ELTROMBOPAG DR. REDDYS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Dr. Reddys 25 mg film-coated tablets EFG

Eltrombopag Dr. Reddys 50 mg film-coated tablets EFG

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

1. What is Eltrombopag Dr. Reddys and what is it used for

Eltrombopag Dr. Reddys contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists, used to help increase the number of platelets in the blood. Platelets are cells in the blood that help reduce or prevent bleeding.

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

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have a higher risk of bleeding. Symptoms that patients with ITP may notice are petechiae (small, round, flat red spots under the skin), bruises, nosebleeds, bleeding gums, and inability to control bleeding if cut or injured.

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

2. What you need to know before you take Eltrombopag Dr. Reddys

Do not take Eltrombopag Dr. Reddys

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

Consult your doctorif you think this may affect you.

Warnings and precautions

Consult your doctor before starting Eltrombopag:

• if you have liver problems. People who have a low platelet count and advanced chronic liver disease are at higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of Eltrombopag outweighs the risks, you will be closely monitored during treatment.

• if you have a risk of blood clotsin veins or arteries, or if you know that blood clots are common in your family.

The risk of blood clots may be higherin the following circumstances:

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking birth control pills or hormone replacement therapy
• if you have recently undergone surgery or have suffered physical trauma
• if you are severely overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease.

If you are in any of these situations, tell your doctorbefore starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of 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 disease. If you have MDS and take Eltrombopag Dr. Reddys, MDS may worsen.

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

Eye exams

Your doctor will recommend that you have an eye exam to check for cataracts. If you do not have regular eye exams, your doctor will ask you to have them. They should also examine your retina (the light-sensitive layer at the back of the eye) to see if there is bleeding in the retina or around it.

You will need to have regular blood tests

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

Blood tests to check liver function

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon-based treatment along 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 frequently while taking it to check your liver function. It may be necessary to stop treatment with eltrombopag if the levels of these markers increase too much or if you have any other sign of liver damage.

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

Blood tests for platelet count

If you stop treatment with eltrombopag, it is likely that within a few days, you will have low platelet counts again (thrombocytopenia). Your platelet counts will be monitored, and your doctor will advise you on the precautions to take.

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

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

• swelling, painor tenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by severe chest pain or rapid breathing

• abdominal pain (stomach), enlarged abdomen, blood in your stool.

Tests to examine your bone marrow

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

Review of gastrointestinal bleeding

If you are taking interferon-based treatment along with eltrombopag, you will be monitored for signs of bleeding in your stomach or intestine after you stop taking eltrombopag.

Heart monitoring

Your doctor may consider monitoring your heart while you are taking eltrombopag, using an electrocardiogram, if necessary.

Elderly (65 years and over)

There is limited data on the use of eltrombopag in patients aged 65 years or older. If you are 65 or older, you should be cautious when using eltrombopag.

Children and adolescents

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

Other medicines and Eltrombopag Dr. Reddys

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

Some common medicines may interact with Eltrombopag Dr. Reddys(including prescription medicines, over-the-counter medicines, and minerals). These include:

• antacid medicines for indigestion, heartburn, or stomach ulcers

(see also section 3 “When to take it”).

• statin medicines to lower cholesterol
• certain medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in transplantsor immune system diseases
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be present in vitamin and mineral supplements(see also section 3 “When to take it”).
• 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; it may be necessary to adjust the dose or change the times when you take them. Your doctor will review the medicines you are taking and recommend alternatives if necessary.

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

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

Taking Eltrombopag Dr. Reddys with food and drinks

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

Pregnancy and breastfeeding

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

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

Do not breastfeed while taking Eltrombopag Dr. Reddys. It is not known if Eltrombopag Dr. Reddys passes into breast milk.

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

Driving and using machines

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

Do not drive or use machinesunless you are sure that Eltrombopag Dr. Reddys does not affect you.

Eltrombopag Dr. Reddys contains lactose and sodium

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

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

3. How to take Eltrombopag Dr. Reddys

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

How much to take

For ITP

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

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

Eltrombopag may take 1 to 2 weeks to work. Based 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 notconsume any of the following:

• dairy productssuch as cheese, butter, yogurt, or ice cream
• milk or milkshakes, milk-based drinks, 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, consult your doctor.

Other pharmaceutical forms or concentrations may be more suitable for administration to children. For doses that cannot be achieved with Eltrombopag Dr. Reddys, other concentrations of eltrombopag are available.

If you take more Eltrombopag Dr. Reddys 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 the appropriate treatment immediately.

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

If you forget to take Eltrombopag Dr. Reddys

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

If you stop taking Eltrombopag Dr. Reddys

Do not stop taking eltrombopag without consulting your doctor first. If your doctor advises you to stop treatment, your platelet counts will be monitored every week for four 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 side effects

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

Symptoms to pay attention to: consult your doctor

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

Increased risk of blood clots

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

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

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

Liver problems

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. Liver problems (increased liver enzymes in blood tests) are common and 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:

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

What to Expect

Bleeding or Bruising After Stopping Treatment

Two weeks after stopping treatment with eltrombopag, your platelet levels will normally drop to levels similar to those before starting eltrombopag. A decrease in platelet levels can increase the risk of bleeding or bruising. Your doctor will check your platelet levels for at least 4 weeks after stopping treatment with eltrombopag.

Contact your doctorif you experience bleeding or bruising when stopping eltrombopag.

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

• black, tarry stools (a rare side effect that can affect up to 1 in 100 people).
• blood in stools
• 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 with Eltrombopag Treatment 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, 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 menstrual bleeding
• irritation of the throat and difficulty swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• inflammation of the gums
• loss of appetite
• tingling, itching, or numbness
• decreased sensitivity in the skin
• drowsiness
• ear pain
• pain, swelling, and sensitivity in one leg (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood from a broken blood vessel (hematoma)
• hot flashes
• changes 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, itchy rash, 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 of 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 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 (a substance produced by the liver)
• increase in some protein levels

Uncommon Adverse Effects

May affect up to 1 in 100people:

• allergic reaction
• disruption 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 blood clot in the lungs (see “Increased Risk of Blood Clots” earlier in section 4)
• partial loss of lung function due to a blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein that could be signs of blood clots in a vein
• yellowish skin and/or abdominal pain that could be signs of a blockage of a bile duct, liver injury, liver damage due to inflammation (see “Liver Problems” earlier in section 4)
• liver damage due to medication
• rapid or irregular heartbeat, blue discoloration of the skin, changes 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
• balance problems, speech and nerve problems, tremors
• pain or abnormal sensations in the skin
• paralysis of one side of the body
• migraine with aura
• nerve pain
• enlargement or swelling of blood vessels that cause headaches
• eye problems including increased tearing, clouding of the eye lens (cataracts), bleeding in the retina, dry eyes
• problems with the nose, throat, and sinuses, breathing problems while sleeping
• blisters/pain in the 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
• changes in the mouth including dryness or irritation in the mouth, tongue pain, bleeding gums, mouth ulcers
• sunburn
• feeling hot, feeling anxious
• redness or swelling around wounds
• bleeding around a catheter (if you have one) in the skin
• feeling of a foreign body
• kidney problems including inflammation of the kidneys, excessive urination at night, kidney failure, white blood cells in urine
• cold sweats
• feeling of general discomfort
• skin infection
• skin changes including 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 may indicate certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in 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 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 10children

• infection of the nose, 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
• throat and nose pain
• itching, runny nose, or stuffiness
• irritation of the throat, runny nose, nasal congestion, and sneezing
• changes in the mouth including dryness, irritation in the mouth, sensitivity in the tongue, 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 10people:

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

Very Common Adverse Effects That May Appear in Blood Tests:

• decrease in red blood cell count (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
• weight loss
• sleep disorders, excessive 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, yellowish color in the white of the eyes
• retinal bleeding
• feeling of spinning
• rapid or irregular heartbeat, difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and difficulty swallowing
• digestive problems including vomiting, stomach pain, indigestion, constipation, bloating, gas, changes in bowel movements, abdominal pain or discomfort
• toothache
• liver problems including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage due to medication (see “Liver Problems” earlier in section 4)
• skin changes including rash, dry skin, eczema, 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
• infection of the nose, sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common Adverse Effects That May Appear in Blood Tests:

• increase in blood sugar (glucose) levels
• decrease in white blood cell count
• decrease in neutrophil count
• decrease in albumin levels in blood
• decrease in hemoglobin levels
• increase in blood bilirubin levels (a substance produced by the liver)
• changes in enzymes that control blood clotting

Uncommon Adverse Effects

May affect up to 1 in 100people:

• pain when urinating
• changes in heart rhythm (prolonged QT interval)
• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes including color changes, 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 red blood cell count (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 10people:

• cough
• headache
• pain in the mouth and throat
• diarrhea
• dizziness, nausea
• joint pain (arthralgia)
• pain in the limbs (arms, legs, hands, and feet)
• vertigo
• feeling very tired
• fever
• chills
• eye itching
• blisters in the mouth
• bleeding gums
• 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 eyes, 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 or discomfort, bloating, gas, changes in bowel movements, stool color changes
• 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
• disruption 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 levels (a substance produced by the liver)
• decrease in white blood cell count

Adverse Effects of Unknown Frequency

Cannot be estimated from the available data

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

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use 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 Dr. Reddys

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 blister after "EXP".

The expiry date refers to the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Eltrombopag Dr. Reddys

The active ingredient of Eltrombopag Dr. Reddys 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.

Coated Tablets of 75 mg

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

The other components are: mannitol (E421), microcrystalline cellulose (E460), povidone (E1201), lactose monohydrate, sodium carboxymethyl starch type A (potato), colloidal anhydrous silica, magnesium stearate (E572), poly(vinyl alcohol) (E1203), talc (E553b), macrogol (E1521), red iron oxide (E172), and for 25 mg and 75 mg also black iron oxide (E172) and yellow iron oxide (E172).

Appearance and Packaging of the Product

The Eltrombopag Dr. Reddys 25 mg coated tablets are round, biconvex, brown to dark brown in color, approximately 7 mm in size, marked with “EL” on one side and “2” on the other.

The Eltrombopag Dr. Reddys 50 mg coated tablets are round, biconvex, brown to reddish-brown in color, approximately 9 mm in size, marked with “EL” on one side and “3” on the other.

The Eltrombopag Dr. Reddys 75 mg coated tablets are round, biconvex, light brown to brown in color, approximately 11 mm in size, marked with “EL” on one side and “4” on the other.

They are supplied in blisters of:

14, 28 or 84 coated tablets and a multiple pack of 84 (3 x 28) coated tablets.

Single-dose blisters in a box containing 28 x 1 coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3

030138 Bucharest

Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:December 2024

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