Elrevolan

Patient Information Leaflet

Elrevolan 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

Eltrombopag
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Elrevolan is and what it is used for

Elrevolan 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.

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

ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms in patients with ITP may include petechiae (small, flat, red, round spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding from cuts or injuries.

• Elrevolan may also be used to treat low platelet count (thrombocytopenia) in patients with hepatitis C virus (HCV), if they have had problems with adverse reactions during interferon therapy. Many people with hepatitis C have a low platelet count not only due to the disease itself but also because of certain antiviral medications used to treat it. Taking Elrevolan may make it easier for you to complete a full course of antiviral treatment (peginterferon and ribavirin). -

Do not take Elrevolan

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 under ‘What Elrevolan contains’ ). Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking Elrevolan:

• if you have liver problems. People who have a low platelet count and advanced chronic (long-term) liver disease are at higher risk of experiencing side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking Elrevolan outweigh the risks, you will be closely monitored during treatment. -
• if you are at risk of forming blood clots in veins or arteries, or if you know that blood clotting is common in your family. -
• You may be at higher risk of blood clot formation if: -
• you are elderly
• you have to remain bedridden for a long time
• you have cancer
• you are taking oral contraceptives or hormone replacement therapy
• you have recently undergone surgery or suffered physical trauma
• you are very overweight (obese)
• you are a smoker
• you have advanced chronic liver disease
• If any of these apply to you, inform your doctor before starting treatment. You must not take Elrevolan unless your doctor considers that the expected benefits outweigh the risk of blood clot formation.
• if you have cataracts (clouding of the eye's lens) -
• if you have another blood disorder such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check that you do not have this blood disorder before you start taking Elrevolan. If you have MDS and take Elrevolan, the MDS may worsen. - Inform your doctor if any of these apply to you.

Eye examination
Your doctor will recommend regular checks for cataracts. If you do not have routine eye exams, your doctor will schedule regular examinations. You may also be monitored for any bleeding in or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular blood tests
Before starting Elrevolan, 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.
Liver function blood tests
Elrevolan may alter the results of blood tests that can indicate liver damage—an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatment in combination with Elrevolan for low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to monitor liver function before starting Elrevolan and during treatment. You may need to stop taking Elrevolan if levels of these enzymes rise too much, or if physical signs of liver damage appear.
Please read the information ‘ Liver problems ’ in section 4 of this Leaflet
Blood tests for platelet count
If you stop taking Elrevolan, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored, and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clot formation. However, blood clots can also form with normal or even low platelet counts. Your doctor will adjust the dose of Elrevolan to ensure that your platelet count does not rise too high.

Seek immediate medical help if you experience any of the following signs indicating a blood clot :
swelling, pain, or tenderness in one leg
sudden onset of breathlessness, especially along with sharp chest pain or rapid breathing
abdominal pain, abdominal swelling, blood in the stool
Bone marrow monitoring tests
In people who may have bone marrow problems, medicines like Elrevolan could worsen these conditions. Signs of bone marrow abnormalities may appear as unusual results in blood tests. Your doctor may perform tests to directly monitor your bone marrow during treatment with Elrevolan.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Elrevolan, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Elrevolan.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Elrevolan and may perform an electrocardiogram (ECG).
Elderly patients (65 years and older)
There is limited data on the use of Elrevolan in patients aged 65 years and older. Exercise caution when taking Elrevolan if you are 65 years of age or older.
Children and adolescents
Elrevolan 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 low platelet count due to hepatitis C.
Other medicines and Elrevolan
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 common medicines interact with Elrevolan – including prescription and over-the-counter medicines and mineral supplements. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also ‘ When to take it ’ in section 3)
• statins, used to lower cholesterol -
• certain medicines for HIV infection, such as lopinavir and/or ritonavir -
• cyclosporine, used in transplantation and immune disorders -
• mineral supplements such as iron, calcium, magnesium, aluminium, selenium, and zinc found in vitamin and mineral supplements (see also “ When to take it ” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer -

Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Elrevolan, or you may need to adjust your dose or change the timing of administration.
Your doctor will review all the medicines you are taking and, if necessary, suggest appropriate alternatives.
There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol, and/or azathioprine, you may need to take a lower dose or stop taking them while on Elrevolan.
Elrevolan with food and drinks
Do not take Elrevolan with beverages or products derived from milk and cheese, as the calcium in dairy products affects the absorption of the medicine. For further information, see ‘ When to take it ’ in section 3.
Pregnancy and breastfeeding
Do not use Elrevolan if you are pregnant unless specifically recommended by your doctor. The effects of Elrevolan during pregnancy are not known.

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

Do not breastfeed while taking Elrevolan. It is not known whether Elrevolan passes into breast milk.
If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Elrevolan may cause dizziness and other side effects that may reduce your alertness.
Do not drive or operate machinery unless you are certain you are not affected.
Elrevolan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

2. How to take Elrevolan

Take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist. Do not change the dose or dosing schedule of Elrevolan
unless your doctor or pharmacist advises you to do so. While taking Elrevolan, you will be under
the care of a doctor experienced in the treatment of your condition.
How much to take
For ITP
Adults and children (6 to 17 years of age) – the recommended starting dose for ITP is one 50 mg
tablet of Elrevolan daily. If you are of East or Southeast Asian origin, you may need to start with a
lower dose of 25 mg.
Children (1 to 5 years of age) – the recommended starting dose for ITP is one 25 mg tablet of
Elrevolan daily.
For Hepatitis C
Adults – the recommended starting dose for hepatitis C is one 25 mg tablet of Elrevolan
daily. If you are of East or Southeast Asian origin, you will start with the same dose of 25 mg.
Elrevolan may take 1 to 2 weeks to take effect. Based on your response to Elrevolan, your doctor
may recommend adjusting the daily dose.
How to take the tablets
Swallow the tablet whole with some water.
When to take it
Make sure that

• within the 4 hours before taking Elrevolan –
• and within the 2 hours after taking Elrevolan –

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream –
• milk or milk-based smoothies, milk-containing drinks, 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. –

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

For further advice on suitable foods and drinks, consult your doctor.
If you take more Elrevolan than you should
Contact your doctor or pharmacist immediately. If possible, show them the pack or
this leaflet. You will be monitored for any signs or symptoms of adverse effects and treated
appropriately without delay.
If you forget to take Elrevolan
Take the next dose at your usual time. Do not take more than one dose of Elrevolan in a day.
If you stop taking Elrevolan
Do not stop taking Elrevolan without speaking to your doctor. If your doctor advises you to
discontinue treatment, your platelet count will be monitored weekly for four weeks. See also
‘Bleeding or bruising after stopping treatment’ in section 4.
If you have any questions about using this medicine, consult your doctor or pharmacist.

3. Possible side effects

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

Symptoms requiring attention: consult a doctor
People taking Elrevolan 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 experience any of these symptoms.

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

Seek immediate medical help if you experience signs or symptoms of a blood clot, such as:

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden onset of shortness of breath, especially accompanied by sharp chest pain or rapid breathing
• abdominal pain (stomach pain), abdominal swelling, blood in the stool

Liver problems
Elrevolan may cause changes detectable in blood tests that could indicate liver damage. Liver problems (increased liver enzymes detected in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.
If you experience any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine that is unusually dark in color

Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks after stopping Elrevolan, platelet counts usually decrease to the level they were before starting Elrevolan. Lower platelet counts may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Elrevolan.
Inform your doctor if you experience bleeding or bruising after stopping Elrevolan.
Some people have experienced gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and Elrevolan. 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 material resembling coffee grounds

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

The following side effects have been reported in association with Elrevolan treatment in adult patients with ITP:

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

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

Very common side effects detectable in blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

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

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual period
• sore throat and pain during swallowing
• eye problems including abnormalities in eye tests, dry eyes, eye pain, blurred vision
• vomiting
• influenza
• herpes labialis
• 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
• sensation of tingling, prickling, or numbness, commonly referred to as "pins and needles"
• decreased skin sensitivity
• feeling of drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood from a ruptured blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormalities in liver function
• skin disorders including excessive sweating, irregular itchy rash, red spots, changes in skin appearance
• hair loss
• urine that appears foamy, frothy, or fizzy (signs of protein in the urine)
• high temperature, feeling of warmth
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• dizziness (vertigo)
• gas/bloating due to digestion

Common side effects detectable in blood tests:

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

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

• allergic reaction

• interruption of blood flow to part of the heart

• sudden respiratory failure, especially if accompanied by sharp chest pain and/or rapid breathing, which may indicate a blood clot in the lungs (see 'Increased risk of blood clots' at the beginning of section 4)

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

• possible pain, swelling, and/or redness around a vein, which could indicate blood clot formation in a vein

• yellowing of the skin and/or abdominal pain, which could indicate obstruction of the bile duct, liver injury, or liver damage due to inflammation (see 'Liver problems' at the beginning of section 4)

• liver damage due to medication use

• increased heart rate, irregular heartbeat, bluish skin colouration, heart rhythm disorders (QT prolongation), which could indicate a cardiovascular disorder

• blood clot

• redness

• painful swelling of joints due to uric acid (gout)

• loss of interest, mood changes, uncontrollable crying or crying at unexpected times

• balance problems, speech and nerve function issues, tremor

• painful or abnormal skin sensations

• paralysis on one side of the body

• migraine with aura

• nerve damage

• dilation or swelling of blood vessels causing headache

• eye problems including increased tear production, clouding of the eye lens (cataract), retinal bleeding, dry eyes

• problems with nose, throat, and sinuses, breathing problems during sleep

• blisters/sores in the mouth and throat

• loss of appetite

• digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting with blood

• bleeding from the rectum, change in stool colour, abdominal swelling, constipation

• mouth problems including dry mouth, sore mouth, painful tongue, bleeding gums, mouth discomfort

• sunburn

• feeling hot, anxiety sensation

• redness or swelling around a wound

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

• sensation of a foreign body

• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine

• cold sweat

• general feeling of malaise

• skin infection

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

• muscle weakness

• cancer of the rectum and colon

Uncommon side effects detectable in laboratory tests:

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

The following side effects have been reported in association with Elrevolan treatment in paediatric patients (aged 1 to 17 years) with ITP:
If these side effects worsen, inform your doctor, pharmacist, or nurse.

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

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

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

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

The following side effects have been reported in association with Elrevolan in combination with peginterferon and ribavirin in patients with HCV:

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

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

Very common side effects detectable in blood tests:

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

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

• urinary tract infections

• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache

• weight loss

• sleep disorders, abnormal drowsiness, depression, anxiety

• dizziness, difficulty concentrating and memory problems, mood changes

• decreased brain function due to liver damage

• tingling or numbness in hands or feet

• fever, headache

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

• retinal bleeding

• dizziness (vertigo)

• fast or irregular heartbeat (palpitations), shortness of breath

• productive cough, runny nose, influenza, herpes labialis, sore throat, and discomfort during swallowing

• digestive system problems, including vomiting, stomach pain, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus

• toothache, liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), liver damage due to medication (see 'Liver problems' at the beginning of section 4)

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

• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands, or feet), muscle spasms

• irritability, general feeling of malaise, skin reaction such as redness, swelling, and pain at injection site, chest pain and discomfort, fluid accumulation in the body or extremities causing swelling

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

• depression, anxiety, sleep disorders, nervousness

Common side effects detectable in blood tests:

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system:

Website: 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.

4. How to store Elrevolan

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 pack.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

5. Contents of the pack and other information

What Elrevolan contains
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: hypromellose, macrogol 3350, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171), low-substituted hydroxypropylcellulose, talc.
Elrevolan 50 mg film-coated tablets also contain red iron oxide (E172), yellow iron oxide (E172) and indigo carmine (E132).
Elrevolan 75 mg film-coated tablets also contain red iron oxide (E172) and indigo carmine (E132).

Description of the appearance of Elrevolan and contents of the pack
Elrevolan 12.5 mg film-coated tablets are round, biconvex, white, with 'L' engraved on one side.
Elrevolan 25 mg film-coated tablets are round, biconvex, white, with '25' engraved on one side.
Elrevolan 50 mg film-coated tablets are round, biconvex, brown, with '50' engraved on one side.
Elrevolan 75 mg film-coated tablets are round, biconvex, pink, with '75' engraved on one side.

The tablets are supplied in aluminium blisters within a pack containing 7, 10, 28 or 30 film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer
ELPEN Pharmaceutical Co. Inc., Marathonos Ave. 95, Pikermi, Attiki, 19009, Greece
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Elrevolan 12.5 mg-Filmtabletten
Elrevolan 25 mg-Filmtabletten
Elrevolan 50 mg-Filmtabletten
Elrevolan 75 mg-Filmtabletten
Hungary Elrevolan 12.5 mg filmtabletta
Elrevolan 25 mg filmtabletta
Elrevolan 50 mg filmtabletta
Elrevolan 75 mg filmtabletta
Italy Elrevolan