Eltrombopag Vivanta 25 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking this medicine because 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Eltrombopag Vivanta is and what it is 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 blood cells that help reduce or prevent bleeding.

• Eltrombopag is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already received other medications (corticosteroids or immunoglobulins) that were ineffective.

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may experience include petechiae (small, round, flat, red spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding if cut or injured.

• Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in cases where they have experienced problems with adverse effects from interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also because of antiviral treatments used to treat it. Taking this medicine may help them complete their course of antiviral therapy (peginterferon and ribavirina).

2. What you need to know before taking Eltrombopag Vivanta

Do not take Eltrombopag Vivanta

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

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

? Consult your doctor if you think this may apply to you.

Warnings and precautions

Talk to your doctor before starting Eltrombopag Vivanta:

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

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

• if you are elderly
• if you have been bedridden for a long period of time
• if you have cancer
• if you are taking oral contraceptives 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 you are in any of these situations, inform your doctor before starting treatment. You should not take this medicine unless your doctor considers that the expected benefit outweighs the risk of developing blood clots.

• if you have cataracts (the lens of the eye becomes cloudy).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting this medicine, your doctor will perform tests to confirm you do not have this condition. If you have MDS and take eltrombopag, the MDS may worsen.

? Inform your doctor if you are in any of these situations.

Eye examinations

Your doctor will recommend that you have an eye examination to check for cataracts. If you do not routinely have eye check-ups, your doctor will ask you to have them. Your retina (the layer of light-sensitive cells at the back of the eye) should also be examined to detect any bleeding in or around the retina.

You will need 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 blood test results indicating liver damage – an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, the standard treatment used together with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting eltrombopag and regularly while taking it to monitor your liver function. It may be necessary to interrupt treatment with eltrombopag if these markers increase too much or if you show any other signs of liver damage.

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

Blood tests for platelet count (levels)

If you stop treatment with this medicine, your platelet levels are likely to drop again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the necessary precautions.

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

Seek immediate medical help if you experience any of the following signs of a thrombus:

• swelling, pain, or tenderness in one leg
• sudden shortness of breath, occasionally accompanied by sharp chest pain or rapid breathing
• abdominal pain, enlarged abdomen, blood in the stool.

Examination of bone marrow

In people with bone marrow disorders, medicines such as eltrombopag may worsen these abnormalities. Signs of bone marrow changes may appear as abnormal results in your blood tests. Your doctor may also perform tests to directly examine your bone marrow during treatment with this medicine.

Monitoring for gastrointestinal bleeding

If you are taking interferon, the standard treatment used together with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestines after you stop taking eltrombopag.

Heart monitoring

Your doctor may, if necessary, monitor your heart during treatment with eltrombopag using an electrocardiogram.

Elderly people (65 years and older)

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

Children and adolescents

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

Other medicines and Eltrombopag Vivanta

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained 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 section 3 "When to take it").
• statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or immunological disorders
• minerals such as iron, calcium, magnesium, aluminium, 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 doctor if you are taking any of these medicines. Some should not be taken with eltrombopag; dose adjustments may be needed, or the timing of administration may need to be changed. 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 an increased risk of bleeding. Your doctor will discuss this with you.

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

Taking Eltrombopag Vivanta with food and drink

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 section 3, "When to take it".

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnant unless specifically recommended by your doctor. The effect of eltrombopag during pregnancy is unknown.

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

Do not breastfeed while taking eltrombopag. It is unknown 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 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 administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose or treatment regimen with eltrombopag unless advised by your doctor or pharmacist. While you are taking eltrombopag, you will be under the supervision of a specialist doctor experienced in treating your condition.

How much to take

For ITP

Adults and children (aged 6 to 17 years) – the usual starting dose for ITP is one 50 mg tablet of eltrombopag per day. If you are of East or Southeast Asian ancestry, you may need to start treatment with a lower dose of 25 mg.

Children (aged 1 to 5 years) – the usual starting dose for ITP is one 25 mg tablet of eltrombopag per day.

For Hepatitis C

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

This medicine 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 water.

When to take it

Make sure that –

• in the 4 hours before taking eltrombopag
• and in the 2 hours after taking eltrombopag

you do not consume any of the following:

• dairy foods such 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 will not properly absorb the medicine.

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

If you take more Eltrombopag Vivanta than you should

Contact your doctor or pharmacist immediately. If possible, show them the packaging or this leaflet. You will be monitored for signs or symptoms of adverse effects and will receive appropriate treatment immediately.

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

If you forget to take Eltrombopag Vivanta

Take the next dose at your 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 consulting your doctor first. If your doctor advises stopping 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 any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Symptoms to which you should pay attention: consult your doctor

People taking this medicine for either ITP or low platelet counts associated with hepatitis C may develop signs related to potentially serious adverse effects. It is important that you inform your doctor if you experience any of these symptoms.

Increased risk of blood clots

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

Seek immediate medical help if you experience any signs or symptoms of a blood clot, such as:

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden shortness of breath, exceptionally accompanied by sharp chest pain or rapid breathing
• abdominal (stomach) pain, enlarged abdomen, blood in your stools

Liver problems

Eltrombopag may cause changes detectable in blood tests, which could be signs of liver damage. Liver problems (elevated liver enzymes 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 the white part of the eyes (jaundice)
• unusually dark-colored urine

? Contact your doctor immediately

Bleeding or bruising after stopping treatment

Within two weeks after stopping treatment with eltrombopag, your platelet levels usually fall to levels similar to those you had 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 four weeks after stopping eltrombopag treatment.

? Contact your doctor if you experience bleeding or bruising after stopping eltrombopag.

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

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

? Contact 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

• Common cold
• Dizziness (nausea)
• Diarrhea
• Cough
• Infection of the nose, sinuses, throat, and respiratory tract (upper respiratory tract infection)
• Back pain

Very common adverse effects detectable in blood tests

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

Common adverse effects

May affect up to 1 in 10 people

• Muscle pain, muscle spasms, muscle weakness

• Bone pain

• Heavy menstrual periods

• Sore throat and difficulty swallowing

• Eye problems including abnormal eye test results, dry eyes, eye pain, blurred vision

• Vomiting

• Influenza (flu)

• Cold sores

• Pneumonia

• Sinus irritation and inflammation (swelling)

• Swelling, inflammation, and infection of the tonsils

• Infection of the lungs, sinuses, nose, and throat

• Gum inflammation

• Loss of appetite

• Tingling, itching, or numbness

• Decreased skin sensitivity

• Drowsiness

• Ear pain

• Pain, swelling, and tenderness in one leg (usually the calf), with warm skin in the affected area (signs of a deep vein thrombosis)

• Localized swelling filled with blood due to a ruptured blood vessel (hematoma)

• Hot flushes

• Mouth disorders including dryness or irritation in the mouth, tongue sensitivity, bleeding gums, mouth ulcers

• Runny nose

• Toothache

• Abdominal pain

• Abnormal liver function

• Skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance

• Hair loss

• Foamy or bubbly urine (signs of protein in the urine)

• Elevated temperature, feeling of warmth

• Chest pain

• Feeling of weakness

• Sleep disturbances, depression

• Migraine

• Decreased vision

• Sensation of spinning (vertigo)

• Gas (flatulence)

Common adverse effects detectable in blood tests:

• Decrease in red blood cell count (anemia)
• Decrease in platelet count (thrombocytopenia)
• Decrease in white blood cell count
• Decrease in hemoglobin levels
• Increase in eosinophils
• Increase in white blood cell count (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 levels (a substance produced by the liver)
• Increase in certain protein levels

Uncommon adverse effects

May affect up to 1 in 100 people:

• Allergic reaction
• Interruption of blood supply to parts of the heart
• Sudden breathing difficulty, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary clot (see
• “Increased risk of blood clots ” above in section 4)
• Partial loss of lung function due to blockage in the pulmonary artery
• Possible pain, swelling, and/or redness around a vein, which could be signs of venous clots
• Yellowish skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see “Liver problems ”

above in section 4)

• Liver damage due to medication

• Faster heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disturbances (prolongation of QT interval), which could indicate a heart or blood vessel disorder

• Blood clots

• Hot flushes

• Joint pain and swelling due to uric acid (gout)

• Loss of interest, mood changes, uncontrollable or unexpected crying

• Balance problems, speech and nerve function disturbances, tremors

• Pain or abnormal sensations in the skin

• Paralysis on one side of the body

• Migraine with aura

• Nerve pain

• Dilation or swelling of blood vessels causing headache

• Eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes

• Nose, throat, and sinus problems, breathing difficulties during sleep

• Blisters/pain in mouth and throat

• Loss of appetite

• Digestive system problems, including frequent bowel movements, food poisoning, blood in stools, vomiting blood

• Rectal bleeding, changes in stool color, abdominal swelling, constipation

• Mouth disorders, including dryness or irritation in the mouth, tongue pain, bleeding gums, mouth discomfort

• Sunburn

• Feeling warm, anxiety sensation

• Redness or inflammation around wounds

• Bleeding around a catheter (if present) in the skin

• Foreign body sensation

• Kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine

• Cold sweat

• General malaise

• Skin infection

• Skin changes including skin discoloration, peeling, redness, itching, and sweating

• Muscle weakness

• Rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• Changes in the shape of white blood cells
• Presence of immature white blood cells, which may indicate 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 levels
• Increase in protein in urine
• Increase in blood albumin levels
• Increase in total blood protein levels
• Decrease in blood albumin levels
• Increase in urine pH
• Increase in hemoglobin levels

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

If any of these adverse effects worsen, please 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)
• Diarrhea
• Abdominal pain
• Cough
• Elevated temperature
• Dizziness (nausea)

Common adverse effects

May affect up to 1 in 10 children

• Difficulty sleeping (insomnia)
• Toothache
• Sore throat and nasal pain
• Itching, runny nose, or nasal congestion
• Sore throat, runny nose, nasal congestion, and sneezing
• Mouth disorders including dryness, irritation in the mouth, 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:

• Headache
• Loss of appetite
• Cough
• Dizziness (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 detectable in blood tests:

• Decrease in red blood cell count (anemia)

Common adverse effects

May affect up to 1 in 10 people:

• Urinary tract infection
• Inflammation of 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
• Decreased brain function due to liver damage
• Tingling or numbness in hands and feet
• Fever, headache
• 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 eyes
• Retinal bleeding
• Sensation of spinning
• Rapid and irregular heartbeats (palpitations), difficulty breathing
• Cough with phlegm, runny nose, flu (influenza), cold sores, sore throat, and difficulty swallowing
• Digestive system disorders, including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids (piles)
• Abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (esophagus)
• Toothache
• Liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage due to medication (see “Liver problems ” above 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, limb pain (arms, legs, hands, 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
• Infection of nose, sinuses, throat, and respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucous lining of the bronchi
• Depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

• Increase in blood sugar (glucose) levels
• Decrease in white blood cell count
• Decrease in neutrophil count
• Decrease in blood albumin
• Decrease in hemoglobin levels
• Increase in 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:

• Pain during urination
• Heart rhythm disturbances (prolongation of QT interval)
• Stomach flu (gastroenteritis), sore throat
• Blisters/pain in the mouth, stomach inflammation
• Skin changes, including color changes, peeling, skin redness, itching, injury, and night sweats
• Blood clots in liver veins (possible liver and/or digestive system damage)
• Poor clotting in small blood vessels with kidney failure
• Itching and bruising at 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 with eltrombopag treatment in patients with severe aplastic anemia (SAA)

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

Very common adverse effects

May affect more than 1 in 10 people:

• Cough
• Headache
• Mouth and throat pain
• Diarrhea
• Dizziness, nausea
• Joint pain (arthralgia)
• Limb pain (arms, legs, hands, feet)
• Vertigo
• Feeling very tired
• Fever
• Chills
• Itchy eyes
• Mouth blisters
• Bleeding gums
  • Abdominal pain
  • Muscle spasms

Very common adverse effects detectable in blood tests

• Abnormal changes in bone marrow cells
• Increase in liver enzymes (aspartate aminotransferase (AST))

Common adverse effects

May affect up to 1 in 10 people:

• Anxiety

• Depression

• Feeling cold

• General malaise

• Eye problems including vision disturbances, clouding of the eye lens (cataracts), spots or deposits in the eye (floaters), dry eyes, itchy eyes, yellowing of the whites of the eyes or skin

• Nosebleeds

• Digestive problems including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach,

• Flatulence/gas, constipation, intestinal motility disturbances that may cause constipation, bloating, diarrhea, and/or the previously mentioned symptoms, 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 lower limbs due to fluid accumulation

• Abnormal urine color

• Interruption of blood flow to the spleen (splenic infarction)

• Runny nose

Common adverse effects detectable in blood tests

• Increase in certain enzymes due to muscle breakdown (creatine phosphokinase)
• Iron accumulation in the body (iron overload)
• Decrease in blood sugar levels (hypoglycemia)
• Increase in bilirubin in blood (a substance produced by the liver)
• Decrease in white blood cell count

Adverse effects with unknown frequency

Frequency cannot be estimated from available data

• Skin discoloration
• Darkening of the skin
• Liver damage due to medication

Reporting of adverse effects

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

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 pack and on the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, 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 Vivanta

The active substance in 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:

Tablet core: mannitol (E421), povidone (E1201), microcrystalline cellulose (E460(i)), sodium carboxymethyl starch (from potato), magnesium stearate (E470b).

Tablet coating:

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), indigo carmine aluminium 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 of the product and contents of the pack

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

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

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

They are supplied in aluminium blisters within a cardboard carton containing 14 or 28 film-coated tablets, and multiple packs containing 84 tablets (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 responsible for manufacturing

Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park, Paola,
PLA3000
Malta

or

MSN Labs Europe Limited
KW20A Corradino Park, Paola,
PLA3000
Malta

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch
C/Guzmán el Bueno, 133, edificio Britannia
28003 Madrid
Spain

This medicinal product 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 comprimidos recubiertos con película EFG
Eltrombopag Vivanta 50 mg comprimidos recubiertos con película EFG
Eltrombopag Vivanta 75 mg comprimidos recubiertos con película 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 most recent revision of this leaflet: February 2025.

Other sources of information

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