Eltrombopag Accord 50 mg film-coated tablets EFG

Package leaflet: Information for the user

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 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 you should not give it to other people, even if they have the same symptoms as you, because it could 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 Accord is and what it is used for
2. What you need to know before taking Eltrombopag Accord
3. How to take Eltrombopag Accord
4. Possible side effects
5. How to store 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 blood cells that help reduce 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 already taken other medications (corticosteroids or immunoglobulins) that have not worked for them.

• ITP is caused by a low platelet count (thrombocytopenia). People with ITP have a higher 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 they are cut or injured.

• Eltrombopag Accord may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in cases where they have had 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 due to antiviral treatments used to treat it. Taking Eltrombopag Accord may help them complete their antiviral treatment course (pegylated interferon and ribavirin).

2. What you need to know before taking Eltrombopag Accord

Do not take Eltrombopag Accord

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

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

Warnings and precautions

Talk to your doctor before starting to take Eltrombopag Accord:

• if you have liver problems. People who have low platelet counts as well as chronic advanced 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 Accord outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in veins or arteries, or if you know that blood clots are common in your family.

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

• if you are elderly
• if you have 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 chronic and advanced liver disease.

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

• if you have cataracts (clouding of the lens, the clear part of 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 condition. If you have MDS and take Eltrombopag Accord, 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 light-sensitive layer at the back of the eye) should also be examined to detect any bleeding in or around the retina.

Regular blood tests are required

Before you start taking Eltrombopag Accord, 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 monitor liver function

Eltrombopag Accord may cause blood test results indicating liver damage — an increase in certain liver enzymes, especially bilirubin and alanine/aspartate aminotransferase. If you are taking interferon as part of your standard treatment along 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 regularly during treatment to monitor your liver function. You may need to stop treatment with Eltrombopag Accord 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 to monitor platelet count (levels)

If you stop treatment with Eltrombopag Accord, 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 precautions you should take.

Very high platelet levels may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet levels. Your doctor will adjust the dose of Eltrombopag Accord 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 blood clot:

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

Tests to examine your bone marrow

In people with bone marrow disorders, medicines like Eltrombopag Accord may worsen these conditions. Signs of bone marrow changes may appear as abnormal results in your blood tests. Your doctor may also perform tests to directly assess your bone marrow during treatment with Eltrombopag Accord.

Monitoring for gastrointestinal bleeding

If you are taking interferon as part of your standard treatment along with Eltrombopag Accord, you will be monitored for any signs of bleeding in your stomach or intestines after you stop taking Eltrombopag Accord.

Heart monitoring

Your doctor may consider monitoring your heart with an electrocardiogram (ECG) during treatment with Eltrombopag Accord, if necessary.

Elderly people (65 years and older)

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

Children and adolescents

The use of Eltrombopag Accord is not recommended in children under 1 year of age with ITP (immune thrombocytopenia). 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 need to take any other medicines. This includes medicines obtained without a prescription and vitamins.

Some commonly used medicines may interact with Eltrombopag Accord (including prescription, 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
• ciclosporin, used in organ transplants 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 Viatris; dose adjustments may be needed, or the timing of administration may need to be changed. Your doctor will review your current medications and recommend alternatives if necessary.

If you are also taking medicines to prevent blood clots, your risk of bleeding may be increased. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine along with 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 Viatris 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 Viatris if you are pregnant unless specifically advised by your doctor. The effects of Eltrombopag Accord during pregnancy are unknown.

• Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Use a reliable method of contraception to prevent pregnancy while taking Eltrombopag Accord.
• If you become pregnant during treatment with Eltrombopag Accord, inform your doctor immediately.

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

→ If you are breastfeeding or planning to breastfeed, inform your doctor.

Driving and using machines

Eltrombopag Accord may cause dizziness and other adverse effects that may reduce your alertness.

→ Do not drive or operate machinery unless you are certain that Eltrombopag Accord does not affect you.

Eltrombopag Accord contains sodium and isomalt

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

This medicine also contains isomalt (E 953). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Eltrombopag Accord

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

While taking Eltrombopag Accord, you will be under the supervision of a specialist doctor experienced in treating your condition.

How much to take

For ITP

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

Children (1 to 5 years of age) – the usual starting dose for ITP is one 25 mg tablet of Eltrombopag Accord daily.

For hepatitis C

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

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

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 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.

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

If you take more Eltrombopag Accord 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.

If you forget to take Eltrombopag Accord

Take the next dose at your 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 first consulting your doctor. 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 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 everyone will experience them.

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

People taking Eltrombopag Viatris 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 a blood clot, and medicines such as Eltrombopag Viatris may worsen this problem. Sudden blockage of a blood vessel by a clot is an uncommon adverse effect and may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs 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 pain, enlarged abdomen, blood in your stools.

Liver problems

Eltrombopag Accord 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 whites 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 Accord, your platelet levels will usually fall to levels similar to those you had before starting Eltrombopag Accord. 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 treatment with Eltrombopag Accord.

→ Contact your doctor if you experience bleeding or bruising after stopping Eltrombopag Accord.

Some people experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag Accord. 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 resembling coffee grounds

→ Contact your doctor immediately if you experience any of these symptoms.

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

Very common adverse effects

May affect more than 1 in 10 people

• cold
• feeling dizzy (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
• throat irritation and discomfort when swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain, blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• 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 rupture of a blood vessel (hematoma)
• hot flushes
• mouth disorders including dry or irritated 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 hot
• chest pain
• feeling weak
• difficulty sleeping, 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 (a substance produced by the liver)
• increase in 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 embolism (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)
• drug-induced liver injury
• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, changes in heart rhythm (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)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance problems, speech and nerve function disorders, 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, difficulty breathing while sleeping
• mouth and throat blisters/pain
• loss of appetite
• digestive problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• mouth disorders including dry or irritated mouth, tongue pain, bleeding gums, mouth discomfort
• sunburn
• feeling hot, anxiety
• 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 sweats
• 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 Viatris 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
• feeling dizzy (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 Viatris 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 malaise
• 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, yellowing of the whites of the eyes
• retinal bleeding
• sensation of spinning
• rapid or irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and discomfort when swallowing
• digestive disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding in the throat (esophagus)
• toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (see "Liver problems" above in section 4)
• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin 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 the injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
• nose, sinus, throat, and respiratory tract infection, 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:

• increase in blood sugar (glucose)
• 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 when urinating
• changes in heart rhythm (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, lesions, 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 Viatris 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
• 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 problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eyes, itchy eyes, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, flatulence, constipation, changes in intestinal motility that may cause constipation, bloating, diarrhea, and/or the symptoms mentioned above, changes in stool color
• fainting
• skin problems including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common adverse effects 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 blood bilirubin (a substance produced by the liver)
• decrease in white blood cell count

Adverse effects of unknown frequency

Frequency cannot be estimated from available data

• skin discoloration
• darkening of the skin
• drug-induced liver injury

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 through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 stated on the packaging and blister.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. 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 components 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 for the 75 mg tablet].

Presentation of the product and contents of the pack

Eltrombopag Accord 12.5 mg film-coated tablets

Orange to brownish, round, biconvex, film-coated tablet, engraved with "I" on one side, approximately 5.5 mm in diameter.

Eltrombopag Accord 25 mg film-coated tablets

Dark pink, round, biconvex, film-coated tablet, engraved with "II" on one side, approximately 8 mm in diameter.

Eltrombopag Accord 50 mg film-coated tablets

Pink, round, biconvex, film-coated tablet, engraved with "III" on one side, approximately 10 mm in diameter.

Eltrombopag Accord 75 mg film-coated tablets

Red to brownish, round, biconvex, film-coated tablet, engraved with "IV" on one side, approximately 12 mm in diameter.

Supplied in aluminium 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 perforated aluminium 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 Authorisation 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, The Netherlands

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009, Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation 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 the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. Links to other websites on rare diseases and treatments are also provided.