Eltrombopag Kern Pharma 75 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

• Eltrombopag is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year or older who have already received other medications (corticosteroids or immunoglobulins) that were ineffective.

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 the size of a pinprick 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 experienced problems with adverse effects from interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also due to antiviral treatments used to treat it. Taking eltrombopag may help them complete their antiviral treatment course (peginterferon and ribavirina).

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

Do not take Eltrombopag Kern Pharma

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

? Consult your doctor if you think this may apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking eltrombopag:

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

• if you are at risk of developing a thrombus (blood clot) in veins or arteries, or if you know that blood clots are common in your family.

The risk of developing a thrombus 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 suffered physical injury
• if you are significantly overweight (obesity)
• if you smoke
• 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 lens in the eye).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting eltrombopag, your doctor will perform tests to check that you do not have this condition. If you have MDS and take this medicine, the MDS may worsen.

? Inform your doctor if any of these situations apply to you.

Eye examinations

Your doctor will recommend that you have an examination to check for cataracts. If you do not routinely have regular eye exams, 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 regular blood tests

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

Blood tests to monitor liver function

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

You will have blood tests before starting eltrombopag and regularly during treatment to monitor your liver function. You may need to stop treatment with eltrombopag if these markers increase too much or if you show any other signs of liver damage.

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

Blood tests to monitor platelet count (levels)

If you stop treatment with eltrombopag, your platelet levels are likely to drop again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the precautions you should take.

Very high platelet levels may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet levels. Your doctor will adjust the dose of eltrombopag 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 one leg
• sudden shortness of breath, rarely accompanied by sharp chest pain or rapid breathing
• abdominal pain, enlarged abdomen, blood in stools.

Tests to examine your bone marrow

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

Monitoring for gastrointestinal bleeding

If you are taking 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 may perform an electrocardiogram (ECG).

Elderly people (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 Kern Pharma

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, over-the-counter medicines, and minerals). These include:

• antacid medicines used to treat indigestion, heartburn, or stomach ulcers (see also section 3 “How to take Eltrombopag Kern Pharma”).
• medicines called statins, used to lower cholesterol
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or in immune system disorders
• 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 doctor if you are taking any of these medicines. Some should not be taken with eltrombopag; dose adjustments may be needed, or the timing of administration may need to be changed. 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 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 or stop treatment with these medicines.

Taking Eltrombopag Kern Pharma 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 Kern Pharma”.

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 plan 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 not known whether eltrombopag passes into breast milk.

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

Driving and using 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 Kern Pharma contains isomalt (E-953) and sodium

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

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

3. How to take Eltrombopag Kern Pharma

Follow exactly the instructions for administering this medicine as 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 you are 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 per day. 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 per day.

For hepatitis C

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

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

How to take the tablets

Swallow the tablet whole with water.

When to take it

Make sure that during:

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

you do not consume any of the following:

• dairy foods such as cheese, butter, yoghurt, or ice cream
• milk or milkshakes, drinks containing milk, yoghurt, or cream
• antacids, a type of medicine used 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 further information on suitable foods and drinks, consult your doctor.

If you take more Eltrombopag Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eltrombopag Kern Pharma

Take the next dose at your 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 consulting your doctor. If your doctor advises stopping treatment, your platelet levels will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

People taking eltrombopag for either ITP or low platelet count associated with hepatitis C may develop signs related to potentially serious adverse effects. It is important that you inform your doctor if you develop any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing a blood clot, and medicines such as eltrombopag may worsen this problem. Sudden blockage of a blood vessel by a thrombus is an uncommon adverse effect and may affect up to 1 in 100 people.

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

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

Liver problems

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

If you experience any of the following signs of liver problems:

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

?contact your doctor immediately

Bleeding or bruising after stopping treatment

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

? 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 adverse effect that may affect up to 1 in 100 people).
• blood in the stools
• vomiting blood or material that looks like coffee grounds

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

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

Very common adverse effects

May affect more than 1 in 10 people

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

Very common adverse effects that may be seen in blood tests

• increased liver enzymes (alanine aminotransferase [ALT])

Common adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual periods
• throat irritation and discomfort when swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• swelling (inflammation) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, itching, or numbness
• reduced skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually the calf) with warm skin in the affected area (signs of a deep vein thrombosis)
• localized swelling filled with blood due to rupture of a blood vessel (hematoma)
• hot flushes
• mouth disorders including dryness or irritation in the mouth, tongue sensitivity, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in the urine)
• elevated temperature, feeling hot
• chest pain
• feeling weak
• difficulty sleeping, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• gas (flatulence)

Common adverse effects that may appear in blood tests:

• decreased number of red blood cells (anemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased hemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leukocytosis)
• increased level of uric acid
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase [AST])
• increased blood bilirubin levels (a substance produced by the liver)
• increased levels of certain proteins

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction
• interruption of blood supply to parts of the heart
• sudden difficulty breathing, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary embolism (see "Increased risk of thrombosis" above in section 4)
• partial loss of lung function caused by blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could be signs of venous thrombosis
• yellowish skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see "Liver problems" above in section 4)
• liver damage due to medication
• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, changes in heart rhythm (prolongation of QT interval), which could be signs of a heart and blood vessel disorder
• blood clots
• hot flushes
• joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance problems, speech and nerve function disturbances, tremors
• pain or abnormal sensations in the skin
• paralysis on one side of the body
• migraine with aura
• nerve pain
• dilation or swelling of blood vessels causing headache
• eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes
• nose, throat, and sinus problems, difficulty breathing during sleep
• blisters/pain in mouth and throat
• loss of appetite
• digestive problems, including frequent bowel movements, food poisoning, blood in stools, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• mouth disorders, including dryness or irritation in the mouth, tongue pain, bleeding gums, mouth discomfort
• sunburn
• feeling hot, anxiety sensation
• redness or swelling around wounds
• bleeding around a catheter (if present) in the skin
• sensation of a foreign body
• kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine
• cold sweat
• general malaise
• skin infection
• skin changes including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon adverse effects that may appear in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased blood albumin levels
• increased total protein levels
• decreased blood albumin levels
• increased urine pH
• increased hemoglobin levels

The following adverse effects have been reported 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

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

Common adverse effects

May affect up to 1 in 10 children

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

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

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects that may appear in blood tests:

• decreased number of red blood cells (anemia)

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection
• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation, or inflammation of the mouth, toothache
• infection of the nose, 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
• decreased brain function due to liver damage
• tingling or numbness in hands and feet
• fever, headache
• eye problems, including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellowing of the white part of the eyes
• retinal bleeding
• sensation of spinning
• rapid and irregular heartbeats (palpitations), difficulty breathing
• productive cough, runny nose, flu (influenza), cold sores, throat irritation, and discomfort when swallowing
• digestive disorders, including vomiting, stomach pain, indigestion, constipation, bloated stomach, altered taste, 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), liver damage due to medication (see "Liver problems" above in section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, feet), muscle spasms
• irritability, general malaise, skin reactions such as redness or swelling and pain at injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
• depression, anxiety, sleep problems, restlessness

Common adverse effects that may appear in blood tests:

• increased blood sugar (glucose)
• decreased number of white blood cells
• decreased number of neutrophils
• decreased blood albumin
• decreased hemoglobin levels
• increased blood bilirubin levels (a substance produced by the liver)
• changes in enzymes controlling blood coagulation

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating
• changes in heart rhythm (prolongation of QT interval)
• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes, including color changes, peeling, skin redness, itching, skin lesions, and night sweats
• blood clots in liver veins (possible liver and/or digestive system damage)
• poor coagulation in small blood vessels with kidney failure
• itching and bruising at injection site, chest discomfort
• decreased 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 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:

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

Very common adverse effects that may appear in blood tests

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

Common adverse effects

May affect up to 1 in 10 people:

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

Common adverse effects that may appear in blood tests

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

Adverse effects with unknown frequency

Frequency cannot be estimated from available data

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eltrombopag Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eltrombopag Kern Pharma film-coated tablets EFG

The active substance is eltrombopag.

12.5 mg film-coated tablets

Each film-coated tablet contains 12.5 mg of eltrombopag (as eltrombopag olamine).

25 mg film-coated tablets

Each film-coated tablet contains 25 mg of eltrombopag (as eltrombopag olamine).

50 mg film-coated tablets

Each film-coated tablet contains 50 mg of eltrombopag (as eltrombopag olamine).

75 mg film-coated tablets

Each film-coated tablet contains 75 mg of eltrombopag (as 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 (tablet core); 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 tablets also contain yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Eltrombopag Kern Pharma 12.5 mg film-coated tablets EFG are orange-brown, round, biconvex tablets, with "I" engraved on one side 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 side 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 side 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 side and a diameter of approximately 12 mm.

The tablets are supplied in single-dose pre-cut blisters made of oPA/Al/PVC/Al, packed in a carton 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

The Netherlands

or

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat

Barcelona, Spain

Date of the most recent revision of this leaflet: September 2024

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