Eltrombopag Dr. Reddys 75 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Eltrombopag Dr. Reddys is and what it is 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 blood cells 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 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 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, in cases where 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 because of the antiviral treatments used to treat it. Taking Eltrombopag Dr. Reddys may help them complete their course of antiviral therapy (peginterferon and ribavirina).

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

Do not take Eltrombopag Dr. Reddys

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

? Consult your doctor if you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take Eltrombopag:

• if you have liver problems. Individuals with low platelet counts as well as chronic advanced liver disease (long-standing) have an increased risk of adverse reactions, liver damage that may 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 are at risk of developing a thrombus (blood clot) in veins or arteries, or if you know that blood clots occur frequently in your family.

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

• if you are elderly
• if you have been bedridden 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 trauma
• if you are significantly overweight (obesity)
• if you are a smoker
• if you have chronic and advanced 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 of the eye).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting eltrombopag, your doctor will perform tests to confirm you do not have this condition. If you have MDS and take Eltrombopag Dr. Reddy's, 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 examination to check for cataracts. If you do not have routine eye examinations, your doctor will ask you to have them. Your retina (the layer of light-sensitive cells at the back of the eye) should also be examined to check for bleeding in or around the retina.

You will need to have regular blood tests

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

Blood test to check 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 treatment together with eltrombopag to treat low platelet levels due to hepatitis C, this may worsen any existing liver problems.

You will have blood tests before starting eltrombopag and frequently while taking it to monitor your liver function. You may need to stop treatment with eltrombopag if levels of these markers increase too much or if you develop any other signs of liver damage.

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

Blood test for platelet count (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 necessary precautions to take.

Very high platelet levels may increase the risk of blood clot formation. However, blood clots can also form even when platelet levels are normal or low. 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 sudden chest pain or rapid breathing

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

Bone marrow examination analysis

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

Review of gastrointestinal bleeding

If you are taking interferon, a baseline treatment along with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestines after you stop taking eltrombopag.

Heart Monitoring

Your doctor may consider, if necessary, monitoring your heart during treatment with eltrombopag using an electrocardiogram.

Elderly patients (65 years and older)

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

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 Dr. Reddys

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 Dr. Reddys (including prescription, non-prescription medicines, and minerals). These include:

• antacid medicines used to treat indigestion, heartburn, or stomach ulcers
  (see also section 3 "When to take it").

• medicines called statins, used to lower cholesterol

• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir

• cyclosporine, used in organ transplantation or immunological disorders

• minerals such as iron, calcium, magnesium, aluminium, 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 doctor if you are taking any of these medicines. Some should not be taken with eltrombopag, a dose adjustment may be necessary, or the timing of administration may need to be changed. Your doctor will review the medicines you are taking and recommend alternatives if needed.

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

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

Taking Eltrombopag Dr. Reddy's with food and drinks

Do not take Eltrombopag Dr. Reddy's with food or dairy drinks, 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 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 Dr. Reddys. It is unknown whether Eltrombopag Dr. Reddys passes into breast milk.

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

Driving and use of machines

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

? Do not drive or operate machinery unless you are certain that Eltrombopag Dr. Reddys does not affect you.

Eltrombopag Dr. Reddys contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult with him 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 exactly the instructions for using this medicine 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 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 tablet of eltrombopag 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 tablet of eltrombopag per day.

For Hepatitis C

Adults - the usual starting dose for hepatitis C is one 25 mg tablet of eltrombopag daily. If you are of East or Southeast Asian ancestry, initiate 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 –

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

you do not consume any of the following:

• dairy foods such as cheese, butter, yogurt, or ice cream
• milk or milkshakes, drinks made with milk, yogurt, or cream
• antacids, a type of medicine for indigestion and heartburn
• certain vitamin and mineral supplements, including iron, calcium, magnesium, aluminium, selenium, and zinc.

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

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

Other pharmaceutical forms or concentrations may be more appropriate 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

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 appropriate treatment will be administered 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 medication and the amount ingested.

If you forget to take Eltrombopag Dr. Reddys

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

If treatment with Eltrombopag Dr. Reddys is interrupted

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Symptoms you should watch for: consult your doctor

Patients taking eltrombopag for ITP as well as for low platelet counts associated with hepatitis C may experience signs related to possible serious adverse effects. It is important that you inform your doctor if you develop any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing a blood clot, and medications such as eltrombopag may worsen this problem. Sudden blockage of a blood vessel by a clot 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 a blood clot, 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 (stomach) pain, enlarged abdomen, blood in your stools.

Liver problems

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

If you experience any signs of liver problems:

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

? Contact your doctor immediately

Bleeding or bruising after stopping treatment

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

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

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

• black, tarry stools (discoloration of stools is an uncommon side effect which 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 have any of these symptoms.

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

Very common side effects

May affect more than 1 in 10 people

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

Very common adverse effects that may be seen in blood tests

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

Frequent adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstrual periods
• throat irritation and discomfort when swallowing
• eye problems including abnormalities in eye tests, dry eye, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• 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 sensation
• decreased 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 blood clot in a deep vein)
• localized swelling filled with blood due to rupture of a blood vessel (hematoma)
• hot flushes
• mouth disorders including dry or irritated mouth, sore 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)
• elevated temperature, feeling of warmth
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• flatulence

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 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 levels of certain proteins

Uncommon adverse effects

These 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 blood clot in the lungs (see "Increased risk of blood clots" earlier in section 4)
• partial loss of lung function caused by a blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could be signs of blood clots in a vein
• yellowing of the skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see "Liver problems" earlier in section 4)
• liver damage due to medication
• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, changes in heart rhythm (prolongation of the QT interval), which could be signs of a disorder related to the heart and blood vessels
• blood clots
• hot flashes
• joint pain and swelling due to uric acid (gout)
• lack of interest, changes in mood, 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 eye
• nose, throat, and sinus problems, breathing difficulties during sleep
• blisters/pain in mouth and throat
• loss of appetite
• digestive system problems, including frequent bowel movements, food poisoning, blood in stool, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• mouth disorders, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth discomfort
• sunburn
• feeling hot, sensation of anxiety
• redness or inflammation 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 feeling of 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 levels of calcium
• decreased number of red blood cells (anemia) due to excessive destruction of red blood cells (hemolytic anemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased levels of albumin in blood
• increased total protein levels
• decreased levels of albumin in blood
• increased urine pH
• increased hemoglobin levels

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

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

Very common adverse effects

May affect more than 1 in 10 children

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

Frequent 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, mouth irritation, tongue sensitivity, gum bleeding, mouth ulcers

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

Very common adverse reactions

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 illness
• swelling of hands or feet
• chills

Very common adverse effects that may appear in blood tests:

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

Frequent 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
• 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, yellowish coloration in the white part of the eyes
• retinal bleeding
• sensation of spinning (vertigo)
• rapid and irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, influenza (flu), cold sores, throat irritation, and discomfort when swallowing
• gastrointestinal disturbances, 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), drug-induced liver damage (see “Liver problems” earlier in section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, and feet), muscle spasms
• irritability, general malaise, skin reactions such as redness, swelling, and pain at the injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
• infection of the nose, sinuses, throat, and respiratory tract; common cold (upper respiratory tract infection); inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disturbances, nervousness

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

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

If these adverse reactions 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)
• pain in limbs (arms, legs, hands and 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 laboratory tests

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

Frequent adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general malaise
• eye problems including vision disturbances, clouding of the eye's lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eyes, itchy eyes, yellowing of the whites of the eyes or of the skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, swelling of the tongue, vomiting, loss of appetite, stomach pain/discomfort, stomach swelling, 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 coloration
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Frequent adverse effects that may appear in laboratory tests

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

Adverse reactions of unknown frequency

Frequency cannot be estimated from the available data

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

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, 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 on the blister after "EXP".

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Eltrombopag Dr. Reddys

The active substance 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.

75 mg Film-coated Tablets

Each film-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 (from potato), colloidal anhydrous silica, magnesium stearate (E572), poly(vinyl alcohol) (E1203), talc (E553b), macrogol (E1521), red iron oxide (E172); for 25 mg and 75 mg also black iron oxide (E172) and yellow iron oxide (E172).

Appearance of the Product and Contents of the Pack

Eltrombopag Dr. Reddy's 25 mg film-coated tablets are round, biconvex, film-coated tablets, brown to dark brown in colour, approximately 7 mm in size, marked with "EL" on one side and "2" on the other.

Eltrombopag Dr. Reddy's 50 mg film-coated tablets are round, biconvex, film-coated tablets, brown to reddish brown in colour, approximately 9 mm in size, marked with "EL" on one side and "3" on the other.

Eltrombopag Dr. Reddy's 75 mg film-coated tablets are round, biconvex, film-coated tablets, light brown to brown in colour, 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 film-coated tablets and a multiple pack of 84 (3 x 28) film-coated tablets.

Unit-dose blisters in a carton containing 28 x 1 film-coated tablets.

Only certain 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 Bucuresti

Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

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

Member State	Medicinal Product Name
Sweden	Eltrombopag Reddy 25 mg film-coated tablets Eltrombopag Reddy 50 mg film-coated tablets Eltrombopag Reddy 75 mg film-coated tablets
Austria	Eltrombopag Reddy 25 mg Filmtabletten Eltrombopag Reddy 50 mg Filmtabletten Eltrombopag Reddy 75 mg Filmtabletten
Germany	Eltrombopag Reddy 25 mg Filmtabletten Eltrombopag Reddy 50 mg Filmtabletten Eltrombopag Reddy 75 mg Filmtabletten
Spain	Eltrombopag Dr. Reddy's 25 mg film-coated tablets EFG Eltrombopag Dr. Reddy's 50 mg film-coated tablets EFG Eltrombopag Dr. Reddy's 75 mg film-coated tablets EFG
Italy	Eltrombopag Dr. Reddy’s 25 mg film-coated tablets Eltrombopag Dr. Reddy’s 50 mg film-coated tablets Eltrombopag Dr. Reddy’s 75 mg film-coated tablets
Romania	Eltrombopag Dr. Reddy’s 25 mg film-coated tablets Eltrombopag Dr. Reddy’s 50 mg film-coated tablets Eltrombopag Dr. Reddy’s 75 mg film-coated tablets

Date of the last revision of this leaflet: December 2024

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