling, itching, or numbness
• decreased sensitivity in the skin
• drowsiness
• ear pain
• pain, swelling, and sensitivity in one leg (generally the calf) with hot skin in the affected area (signs of a blood clot in a deep vein)

• localized swelling filled with blood from a broken blood vessel (hematoma)
• hot flashes
• alterations in the mouth including dryness or irritation in the mouth, sensitivity in the tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, rash with itching, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in the urine)
• high temperature, feeling of heat
• chest pain
• feeling of weakness
• sleep problems, depression

• migraine
• decreased vision
• feeling that everything is spinning (vertigo)
• gas

Common Adverse Effects that may appear in Blood Tests:

• decrease in the number of red blood cells (anemia)
• decrease in the number of platelets (thrombocytopenia)
• decrease in the number of white blood cells
• decrease in hemoglobin levels
• increase in the number of eosinophils
• increase in the number of white blood cells (leukocytosis)
• 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 some protein levels

Rare Adverse Effects

May affect up to 1 in 100people:

• allergic reaction
• interruption of blood supply to parts of the heart
• sudden difficulty breathing, especially when accompanied by acute chest pain and/or agitated breathing, which could be signs of a pulmonary thrombus (see
• “Increased Risk of Thrombosis” earlier in section 4)
• partial loss of lung function caused by a blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein that could be signs of thrombosis in a vein
• yellowish skin and/or abdominal pain that could be signs of a bile duct obstruction, liver injury, liver damage due to inflammation (see “Liver Problems”

earlier in section 4)

• liver damage due to medication
• rapid or irregular heartbeat, discoloration of the skin, alterations in heart rhythm (prolongation of the QT interval) that could be a sign of a heart and blood vessel disorder.
• blood clots
• hot flashes
• joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrolled crying or that occurs unexpectedly
• balance problems, speech and nervous system alterations, tremors
• pain or abnormal sensations in the skin
• paralysis of one side of the body
• migraine with aura
• nerve pain
• expansion or swelling of blood vessels that cause headaches
• eye problems, including increased tearing, blurred vision, cataracts, retinal hemorrhage, dry eye
• problems with the nose, throat, and sinuses, breathing problems while sleeping
• blisters/pain in the mouth and throat
• loss of appetite

• digestive problems, including frequent bowel movements, food poisoning, blood in stool, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• alterations in the mouth, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth sores
• sunburn
• feeling hot, feeling anxious
• redness or swelling around wounds
• bleeding around a catheter (if you have one) in the skin
• feeling of a foreign body
• kidney problems, including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine
• cold sweat
• feeling of general discomfort
• skin infection
• skin changes, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• colon and rectal cancer

Rare Adverse Effects that may appear in Blood Tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that may be indicative of certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in neutrophils
• increase in blood urea
• increase in protein 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 hemoglobin levels

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

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10children

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

Common Adverse Effects

May affect up to 1 in 10children

• difficulty sleeping (insomnia)
• toothache
• throat and nose pain
• itching, runny nose, or stuffiness
• irritation of the throat, runny nose, nasal congestion, and sneezing
• alterations in the mouth, including dryness, irritation in the mouth, sensitivity in the tongue, gum bleeding, mouth ulcers

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

Very Common Adverse Effects

May affect more than 1 in 10people:

• headache
• loss of appetite
• cough
• feeling dizzy (nausea), diarrhea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• hair loss
• feeling weak
• flu-like discomfort
• swelling of hands or feet
• chills

Very Common Adverse Effects that may appear in Blood Tests:

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

Common Adverse Effects

May affect up to 1 in 10people:

• urinary tract infection
• inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation, or inflammation of the mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes
• decrease in brain function due to liver damage
• tingling or numbness in hands and feet
• fever, headache
• eye problems, including blurred vision, cataracts, dry eye, small yellow deposits in the retina, yellowish color in the white area of the eyes
• retinal bleeding
• feeling that everything is spinning
• rapid or irregular heartbeat, difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation, and difficulty swallowing
• digestive alterations, including vomiting, stomach pain, indigestion, constipation, stomach swelling, alterations in taste, hemorrhoids, abdominal pain or discomfort
• swelling of blood vessels and bleeding in the throat (esophagus)
• toothache
• liver problems, including liver tumor, yellowish color in the white area of the eyes or skin (jaundice), liver damage due to medication (see “Liver Problems” earlier in
• section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, pain in the limbs (arms, legs, hands, and feet), muscle spasms
• irritability, feeling of general discomfort, skin reactions such as redness or swelling and pain at the injection site, chest pain, and discomfort, fluid retention in the body or limbs that causes swelling
• infection of the nose, nasal sinuses, throat, and respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common Adverse Effects that may appear in Blood Tests:

• increase in blood sugar (glucose)
• decrease in the number of white blood cells
• decrease in the number of neutrophils
• decrease in blood albumin
• decrease in hemoglobin levels
• increase in blood bilirubin (a substance produced by the liver)
• changes in the enzymes that control blood coagulation

Rare Adverse Effects

May affect up to 1 in 100people:

• pain when urinating
• alterations in heart rhythm (prolongation of the QT interval)
• stomach flu (gastroenteritis), throat pain
• blisters/pain in the mouth, stomach inflammation
• skin changes, including changes in color, peeling, skin redness, itching, and sweating at night
• blood clots in the liver veins (possible liver damage and/or digestive system damage)
• poor blood clotting in small blood vessels with kidney failure
• itching and bruising at the injection site, chest discomfort
• decrease in red blood cell count (anemia) caused by massive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• liver failure

The following adverse effects have been observed in relation to treatment with eltrombopag in patients with severe aplastic anemia (SAA)

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10people:

• cough
• headache
• pain in the mouth and throat
• diarrhea
• dizziness, nausea
• joint pain (arthralgia)
• pain in the limbs (arms, legs, hands, and feet)
• dizziness
• feeling very tired
• fever
• chills
• eye itching
• blisters in the mouth
• gum bleeding
• abdominal pain
• muscle spasms

Very Common Adverse Effects that may appear in a Blood Test

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

Common Adverse Effects

May affect up to 1 in 10people:

• anxiety
• depression
• feeling cold
• feeling of general discomfort
• eye problems, including vision problems, blurred vision, cataracts, floaters, dry eye, itching eyes, yellowish color in the white area of the eyes or skin
• nosebleeds
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain or discomfort, stomach swelling
• gas/bloating, constipation, changes in bowel movements, changes in stool color
• fainting
• skin problems, including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood flow to the spleen (splenic infarction)

• runny nose

Common Adverse Effects that may appear in a Blood Test

• increase in some enzymes due to muscle breakdown (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycemia)
• increase in blood bilirubin (a substance produced by the liver)
• decrease in the number of white blood cells

Adverse Effects of Unknown Frequency

Cannot be estimated from the available data

• skin discoloration
• skin darkening
• liver damage due to medication

Reporting of Adverse Effects

If you experience any type of adverse effect, co

5. Storage of Eltrombopag Vivanta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after CAD. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Eltrombopag Vivanta

The active substance of Eltrombopag Vivanta is eltrombopag.

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

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

Eltrombopag Vivanta 75 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other ingredients (excipients) are:

Core of the tablet: mannitol (E421), povidone (E1201), microcrystalline cellulose (E460(i)), sodium carboxymethyl starch (from potato), magnesium stearate (E470b).

Coating of the tablet:

Eltrombopag Vivanta 25 mg film-coated tablets: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), red iron oxide (E172).

Eltrombopag Vivanta 50 mg film-coated tablets: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), carmine indigo lake (E132), yellow iron oxide (E172).

Eltrombopag Vivanta 75 mg film-coated tablets: hypromellose (E464), red iron oxide (E172), macrogol (E1521), titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172).

Appearance and packaging of the product

Eltrombopag Vivanta 25 mg are light orange to orange, round, biconvex film-coated tablets, approximately 7 mm in diameter, engraved with “ME” on one side and “13” on the other.

Eltrombopag Vivanta 50 mg are light blue to blue, round, biconvex film-coated tablets, approximately 9 mm in diameter, engraved with “ME” on one side and “14” on the other.

Eltrombopag Vivanta 75 mg are brown, round, biconvex film-coated tablets, approximately 10 mm in diameter, engraved with “ME” on one side and “15” on the other.

They are presented in aluminum blisters in a cardboard box containing 14 or 28 film-coated tablets and multiple packs containing 84 (3 packs of 28) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder

Vivanta Generics s.r.o

Trtinova 260/1, Cakovice,

19600, Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola,

PLA3000

Malta

or

MSN Labs Europe Limited

KW20A Corradino Park, Paola,

PLA3000

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. branch in Spain

C/Guzmán el Bueno, 133, Britannia building

28003 Madrid

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

Germany:Eltrombopag Vivanta 25 mg Filmtabletten

Eltrombopag Vivanta 50 mg Filmtabletten

Eltrombopag Vivanta 75 mg Filmtabletten

Cyprus:Eltrombopag MSN 25 mg film-coated tablets

Eltrombopag MSN 50 mg film-coated tablets

Denmark:Eltrombopag Vivanta

Spain:Eltrombopag Vivanta 25 mg film-coated tablets EFG

Eltrombopag Vivanta 50 mg film-coated tablets EFG

Eltrombopag Vivanta 75 mg film-coated tablets EFG

Finland:Eltrombopag Vivanta 25 mg kalvopäällysteiset tabletit

Eltrombopag Vivanta 50 mg kalvopäällysteiset tabletit

Eltrombopag Vivanta 75 mg kalvopäällysteiset tabletit

France:Eltrombopag Vivanta 25 mg, comprimé pelliculé

Eltrombopag Vivanta 50 mg, comprimé pelliculé

Eltrombopag Vivanta 75 mg, comprimé pelliculé

Italy:Eltrombopag Vivanta

Ireland:Eltrombopag MSN 25 mg film-coated tablets

Eltrombopag MSN 50 mg film-coated tablets

Malta:Eltrombopag MSN 25 mg film-coated tablets

Norway:Eltrombopag Vivanta

Netherlands:Eltrombopag Vivanta 12.5 mg filmomhulde tabletten

Eltrombopag Vivanta 25 mg filmomhulde tabletten

Eltrombopag Vivanta 50 mg filmomhulde tabletten

Eltrombopag Vivanta 75 mg filmomhulde tabletten

Czech Republic:Eltrombopag Vivanta

Sweden:Eltrombopag Vivanta 25 mg filmdragerade tabletter

Eltrombopag Vivanta 50 mg filmdragerade tabletter

Eltrombopag Vivanta 75 mg filmdragerade tabletter

Date of the last revision of this leaflet:February 2025.

Other sources of information

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