Eltrombopag Tarbis 25 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Eltrombopag Tarbis 25 mg film-coated tablets EFG

Eltrombopag Tarbis 50 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. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine 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 taken 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 adverse effects of interferon-based treatment have been problematic. 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 Eltrombopag may help them complete their antiviral treatment course (peginterferon and ribavirina).

2. What you need to know before taking Eltrombopag Tarbis

Do not take Eltrombopag Tarbis

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 under the title “Composition of Eltrombopag Tarbis”).

?Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take Eltrombopag Tarbis:

• 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 that 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 eltrombopag 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 eltrombopag, 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 exams, 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 check for 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 assess 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, your liver problems may worsen.

You will have blood tests before starting eltrombopag and frequently during treatment to monitor your liver function. You may need to stop treatment with eltrombopag if levels of these markers increase too much or if you develop any other signs of liver damage.

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

Blood tests to monitor platelet count (levels)

If you stop treatment with eltrombopag, your platelet levels are likely to become low again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the precautions you should take.

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 eltrombopag to ensure that your 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 stools.

Bone marrow examination

In people with bone marrow disorders, medicines such as eltrombopag may worsen these conditions. Signs of bone marrow changes 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, 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 (ECG).

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 eltrombopag.

Children and adolescents

The use of eltrombopag is not recommended 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.

Other medicines and Eltrombopag Tarbis

Tell 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 Tarbis (including prescription and non-prescription medicines and minerals). These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also section 3 “When to take it”).
• medicines called statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplants or in immune 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 eltrombopag, it may be necessary to reduce the dose or discontinue treatment with these medicines.

Taking Eltrombopag Tarbis 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 advised 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 eltrombopag.
• If you become pregnant during treatment with eltrombopag, inform your doctor.

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

?If you are breastfeeding or plan 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 Tarbis contains sodium

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

3. How to take Eltrombopag Tarbis

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose or treatment regimen of eltrombopag unless your doctor or pharmacist advises you to do so. 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.

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 water.

When to take it

Make sure that during:

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

you do not consume any of the following:

• dairy foods such as cheese, butter, yoghurt, or ice cream
• milk or milkshakes, drinks made with milk, yoghurt, or cream
• antacids, a type of medicine used for indigestion and heartburn
• certain vitamin and mineral supplements, including iron, calcium, magnesium, aluminium, selenium, and zinc.

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

Take Eltrombopag

For more information about which foods and drinks are suitable, consult your doctor.

If you take more Eltrombopag Tarbis 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 be given 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.

If you forget to take Eltrombopag Tarbis

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

If you stop taking Eltrombopag Tarbis

Do not stop taking eltrombopag without first 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 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 pay attention to: consult your doctor

Patients taking eltrombopag 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 develop any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing blood clots, and medicines such as eltrombopag may worsen this risk. Sudden blockage of a blood vessel by a thrombus 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 thrombosis, 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 indicate 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 will usually fall to levels similar to those 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. ?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 (discoloration of stools is an uncommon adverse effect that may affect up to 1 in 100 people)
• blood in the stools
• vomiting blood or material resembling 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

• 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

• increased 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
• throat irritation and difficulty swallowing
• eye problems including abnormalities in eye tests, dry eyes, eye pain, blurred vision
• vomiting
• influenza (flu)
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• inflammation (swelling) and infection of the tonsils
• lung, sinus, nose, and throat infections
• 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 weak
• sleep disturbances, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• flatulence

Common adverse effects detectable in blood tests:

• decreased number of red blood cells (anemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased hemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leukocytosis)
• increased uric acid levels
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase, AST)
• increased blood bilirubin levels (a substance produced by the liver)
• increased levels of certain proteins

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 indicate a pulmonary thrombosis (see "Increased risk of thrombosis" 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 indicate venous thrombosis
• yellowish skin and/or abdominal pain, which could indicate 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 discoloration of the skin, heart rhythm disturbances (prolongation of QT interval), which could indicate a cardiovascular disorder
• blood clots
• hot flushes
• joint pain and swelling due to uric acid (gout)
• lack 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 excessive tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes
• nose, throat, and sinus problems, difficulty breathing during sleep
• blisters/pain in mouth and throat
• loss of appetite
• digestive problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood
• rectal bleeding, changes in stool color, abdominal bloating, 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
• sensation 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
• general malaise
• skin infection
• skin changes including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• colorectal 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
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased blood albumin levels
• increased total protein levels
• decreased blood albumin levels
• increased urine pH
• increased hemoglobin levels

The following adverse effects have been reported with eltrombopag treatment 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 10 children

• infection of the nose, sinuses, throat, and upper respiratory tract, 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
• throat irritation, 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 Tarbis 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
• 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 detectable in blood tests:

• decreased number of red blood cells (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, yellow 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, throat irritation and difficulty swallowing
• digestive disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, altered taste, 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, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

• increased blood sugar (glucose) levels
• decreased number of white blood cells
• decreased number of neutrophils
• decreased blood albumin levels
• decreased hemoglobin levels
• increased blood bilirubin levels (a substance produced by the liver)
• changes in enzymes controlling blood coagulation

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating
• 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, skin lesions, and night sweats
• blood clots in liver veins (possible liver and/or digestive system damage)
• poor coagulation in small blood vessels with kidney failure
• itching and bruising at injection site, chest discomfort
• decreased number of red blood cells (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 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
• eye itching
• mouth blisters
• bleeding gums
• abdominal pain
• muscle spasms

Very common adverse effects detectable in blood tests

• abnormal changes in bone marrow cells
• increased 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 problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eyes, eye itching, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, flatulence/digestive gas, constipation, changes in intestinal motility that may cause constipation, bloating, diarrhea, and/or the aforementioned 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

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

Adverse effects of 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Tarbis

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. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Eltrombopag Tarbis

The active substance in Eltrombopag Tarbis is eltrombopag.

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

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

Other components are:

Tablet core: Microcrystalline cellulose, mannitol (E421), povidone (K-30), sodium carboxymethyl starch type A (from potato), magnesium stearate.

Coating: Hypromellose (E464), macrogol (E1521), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) (only for 25 mg).

Appearance of the product and contents of the pack

Eltrombopag Tarbis 25 mg film-coated tablets

Yellow, round, bevel-edged, biconvex, film-coated tablets, marked with “5” and “5” on either side of the score on one side and “EH” on the other.

Approximate dimensions: 7.1 mm

The tablet can be divided into equal doses.

Eltrombopag Tarbis 50 mg film-coated tablets

White to off-white, round, bevel-edged, biconvex, film-coated tablets, marked with “E56” on one side and “H” on the other.

Approximate dimensions: 9.0 mm

Blister packs containing 14, 28, and 84 film-coated tablets, and perforated unit-dose blisters containing 14 x 1, 28 x 1, and 84 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

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

Germany: Eltrombopag Amarox 25 mg/50 mg Filmtabletten

The Netherlands: Eltrombopag Amarox 25 mg/50 mg filmomhulde tabletten

Spain: Eltrombopag Tarbis Farma 25 mg/50 mg comprimidos recubiertos con película EFG

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/