ELTROMBOPAG KERN PHARMA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Kern Pharma 12.5 mg film-coated tablets EFG

Eltrombopag Kern Pharma 25 mg film-coated tablets EFG

Eltrombopag Kern Pharma 50 mg film-coated tablets EFG

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

1. What is Eltrombopag Kern Pharma and what is it used for

Eltrombopag belongs to a group of medicines called thrombopoietin receptor agonists, which are 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 above who have had other treatments (such as corticosteroids or immunoglobulins) that have not worked.

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

• Eltrombopag 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 a course of antiviral treatment (peginterferon and ribavirin).

2. What you need to know before you take Eltrombopag Kern Pharma

Do not take Eltrombopag Kern Pharma

• to eltrombopag or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think this may apply to you.

Warnings and precautions

Tell your doctor or pharmacist before you start taking eltrombopag:

• . People who have a low platelet count, as well as advanced chronic liver disease, have a higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor thinks that the benefits of taking this medicine outweigh the risks, they will closely monitor you during treatment.

• if you are at risk of having a blood clotin your veins or arteries, or if you know that blood clots are a common problem in your family.

The risk of having a blood clot may be higherin the following situations:

• 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 had surgery or physical trauma
• if you are severely overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease.

If you are in any of these situations, tell your doctorbefore starting treatment. You should not take eltrombopag unless your doctor thinks that the benefits of taking this medicine outweigh the risk of having blood clots.

• (the lens in the eye becomes cloudy).
• , such as myelodysplastic syndrome (MDS). Before you start taking eltrombopag, your doctor will do tests to check that you do not have this disease. If you have MDS and take this medicine, the MDS may get worse.

Tell your doctorif 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 examinations, your doctor may ask you to have one. They will 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 you start taking eltrombopag, your doctor will do a blood test to check your blood cells, including your platelets. These tests will be repeated regularly while you are taking the medicine.

Blood tests to check your liver function

Eltrombopag may cause changes in your blood test results that show liver damage - an increase in some 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 get worse.

You will have blood tests before you start taking eltrombopag and regularly while you are 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 to check your platelet count

If you stop taking eltrombopag, it is likely that your platelet count will fall again within a few days. Your platelet count will be checked and your doctor will tell you what precautions to take.

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

Seek medical help immediatelyif you get any of the following signs of a blood clot:

• swelling, painor tenderness in one leg
• sudden difficulty breathing, which may be accompanied by sharp chest pain or rapid breathing
• abdominal pain(stomach), enlarged abdomen, blood in your stools.

Tests to examine your bone marrow

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

Review of bleeding in the gut

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

Heart monitoring

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

Elderly people (65 years and over)

There is limited information on the use of eltrombopag in patients aged 65 years and over. Eltrombopag should be used with caution in patients aged 65 years and over.

Children and adolescents

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

Other medicines and Eltrombopag Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and vitamins.

Some common medicines may interact with eltrombopag(including prescription medicines, non-prescription medicines, and minerals). These include:

• antacids for indigestion, heartburn, or stomach ulcers(see also section 3 “How to take Eltrombopag Kern Pharma”).
• statins, for lowering cholesterol
• certain medicines for HIV infection, such as lopinavir and/or ritonavir
• ciclosporin, used in transplantsor immune system diseases
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be present in vitamin and mineral supplements(see also section 3 “How to take Eltrombopag Kern Pharma”).
• medicines such as methotrexate and topotecan, used to treat cancer.

Consult your doctorif you are taking any of these medicines. Some should not be taken with eltrombopag, 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 may be a higher risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprinewith eltrombopag, you may need to reduce the dose or stop treatment with these medicines.

Taking Eltrombopag Kern Pharma with food and drink

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 Kern Pharma”.

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnantunless your doctor specifically recommends it. The effects of eltrombopag during pregnancy are not known.

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

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

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

Driving and using machines

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

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

Eltrombopag Kern Pharma contains isomalt (E953) and sodium

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

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

3. How to take Eltrombopag Kern Pharma

Follow exactly the instructions given to you by your doctor. If you are not sure, ask your doctor or pharmacist. Do not change the dose or stop treatment with eltrombopag unless your doctor or pharmacist tells you to. While you are taking eltrombopag, you will be under the care of a specialist doctor with experience in treating your condition.

How much to take

For ITP

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

Children(aged 1 to 5 years) - the usual starting dose for ITP is one 25 mg tabletof eltrombopag per day.

For hepatitis C

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

Eltrombopag may take 1 to 2 weeks to start working. 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 beforetaking eltrombopag
• and in the 2 hours aftertaking eltrombopag

you do noteat or drink:

• dairy productssuch as cheese, butter, yogurt, or ice cream
• milk or milkshakes, drinks that contain 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.

For more information on what foods and drinks are suitable, ask your doctor.

If you take more Eltrombopag Kern Pharma than you should

Consult 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 any necessary treatment.

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

If you forget to take Eltrombopag Kern Pharma

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

If you stop taking Eltrombopag Kern Pharma

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

People taking eltrombopag for both ITP and low platelet count associated with hepatitis C may exhibit signs related to potential serious adverse effects. It is essential that you inform your doctor if you develop symptoms.

Higher Risk of Thrombosis

Some people may have a higher risk of suffering a thrombus, and medications like eltrombopag can worsen this problem. The sudden blockage of a blood vessel by a thrombus is a rare adverse effect that can affect up to 1 in 100 people.

Seek immediate medical attention if you experience signs or symptoms of thrombosis, such as:

• swelling, pain, heat, redness, orsensitivity in one leg.
• sudden difficulty breathing, exceptionally accompanied by acute chest pain or agitated breathing.
• abdominal pain (stomach),enlarged abdomen, blood in your stool.

Liver Problems

Eltrombopag may cause changes that appear in blood tests, which can be signs of liver damage. Liver problems (elevated liver enzymes in blood tests) are frequent and can affect up to 1 in 10 people. Other liver problems are rare and can affect up to 1 in 100 people.

If you have any signs of liver problems:

• yellowish coloron the skin or in the white area of the eyes (jaundice)
• dark-colored urinethat is unusual.

?contact your doctor immediately

Bleeding or Hematoma after Treatment Discontinuation

Within two weeks after discontinuing treatment with eltrombopag, your platelet levels will normally drop to levels similar to those before starting treatment with this medication. A decrease in platelet levels can increase the risk of bleeding or hematoma. Your doctor will check your platelet levels for at least 4 weeks after discontinuing treatment with eltrombopag.

? Contact your doctorif you experience bleeding or hematoma when stopping eltrombopag.

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

• black, tar-like stools (stool discoloration is a rare adverse effect that can affect up to 1 in 100 people).
• blood in the stool
• vomiting blood or something that looks like coffee grounds

? Contact your doctor immediatelyif you experience any of these symptoms.

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

Very Common Adverse Effects

May affect more than 1 in 10people

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

Very Common Adverse Effects that May Appear in Blood Tests:

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

Common Adverse Effects

May affect up to 1 in 10people

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstruation
• irritation of the throat and discomfort when swallowing
• eye problems including abnormal eye tests, dry eye, eye pain, and blurred vision
• vomiting
• flu
• cold sore
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection in the tonsils
• infection of the lungs, sinuses, nose, and throat
• inflammation of the gums
• loss of appetite
• feeling of tingling, itching, or numbness
• decreased sensitivity in the skin
• drowsiness
• ear pain
• pain, swelling, and sensitivity in one leg (generally 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 rupture of a blood vessel (hematoma)
• hot flashes
• alterations in the mouth including dryness or irritation in the mouth, sensitivity in the tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, rash with itching, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in the urine)
• high temperature, feeling of heat
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• feeling that everything is spinning (vertigo)
• gas

Common Adverse Effects that May Appear in Blood Tests:

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

Uncommon Adverse Effects

May affect up to 1 in 100people:

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

Uncommon Adverse Effects that May Appear in Blood Tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that can be indicative of certain diseases
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in the number of myelocytes
• increase in neutrophils
• increase in blood urea
• increase in protein in urine
• increase in albumin levels in blood
• increase in total protein levels
• decrease in albumin levels in blood
• increase in urine pH
• increase in hemoglobin levels

The following adverse effects have been reported in relation to treatment with eltrombopag in children (1 to 17 years) with ITP

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10children

• infection of the nose, nasal sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• high temperature
• feeling of dizziness (nausea)

Common Adverse Effects

May affect up to 1 in 10children

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

The following adverse effects have been reported in relation to treatment with eltrombopag in combination with peginterferon and ribavirin in patients with HCV

Very Common Adverse Effects

May affect more than 1 in 10people:

• headache
• loss of appetite
• cough
• feeling dizzy (nausea), diarrhea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• hair loss
• feeling weak
• discomfort similar to that caused by the flu
• swelling of hands or feet
• chills

Very Common Adverse Effects that May Appear in Blood Tests:

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

Common Adverse Effects

May affect up to 1 in 10people:

• urinary tract infection
• inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation, or inflammation of the mouth, toothache
• infection of the nose, nasal sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes
• decrease in brain function due to liver damage
• tingling or numbness in hands and feet
• fever, headache
• eye problems, including clouding of the eye lens (cataracts), dry eye, small yellow deposits in the retina, yellowish color in the white area of the eyes
• retinal bleeding
• feeling that everything is spinning
• rapid and irregular heartbeats (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sore, throat irritation, and discomfort when swallowing
• digestive system alterations, including vomiting, stomach pain, indigestion, constipation, bloating, gas, changes in bowel movements, and/or the aforementioned symptoms, changes in stool color
• toothache
• liver problems, including liver tumor, yellowing of the white area of the eyes or skin (jaundice), liver damage due to medication (see “Liver Problems” 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

Common Adverse Effects that May Appear in Blood Tests:

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

Uncommon Adverse Effects

May affect up to 1 in 100people:

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

The following adverse effects have been observed in relation to treatment with eltrombopag in patients with severe aplastic anemia (SAA)

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10people:

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

Very Common Adverse Effects that May Appear in a Blood Test:

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

Common Adverse Effects

May affect up to 1 in 10people:

• anxiety
• depression
• feeling cold
• feeling of general discomfort
• eye problems, including vision problems, clouding of the eye lens (cataracts), floaters in the eye, dry eye, eye itching, yellowing of the white area of the eyes or skin
• nosebleeds
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain, stomach swelling, gas, changes in bowel movements, and/or the aforementioned symptoms, changes in stool color
• fainting
• skin problems, including red spots or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common Adverse Effects that May Appear in a Blood Test:

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

Adverse Effects of Unknown Frequency

Cannot be estimated from the available data

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist.

5. Conservation of Eltrombopag Kern Pharma

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Eltrombopag Kern Pharma film-coated tablets EFG

The active ingredient is eltrombopag

12.5 mg film-coated tablets

Each film-coated tablet contains 12.5 mg of eltrombopag (in the form of eltrombopag olamine).

25 mg film-coated tablets

Each film-coated tablet contains 25 mg of eltrombopag (in the form of eltrombopag olamine).

50 mg film-coated tablets

Each film-coated tablet contains 50 mg of eltrombopag (in the form of eltrombopag olamine).

75 mg film-coated tablets

Each film-coated tablet contains 75 mg of eltrombopag (in the form of eltrombopag olamine).

The other components (excipients) are: microcrystalline cellulose, mannitol (E-421), povidone, isomalt (E-953), calcium silicate, sodium carboxymethyl starch (Type A) (from potato), magnesium stearate (core of the tablet); hypromellose, titanium dioxide (E-171), red iron oxide (E-172), and triacetin (tablet coating).

The 12.5 mg, 25 mg, and 50 mg film-coated tabletsalso contain yellow iron oxide (E-172).

Appearance of the product and package contents

Eltrombopag Kern Pharma 12.5 mg film-coated tablets EFG are orange-brown, round, biconvex tablets, with "I" engraved on one face and a diameter of approximately 5.5 mm.

Eltrombopag Kern Pharma 25 mg film-coated tablets EFG are dark pink, round, biconvex tablets, with "II" engraved on one face and a diameter of approximately 8 mm.

Eltrombopag Kern Pharma 50 mg film-coated tablets EFG are pink, round, biconvex tablets, with "III" engraved on one face and a diameter of approximately 10 mm.

Eltrombopag Kern Pharma 75 mg film-coated tablets EFG are reddish-brown, round, biconvex tablets, with "IV" engraved on one face and a diameter of approximately 12 mm.

They are supplied in precut unit-dose blisters of oPA/Al/PVC/Al in a box containing 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

or

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat

Barcelona, Spain

Date of the last revision of this prospectus: September 2024

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