ELTROMBOPAG GLENMARK 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eltrombopag Glenmark 12.5 mg film-coated tablets EFG

Eltrombopag Glenmark 25 mg film-coated tablets EFG

Eltrombopag Glenmark 50 mg film-coated tablets EFG

Eltrombopag Glenmark 75 mg film-coated tablets EFG

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

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

Contents of the pack

1. What is Eltrombopag Glenmark and what is it used for
2. What you need to know before you take Eltrombopag Glenmark
3. How to take Eltrombopag Glenmark
4. Possible side effects
5. Storage of Eltrombopag Glenmark

1. Contents of the pack and further information

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

Eltrombopag Glenmark 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 to reduce or prevent bleeding.

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

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have a higher risk of bleeding. Symptoms that patients with ITP may notice include petechiae (small, round, flat red spots the size of a pinhead under the skin), bruising, nosebleeds, bleeding gums, and an inability to control bleeding if they cut or injure themselves.

Eltrombopag may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, if 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 may help you complete the cycle of antivirals (peginterferon and ribavirin).

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

Do not take Eltrombopag Glenmark

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

Talk to your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take eltrombopag:

• if you have liver problems. People who have a low platelet count and advanced chronic liver disease (long-standing) are at higher risk of adverse effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of taking this medicine outweighs the risks, they will closely monitor you during treatment.

• if you are at risk of having a blood clot in the veins or arteries, or if you know that the occurrence of clots is common in your family.

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

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking the contraceptive pill or hormone replacement therapy
• if you have recently undergone surgery or have suffered 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, inform your doctor before starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of having blood clots.

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

Tell 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 have regular eye checks, your doctor will ask you to have them. They should also check your retina (the layer of light-sensitive cells at the back of the eye) for bleeding in the retina or around it.

You will need to have regular blood tests

Before starting to take eltrombopag, your doctor will perform a blood test to check your blood cells, including platelets. These tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon-based treatments with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting to take eltrombopag and frequently while taking it to check your liver function. You may need to stop taking eltrombopag if the levels of these markers increase too much or if you have any other 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, it is likely that within a few days, your platelet counts will return to levels similar to those before you started taking eltrombopag. Your platelet counts will be checked and your doctor will tell you what precautions to take.

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

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

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

Tests to examine your bone marrow

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

Review of gastrointestinal bleeding

If you are taking interferon-based treatments with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestine after stopping this medicine.

Heart monitoring

Your doctor may consider it necessary to monitor your heart during treatment with eltrombopag and perform an electrocardiogram (ECG) test.

Elderly people (65 years and over)

There is limited data on the use of eltrombopag in patients aged 65 years or over. Caution should be exercised when using eltrombopag if you are 65 years or over.

Children and adolescents

Eltrombopag 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 Glenmark

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

• antacids for indigestion, heartburn, or stomach ulcers (see also section 3 “How to take Eltrombopag Glenmark”).
• statins to lower cholesterol.
• certain medicines to treat HIV infection, such as lopinavir and/or ritonavir.
• cyclosporine, used in transplants or 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 “How to take Eltrombopag Glenmark”).
• medicines such as methotrexate and topotecan, used to treat cancer.

Talk to your doctor if you are taking any of these medicines. Some should not be taken with eltrombopag; 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 azathioprine with eltrombopag, you may need to reduce the dose or stop treatment with these medicines.

Taking Eltrombopag Glenmark with food and drinks

Do not take eltrombopag with food or dairy products, as the calcium in dairy products affects the absorption of the medicine. For more information, see section 3, “How to take Eltrombopag Glenmark”.

Pregnancy and breastfeeding

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

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

Driving and using machines

Eltrombopag may cause dizziness and have other effects that make you less alert.

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

Eltrombopag Glenmark contains isomalt and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Eltrombopag Glenmark

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, talk to your doctor or pharmacist again. Do not change the dose or treatment schedule of eltrombopag unless your doctor or pharmacist advises you to do so. While taking eltrombopag, you will be under the supervision of a specialist doctor with experience in treating your condition.

How much to take

For ITP

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

Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg 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 descent, start treatment with the same dose of 25 mg.

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

How to take the tablets

Swallow the tablet whole, with water.

When to take it

Make sure that

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

you do not consume any of the following:

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

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

To get more information about what foods and drinks are suitable, talk to your doctor.

If you take more Eltrombopag Glenmark than you should

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

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount used.

If you forget to take Eltrombopag Glenmark

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

If you stop taking Eltrombopag Glenmark

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to pay attention to: see your doctor

People taking eltrombopag for both ITP and low platelet counts associated with hepatitis C may have signs related to serious side effects. It is important that you tell your doctor if you develop these symptoms.

Higher risk of blood clots

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

Seek medical help immediately if you have signs or symptoms of a blood clot, such as:

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

Liver problems

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. Liver problems (increased liver enzymes in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are rare and may affect up to 1 in 100 people.

If you have any 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 2 weeks after stopping treatment with eltrombopag, your platelet counts will usually return to levels similar to those before you started taking eltrombopag. A decrease in platelet counts can increase the risk of bleeding or bruising. Your doctor will check your platelet counts for at least 4 weeks after stopping treatment with this medicine.

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

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

• black, tarry stools
• blood in the stool
• vomiting blood or something that looks like coffee grounds

Contact your doctor immediately if you have any of these symptoms.

The following side effects have been reported in adults with ITP taking eltrombopag:

Very common side effects(may affect more than 1 in 10 people)

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

Very Common Adverse Effectsthat may be seen in blood tests:

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

Common Adverse Effects(may affect up to 1 in 10 people)

• flu, cold sore, pneumonia, irritation and inflammation (swelling) of the breasts, inflammation (swelling) and infection of the tonsils, lung infection, breast infection, nose and throat infection, gum inflammation, throat irritation and difficulty swallowing
• loss of appetite
• sleeping problems, depression
• decreased skin sensitivity, tingling sensation, itching or numbness (tingling), drowsiness, migraine
• eye problems including abnormal eye tests, dry eye, eye pain and blurred vision, decreased vision
• ear pain, feeling of dizziness (vertigo)
• 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
• runny nose
• mouth alterations including dryness or irritation in the mouth, tongue sensitivity, gum bleeding, mouth ulcers, toothache, vomiting, abdominal pain, gas
• abnormal liver function
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance, hair loss
• muscle pain, muscle spasm, muscle weakness, bone pain
• foamy or bubbly urine (signs of protein in the urine)
• heavy menstruation
• high temperature, feeling of heat, chest pain, feeling of weakness

Common Adverse Effectsthat may appear in blood tests:

• decrease in the number of red blood cells (anemia), decrease in the number of platelets (thrombocytopenia), decrease in the number of white blood cells, decrease in hemoglobin levels, increase in the number of eosinophils, increase in the number of white blood cells (leukocytosis)
• increase in uric acid levels, decrease in potassium levels
• increase in liver enzymes (aspartate aminotransferase (AST)), increase in blood bilirubin (a substance produced by the liver)
• increase in some protein levels, increase in creatinine levels
• increase in alkaline phosphatase levels

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• skin infection
• colon and rectal cancer
• allergic reaction
• loss of appetite, joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrolled or unexpected crying
• balance problems, speech and nervous system alterations, tremors, paralysis of one side of the body, migraine with aura, nerve pain, dilation or swelling of blood vessels that cause headache
• eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eye
• fast heartbeat, irregular heartbeat, bluish discoloration of the skin, cardiac rhythm alterations (QT interval prolongation) that could be a sign of a heart and blood vessel disorder, interruption of blood supply to parts of the heart
• possible pain, swelling, and/or redness around a vein that could be signs of blood clots in a vein, blood clots, hot flashes
• sudden difficulty breathing, especially when accompanied by acute chest pain and/or agitated breathing, which could be signs of a blood clot in the lungs (see "Increased risk of blood clots" earlier in section 4), partial loss of lung function caused by a blockage in the pulmonary artery, nose, throat, and sinus problems, breathing problems while sleeping
• mouth alterations, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth discomfort, blisters/pain in mouth and throat, digestive problems including frequent bowel movements, food poisoning, blood in stool, vomiting blood, rectal bleeding, changes in stool color, abdominal swelling, constipation
• yellowish skin and/or abdominal pain that could be signs of a bile duct obstruction, liver injury, liver damage due to inflammation (see "Liver problems" earlier in section 4), liver damage due to medication
• pain or abnormal sensations in the skin, skin changes including skin discoloration, peeling, redness, itching, and sweating, cold sweat
• muscle weakness
• kidney problems, including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• feeling of heat, feeling of anxiety, bleeding around a catheter (if present) in the skin, redness or inflammation around wounds, feeling of general discomfort, feeling of foreign body
• sunburn

Uncommon Adverse Effectsthat may appear in blood tests:

• changes in the shape of red blood cells, 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, presence of immature white blood cells that may be indicative of certain diseases, increase in the number of platelets, increase in hemoglobin levels
• decrease in calcium levels
• increase in blood urea, increase in protein in urine
• increase in blood albumin levels, increase in total protein levels, decrease in blood albumin levels, increase in urine pH

The following adverse effects have been reported in association 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)

• nose, sinus, throat, and upper respiratory tract infections, cold (upper respiratory tract infection)
• cough
• discomfort (nausea), diarrhea, abdominal pain
• high temperature

Common Adverse Effects(may affect up to 1 in 10 children)

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

The following adverse effects have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with CHC:

Very Common Adverse Effects(may affect more than 1 in 10 people)

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

Very Common Adverse Effectsthat may appear in blood tests:

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

Common Adverse Effects(may affect up to 1 in 10 people)

• urinary tract infection, nose, sinus, throat, and upper respiratory tract infections, cold (upper respiratory tract infection), bronchitis, nasal passage, throat, and mouth inflammation, flu-like symptoms, dry mouth, mouth irritation or inflammation, toothache, flu, cold sore
• 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 of hands and feet
• eye problems, including cataracts, dry eye, small yellow deposits in the retina, yellowish color in the white of the eyes, retinal bleeding
• feeling of dizziness (vertigo)
• fast and irregular heartbeats (palpitations)
• breathing difficulties, cough with phlegm, runny nose, throat irritation and difficulty swallowing
• digestive problems, including vomiting, stomach pain, indigestion, constipation, stomach swelling, changes in taste, hemorrhoids, abdominal pain and discomfort, blood vessel swelling and bleeding 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" earlier in section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, pain in the limbs (arms, legs, hands, and feet), muscle spasms
• irritability, feeling of general discomfort, skin reactions such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid retention in the body or limbs that causes swelling
• depression, anxiety, sleep problems, nervousness
• fever, headache

Common Adverse Effectsthat may appear in blood tests:

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

Uncommon Adverse Effects(may affect up to 1 in 100 people)

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

The following adverse effects have been observed in association 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)

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

Very Common Adverse Effectsthat may appear 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)

• interruption of blood flow to the spleen (splenic infarction)
• anxiety, depression
• fainting
• eye problems, including vision problems, blurred vision, cataracts, floaters, dry eye, eye itching, yellowing of the whites of the eyes or skin
• nosebleeds, runny nose
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain and discomfort, stomach swelling, gas, constipation, changes in bowel movements that may cause constipation, swelling, diarrhea, and/or the aforementioned symptoms, changes in stool color
• 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
• abnormal urine color
• weakness (asthenia), swelling of the lower limbs due to fluid accumulation, feeling of general discomfort, feeling of cold

Common Adverse Effectsthat may appear in a blood test:

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

Adverse Effects of Unknown Frequency(cannot be estimated from the available data)

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

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Eltrombopag Glenmark

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

Do not use this medicine after the expiration date that appears on the box and on the blister after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Eltrombopag Glenmark Composition

• The active ingredient is eltrombopag olamine.

Eltrombopag Glenmark 12.5 mg film-coated tablets EFG: each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.

Eltrombopag Glenmark 25 mg film-coated tablets EFG: each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Eltrombopag Glenmark 50 mg film-coated tablets EFG: each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

Eltrombopag Glenmark 75 mg film-coated tablets EFG: each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

• The other ingredients (excipients) are: microcrystalline cellulose, mannitol, povidone, isomalt (E953), calcium silicate, sodium carboxymethyl starch (type A), magnesium stearate (tablet core); hypromellose, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), triacetin (coating material).

Product Appearance and Package Contents

The Eltrombopag Glenmark 12.5 mg film-coated tablets are orange to brown, round, biconvex, marked with "I" on one side, and approximately 5.5 mm in diameter.

The Eltrombopag Glenmark 25 mg film-coated tablets are dark pink, round, biconvex, marked with "II" on one side, and approximately 8 mm in diameter.

The Eltrombopag Glenmark 50 mg film-coated tablets are pink, round, biconvex, marked with "III" on one side, and approximately 10 mm in diameter.

The Eltrombopag Glenmark 75 mg film-coated tablets are red to brown, round, biconvex, marked with "IV" on one side, and approximately 12 mm in diameter.

Eltrombopag Glenmark 12.5 mg is supplied in blisters in a box containing 10, 14, 28, 30, or 84 film-coated tablets or single-dose precut blisters in a box containing 10x1, 14x1, 28x1, 30x1, or 84x1 film-coated tablets.

Eltrombopag Glenmark 25 mg is supplied in blisters in a box containing 10, 14, 28, 30, or 84 film-coated tablets or single-dose precut blisters in a box containing 10x1, 14x1, 28x1, 30x1, or 84x1 film-coated tablets.

Eltrombopag Glenmark 50 mg is supplied in blisters in a box containing 10, 14, 28, 30, or 84 film-coated tablets or single-dose precut blisters in a box containing 10x1, 14x1, 28x1, 30x1, or 84x1 film-coated tablets.

Eltrombopag Glenmark 75 mg is supplied in blisters in a box containing 10, 14, 28, 30, or 84 film-coated tablets or single-dose precut blisters in a box containing 10x1, 14x1, 28x1, 30x1, or 84x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Synthon Hispania S.L.

Calle de Castelló 1

08830 Sant Boi de Llobregat, Barcelona

Spain

Synthon B.V.

Microweg 22

6545 CM, Nijmegen, Gelderland

Netherlands

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Date of last revision of this leaflet: September 2023

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