ELTROMBOPAG 25 mg Film-Coated Tablets

Зміст інструкції

1. Eltrombopag EG 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets
   1. What is Eltrombopag EG and what it is used for
   2. What you need to know before taking Eltrombopag EG
   3. How to take Eltrombopag EG
   4. Possible side effects
   5. How to store Eltrombopag EG
   6. Package contents and other information

Eltrombopag EG 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

Generic medicine

Read this 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Eltrombopag EG 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 EG is used to treat a blood clotting disorder called immune thrombocytopenia (primary) (ITP) in patients (over 1 year of age) who have already taken other medicines (corticosteroids or immunoglobulins) that have not been effective.
• ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have a higher risk of bleeding. Symptoms in patients with ITP may include petechiae (small, flat, round red spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums and being unable to control bleeding from cuts or wounds.
• Eltrombopag EG can also be used in the treatment of low platelet counts (thrombocytopenia) in adult patients with hepatitis C virus (HCV) infection, if they have experienced problems with adverse reactions during interferon use. Many people with hepatitis C have low platelet counts not only as a result of the disease itself but also due to some antiviral medicines used to treat it. Taking Eltrombopag EG may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).
• Eltrombopag EG can also be used to treat adult patients with low blood cell counts caused by severe aplastic anemia (SAA). SAA is a disease in which the bone marrow is damaged, causing a deficiency of red blood cells (anemia), white blood cells (leukopenia) and platelets (thrombocytopenia).

2. What you need to know before taking Eltrombopag EG

DO NOT take Eltrombopag EG

• if you are allergicto eltrombopag or to any of the other ingredients of this medicine (listed in section 6). - Check with your doctorif you think this applies to you.

Warnings and precautions
Talk to your doctor before taking Eltrombopag EG:

• if you have liver problems. People who have a low platelet count, as well as advanced chronic (long-lasting) liver disease, are at higher risk of developing undesirable effects, including liver damage and life-threatening blood clots. If your doctor believes that the benefits of taking Eltrombopag EG outweigh the risks, you will be carefully monitored during treatment.
• if you are at risk of forming blood clotsin the veins or arteries, or if you are aware that blood clot formation is common in your family. You may be at increased risk of blood clot formation:
• as you get older
• if you have been confined to bed for a long time
• if you have cancer
• if you are taking the birth control pill or hormone replacement therapy
• if you have recently had surgery or suffered a 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 tell your doctorbefore starting treatment. You should not take Eltrombopag EG unless your doctor considers that the expected benefits outweigh the risks of blood clot formation.
• if you suffer from cataracts(clouding of the lens of the eye)
• if you suffer from another blood disordersuch as myelodysplastic syndrome (MDS). Your doctor will perform tests to make sure you do not have this blood disorder before you start taking Eltrombopag EG.
• If you have MDS and take Eltrombopag EG, the MDS may worsen.  Tell your doctor if any of these apply to you.

Eye examinations
Your doctor will recommend that you have check-ups for cataracts. If you do not have routine eye checks, your doctor will schedule a regular examination. You may also be checked for any bleeding in the retina or around the retina (the layer of light-sensitive cells in the
back of the eye).

You will need to have regular check-ups
Before starting to take Eltrombopag EG, 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 can alter the results of blood tests that may be a sign of liver damage

• an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminases. If you are undergoing treatment with interferon-based regimens combined with Eltrombopag EG for the treatment of low platelet counts due to hepatitis C, some liver problems may worsen.

You will need to have blood tests to check your liver function before starting to take
Eltrombopag EG and at regular intervals during treatment. You may need to stop taking
Eltrombopag EG if the amount of these substances increases too much, 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 EG, your platelet count is likely to drop again within a few days. The platelet count will be monitored and your doctor will talk to you about the
appropriate precautions.
A very high platelet count may increase the risk of blood clots.
However, blood clots can also form with a normal or even
low platelet count. Your doctor will adjust the dose of Eltrombopag EG to ensure that the platelet count does not
increase too much.

Seek immediate medical helpif you have any of these signs indicating the presence of a

blood clot:

• swelling, painor tenderness in one leg
• sudden shortness of breathespecially with sharp chest pain or rapid breathing
• abdominal pain (stomach), abdominal bloating, blood in the stool

Tests to check the bone marrow
In people who may have bone marrow problems, medicines like eltrombopag could
worsen the problems. Signs of bone marrow changes may become evident as abnormalities
in blood test results.
Your doctor may perform tests to check the bone marrow directly during treatment with
Eltrombopag EG.

Checks for bleeding in the digestive tract
If you are being treated with interferon-based medicines combined with Eltrombopag EG, you will be checked for
any signs of bleeding in your stomach or intestines after stopping taking
Eltrombopag EG.

Heart check
Your doctor may consider it necessary to check your heart during treatment with Eltrombopag EG and
perform an electrocardiogram (ECG).

Elderly people (65 years and over)
There are limited data on the use of eltrombopag in patients aged 65 years or older. Use caution when taking Eltrombopag EG if you are 65 years of age or older.

Children and adolescents
Eltrombopag EG is not recommended in children under 1 year of age with ITP. Furthermore, it is not
recommended in people under 18 years of age with a low platelet count due to hepatitis
C or severe aplastic anemia.

Other medicines and Eltrombopag EG
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines. This includes medicines used without a prescription and vitamins.

Some everyday medicines interact with Eltrombopag EG– including prescription and over-the-counter medicines and minerals. These include:

• antacids to treat indigestion, heartburn or stomach ulcers(see also ‘ When to take it’in section 3)
• medicines called statins, to lower cholesterol
• some medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine used in case of transplantsand immune diseases
• minerals such as iron, calcium, magnesium, aluminum, selenium and zinc found in vitamin and mineral supplements(see also “ When to take it” in section 3)
• medicines such as methotrexate and topotecan, to treat cancer Tell your doctorif you are taking any of these medicines. Some of them may not be taken with Eltrombopag EG, or the dose you take may need to be adjusted, or the time at which it is taken may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, will suggest replacing them appropriately.

There is an increased risk of bleeding if you are also taking medicines to prevent blood
clots. Your doctor will talk to you about this.
If you are taking corticosteroids, danazoland/or azathioprine, you may need to take a lower dose or stop taking them while you are taking Eltrombopag EG.

Eltrombopag EG with food and drink
Do not take Eltrombopag EG with food or drinks containing milk, as the calcium in dairy products affects
the absorption of the medicine. For more information, see ‘ When to take it’in section 3.

Pregnancy and breastfeeding
Do not use Eltrombopag EG if you are pregnant unless your doctor specifically recommends it.
The effect of eltrombopag during pregnancy is unknown.

• Tell your doctor if you are pregnant, if you think you may be, or if you are planning a pregnancy.
• Use a reliable method of contraceptionwhile taking Eltrombopag EG, to prevent pregnancy
• If you become pregnant during treatmentwith Eltrombopag EG, tell your doctor.

Do not breastfeed while taking Eltrombopag EG. It is not known whether eltrombopag passes into breast
milk.
 If you are breastfeedingor planning to breastfeed, tell your doctor.

Driving and using machines
Eltrombopag EG can cause dizzinessand other side effects that lead to decreased
attention.
 Do not drive vehicles or use machinesunless you are sure you are not affected.

Eltrombopag EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Eltrombopag EG

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist. Do not change the dose or the schedule of taking Eltrombopag EG unless your
doctor or pharmacist advises you to do so. While you are taking Eltrombopag EG, you will be under the care
of a doctor with specialized experience in the treatment of your condition.

How much to take
For ITP
Adultsand children(from 6 to 17 years) - the recommended initial dose for ITP is one 50 mg tablet
of Eltrombopag EG per day. If you are of East/South-East Asian origin, you may need to start with

a lower dose, of 25 mg.

Children(from 1 to 5 years) – the recommended initial dose for ITP is one 25 mg tabletof
Eltrombopag EG per day.

For Hepatitis C
Adults- the recommended initial dose for Hepatitis C is one 25 mg tabletof Eltrombopag EG
per day. If you are of East/South-East Asian origin, you will start with the same dose of 25 mg.

For SAA
Adults- the recommended initial dose for SAA is one 50 mg tabletof Eltrombopag EG per
day. If you are of East/South-East Asian origin, you may need to start with a lower dose of
25 mg.
Eltrombopag EG may take 1 to 2 weeks to work. Based on the response to Eltrombopag
EG, your doctor may recommend a change in the daily dose.

How to take the tablets
Swallow the tablet whole, with some water.
Only Eltrombopag EG 25 mg and 50 mg film-coated tablets:
The tablet can be divided into equal doses.

When to take it
Make sure that

• for 4 hours beforetaking Eltrombopag EG
• and for 2 hours aftertaking Eltrombopag EG

you do not consumeany of the following:

• dairy productssuch as cheese, butter, yogurt or ice cream
• milk or milk-based shakes, drinks containing milk, yogurt or cream
• antacids, a type of medicine for indigestion and heartburn
• some vitamin and mineral supplementsincluding iron, calcium, magnesium, aluminum, selenium and zinc.

If you do, the medicine will not be absorbed properly into the body.
NO dairy products, antacids or mineral supplements!

For further advice regarding suitable foods and beverages, consult your doctor.
If you take more Eltrombopag EG than you should
Contact your doctor or pharmacist immediately. If possible, show them the packaging, or this
leaflet. Any signs or symptoms of adverse effects will be checked and treated
immediately appropriately.

If you forget to take Eltrombopag EG
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag EG in a day.

If you stop taking Eltrombopag EG
Do not stop taking Eltrombopag EG without talking to your doctor. If your doctor advises you to
stop treatment, the platelet count will be checked every week for four
weeks. See also ‘Bleeding or bruising after you stop treatment’in the paragraph

• 4.

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

4. Possible side effects

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

Symptoms that require attention: consult a doctor
People who take Eltrombopag EG for ITP or for a low number of platelets in the blood
due to hepatitis C may develop signs of potentially serious side effects. It is important to
inform your doctor if you develop these symptoms.

Higher risk of blood clots
Some people may have a higher risk of blood clots, and medicines like eltrombopag
can 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, rednessor tenderness in oneleg
• sudden onset of shortness of breathespecially together with sharp chest pain or rapid breathing
• abdominal pain (stomach), abdominal bloating, blood in the stool.

Liver problems
Eltrombopag can cause changes that are detected by blood tests and may be signs of
liver damage. Liver problems (increased enzymes detected by 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 have any of these signs of liver problems:

• yellowing of the skin or the whites of the eyes (jaundice)
• urineunusually dark in color Inform your doctor immediately.

Bleeding or bruising after you stop treatment
Within two weeks of stopping Eltrombopag EG, the number of platelets will usually decrease to
what it was before starting Eltrombopag EG. A lower number of platelets may increase the
risk of bleeding or bruising. Your doctor will check the number of platelets for at least 4 weeks
after you have stopped taking Eltrombopag EG.
 Inform your doctorif you have bleeding or bruising after you have stopped Eltrombopag EG.
Some people have bleeding in the digestive tractafter stopping peginterferon, ribavirin and eltrombopag. Symptoms include:

• dark stools (change in stool color is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or something that looks like coffee grounds  Informyour doctor immediately if you experience any of these symptoms.

The following side effects have been reported as being associated with treatment with
eltrombopag in adult patients with ITP:
Very common side effects
These may affect more than 1 in 10 people:

• common cold
• feeling unwell (nausea)
• diarrhea
• cough
• nasal infection, sinus infection, sore throat and upper respiratory tract infection (upper respiratory tract infection)
• back pain

Very common side effects that can become apparent from blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

Common side effects
These may affect up to 1 in 10 people:

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstrual bleeding
• sore throat and pain when swallowing
• eye problems including abnormal eye tests, dry eye, eye pain and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils
• infections of the lungs, sinuses, nose and throat
• inflammation of the gum tissue
• loss of appetite
• a sensation of tingling, prickling or numbness, commonly called "pins and needles"
• decreased skin sensitivity
• feeling sleepy
• 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 from a rupture in a blood vessel (hematoma)
• hot flashes
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• tooth pain
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itchy bumpy rash, red spots, changes in skin appearance
• hair loss
• urine that looks foamy, bubbly or fizzy (signs of protein in the urine)
• high temperature, feeling hot
• chest pain
• feeling weak
• sleep problems, depression
• migraine
• decreased vision
• feeling dizzy
• air/gas due to digestion

Common side effects that can become apparent from blood tests:

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

Uncommon side effects
These may affect up to 1 in 100 people:

• allergic reaction
• interruption of blood flow to a part of the heart
• sudden shortness of breath, especially if accompanied by sharp chest pain and/or rapid breathing, which may be a sign of a blood clot in the lungs (see ‘Higherrisk of blood clots’at the beginning of paragraph 4)
• loss of function of a part of the lung caused by blockage of the pulmonary artery
• possible pain, swelling and/or redness around a vein which may be signs of blood clot formation in a vein
• yellowing of the skin and/or abdominal pain which may be signs of an obstruction in the bile duct, liver injury, liver damage due to inflammation (see ‘Liverproblems’at the beginning of paragraph 4)
• liver damage due to taking drugs
• increased heart rate, irregular heartbeat, bluish discoloration of the skin, heart rhythm disorders (QT prolongation) which may be signs of a heart and blood vessel disorder
• blood clot
• redness
• painful swelling of the joints caused by uric acid (gout)
• lack of interest, mood changes, crying that is difficult to stop or occurs at unexpected times
• balance problems, speech and nerve function problems, tremor
• painful or abnormal sensations of the skin
• 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 lens of the eye (cataract), bleeding in the retina, dry eye
• problems with nose, throat and sinuses, sleep breathing problems
• blisters/sores in the mouth and throat
• loss of appetite
• problems with the digestive system including frequent bowel movements, food poisoning, blood in the stool, vomiting blood
• bleeding from the rectum, change in stool color, abdominal bloating, constipation
• mouth problems including dry mouth, painful mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling warm, feeling anxious
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• feeling of a foreign body
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in the urine
• cold sweat
• general feeling of unwellness
• skin infection
• skin changes including skin discoloration, peeling, redness, itching and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects that can become apparent from laboratory tests:

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

The following additional side effects have been reported as being associated with treatment with
eltrombopag in children (aged 1 to 17 years) with ITP:
If these side effects worsen, tell your doctor, pharmacist or nurse.

Very common side effects
These may affect more than 1 in 10 children:

• nasal infection, sinus infection, sore throat and upper respiratory tract infection, common cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• high temperature
• feeling unwell (nausea)

Common side effects
These may affect up to 1 in 10 children:

• difficulty sleeping (insomnia)
• tooth pain
• pain in nose and throat
• itchy nose, runny or blocked nose
• sore throat, runny nose, nasal congestion and sneezing
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported as being associated with treatment with
eltrombopag in combination with peginterferon and ribavirin in patients affected by HCV:
Very common side effects
These may affect more than 1 in 10 people:

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

Very common side effects that can become apparent from blood tests:

• decreased number of red blood cells (anemia)

Common undesirable effects
These can affect up to 1 in 10 people:

• urinary system infections
• inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes
• decreased brain function following liver damage
• tingling or numbness in the hands or feet
• fever, headache
• eye problems including lens opacification of the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the white of the eye
• retinal bleeding
• sensation of dizziness (vertigo)
• fast or irregular heartbeat (palpitations), shortness of breath
• cough that brings up mucus, runny nose, flu, cold sores, sore throat and difficulty swallowing
• problems of the digestive system, including vomiting, stomach pain, indigestion, constipation, stomach bloating, taste disorders, hemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the esophagus
• toothache
• liver problems, including liver tumor, yellowing of the white of the eyes or skin (jaundice), liver damage due to drugs (see ‘Liver problems’ at the beginning of paragraph 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in the extremities (arms, legs, hands or feet), muscle spasms
• irritability, general feeling of discomfort, skin reaction such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid buildup in the body or extremities causing swelling
• nasal infection, sinusitis, throat and upper respiratory tract infection, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common undesirable effects that may be evident from blood tests:

• increased blood sugar (glucose)
• reduction in the number of white blood cells
• reduction in the number of neutrophils
• reduction of albumin in the blood
• reduction in hemoglobin level
• increased bilirubin in the blood (a substance produced by the liver)
• changes in enzymes that control blood clotting

Uncommon undesirable effects
These can affect up to 1 in 100 people:

• pain during urination
• heart rhythm disturbances (prolongation of the QT interval)
• stomach flu (gastroenteritis), sore throat
• blisters/sores in the mouth, inflammation of the stomach
• skin changes including changes in color, peeling, redness, itching, lesions and night sweats
• blood clots in a vein in the liver (possible liver and/or digestive system damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at the injection site, chest discomfort
• decreased number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• liver failure

The following undesirable effects have been reported as being associated with treatment with
eltrombopag in patients with severe aplastic anemia (SAA):
If these undesirable effects worsen, tell your doctor, pharmacist or nurse.

Very common undesirable effects
These can affect more than 1 in 10 people:

• cough
• headache
• mouth and throat pain
• diarrhea
• feeling unwell (nausea)
• joint pain (arthralgia)
• pain in the extremities (arms, legs, hands and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• blisters in the mouth
• gum bleeding
• abdominal pain
• muscle spasms

Very common undesirable effects that may be evident from blood tests:

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

Common undesirable effects
These can affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general feeling of discomfort
• eye problems that include problems with vision, blurred vision, lens opacification of the eye (cataract), spots or deposits in the eye (floaters in the vitreous), dry eye, itchy eye, yellowing of the skin or whites of the eyes
• nosebleeds
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, stomach bloating, gas in the stomach during digestion/gas, constipation, intestinal motility disorder that can cause constipation, bloating, diarrhea and/or the above symptoms, change in stool color
• fainting
• skin problems that include small red spots or purpura caused by 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
• urine with abnormal color
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common undesirable effects that may be evident from blood tests:

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

Undesirable effects with unknown frequency
The frequency cannot be defined on the basis of the available data

• skin discoloration
• dark skin
• liver damage due to drugs

Reporting of undesirable effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Eltrombopag EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

The active ingredient is eltrombopag (as eltrombopag olamine).
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag
Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
Eltrombopag EG 25 mg film-coated tablets

Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethylcellulose (Type A), magnesium
stearate.

Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc.
Eltrombopag EG 50 mg film-coated tablets

Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethylcellulose (Type A), magnesium
stearate.

Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron
oxide (E172).
Eltrombopag EG 75 mg film-coated tablets

Tablet core
Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethylcellulose (Type A), magnesium
stearate.

Tablet coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).

Description of the appearance of Eltrombopag EG and package contents
Eltrombopag EG 25 mg film-coated tablets
Film-coated tablets of colour from white to pale yellow, round, biconvex, with a breaking line
on one side, of colour from dark red to brown when broken.
Eltrombopag EG 50 mg film-coated tablets
Film-coated tablets of brown colour, round, biconvex, with a breaking line on one side, of
colour from dark red to brown when broken.
Eltrombopag EG 75 mg film-coated tablets
Film-coated tablets of pink colour, round, biconvex.
Eltrombopag EG is available in blisters containing 14, 28 or 84 film-coated tablets or divisible
blisters for unit dose containing 14x1, 28x1 or 84x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Stada Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel 61118 – Germany
Stada Arzneimittel GmbH, Muthgasse 36/2 Vienna 1190 - Austria
Clonmel Healthcare Limited, Waterford Road Clonmel Co. Tipperary E91 D768 – Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT Eltrombopag STADA 25 mg/50 mg/75 mg Filmtabletten
CY Eltrombopag/STADA
DE Eltrombopag AL 25 mg/50 mg/75 mg Filmtabletten
DK Eltrombopag STADA
EE Eltrombopag STADA
EL Eltrombopag/STADA
ES ELTROMBOPAG STADA 25 mg/50 mg/75 mg COMPRIMIDOS RECUBIERTOS CON
PELICULA EFG
FI Eltrombopag STADA 25 mg/50 mg/75 mg kalvopäällysteiset tabletit
FR ELTROMBOPAG EG 25 mg/50 mg/75 mg, comprimé pelliculé
HU Eltrombopag Stada 25 mg/50 mg/75 mg filmtabletta
HR Eltrombopag STADA 25 mg/50 mg/75 mg filmom obložene tablete
IE Eltrombopag Clonmel 25 mg/50 mg/75 mg film-coated tablets
IS Eltrombopag STADA 25 mg/50 mg/75 mg filmuhúðaðar töflur
IT Eltrombopag EG
LT Eltrombopag STADA 25 mg/50 mg/75 mg plėvele dengtos tabletės
LV Eltrombopag STADA 25 mg/50 mg/75 mg apvalkotās tablets
MT Eltrombopag Clonmel 25 mg/50 mg/75 mg film-coated tablets
NL Eltrombopag STADA 25 mg/50 mg/75 mg filmomhulde tabletten
NO Eltrombopag STADA
PL Eltrombopag Stada
RO Eltrombopag Stada 25 mg/50 mg/75 mg comprimate filmate
SK Eltrombopag STADA 25 mg/50 mg/75 mg filmom obalené tablety
SI Eltrombopag STADA 25 mg/50 mg/75 mg filmsko obložene tablete
SE Eltrombopag STADA 25 mg/50 mg/75 mg filmdragerade tabletter