ELTROMBOPAG 12.5 mg Фильм-coated таблетки

Содержание инструкции

1. Eltrombopag Accord 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets
   1. What is Eltrombopag Accord and what it is used for
   2. What you need to know before taking Eltrombopag Accord
   3. How to take Eltrombopag Accord
   4. Possible side effects
   5. How to store Eltrombopag Accord
   6. Package contents and other information

Eltrombopag Accord 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

eltrombopag

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Accord is and what it is used for
• 2. What you need to know before you take Eltrombopag Accord
• 3. How to take Eltrombopag Accord
• 4. Possible side effects
• 5. How to store Eltrombopag Accord
• 6. Contents of the pack and other information

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

Eltrombopag Accord 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 Accord 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 in
case of cuts or wounds.

• Eltrombopag Accord can also be used in the treatment of low platelet counts ( thrombocytopenia) in patients with hepatitis C virus (HCV) infection, if they have experienced problems with adverse reactions during interferon use. Many people with hepatitis C have a low platelet count not only as a result of the disease itself but also due to some antiviral medicines that are used to treat it. Taking Eltrombopag may make it easier for you to complete a full course of antiviral medication (peginterferon and ribavirin).

2. What you need to know before taking Eltrombopag Accord

Do not take Eltrombopag Accord

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

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

• if you have liver problems. People who have a low number of platelets, 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 Accord outweigh the risks, you will be carefully monitored during treatment.
• if you are at risk of developing 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:
• if you are elderly
• if you have had to stay in bed for a long time
• if you have cancer
• if you are taking the birth control pill for contraception 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 Accord 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 Accord. If you have MDS and take Eltrombopag Accord, the MDS may worsen. Tell your doctor if any of these apply to you.

Eye examination
Your doctor will recommend that you have checks for cataracts. If you do not have routine eye exams, your doctor will schedule a regular exam. 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 regular tests
Before starting to take Eltrombopag Accord, 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 Accord can alter the results of blood tests that may be a sign of liver damage - an increase in certain liver enzymes, in particular bilirubin and alanine/aspartate transaminases. If you are undergoing interferon-based treatments in combination with Eltrombopag Accord 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 Accord and during treatment. You may need to stop taking Eltrombopag Accord if the amount of these enzymes increases too much, or if physical 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 Accord, 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 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 Accord 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 onset of shortness of breath, especially together 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 Accord may 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 Accord.

Tests for gastrointestinal bleeding
If you are being treated with interferon-based medicines in combination with Eltrombopag Accord, you will be checked for any signs of bleeding in your stomach or intestines after stopping taking Eltrombopag Accord.

Heart check
Your doctor may need to check your heart during treatment with Eltrombopag Accord and perform an electrocardiogram (ECG).

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

Children and adolescents
Eltrombopag Accord is not recommended in children under 1 year of age with ITP. It is also not recommended in people under 18 years of age with a low platelet count due to hepatitis C.

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

Some of the common medicines interact with Eltrombopag Accord– including prescription and over-the-counter medicines and minerals. These include:

• antacids to treat indigestion, heartburnor 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 which can be found in vitamin and mineral supplements(see also “ When to take it” in section 3)
• medicines such as methotrexate and topotecan, to treat cancerTell your doctorif you are taking any of these medicines. Some of them may not be taken with Eltrombopag Accord, or you may need to adjust the dose you take or you may need to change the time at which it is taken. 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 Accord.

Eltrombopag Accord with food and drink
Do not take Eltrombopag Accord with drinks or dairy products and cheese, 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 Accord if you are pregnantunless your doctor specifically recommends it.
The effect of Eltrombopag Accord during pregnancy is not known.

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

Do not breastfeed while taking Eltrombopag Accord.It is not known whether Eltrombopag Accord passes into breast milk.

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

Driving and using machines
Eltrombopag Accord can cause dizzinessand have other undesirable effects leading to a decrease in attention.

Do not drive vehicles or use machinesunless you are sure you are not affected.

Eltrombopag Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Eltrombopag Accord

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

How much to take
For ITP
Adultsand children(from 6 to 17 years) - the recommended starting dose for ITP is one 50 mg tablet
of Eltrombopag Accord 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 starting dose for ITP is one 25 mg tabletof
Eltrombopag Accord per day.

For Hepatitis C
Adults - the recommended starting dose for Hepatitis Cis one 25 mg tabletof Eltrombopag
Accord per day. If you are of East/South-East Asian origin, you will start with the same dose of 25 mg.
Eltrombopag Accord may take 1 to 2 weeks to work. Based on the response to Eltrombopag Accord, your
doctor may recommend a change in the daily dose.

How to take the tablets
Swallow the tablet whole, with some water.

When to take it
Make sure that -

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

Do notconsume any of the following:

• foodssuch 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.

Take Eltrombopag Accord
For 4 hours before... and for 2 hours after
taking
Eltrombopag…
NO dairy products, antacids or
mineral supplements

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

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

If you stop taking Eltrombopag Accord
Do not stop taking Eltrombopag Accord without talking to your doctor. If your doctor advises you to
stop treatment, the number of platelets will be checked every week for four
weeks. See also ‘ Bleeding or bruising after you stop treatment’ in
section 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 everybody gets them.
li manifestino.

Symptoms that need attention: consult a doctor
People taking Eltrombopag Accord for ITP or low platelet count 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.
Increased risk of blood clots
Some people may have a higher risk of blood clots, and medicines like
Eltrombopag Accord may 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 one leg
• sudden shortness of breathespecially together with sharp chest pain or rapid breathing
• abdominal pain (stomach), abdominal bloating, blood in the stool.

Liver problems
Eltrombopag Accord can cause changes that are detected by blood tests and can be
signs of liver damage. Liver problems (increased enzymes detected with 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 whites of the eyes (jaundice)
• urineunusually dark in colorTell your doctor immediately.

Bleeding or bruising after you have stopped treatment
Within two weeks of stopping Eltrombopag Accord, the platelet count usually
will decrease to what it was before starting Eltrombopag Accord. A lower platelet count
may increase the risk of bleeding or bruising. The doctor will check the platelet count for
at least 4 weeks after you have stopped taking Eltrombopag Accord.

Tell your doctorif you have bleeding or bruising after you have stopped Eltrombopag Accord.
Some people have bleeding in the digestive systemafter stopping peginterferon, ribavirin and Eltrombopag Accord. 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

Tell your doctor immediatelyif you experience any of these symptoms.

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

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

Very common side effects that can be detected with blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

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

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• sore throat and pain when swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain and blurred vision
• vomiting
• flu
• herpeslabialis
• 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
• 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 broken blood vessel (bruise)
• hot flushes
• 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 be detected with 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 100people:

• allergic reaction
• interruption of blood flow to 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 ‘Increased risk of blood clots’ at the beginning of paragraph 4)
• loss of function of 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 a blockage in the bile duct, liver injury, liver damage due to inflammation (see ‘Liver problems’ at the beginning of paragraph 4)
• liver damage due to taking medicines
• fast heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (prolonged QT) 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 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 lens of the eye (cataract), bleeding in the retina, dry eyes
• problems with nose, throat and sinuses, sleep breathing problems
• blisters/sores in the mouth and throat
• loss of appetite
• digestive system problems 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, sore tongue, bleeding gums, discomfort in the mouth
• sunburn
• feeling hot, 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 being unwell
• skin infection
• skin changes including skin discoloration, peeling, redness, itching and sweating
• muscle weakness
• cancer of the rectum and colon

Uncommon side effects that can be detected from laboratory tests:

• changes in the shape of red blood cells
• presence of development of white blood cells which may be indicative of some 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 side effects have been reported as being associated with treatment with
Eltrombopag Accord in pediatric patients (aged between 1 and 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 10children:

• infection of the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• high temperature
• feeling sick (nausea)

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

• 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 Accord in combination with peginterferon and ribavirin in patients affected by HCV:
Very common side effects
These may affect more than 1 in 10people:

• headache
• loss of appetite
• cough
• feeling sick (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 be detected from the blood test:

• decreased number of red blood cells (anemia).

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

• 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 clouding of the eye's lens (cataract), dry eye, small yellow deposits in the retina, yellowing of the white of the eye
• retinal bleeding
• sensation of spinning (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 disturbances, hemorrhoids, pain/discomfort in the stomach, dilated blood vessels and bleeding in the esophagus
• toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage caused by 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
• infection of the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common undesirable effects that may become apparent 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 of hemoglobin level
• increased bilirubin (a substance produced by the liver)
• changes in enzymes that control blood clotting

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

• 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, scaling, 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
• decrease in the 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 up to 1in 10people:

• cough
• headache
• pain in the mouth and throat
• 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 become apparent 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 1in 10people:

• anxiety
• depression
• feeling cold
• general feeling of discomfort
• eye problems that include vision problems, blurred vision, clouding of the eye's lens (cataract), spots or deposits in the eye (vitreous floaters), dry eye, itchy eye, yellowing of the skin or whites of the eyes
• nosebleeds
• problems of the digestive system including difficulty swallowing, pain in the mouth, 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 become apparent 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
Frequency cannot be defined based on available data

• skin discoloration
• dark skin
• liver damage caused by drugs

Reporting of undesirable effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Eltrombopag Accord

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 special storage conditions.
Do not dispose of any medicine in waste water 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 Accord contains
The active ingredient is eltrombopag.

12.5 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of 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 excipients are: mannitol, povidone, microcrystalline cellulose, sodium starch glycolate,
magnesium stearate, isomalt (E 953), calcium silicate, hypromellose, titanium dioxide (E171), triacetin,
red iron oxide (E172) and yellow iron oxide (E172) [except for 75 mg].

Description of the appearance of Eltrombopag Accord and contents of the pack
Eltrombopag Accord 12.5 mg film-coated tablets
Round, biconvex, film-coated tablet, orange to brown in color, with “I” imprinted
on one side and approximately 5.5 mm in diameter.
Eltrombopag Accord 25 mg film-coated tablets
Round, biconvex, film-coated tablet, dark pink in color, with “II” imprinted on one side and
approximately 8 mm in diameter.
Eltrombopag Accord 50 mg film-coated tablets
Round, biconvex, film-coated tablet, pink in color, with “III” imprinted on one side and 10
mm approximately in diameter.
Eltrombopag Accord 75 mg film-coated tablets
Round, biconvex, film-coated tablet, red to brown in color, with “IV” imprinted on
one side and approximately 12 mm in diameter.
They are provided in aluminum blisters (OPA/Alu/PVC-Alu) in a pack containing 14 or
28 tablets and multiple packs containing 84 (3 packs of 28) tablets or in perforated aluminum blisters
(OPA/Alu/PVC-Alu) in a carton containing 14 x 1 or 28 x 1 tablets and
multiple packs containing 84 x 1 (3 packs of 28 x 1) tablets.
The multiple pack containing 84 (3 packs of 28) and 84 x 1 (3 packs of 28 x 1) tablets
is not applicable to the 12.5 mg dosage.
Not all pack sizes may be marketed in your country.

Marketing authorization holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu . Additionally, links to other websites on rare diseases
and related therapeutic treatments are provided.