Eltrombopag Glenmark 25 mg film-coated tablets EFG

Package leaflet: Information for the user

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 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; do not give it to others, 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.

Package leaflet contents

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

2. What you need to know before taking Eltrombopag Glenmark

3. How to take Eltrombopag Glenmark

4. Possible side effects

5. Storage of Eltrombopag Glenmark

6. Contents of the pack and other information

1. What Eltrombopag Glenmark is and what it is 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 reduce or prevent bleeding.

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

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

Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who 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 the antiviral treatments used to treat it. Taking eltrombopag may help them complete their antiviral treatment course (peginterferon and ribavirina).

2. What you need to know before starting Eltrombopag Glenmark

Do not take Eltrombopag Glenmark

• 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 Glenmark”).

Consult your doctor if you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take eltrombopag:

• if you have liver problems. People who have a low platelet count as well as advanced chronic liver disease (long-standing) are at increased risk of adverse effects, liver damage which may be fatal, and blood clots. If your doctor considers that the benefit of taking this medicine 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 occur frequently in your family.

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

• if you are elderly
• if you have had to remain in bed for a prolonged period
• if you have cancer
• if you are taking oral contraceptives or hormone replacement therapy
• if you have recently undergone surgery or have suffered physical injury
• if you are significantly overweight (obesity)
• 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 developing blood clots.

• if you have cataracts (clouding of the eye's lens).
• 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 eltrombopag. If you have MDS and take this medicine, the MDS may worsen.

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

Eye Exams

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

You will need to have regular blood tests

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

Blood tests to check liver function

Eltrombopag may cause blood test results indicating liver damage—a rise in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatments in combination with eltrombopag to treat low platelet levels due to hepatitis C, this could worsen existing liver problems.

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

Read the information "Liver problems" in section 4 of this leaflet.

Blood test for platelet count

If you stop treatment with eltrombopag, your platelet levels are likely to become low again within a few days. 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 clot formation. However, blood clots can also occur with normal or even low platelet levels. Your doctor will adjust the dose of eltrombopag to ensure that the platelet count does not become too high.

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

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

Analysis to examine your bone marrow

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

Review of gastrointestinal bleeding

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

Heart Monitoring

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

Elderly patients (65 years and older)

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

Children and adolescents

The use of eltrombopag is not recommended in children under 1 year of age with ITP. It is also not recommended in children under 18 years of age with low platelet counts due to hepatitis C.

Other medicines and Eltrombopag Glenmark

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and vitamins.

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

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also section 3 "How to take Eltrombopag Glenmark").
• medicines called statins, used to lower cholesterol.
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir.
• cyclosporine, used in transplant patients or for immunological 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.

Consult your doctor if you are taking any of these medicines. Some should not be taken with eltrombopag, a dose adjustment may be necessary, or you may need to change the times at which you take them. Your doctor will review the medicines you are taking and recommend alternatives if needed.

If you are also taking medicines to prevent blood clots, there is an increased risk of bleeding. Your doctor will discuss this with you.

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

Taking Eltrombopag Glenmark with food and drinks

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

Pregnancy and breastfeeding

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

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

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

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

Driving and use of machines

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

Do not drive or operate machinery unless you are certain that eltrombopag does not affect you.

Eltrombopag Glenmark contains isomalt and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

3. How to take Eltrombopag Glenmark

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

How much to take

For ITP

Adults and children (6 to 17 years of age) – the usual starting dose for ITP is one 50 mg eltrombopag tablet 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 eltrombopag tablet daily.

For Hepatitis C

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

Eltrombopag may take 1 to 2 weeks to take effect. 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 foods 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, aluminium, selenium, and zinc.

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

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

If you take more Eltrombopag Glenmark than you should

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

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

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 interrupt treatment with Eltrombopag Glenmark

Do not stop taking eltrombopag without first consulting your doctor. If your doctor advises you to interrupt 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 may cause adverse effects, although not everyone will experience them.

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

People taking eltrombopag for either ITP or low platelet count associated with hepatitis C may experience signs related to possible 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 may worsen this problem. Sudden blockage of a blood vessel by a thrombus is an uncommon adverse effect that may affect up to 1 in 100 people.

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

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

Liver problems

Eltrombopag may cause changes that may show up in blood tests, and which could be signs of liver damage. Liver problems (increased 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 signs of liver problems:

• yellowing of the skin or the white part of the eyes (jaundice)
• unusually dark urine

contact your doctor immediately.

Bleeding or bruising after stopping treatment

Within two weeks after stopping treatment with eltrombopag, your platelet levels will usually fall to levels similar to those you had before starting eltrombopag treatment. A decrease in platelet levels may increase the risk of bleeding or bruising. Your doctor will monitor your platelet levels for at least 4 weeks after stopping treatment with this medicine.

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

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

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

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

The following adverse reactions have been reported in relation to eltrombopag treatment in adult patients with ITP:

Very common adverse reactions (may affect more than 1 in 10 people)

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

Very common adverse effects that may be seen in blood tests:

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

Frequent adverse effects (may affect up to 1 in 10 people)

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of the sinuses, inflammation (swelling) and infection of the tonsils, lung infection, sinus, nose and throat infection, gum inflammation, sore throat and discomfort when swallowing
• loss of appetite
• sleep problems, depression
• decreased skin sensitivity, tingling sensation, itching or numbness (paresthesia), drowsiness, migraine
• eye problems including abnormalities in eye tests, dry eye, eye pain and blurred vision, decreased vision
• ear pain, sensation of spinning (vertigo)
• pain, swelling and tenderness in one leg (usually the calf), with warm skin in the affected area (signs of a blood clot in a deep vein), localized swelling filled with blood due to rupture of a blood vessel (hematoma), hot flushes
• runny nose
• mouth disorders including dryness or irritation in the mouth, tongue sensitivity, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, flatulence
• 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 menstrual periods
• elevated temperature, feeling of warmth, chest pain, feeling of weakness

Frequent 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 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 levels (a substance produced by the liver)
• increase in levels of certain proteins, increase in creatinine levels
• increase in alkaline phosphatase levels

Uncommon adverse effects (may affect up to 1 in 100 people)

• skin infection
• rectal and colon cancer
• allergic reaction
• loss of appetite, joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, crying that is difficult to soothe or occurs unexpectedly
• balance problems, speech and nervous system disturbances, twitching, 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 eye
• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, changes in heart rhythm (QT interval prolongation) which could indicate a heart- or blood vessel-related disorder, interruption of blood supply to parts of the heart
• possible pain, swelling, and/or redness around a vein which could be signs of venous thrombosis, blood clots, hot flashes
• sudden breathing difficulty, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary embolism (see “Increased risk of thrombosis” earlier in section 4), partial loss of lung function caused by blockage in the pulmonary artery, nose, throat, and sinus problems, breathing problems during sleep
• mouth disturbances, including dry or irritated mouth, tongue pain, gum bleeding, mouth discomfort, blisters/pain in mouth and throat, digestive system 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 which could be signs of bile duct obstruction, liver injury, liver damage due to inflammation (see “Liver problems” earlier in section 4), medication-induced liver damage
• pain or abnormal sensations in the skin, skin changes including skin discoloration, peeling, redness, itching, and sweating, cold sweats
• muscle weakness
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• feeling hot, anxiety, bleeding around a catheter (if present) on the skin, redness or inflammation around wounds, general malaise, sensation of a foreign body
• sunburn

Uncommon adverse effects that 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 myelocytes, increase in neutrophils, presence of immature white blood cells which may indicate certain diseases, increase in platelet count, increase in hemoglobin levels
• decreased calcium levels
• increased blood urea, increased protein in urine
• increased blood albumin levels, increased total protein levels, decreased blood albumin levels, increased urine pH

The following adverse reactions have been reported in relation to eltrombopag treatment in children (1 to 17 years of age) with ITP:

If these adverse reactions 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)
• cough
• discomfort (nausea), diarrhea, abdominal pain
• elevated temperature

Frequent adverse effects (may affect up to 1 in 10 children)

• difficulty sleeping (insomnia)
• itching, runny or blocked nose, sore throat, nasal discharge, nasal congestion and sneezing, throat and nasal irritation
• toothache, mouth disorders including dryness, mouth irritation, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse reactions related to eltrombopag treatment in combination with peginterferon and ribavirine have been reported in patients with HCV:

Very common adverse reactions (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 tiredness, flu-like discomfort, feeling of weakness, chills

Very common adverse effects that may appear in blood tests:

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

Frequent adverse effects (may affect up to 1 in 10 people)

• urinary tract infection, nose, sinus, throat and respiratory tract infection, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi, inflammation of nasal passages, throat and mouth, influenza-like symptoms, dry mouth, irritation or inflammation of the mouth, toothache, influenza, cold sores
• 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
• eye problems, including clouding of the eye's lens (cataracts), dry eyes, small yellow deposits in the retina, yellowish discoloration in the white part of the eyes, retinal bleeding
• sensation of spinning (vertigo)
• rapid and irregular heartbeat (palpitations)
• difficulty breathing, cough with phlegm, runny nose, throat irritation and discomfort when swallowing
• gastrointestinal disturbances, including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (esophagus), toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (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, limb pain (arms, legs, hands and feet), muscle spasms
• irritability, general feeling of discomfort, 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
• depression, anxiety, sleep problems, restlessness
• fever, headache

Frequent adverse effects that may appear 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 that control blood clotting

Uncommon adverse effects (may affect up to 1 in 100 people)

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

The following adverse reactions have been observed with eltrombopag treatment in patients with severe aplastic anemia (SAA):

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

Very common adverse reactions (may affect more than 1 in 10 people)

• headache, dizziness
• cough, mouth and throat pain
• diarrhea, nausea, bleeding gums, abdominal pain
• joint pain (arthralgia), limb pain (arms, legs, hands, and feet), muscle spasms
• feeling very tired, fever, chills
• itchy eyes
• mouth blisters

Very common adverse reactions that may appear in blood tests:

• abnormal changes in bone marrow cells
• increased liver enzymes (aspartate aminotransferase, AST)

Common adverse reactions (may affect up to 1 in 10 people)

• interruption of blood flow to the spleen (splenic infarction)
• anxiety, depression
• fainting
• eye problems including vision disturbances, blurred vision, clouding of the lens of the eye (cataracts), spots or deposits in the eye (vitreous floaters), dry eye, itchy eyes, 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/discomfort, stomach bloating, flatulence/digestive gas, constipation, changes in intestinal motility that may cause constipation, bloating, diarrhea and/or the previously mentioned 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, general malaise, feeling cold

Common adverse reactions that may appear in blood tests:

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

Adverse reactions with unknown frequency (cannot be estimated from available data)

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it involves possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide 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 expiry date which is stated on the carton and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Eltrombopag Glenmark

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

Appearance of the Product and Contents of the Pack

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

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

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

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

Eltrombopag Glenmark 12.5 mg is supplied in blister packs within a carton containing 10, 14, 28, 30 or 84 film-coated tablets, or in single-dose perforated blister strips within a carton containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets.

Eltrombopag Glenmark 25 mg is supplied in blister packs within a carton containing 10, 14, 28, 30 or 84 film-coated tablets, or in single-dose perforated blister strips within a carton containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets.

Eltrombopag Glenmark 50 mg is supplied in blister packs within a carton containing 10, 14, 28, 30 or 84 film-coated tablets, or in single-dose perforated blister strips within a carton containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets.

Eltrombopag Glenmark 75 mg is supplied in blister packs within a carton containing 10, 14, 28, 30 or 84 film-coated tablets, or in single-dose perforated blister strips within a carton containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

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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

The Netherlands

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

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark	Eltrombopag Glenmark
Spain	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
Norway	Eltrombopag Glenmark
Netherlands	Eltrombopag Glenmark 12.5 mg tablets Eltrombopag Glenmark 25 mg tablets Eltrombopag Glenmark 50 mg tablets Eltrombopag Glenmark 75 mg tablets
Poland	Eltrombopag Glenmark
Slovakia	Eltrombopag Glenmark 12.5 mg Eltrombopag Glenmark 25 mg Eltrombopag Glenmark 50 mg Eltrombopag Glenmark 75 mg
Sweden	Eltrombopag Glenmark

Date of the most recent review of this leaflet: September 2023.

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