ELTROMBOPAG ACCORD 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eltrombopag Accord 12.5 mg film-coated tablets

Eltrombopag Accord 25 mg film-coated tablets

Eltrombopag Accord 50 mg film-coated tablets

Eltrombopag Accord 75 mg film-coated tablets

eltrombopag

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

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

Eltrombopag Accord 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 to stop or prevent bleeding.

• Eltrombopag Accord is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have had other treatments (such as 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), bruising, nosebleeds, bleeding gums, and an inability to stop bleeding if they cut or injure themselves.

• Eltrombopag Accord 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 Eltrombopag Accord may help you complete the cycle with antivirals (peginterferon and ribavirin).

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

Do not take Eltrombopag Accord

• if you are allergicto eltrombopag or any of the other ingredients of this medicine (listed in section 6 under the heading “Composition of Eltrombopag Accord”).

→ Consult your doctorif you think this may apply to you.

Warnings and precautions

Consult your doctor before starting Eltrombopag Accord:

• if you have liver problems. People who have a low platelet count and advanced chronic liver disease 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 Accord outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of having a blood clotin 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:

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking birth control pills or hormone replacement therapy
• if you have had recent surgery or physical trauma
• if you are severely overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease

→ If you are in any of these situations, tell your doctorbefore starting treatment. You should not take Eltrombopag Accord unless your doctor considers that the expected benefit outweighs the risk of having blood clots.

• if you have cataracts(clouding of the lens in the eye).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting Eltrombopag Accord, your doctor will perform tests to check that you do not have this disease. If you have MDS and take Eltrombopag Accord, 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 will 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 Accord, 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 Accord may cause changes in your liver function tests, including increased levels of certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, a base treatment with Eltrombopag Accord for low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting Eltrombopag Accord and frequently while taking it to check your liver function. It may be necessary to stop Eltrombopag Accord treatment if the levels of these markers increase too much or if you have any other signs of liver damage.

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

Blood tests for platelet count

If you stop taking Eltrombopag Accord, it is likely that your platelet count will decrease again within a few days. Your platelet count will be monitored, and your doctor will advise you on the 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 Eltrombopag Accord 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 a leg
• sudden difficulty breathing, which may be 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 Accord 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 Eltrombopag Accord treatment.

Review of gastrointestinal bleeding

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

Heart monitoring

Your doctor may consider monitoring your heart while you are taking Eltrombopag Accord with an electrocardiogram, if necessary.

Elderly patients (65 years and over)

There is limited data on the use of Eltrombopag Accord in patients aged 65 years and over. If you are 65 or older, you should be cautious when using Eltrombopag Accord.

Children and adolescents

Eltrombopag Accord 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.

Other medicines and Eltrombopag Accord

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 Accord(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
• certain 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 Accord; the dose may need to be adjusted, or you may need to 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 Eltrombopag Accord, it may be necessary to reduce the dose or stop treatment with these medicines.

Taking Eltrombopag Accord with food and drinks

Do not take Eltrombopag Accord 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 takeEltrombopag Accord if you are pregnantunless your doctor specifically recommends it. The effect of Eltrombopag Accord 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 Eltrombopag Accord.
• If you become pregnant during treatmentwith Eltrombopag Accord, tell your doctor.

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

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

Driving and using machines

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

→ Do not drive or use machinesunless you are sure that Eltrombopag Accord does not affect you.

Eltrombopag Accord 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 Accord

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Do not change the dose or treatment schedule of Eltrombopag Accord unless your doctor or pharmacist tells you to.

While taking Eltrombopag Accord, 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 old) - the usual starting dose for ITP is one 50 mg tabletof Eltrombopag Accord 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 old) - the usual starting dose for ITP is one 25 mg tabletof Eltrombopag Accord per day.

For hepatitis C

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

Eltrombopag Accord may take 1 to 2 weeks to work. Based on your response to Eltrombopag Accord, 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 Accord
• and in the 2 hours aftertaking Eltrombopag Accord

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
• some 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 Accord than you should

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

If you forget to take Eltrombopag Accord

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

If you stop taking Eltrombopag Accord

Do not stop taking Eltrombopag Accord without consulting your doctor first. If your doctor advises you to stop treatment, your platelet count 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 Eltrombopag Viatris 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 medications like Eltrombopag Viatris can 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 present 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 Accord 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 Interruption

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

→ Contact your doctorif you have bleeding or hematoma when stopping Eltrombopag Accord.

Some people have bleeding in the digestive systemafter stopping peginterferon, ribavirin, and Eltrombopag Accord. 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 doctorimmediately if you have any of these symptoms.

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

Very Common Adverse Effects

May affect more than 1 in 10people

• 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 discomfort when swallowing
• eye problems including abnormal eye tests, dry eye, eye pain, and blurred vision
• vomiting
• flu
• cold sore
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection in 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 (usually 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 sores
• 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 the level of uric acid
• 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

Uncommon 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” above 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” above in section 4)
• liver damage due to medication
• rapid or irregular heartbeat, discoloration of the skin, alterations in heart rhythm (prolonged 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 headache
• eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eye
• nose, throat, and sinus problems, breathing problems when sleeping
• blisters/pain in mouth and throat
• loss of appetite
• digestive system 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 inflammation 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
• rectal and colon cancer

Uncommon Adverse Effects that may appear in Blood Tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that can be indicative of certain diseases
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in the number of 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 Viatris 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, 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
• sore throat and nose
• 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 sores

The following adverse effects have been reported in relation to treatment with Eltrombopag Viatris 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
• discomfort similar to that produced by the flu
• 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 clouding of the eye lens (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 and irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sore, throat irritation, and discomfort when swallowing
• digestive system alterations, including vomiting, stomach pain, indigestion, constipation, stomach swelling, alterations in taste, hemorrhoids (piles), abdominal pain/discomfort, swelling of blood vessels, and bleeding in the throat (esophagus)
• toothache
• liver problems, including liver tumor, yellowing of the white area 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, 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, cold (upper respiratory tract infection), inflammation of the mucous membrane that lines 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 albumin levels in blood
• decrease in hemoglobin levels
• increase in blood bilirubin levels (a substance produced by the liver)
• changes in the enzymes that control blood coagulation

Uncommon Adverse Effects

May affect up to 1 in 100people:

• pain when urinating
• alterations in heart rhythm (prolonged QT interval)
• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes, including color changes, peeling, skin redness, itching, and nocturnal sweating
• 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 the 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 in relation to treatment with Eltrombopag Viatris 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, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eye, eye itching, 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/discomfort, stomach swelling, gas/bloating, constipation, alterations in intestinal motility that can cause constipation, bloating, diarrhea, and/or the aforementioned symptoms, changes in stool color
• fainting
• skin problems, including red spots 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 circulation 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 levels (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, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect.

5. Storage of Eltrombopag Accord

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 carton and on the blister.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eltrombopag Accord

The active substance is eltrombopag.

12.5 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine, equivalent to 12.5 mg of eltrombopag.

25 mg film-coated tablets

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

50 mg film-coated tablets

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

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine, equivalent to 75 mg of eltrombopag.

The other ingredients are: mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, isomalt (E 953), calcium silicate, hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172), yellow iron oxide (E172) [except 75 mg].

Appearance and packaging

Eltrombopag Accord 12.5 mg film-coated tablets

Round, biconvex, film-coated tablet of orange to brown color, engraved with “I” on one side and approximately 5.5 mm in diameter.

Eltrombopag Accord 25 mg film-coated tablets

Round, biconvex, film-coated tablet of dark pink color, engraved with “II” on one side and approximately 8 mm in diameter.

Eltrombopag Accord 50 mg film-coated tablets

Round, biconvex, film-coated tablet of pink color, engraved with “III” on one side and approximately 10 mm in diameter.

Eltrombopag Accord 75 mg film-coated tablets

Round, biconvex, film-coated tablet of red to brown color, engraved with “IV” on one side and approximately 12 mm in diameter.

They are supplied in aluminum blisters (OPA/Alu/PVC-Alu) in a carton containing 14, 28 or 84 tablets and multiple packs containing 84 tablets (3 packs of 28) or in aluminum perforated blisters (OPA/Alu/PVC-Alu) in a carton containing 14x1, 28x1 or 84x1 tablets and multiple packs containing 84x1 tablets (3 packs of 28x1).

Only certain pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

Synthon Hispania S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat, Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen, Netherlands

For further information about this medicine, please contact the local representative of the marketing authorization holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website https://www.ema.europa.eu. There are also links to other websites on rare diseases and treatments.