Eltrombopag Cipla 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Cipla 25 mg film-coated tablets EFG

Eltrombopag Cipla 50 mg film-coated tablets EFG

Eltrombopag Cipla 75 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Eltrombopag Cipla contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is 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 taken other medications (corticosteroids or immunoglobulins) that have not worked for them.

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

• Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, if they have had problems with adverse effects from interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself, but also due to 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 taking Eltrombopag Cipla

Do not take Eltrombopag Cipla

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 affect you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems. People who have low platelet counts and also chronic advanced liver disease (long-standing) are at higher risk of experiencing adverse effects, liver damage (which can 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 blood clot in the veins or arteries, or if you know that blood clots are common in your family.

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

• if you are elderly
• if you have had to remain in bed for a long period of time
• if you have cancer
• if you are taking oral contraceptives or hormone replacement therapy
• if you have recently undergone surgery or suffered physical injury
• if you are significantly overweight (obesity)
• if you smoke
• if you have advanced chronic liver disease.

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

• if you have cataracts (the lens of the eye becomes cloudy).
• 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 you are in any of these situations.

Eye examinations

Your doctor will recommend that you have an eye examination to check for cataracts. If you do not routinely have eye check-ups, your doctor will ask you to have them. Your retina (the 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 transaminase. 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. It may be necessary to interrupt 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 become low again (thrombocytopenia) 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 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, occasionally accompanied by sharp chest pain or rapid breathing
• abdominal pain, enlarged abdomen, blood in the stools.

Bone marrow examination

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 examine 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 Cipla

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

Some commonly used medicines may interact with eltrombopag (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 Cipla”).
• medicines called statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplants or 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 Cipla”).
• 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 Cipla with food and drink

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 Cipla”.

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 might 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 unknown 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 Cipla contains sodium

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

Eltrombopag Cipla contains sunset yellow FCF (E-110)

It may cause allergic-type reactions.

3. How to take Eltrombopag Cipla

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose or treatment regimen of eltrombopag unless advised by your doctor or pharmacist. While taking eltrombopag, you will be under the supervision of a specialist doctor experienced in the treatment of your condition.

How much to take For ITP

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

Children (1 to 5 years of age) – the usual starting dose for ITP is one 25 mg tablet of eltrombopag per day.

For hepatitis C

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

• 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, 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 Cipla 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eltrombopag Cipla

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

If you stop taking Eltrombopag Cipla

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 produce adverse effects, although not everyone will experience them.

Symptoms you should pay attention to: consult your doctor

Patients taking eltrombopag both for ITP and for 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 experience any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing a thrombus, 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 detectable in blood tests, which could indicate liver damage. Liver problems (elevated liver enzymes in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people. If you experience any 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 drop to levels similar to those you had before starting 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 patients experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry-looking stools (discoloration of stools is an uncommon adverse effect that may affect up to 1 in 100 people).
• blood in stools
• vomiting blood or material resembling coffee grounds

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

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

Very common adverse effects

May affect more than 1 in 10 people

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

Very common adverse effects detectable in blood tests

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

Common adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle cramps, muscle weakness
• bone pain
• heavy menstrual periods
• throat irritation and discomfort when swallowing
• eye problems including abnormal eye test results, dry eye, eye pain, blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• swelling (inflammation) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, itching, or numbness
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually 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, gum bleeding, 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 urine)
• elevated temperature, feeling hot
• chest pain
• feeling weak
• trouble sleeping, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• gas

Common adverse effects detectable in blood tests:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction
• interruption of blood supply to parts of the heart
• sudden breathing difficulty, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary thrombus (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 indicate a heart- or blood vessel-related disorder
• blood clots
• hot flushes
• joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance problems, speech and nerve function disorders, tremors
• nerve pain or abnormal skin sensations
• 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
• nose, throat, and sinus problems, breathing difficulties 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, gum bleeding, mouth discomfort
• sunburn
• feeling hot, anxiety sensation
• redness or swelling around wounds
• bleeding around a catheter (if present) in the skin
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine
• cold sweat
• general malaise
• skin infection
• skin changes including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that may indicate certain diseases
• increase in number of platelets
• decrease in calcium levels
• decrease in number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in neutrophils
• increase in blood urea levels
• increase in protein in urine
• increase in blood albumin levels
• increase in total protein levels
• decrease in blood albumin levels
• increase in urine pH
• increase in 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 nose
• itching, runny nose, or nasal congestion
• throat irritation, runny nose, nasal congestion, and sneezing
• mouth disorders including dryness, irritation in the mouth, tongue sensitivity, gum bleeding, 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 detectable in blood tests:

• decrease in 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 nose, sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucosa 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 eye, small yellow deposits in the retina, yellowish color in the white part of the eyes
• retinal bleeding
• sensation of spinning
• rapid and irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and discomfort when swallowing
• digestive disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding in throat (esophagus) blood vessels
• toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (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 cramps
• irritability, general malaise, skin reactions such as redness or swelling and pain at injection site, chest pain and discomfort, fluid retention in body or limbs causing swelling
• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

• increase in blood sugar (glucose)
• decrease in number of white blood cells
• decrease in number of neutrophils
• decrease in blood albumin
• decrease in hemoglobin levels
• increase in 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
• decrease in 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
• eye itching
• mouth blisters
• gum bleeding
• abdominal pain
• muscle cramps

Very common adverse effects detectable in blood tests

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

Common adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general malaise
• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (floaters), dry eye, eye itching, 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, stomach bloating,

flatulence/digestive 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 detectable in blood tests

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

Adverse effects with unknown frequency

Frequency cannot be estimated from available data

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

Reporting of adverse effects

If you experience any 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 Cipla

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Eltrombopag Cipla film-coated tablets EFG

The active substance is eltrombopag.

25 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

50 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other components (excipients) are:

Tablet core: Maltose, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone K30 and magnesium stearate.

Tablet coating:

25 mg film-coated tablets: poly(vinyl alcohol), talc, glyceryl caprilate and glyceryl dicaprilate, sodium lauryl sulfate, titanium dioxide (E-171) and indigo carmine (E-132).

50 mg film-coated tablets: poly(vinyl alcohol), talc, glyceryl caprilate and glyceryl dicaprilate, sodium lauryl sulfate, titanium dioxide (E-171) and sunset yellow FCF (E-110).

75 mg film-coated tablets: poly(vinyl alcohol), talc, glyceryl caprilate and glyceryl dicaprilate, sodium lauryl sulfate, titanium dioxide (E-171) and iron oxide red (E-172).

Nature and contents of the container

Eltrombopag Cipla 25 mg film-coated tablets EFG are blue, round, biconvex tablets (approximately 7.1 mm in diameter) with "E2" engraved on one side.

Eltrombopag Cipla 50 mg film-coated tablets EFG are orange, round, biconvex tablets (approximately 8.2 mm in diameter) with "E5" engraved on one side.

Eltrombopag Cipla 75 mg film-coated tablets EFG are dark pink, round, biconvex tablets (approximately 10.1 mm in diameter) with "E7" engraved on one side.

The tablets are supplied in OPA/Al/PVC/Al blisters, packed in a carton containing 14, 28 or 84 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.
São Martinho do Bispo
3045-016 Coímbra
Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edificio Britannia
28003, Madrid
Spain

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

Germany: Eltrombopag Cipla Filmtabletten
Spain: Eltrombopag Cipla comprimidos recubiertos con película EFG
Italy: Eltrombopag Cipla compresse rivestite con film
Portugal: Eltrombopag Cipla comprimidos revestidos por película

Date of the most recent revision of this leaflet: January 2025

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