Eltrombopag Dr. Reddy's

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
eltrombopag
Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed
for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
What Eltrombopag Dr. Reddy’s is and what it is used for
What you need to know before taking Eltrombopag Dr. Reddy’s
How to take Eltrombopag Dr. Reddy’s
Possible side effects
How to store Eltrombopag Dr. Reddy’s
Contents of the pack and other information

1. What Eltrombopag Dr. Reddy’s is and what it is used for

Eltrombopag Dr. Reddy’s 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 Dr. Reddy’s is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already taken other medicines (corticosteroids or immunoglobulins) that were not effective.
ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may notice include petechiae (small flat red spots under the skin the size of a pinprick), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding from cuts or injuries.
Eltrombopag Dr. Reddy’s may also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced problems with adverse reactions during treatment with interferon. Many people with hepatitis C have a low platelet count, not only due to the disease itself but also because of some antiviral medicines used to treat it. By taking Eltrombopag Dr. Reddy’s, it may be easier for you to complete a full course of antiviral therapy (peginterferon and ribavirin).

2. What you should know before taking Eltrombopag Dr. Reddy’s

Do not take Eltrombopag Dr. Reddy’s
if you are allergic to eltrombopag or to any of the other ingredients of this medicine
(listed in section 6 under "What Eltrombopag Dr. Reddy’s contains").
→ Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking Eltrombopag Dr. Reddy’s:
if you have liver problems. People who have low platelet counts and advanced chronic (long-term) liver disease are at higher risk of side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking Eltrombopag Dr. Reddy’s outweigh the risks, you will be closely monitored during treatment.
if you are at risk of forming blood clots in veins or arteries, or if you know that blood clots are common in your family.
You may be at increased risk of blood clot formation:
if you are elderly
if you have had to remain in bed 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 suffered physical trauma
if you are very overweight (obese)
if you are a smoker
if you have advanced chronic liver disease

• If any of these apply to you, inform your doctor before starting treatment. You must not take Eltrombopag Dr. Reddy’s unless your doctor considers that the expected benefits outweigh the risk of blood clots.
• if you have cataracts (clouding of the eye's lens)
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check that you do not have this blood disorder before starting Eltrombopag Dr. Reddy’s. If you have MDS and take Eltrombopag Dr. Reddy’s, your MDS may worsen.
• Inform your doctor if any of these situations apply to you.

Eye examinations
Your doctor will recommend regular check-ups for cataracts. If you do not routinely have eye exams, your doctor will arrange regular monitoring. You may also be monitored for signs of bleeding inside or around the retina (the layer of light-sensitive cells at the back of the eye).

You will need regular blood tests
Before starting Eltrombopag Dr. Reddy’s, your doctor will perform blood tests to check your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.

Blood tests for liver function
Eltrombopag Dr. Reddy’s may alter blood test results that could indicate liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatments in combination with Eltrombopag Dr. Reddy’s for low platelet counts due to hepatitis C, some liver problems may worsen.
Before starting Eltrombopag Dr. Reddy’s and at regular intervals during treatment, you will need blood tests to monitor liver function. You may need to stop taking Eltrombopag Dr. Reddy’s if levels of these enzymes become too high or if other signs of liver damage appear.
Read the information " Liver problems " in section 4 of this leaflet.

Blood tests for platelet count
If you stop taking Eltrombopag Dr. Reddy’s, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored, and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clots. However, blood clots can also form even when the platelet count is normal or even low. Your doctor will adjust the dose of Eltrombopag Dr. Reddy’s to ensure that your platelet count does not become too high.

Seek immediate medical help if you experience any of the following signs indicating a blood clot:
swelling, pain, or tenderness in one leg
sudden onset of shortness of breath, especially if accompanied by sharp chest pain or rapid breathing
abdominal (stomach) pain, swollen abdomen, blood in stool

Tests to monitor bone marrow
In people with bone marrow disorders, medicines like Eltrombopag Dr. Reddy’s may worsen the condition. Signs of bone marrow changes may appear as abnormal results in blood tests. During treatment with Eltrombopag Dr. Reddy’s, your doctor may also perform tests to directly monitor your bone marrow.

Tests for gastrointestinal bleeding
If you are receiving interferon-based treatments together with Eltrombopag Dr. Reddy’s, you will be monitored for signs of bleeding in the stomach or intestines after stopping Eltrombopag Dr. Reddy’s.

Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Dr. Reddy’s and may perform an electrocardiogram (ECG).

Elderly people (65 years and older)
There is limited data on the use of Eltrombopag Dr. Reddy’s in patients aged 65 years and older. Caution is required when using Eltrombopag Dr. Reddy’s in patients aged 65 years or older.

Children and adolescents
Eltrombopag Dr. Reddy’s is not recommended for children under 1 year of age with ITP. It is also not recommended for people under 18 years of age with low platelet counts due to hepatitis C.

Other medicines and Eltrombopag Dr. Reddy’s
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 interact with Eltrombopag Dr. Reddy’s, including prescription and over-the-counter medicines and minerals. These include:
antacids used to treat indigestion, heartburn, or gastric ulcers
(see also "When to take it" in section 3)
statins, used to lower cholesterol
certain medicines for HIV infection, such as lopinavir and/or ritonavir
cyclosporine, used in the context of organ transplants or immune disorders
minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be present in vitamin and mineral supplements (see also "When to take it" in section 3)
medicines such as methotrexate and topotecan, used to treat cancer
Inform your doctor if you are taking any of these medicines. Some of these medicines should not be taken with Eltrombopag Dr. Reddy’s, or you may need to adjust the dose or change the timing of administration.
Your doctor will review the medicines you are taking and, if necessary, suggest suitable alternatives.
If you are also taking medicines to prevent blood clots, your risk of bleeding is increased. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol and/or azathioprine, it may be necessary to reduce or discontinue their use during treatment with Eltrombopag Dr. Reddy’s.

Eltrombopag Dr. Reddy’s with food and drinks
Do not take Eltrombopag Dr. Reddy’s with foods or drinks containing milk, as the calcium in dairy products affects the absorption of the medicine. For further information, see "When to take it" in section 3.

Pregnancy and breastfeeding
Do not use Eltrombopag Dr. Reddy’s during pregnancy, unless specifically recommended by your doctor. The effect of Eltrombopag Dr. Reddy’s during pregnancy is unknown.
Inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Use a reliable method of contraception while taking Eltrombopag Dr. Reddy’s to prevent pregnancy.
If you become pregnant during treatment with Eltrombopag Dr. Reddy’s, inform your doctor.
Do not breastfeed while taking Eltrombopag Dr. Reddy’s.
It is not known whether Eltrombopag Dr. Reddy’s passes into breast milk.
→ If you are breastfeeding or planning to breastfeed, inform your doctor.

Driving and using machines
Eltrombopag Dr. Reddy’s may cause dizziness and other side effects that may reduce your attention.
→ Do not drive or operate machinery unless you are certain you are not affected.

Eltrombopag Dr. Reddy’s contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Eltrombopag Dr. Reddy’s

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Dr. Reddy’s unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Dr. Reddy’s, you will be under the care of a doctor experienced in treating your condition.

Dosage for ITP
Adults and children (6 to 17 years of age) – the recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Dr. Reddy’s daily. If you are of East/Southeast Asian origin, you may need to start with a lower dose of 25 mg.
Children (1 to 5 years of age) – the recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Dr. Reddy’s daily.

For Hepatitis C
Adults – the recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Dr. Reddy’s daily. If you are of East/Southeast Asian origin, you will start with the same 25 mg dose.

Eltrombopag Dr. Reddy’s may take 1 to 2 weeks to take effect. Depending on your response to Eltrombopag Dr. Reddy’s, your doctor may recommend adjusting the daily dose.

How to take the tablets
Swallow the tablet whole with a glass of water.

When to take it
Make sure that:

• in the 4 hours before taking Eltrombopag Dr. Reddy’s
• and in the 2 hours after taking Eltrombopag Dr. Reddy’s

you do not consume any of the following:

• dairy products such as cheese, butter, yoghurt, or ice cream
• milk or milk-based shakes, drinks containing milk, yoghurt, or cream
• antacids, a type of medicine used for indigestion and heartburn
• certain mineral and vitamin supplements, including iron, calcium, magnesium, aluminium, selenium, and zinc

If you do, the medicine will not be properly absorbed by your body.

For further advice on suitable foods and drinks, consult your doctor.
Other pharmaceutical forms/dosages may be more suitable for administration to children.
Other products are available for dosages that cannot be achieved with Eltrombopag Dr. Reddy’s.

If you take more Eltrombopag Dr. Reddy’s than you should
Contact your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for any signs or symptoms of adverse effects and will receive appropriate treatment without delay.

If you forget to take Eltrombopag Dr. Reddy’s
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Dr. Reddy’s in a single day.

If you stop taking Eltrombopag Dr. Reddy’s
Do not stop taking Eltrombopag Dr. Reddy’s without first discussing it with your doctor. If your doctor advises stopping treatment, your platelet count will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms requiring attention: consult a doctor
People taking Eltrombopag Dr. Reddy’s for ITP or for low platelet counts in the blood due to hepatitis C may develop symptoms of potentially serious side effects.
It is important to inform your doctor if you develop any of these symptoms.
Higher risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as Eltrombopag Dr. Reddy’s could worsen this problem. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs and symptoms of a blood clot, such as:
swelling, pain, warmth, redness or tenderness in one leg
sudden onset of shortness of breath, especially if accompanied by sharp chest pain or rapid breathing
abdominal pain (stomach pain), abdominal swelling, blood in the stool.
Liver problems
Eltrombopag Dr. Reddy’s 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 of the following signs of liver problems:
yellowing of the skin or whites of the eyes (jaundice)
urine of unusually dark colour
→ Inform your doctor immediately.
Bleeding or bruising after stopping treatment
Within two weeks of stopping Eltrombopag Dr. Reddy’s, platelet counts in the blood usually return to the levels observed before starting Eltrombopag Dr. Reddy’s. Lower platelet counts may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Eltrombopag Dr. Reddy’s.
→ Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Dr. Reddy’s.
Some people may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag Dr. Reddy’s. Symptoms include:
black, tarry stools (change in stool colour is an uncommon side effect that may affect up to 1 in 100 people)
blood in the stool
vomiting blood or material resembling coffee grounds
→ Inform your doctor immediately if you experience any of these symptoms.
The following side effects have been reported as associated with treatment with Eltrombopag Dr. Reddy’s in adult patients with ITP:
Very common side effects
These may affect more than 1 in 10 people:
Common cold
nausea
diarrhoea
cough
nasal, sinus, throat, and upper respiratory tract infection (upper respiratory tract infection)
back pain
Very common side effects that may be detected in blood tests
increase in liver enzymes (alanine aminotransferase (ALT))
Common side effects
These may affect up to 1 in 10 people:
muscle pain, muscle cramp, muscle weakness
bone pain
heavy menstrual period
sore throat and pain when swallowing
eye problems, including abnormal eye tests, dry eye, eye pain, blurred vision
vomiting
influenza
herpes labialis
pneumonia
irritation and inflammation (swelling) of the sinuses
inflammation (swelling) and infection of the tonsils
infection of the lungs, sinuses, nose, and throat
inflammation of the gum tissue
loss of appetite
tingling, pricking, or numbness sensation, commonly known as "pins and needles"
decreased skin sensitivity
drowsiness
ear pain
pain, swelling, and tightness in one leg (usually 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 (haematoma)
hot flushes
mouth problems, including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
runny nose
toothache
abdominal pain
liver function abnormalities
skin changes, including excessive sweating, irregular itchy rash, red spots, changes in skin appearance
hair loss
urine that appears foamy, frothy, or fizzy (signs of protein in the urine)
high temperature, feeling hot
chest pain
feeling of weakness
sleep problems, depression
migraine
decreased vision
dizziness (vertigo)
gas/bloating due to digestion
Common side effects that may be detected in blood tests
decrease in red blood cell count (anaemia)
decrease in platelet count (thrombocytopenia)
decrease in white blood cell count
decrease in haemoglobin level
increase in eosinophil count
increase in white blood cell count (leucocytosis)
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 certain protein levels
Uncommon side effects
These may affect up to 1 in 100 people:
allergic reaction
interruption of blood flow to part of the heart
sudden shortness of breath, especially if accompanied by acute chest pain and/or rapid breathing, which could indicate a blood clot in the lungs (see " Higher risk of blood clots " at the beginning of section 4)
loss of function in part of the lung due to blockage of the pulmonary artery
possible pain, swelling, and/or redness around a vein, which could indicate blood clot formation in a vein
yellowing of the skin and/or abdominal pain, which could indicate bile duct obstruction, liver injury, or liver damage due to inflammation (see " Liver problems " at the beginning of section 4)
liver damage due to medication
rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT prolongation), which could indicate a heart or blood vessel disorder
blood clot
flushing
painful swelling of joints due to uric acid (gout)
loss of interest, mood changes, uncontrollable crying or crying at unexpected times
balance problems, speech difficulties, nerve dysfunction, tremor
painful or abnormal skin sensations
paralysis on one side of the body
migraine with aura
nerve damage
dilation or swelling of blood vessels causing headache
eye problems, including increased tear production, clouding of the eye lens (cataract), retinal bleeding, dry eye
nose, throat, and sinus problems, breathing problems during sleep
blisters/sores in the mouth and throat
loss of appetite
gastrointestinal problems, including frequent bowel movements, food poisoning, blood in stool, vomiting with blood
rectal bleeding, change in stool colour, abdominal swelling, constipation
mouth problems, including dry or sore mouth, tongue pain, bleeding gums, mouth discomfort
sunburn
feeling of heat, anxiety sensation
redness or swelling around a wound
bleeding around a catheter (if present) in the skin
foreign body sensation
kidney problems, including kidney inflammation, excessive urination 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 side effects that may be detected in laboratory tests
changes in red blood cell shape
presence of abnormal white blood cell development, which may indicate certain diseases
increase in platelet count
decrease in calcium levels
decrease in red blood cell count (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
increase in myelocyte count
increase in band neutrophils
increase in blood urea levels
increase in protein levels 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 haemoglobin level
The following additional side effects have been reported as associated with treatment with Eltrombopag Dr. Reddy’s in children (aged 1 to 17 years) with ITP:
If these side effects become severe, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect more than 1 in 10 children
nasal, sinus, throat, and upper airway infection, common cold (upper respiratory tract infection)
diarrhoea
abdominal pain
cough
high temperature
feeling of malaise (nausea)
Common side effects
These may affect up to 1 in 10 children
difficulty sleeping (insomnia)
toothache
nasal and throat pain
nasal itching, runny or blocked nose
sore throat, runny nose, nasal congestion, and sneezing
mouth problems, including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
The following side effects have been reported as associated with treatment with Eltrombopag Dr. Reddy’s in combination with peginterferon and ribavirin in patients with HCV:
Very common side effects
These may affect more than 1 in 10 people
headache
loss of appetite
cough
feeling of malaise (nausea), diarrhoea
muscle pain, muscle weakness
itching
feeling of fatigue
fever
unusual hair loss
feeling of weakness
influenza-like illness
swelling of hands or feet
chills
Very common side effects that may be detected in blood tests
decrease in red blood cell count (anaemia)
Common side effects
These may affect up to 1 in 10 people
urinary tract infection
inflammation of the nose, throat, and mouth, influenza-like symptoms, dry mouth, inflamed or sore 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 (cataract), dry eye, small yellow deposits in the retina, yellowing of the white of the eye
retinal bleeding
dizziness (vertigo)
fast or irregular heartbeat (palpitations), shortness of breath
cough with phlegm, runny nose, influenza, herpes labialis, sore throat, and discomfort when swallowing
gastrointestinal problems, including vomiting, stomach ache, indigestion, constipation, stomach swelling, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus
toothache
liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see " Liver problems " at the beginning of section 4)
skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
joint pain, back pain, bone pain, limb pain (arms, legs, hands or feet), muscle cramps
irritability, general feeling of malaise, skin reaction such as redness, swelling, and pain at injection site, chest pain and discomfort, fluid accumulation in the body or extremities causing swelling
nasal, sinus, throat, and upper airway infection, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
depression, anxiety, sleep disorders, nervousness
Common side effects that may be detected in blood tests
increase in blood sugar (glucose)
decrease in white blood cell count
decrease in neutrophil count
decrease in albumin level in blood
decrease in haemoglobin level
increase in blood bilirubin (a substance produced by the liver)
changes in enzymes controlling blood clotting
Uncommon side effects
These may affect up to 1 in 100 people
painful urination
heart rhythm disorders (QT interval prolongation)
gastrointestinal flu (gastroenteritis), sore throat
blisters/sores in the mouth, stomach inflammation
skin changes, including colour change, peeling, redness, itching, lesions, and night sweats
blood clots in a liver vein (possible liver and/or gastrointestinal damage)
abnormal blood clotting in small blood vessels with kidney failure
rash, bruising at injection site, chest discomfort
decrease in red blood cell count (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
confusion, agitation
liver failure
The following side effects have been reported as associated with treatment with Eltrombopag Dr. Reddy’s in patients with severe aplastic anaemia (SAA):
If these side effects become severe, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect more than 1 in 10 people
cough
headache
mouth and throat pain
diarrhoea
feeling of malaise (nausea)
joint pain (arthralgia)
limb pain (arms, legs, hands, and feet)
dizziness
feeling of extreme fatigue
fever
chills
itchy eyes
mouth blisters
bleeding gums
abdominal pain
muscle cramps
Very common side effects that may be detected in blood tests
abnormal changes in bone marrow cells
increase in liver enzyme levels (aspartate aminotransferase (AST))
Common side effects
These may affect up to 1 in 10 people
anxiety
depression
feeling cold
general feeling of malaise
eye problems, including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eye, itchy eyes, yellowing of the whites of the eyes or skin
nosebleeds
gastrointestinal problems, including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, stomach swelling, gas/bloating during digestion, constipation, intestinal motility disorders that may cause constipation, bloating, diarrhoea and/or the above-mentioned symptoms, change in stool colour
fainting
skin problems, including small red spots or purpura due to bleeding under the skin (petechiae), rash, itching, hives, skin lesion
back pain
muscle pain
bone pain
weakness (asthenia)
swelling of lower limbs due to fluid accumulation
abnormal urine colour
interruption of blood supply to the spleen (splenic infarction)
runny nose
Common side effects that may be detected in blood tests
increase in enzymes due to muscle injury (creatine phosphokinase)
iron accumulation in the body (iron overload)
decrease in blood sugar levels (hypoglycaemia)
increase in blood bilirubin (a substance produced by the liver)
decrease in white blood cell levels
Side effects with unknown frequency
Frequency cannot be determined from the available data
change in skin colour
darkening of the skin
drug-induced liver damage
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eltrombopag Dr. Reddy’s contains
25 mg film-coated tablets
50 mg film-coated tablets
75 mg film-coated tablets
The other excipients are: mannitol (E421), microcrystalline cellulose (E460), povidone (E1201), lactose monohydrate, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate (E572), polyvinyl 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).

Description of the appearance of Eltrombopag Dr. Reddy’s and contents of the pack
Eltrombopag Dr. Reddy’s 25 mg film-coated tablets are round, biconvex, brown to dark brown tablets, approximately 7 mm in diameter, marked with "EL" on one side and "2" on the other.
Eltrombopag Dr. Reddy’s 50 mg film-coated tablets are round, biconvex, brown to reddish-brown tablets, approximately 9 mm in diameter, marked with "EL" on one side and "3" on the other.
Eltrombopag Dr. Reddy’s 75 mg film-coated tablets are round, biconvex, light brown to brown tablets, approximately 11 mm in diameter, marked with "EL" on one side and "4" on the other.

Eltrombopag Dr. Reddy’s is available in packs containing 14, 28, or 84 film-coated tablets, in a multiple pack containing 84 film-coated tablets (comprising 3 packs of 28 film-coated tablets each), and in a unit-dose divisible blister pack containing 28 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories S.R.L.,
313, Splaiul Unirii,
Building H, 1st floor, sector 3,
Bucharest, 030138,
Romania
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Eltrombopag Reddy 25 mg Filmtabletten; Eltrombopag Reddy 50 mg Filmtabletten; Eltrombopag Reddy 75 mg Filmtabletten
Germany Eltrombopag beta 25 mg Filmtabletten; Eltrombopag beta 50 mg Filmtabletten; Eltrombopag beta 75 mg Filmtabletten
Italy Eltrombopag Dr. Reddy’s
Romania Eltrombopag Dr. Reddy’s 25 mg comprimate filmate; Eltrombopag Dr. Reddy’s 50 mg comprimate filmate
Spain Eltrombopag Dr. Reddys 25 mg comprimidos recubiertos con película EFG; Eltrombopag Dr. Reddys 50 mg comprimidos recubiertos con película EFG; Eltrombopag Dr. Reddys 75 mg comprimidos recubiertos con película EFG
Sweden Eltrombopag Reddy
07/2025