Eltrombopag STADA 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Eltrombopag Stada 25mg film-coated tablets EFG

Eltrombopag Stada 50mg film-coated tablets EFG

Eltrombopag Stada 75mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may experience include petechiae (small, flat, red spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding if cut or injured.

• Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in cases where they have had problems with adverse effects from interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also because of antiviral treatments used to treat it. Taking eltrombopag may help them complete their course of antiviral therapy (peginterferon and ribavirin).

2. What you need to know before starting Eltrombopag Stada

DO NOT take Eltrombopag Stada

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take Eltrombopag Stada:

• if you have liver problems. People who have low platelet counts as well as advanced chronic liver disease (long-standing) are at increased risk of adverse effects, including liver damage that may be fatal, and blood clots. If your doctor considers that the benefit of eltrombopag outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of developing a blood clot in veins or arteries, or if you know that blood clots are common in your family.

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

• if you are elderly
• if you have been bedridden for a long period of time
• if you have cancer
• if you are taking oral contraceptives or hormone replacement therapy
• if you have recently undergone surgery or suffered physical injury
• if you are significantly overweight (obesity)
• if you are a smoker
• if you have advanced chronic liver disease.

If you are in any of these situations, inform your doctor before starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of developing blood clots.

• if you have cataracts (clouding of the lens of the eye).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting eltrombopag, your doctor will perform tests to confirm you do not have this condition. If you have MDS and take eltrombopag, the MDS may worsen.

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

Eye examinations

Your doctor will recommend that you have an eye examination to check for cataracts. If you do not routinely have eye check-ups, your doctor will ask you to have them. Your retina (the layer of light-sensitive cells at the back of the eye) should also be examined to detect any bleeding in or around the retina.

You will need regular blood tests

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

Blood tests to monitor liver function

Eltrombopag may cause blood test results indicating liver damage – an increase in certain liver enzymes, especially bilirubin and alanine/aspartate aminotransferase. If you are taking interferon, the standard treatment used together with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting eltrombopag and regularly during treatment to monitor your liver function. You may need to stop treatment with eltrombopag if levels of these markers rise too much or if you show any other signs of liver damage.

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

Blood tests for platelet count (levels)

If you stop treatment with eltrombopag, your platelet levels are likely to drop again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the precautions you should take.

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

Seek immediate medical help if you experience any of the following signs of a blood clot:

• swelling, pain, or tenderness in one leg
• sudden shortness of breath, rarely accompanied by sharp chest pain or rapid breathing
• abdominal pain, enlarged abdomen, blood in stools

Examination of bone marrow

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

Monitoring for gastrointestinal bleeding

If you are taking interferon, the standard treatment used together with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestines after you stop taking eltrombopag.

Heart monitoring

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

Elderly people (65 years and older)

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

Children and adolescents

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

Other medicines and Eltrombopag Stada

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

Some commonly used medicines may interact with eltrombopag (including prescription and non-prescription medicines and minerals). These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also section 3 “When to take it”).
• medicines called statins, used to lower cholesterol
• some medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or immunological disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be present in vitamin and mineral supplements (see also section 3 “When to take it”).
• medicines such as methotrexate and topotecan, used to treat cancer

Consult your doctor if you are taking any of these medicines. Some should not be taken with eltrombopag; dose adjustments may be needed, or the timing of administration may need to be changed. Your doctor will review your current medications and recommend alternatives if necessary.

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

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

Taking Eltrombopag Stada with food and drinks

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

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnant unless specifically advised by your doctor. The effect of eltrombopag during pregnancy is unknown.

• Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Use a reliable method of contraception to prevent pregnancy while taking eltrombopag.
• If you become pregnant during treatment with eltrombopag, inform your doctor.

Do not breastfeed while taking eltrombopag. It is unknown whether eltrombopag passes into breast milk.

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

Driving and using machines

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

Do not drive or operate machinery unless you are certain that eltrombopag does not affect you.

Eltrombopag Stada contains sodium

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

3. How to take Eltrombopag Stada

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

How much to take

For ITP

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

Children (1 to 5 years of age) – the usual starting dose for ITP is one 25mg eltrombopag tablet per day.

For Hepatitis C

Adults – the usual starting dose for hepatitis C is one 25mg eltrombopag tablet per day. If you are of East or Southeast Asian ancestry, start treatment with the same 25mg dose.

Eltrombopag may take 1 to 2 weeks to take effect. Depending on your response to eltrombopag, your doctor may recommend adjusting your daily dose.

How to take the tablets

Swallow the tablet whole with water.

Eltrombopag Stada 25 mg and Eltrombopag Stada 50 mg:

The tablet may be divided into equal doses.

When to take it

Make sure that you do not consume any of the following:

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

during the 4 hours before and the 2 hours after taking eltrombopag.

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

For more information about suitable foods and drinks, consult your doctor.

If you take more Eltrombopag Stada than you should

Contact your doctor or pharmacist immediately. If possible, show them the packaging or this leaflet. You will be monitored for signs or symptoms of adverse effects and will be given appropriate treatment immediately.

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

If you forget to take Eltrombopag Stada

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

If you stop taking Eltrombopag Stada

Do not stop taking eltrombopag without first consulting your doctor. If your doctor advises stopping treatment, your platelet levels will be monitored weekly for four weeks. See also “Bleeding or bruising after stopping treatment” in section 4.

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

4. Possible adverse effects

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

Symptoms to which you should pay attention: consult your doctor

People taking eltrombopag for either ITP or low platelet counts associated with hepatitis C may develop signs related to potentially serious adverse effects. It is important that you inform your doctor if you develop any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing blood clots, and medicines such as eltrombopag may worsen this problem. Sudden blockage of a blood vessel by a clot is an uncommon adverse effect and may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs or symptoms of thrombosis, such as:

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden shortness of breath, exceptionally accompanied by sudden chest pain or rapid breathing
• abdominal pain, enlarged abdomen, blood in stools.

Liver problems

Eltrombopag 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 signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• unusually dark-coloured urine

contact your doctor immediately.

Bleeding or bruising after stopping treatment

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

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

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

• black, tarry stools (discoloration of stools is an uncommon adverse effect that may affect up to 1 in 100 people)
• blood in stools
• vomiting blood or material resembling coffee grounds

Contact your doctor immediately if you experience any of these symptoms.

The following adverse effects have been reported with eltrombopag treatment in adult patients with ITP:

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects detectable in blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

Common adverse effects

May affect up to 1 in 10 people:

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• sore throat and difficulty swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• swelling (inflammation) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, itching, or numbness
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually the calf), with warm skin in the affected area (signs of a deep vein thrombosis)
• localized swelling filled with blood due to rupture of a blood vessel (haematoma)
• hot flushes
• mouth disorders including dry or irritated mouth, tongue sensitivity, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in urine)
• elevated temperature, feeling of warmth
• chest pain
• feeling weak
• difficulty sleeping, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• flatulence

Common adverse effects detectable in blood tests:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction

• interruption of blood supply to parts of the heart

• sudden shortness of breath, especially when accompanied by sudden chest pain and/or rapid breathing, which could be signs of a pulmonary thrombosis (see "Increased risk of thrombosis" above in section 4)

• partial loss of lung function due to blockage in the pulmonary artery

• possible pain, swelling, and/or redness around a vein, which could be signs of venous thrombosis

• yellowish skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see "Liver problems" above in section 4)

• drug-induced liver injury

• faster heartbeat, irregular heartbeat, bluish discolouration of the skin, heart rhythm disturbances (prolongation of QT interval), which could indicate a disorder related to the heart and blood vessels

• blood clots

• hot flushes

• joint pain and swelling due to uric acid (gout)

• lack of interest, mood changes, uncontrollable or unexpected crying

• balance problems, speech and nervous system disturbances, tremors

• pain or abnormal sensations in the skin

• paralysis on one side of the body

• migraine with aura

• nerve pain

• dilation or swelling of blood vessels causing headache

• eye problems including excessive tearing, clouding of the eye lens (cataracts), retinal haemorrhage, dry eyes

• nose, throat, and sinus problems, breathing difficulties during sleep

• mouth and throat blisters/pain

• loss of appetite

• digestive problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood

• rectal bleeding, changes in stool colour, abdominal swelling, constipation

• mouth disorders including dry or irritated mouth, tongue pain, bleeding gums, mouth discomfort

• sunburn

• feeling warm, anxiety

• redness or inflammation around wounds

• bleeding around a catheter (if present) in the skin

• sensation of a foreign body

• kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine

• cold sweats

• general malaise

• skin infection

• skin changes including skin discolouration, peeling, redness, itching, and sweating

• muscle weakness

• rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased blood albumin levels
• increased total protein levels
• decreased blood albumin levels
• increased urine pH
• increased haemoglobin levels

The following adverse effects have been reported with eltrombopag treatment in children (1 to 17 years) with ITP:

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

Very common adverse effects

May affect more than 1 in 10 children:

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

Common adverse effects

May affect up to 1 in 10 children:

• difficulty sleeping (insomnia)
• toothache
• sore throat and nasal pain
• itching, runny or blocked nose
• sore throat, runny nose, nasal congestion, and sneezing
• mouth disorders including dryness, irritation in the mouth, tongue sensitivity, bleeding gums, mouth ulcers

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

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection

• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation or inflammation of the mouth, toothache

• weight loss

• sleep disorders, abnormal drowsiness, depression, anxiety

• dizziness, attention and memory problems, mood changes

• decreased brain function due to liver damage

• tingling or numbness in hands and feet

• fever, headache

• eye problems including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes

• retinal bleeding

• sensation of spinning

• rapid and irregular heartbeats (palpitations), shortness of breath

• productive cough, runny nose, flu (influenza), cold sores, sore throat and difficulty swallowing

• digestive disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, haemorrhoids (piles), abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (oesophagus)

• toothache

• liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see "Liver problems" above in section 4)

• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss

• joint pain, back pain, bone pain, limb pain (arms, legs, hands, feet), muscle spasms

• irritability, general malaise, skin reactions such as redness or swelling and pain at injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling

• infection of nose, sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucosa lining the bronchi

• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

• increased blood sugar (glucose)
• decreased number of white blood cells
• decreased number of neutrophils
• decreased blood albumin
• decreased haemoglobin levels
• increased blood bilirubin levels (a substance produced by the liver)
• changes in enzymes controlling blood clotting

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating

• heart rhythm disturbances (prolongation of QT interval)

• stomach flu (gastroenteritis), sore throat

• mouth blisters/pain, stomach inflammation

• skin changes including colour changes, peeling, skin redness, itching, lesions, and night sweats

• blood clots in liver veins (possible liver and/or digestive system damage)

• poor clotting in small blood vessels with kidney failure

• itching and bruising at injection site, chest discomfort

• decreased number of red blood cells (anaemia) caused by massive destruction of red blood cells (haemolytic anaemia)

• confusion, agitation

• liver failure

The following adverse effects have been observed with eltrombopag treatment in patients with severe aplastic anaemia (SAA):

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

Very common adverse effects

May affect more than 1 in 10 people:

• cough
• headache
• mouth and throat pain
• diarrhoea
• dizziness, nausea
• joint pain (arthralgia)
• limb pain (arms, legs, hands, feet)
• vertigo
• feeling very tired
• fever
• chills
• itchy eyes
• mouth blisters
• bleeding gums
• abdominal pain
• muscle spasms

Very common adverse effects detectable in blood tests:

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

Common adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general malaise
• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (floaters), dry eyes, itchy eyes, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, flatulence/gas, constipation, intestinal motility changes that may cause constipation, bloating, diarrhoea, and/or the above-mentioned symptoms, changes in stool colour
• fainting
• skin problems including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of lower limbs due to fluid accumulation
• abnormal urine colour
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common adverse effects detectable in blood tests:

• increased muscle enzyme levels due to muscle breakdown (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decreased blood sugar levels (hypoglycaemia)
• increased blood bilirubin (a substance produced by the liver)
• decreased number of white blood cells

Adverse effects of unknown frequency

Frequency cannot be estimated from available data:

• skin discolouration

• darkening of the skin

• drug-induced liver injury

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eltrombopag Stada

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 after "EXP".

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Eltrombopag Stada

The active substance is eltrombopag (as eltrombopag olamine).

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.

Eltrombopag Stada 25 mg Film-coated Tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (from potato), magnesium stearate

Film-coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc

Eltrombopag Stada 50 mg Film-coated Tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (from potato), magnesium stearate

Film-coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172)

Eltrombopag Stada 75 mg Film-coated Tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (from potato), magnesium stearate

Film-coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172)

Appearance of the Product and Contents of the Pack

Eltrombopag Stada 25 mg Film-coated Tablets EFG

Film-coated tablets, round, biconvex, white to pale yellow in colour, with a dark red to brown score line on one side.

Eltrombopag Stada 50 mg Film-coated Tablets EFG

Film-coated tablets, round, biconvex, brown in colour, with a dark red to brown score line on one side.

Eltrombopag Stada 75 mg Film-coated Tablets EFG

Film-coated tablets, round, biconvex, pink in colour.

Eltrombopag Stada is available in blister packs containing 14, 28 or 84 film-coated tablets, or in perforated unit dose blisters containing 14x1, 28x1 or 84x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

or

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

or

Clonmel Healthcare Limited
Waterford Road,
Clonmel, Co. Tipperary, E91 D768,
Ireland

or

Centrafarm Services B.V.
Van De Reijtstraat 31 E,
Breda, 4814 NE,
Netherlands

Date of the most recent revision of this leaflet: December 2024

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