Revolve

Patient Information Leaflet

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

eltrombopag
Please read all of this leaflet carefully before you start 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 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, tell your doctor or pharmacist. See section 4.
• The information in this leaflet is intended for you or for the child, but the text will refer only to "you".

Contents of this leaflet

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

1. What Revolade is and what it is used for

Revolade 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.

• Revolade 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 medicines (corticosteroids or immunoglobulins) that were not effective.

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

• Revolade may also be used to treat low platelet counts (thrombocytopenia) in patients with hepatitis C virus (HCV) who have experienced problems due to adverse reactions during interferon therapy. 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 Revolade may make it easier for you to complete a full course of antiviral treatment (pegylated interferon and ribavirin).

• Revolade may 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, leading to a deficiency of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).

2. What you need to know before taking Revolade

Do not take Revolade

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

Warnings and precautions
Talk to your doctor before taking Revolade:

• 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 Revolade outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in veins or arteries, or if you know that blood clotting is common in your family.
• You may be at increased risk of blood clot formation:
  • if you are elderly
  • if you have been bedridden for a long time
  • if you have cancer
  • if you are taking birth control pills or hormone replacement therapy
  • if you have recently undergone surgery or suffered physical trauma
  • if you are very overweight (obese)
  • if you are a smoker
  • if you have advanced chronic liver disease ➔ If any of these apply to you, inform your doctor before starting treatment. You must not take Revolade 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 whether you have this blood disorder before you start taking Revolade. If you have MDS and take Revolade, your 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 routinely have eye exams,
your doctor will schedule regular examinations. You may also be monitored for any
bleeding in the retina or around the retina (the layer of light-sensitive cells at the back
of the eye).
You will need regular tests
Before starting Revolade, your doctor will perform blood tests to monitor blood cells,
including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Revolade may alter blood test results, which could indicate liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatments in combination with Revolade for low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to monitor liver function before starting Revolade and during treatment. You may need to stop taking Revolade if levels of these enzymes rise 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 Revolade, your platelet count will likely decrease again within a few days. Your platelet count will be monitored, and your doctor will advise you on appropriate precautions.
A very high platelet count may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust your dose of Revolade 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 shortness of breath, especially together with sharp chest pain or rapid breathing
• abdominal pain, abdominal swelling, blood in stools

Tests to monitor bone marrow
In people who may have bone marrow problems, medicines like Revolade could worsen these conditions. Signs of bone marrow abnormalities may appear as abnormalities in blood test results. Your doctor may perform tests to directly monitor your bone marrow during treatment with Revolade.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Revolade, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Revolade.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Revolade and may perform an electrocardiogram (ECG).
Elderly people (65 years and older)
There is limited data on the use of Revolade in patients aged 65 years and older. Exercise caution when taking Revolade if you are aged 65 years or older.
Children and adolescents
Revolade is not recommended in children under 1 year of age with ITP. Also, it is not recommended in people under 18 years of age with low platelet count due to hepatitis C or severe aplastic anaemia.
Other medicines and Revolade
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 Revolade – including prescription and over-the-counter medicines and minerals. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also ‘When to take it’ in section 3)

• medicines called statins, used to lower cholesterol

• certain medicines to treat HIV infection, such as lopinavir and/or ritonavir

• cyclosporine used in transplants and immune disorders

• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be 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 Revolade, or you may need to adjust your dose, or
  it may be necessary to change the timing of administration. Your doctor will review all
  the medicines you are taking and, if necessary, suggest appropriate substitutions.
  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 Revolade.
  Revolade with food and drinks
  Do not take Revolade 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 Revolade if you are pregnant unless specifically recommended by your doctor. The effect of Revolade during pregnancy is unknown.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.

• Use a reliable method of contraception while taking Revolade to prevent pregnancy.

• If you become pregnant during treatment with Revolade, inform your doctor.

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

3. How to take Revolade

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Revolade unless your doctor or pharmacist advises you to do so. While you are taking Revolade, you will be under the care of a doctor experienced in treating 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 Revolade once 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 Revolade once daily.

For Hepatitis C
Adults – the recommended starting dose for hepatitis C is one 25 mg tablet of Revolade once daily. If you are of East or Southeast Asian origin, you will start with the same 25 mg dose.

For SAA
Adults – the recommended starting dose for SAA is one 50 mg tablet of Revolade once daily. If you are of East or Southeast Asian origin, you may need to start with a lower dose of 25 mg.

Revolade may take 1 to 2 weeks to start working. Based on your response to Revolade, your doctor may recommend adjusting your 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 Revolade
• and within the 2 hours after taking Revolade

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 may not be properly absorbed into your body.

For further advice on suitable foods and drinks, consult your doctor.
If you take more Revolade 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 side effects and treated appropriately and immediately.
If you forget to take Revolade
Take the next dose at your usual time. Do not take more than one dose of Revolade in a single day.
If you stop taking Revolade
Do not stop taking Revolade without talking to your doctor. If your doctor advises you to stop 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms requiring attention: consult a doctor
People who take Revolade for ITP or low platelet count 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.
Higher risk of blood clots
Some people may have a higher risk of blood clots, and medicines such as Revolade could worsen this problem. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

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

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

Liver problems
Revolade may cause changes detectable in blood tests, which 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 have 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 Revolade, platelet counts usually decrease to the level they were before starting Revolade. A lower platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Revolade.
➔  Inform your doctor if you experience bleeding or bruising after stopping Revolade.
Some people have gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and Revolade. 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 as associated with Revolade treatment in
adult patients with ITP:
Very common side effects
These may affect more than 1 person in 10 :

• 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 that may be detected in blood tests:

• increase in the liver enzyme alanine aminotransferase (ALT)

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

• muscle pain, muscle cramps, muscle weakness
• bone pain
• heavy menstrual period
• sore throat and pain when swallowing
• eye problems including abnormal 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, pricking, or numbness, commonly known as "pins and needles"
• decreased skin sensitivity
• feeling drowsy
• earache
• 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 blood vessel rupture (haematoma)
• hot flushes
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function abnormalities
• skin 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 hot
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (dizziness)
• gas/bloating due to digestion

Common side effects that may be detected 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 eosinophils
• increase in white blood cell count (leucocytosis)
• increase in uric acid levels
• decrease in potassium levels
• increase in creatinine levels
• increase in alkaline phosphatase levels
• increase in the liver enzyme aspartate aminotransferase (AST)
• increase in blood bilirubin (a substance produced by the liver)
• increase in certain protein levels

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

• 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 be a sign of a blood clot in the lungs (see 'Higher risk of blood clots' at the beginning of section 4)
• loss of function in part of the lung caused by blockage of the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could be signs of blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see 'Liver problems' at the beginning of section 4)
• liver damage due to drug intake
• increased heart rate, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT prolongation), which could be signs of a heart and blood vessel disorder
• blood clot
• redness
• painful joint swelling caused by uric acid (gout)
• loss of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech and nervous system disorders, 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
• mouth and throat blisters/ulcers
• 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
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweat
• general feeling of malaise
• skin infection
• skin changes including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects that may be detected in laboratory tests:

• changes in the shape of red blood cells
• presence of development of white blood cells that may indicate certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (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 level

The following side effects have been reported as associated with Revolade 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 child in 10 :

• 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 child in 10 :

• 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 as associated with Revolade treatment in
combination with peginterferon and ribavirin in HCV patients:
Very common side effects
These may affect more than 1 person in 10 :

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

Very common side effects that may be detected in blood tests:

• decrease in red blood cell count (anaemia)

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

• 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, problems with concentration and memory, mood changes
• decreased brain function following 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
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, herpes labialis, sore throat and discomfort when swallowing
• digestive system problems, including vomiting, stomach ache, 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), drug-induced liver damage (see 'Liver problems' at the beginning of section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands, feet), muscle cramps
• irritability, general feeling of malaise, skin reaction such as redness or 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 that may be detected in blood tests:

• increased blood sugar (glucose)
• reduction in white blood cell count
• reduction in neutrophil count
• reduction in blood albumin
• reduction in haemoglobin level
  • increase in blood bilirubin (a substance produced by the liver)
• changes in enzymes controlling blood clotting

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

• pain during urination
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters/ulcers 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 cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported as associated with Revolade treatment in
patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect up to 1 person in 10 :

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

Very common side effects that may be detected in blood tests:

• abnormal changes in bone marrow cells
• increase in the liver enzyme aspartate aminotransferase (AST)

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

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eyes, itchy eyes, 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 ache/discomfort, stomach bloating, gas during digestion, constipation, intestinal motility disorder that may cause constipation, bloating, diarrhoea and/or the above-mentioned symptoms, change in stool colour
• fainting
• skin problems including small red or purple spots caused by bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• bleeding gums
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of lower limbs due to fluid accumulation
• abnormally coloured urine
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects that may be detected in blood tests:

• increase in enzymes due to muscle injury (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increase in blood bilirubin (a substance produced by the liver)
• reduction in white blood cell count

Side effects with unknown frequency
Frequency cannot be determined from available data

• skin discoloration
• dark skin
• drug-induced liver damage

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

5. How to store Revolade

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. The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What Revolade contains
12.5 mg film-coated tablets
25 mg film-coated tablets
50 mg film-coated tablets
75 mg film-coated tablets
The other excipients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline
cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Revolade 50 mg film-coated tablets also contain red iron oxide (E172), yellow iron oxide (E172).
Revolade 75 mg film-coated tablets also contain red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Revolade and contents of the pack
Revolade 12.5 mg film-coated tablets are round, biconvex, white, with ‘GS MZ1’ and ‘12.5’ engraved on one side.
Revolade 25 mg film-coated tablets are round, biconvex, white, with ‘GS NX3’ and ‘25’ engraved on one side.
Revolade 50 mg film-coated tablets are round, biconvex, brown, with ‘GS UFU’ and ‘50’ engraved on one side.
Revolade 75 mg film-coated tablets are round, biconvex, pink, with ‘GS FFS’ and ‘75’ engraved on one side.
They are supplied in aluminium blisters in a pack containing 14 or 28 film-coated tablets and a multiple pack containing 84 (3 packs of 28) film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Lek d.d
Verovskova Ulica 57
Ljubljana 1526
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana 1000
Slovenia
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Lithuania
Novartis Pharma N.V. SIA Novartis Baltics Lithuania branch
Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

Bulgaria Luxembourg/Luxembourg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Tel: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Czech Republic Hungary
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Denmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Germany Netherlands
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Estonia Norway
SIA Novartis Baltics Estonia branch Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Greece Austria
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Tel: +30 210 281 17 12 Tel: +43 1 86 6570

Spain Poland
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Croatia Romania
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel: +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenia
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Iceland Slovakia
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italy Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Cyprus Sweden
Novartis Pharma Services Inc. Novartis Sverige AB
Tel: +357 22 690 690 Tel: +46 8 732 32 00

Latvia
SIA Novartis Baltics
Tel: +371 67 887 070

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Patient information leaflet

Revolade 25 mg oral suspension powder

eltrombopag
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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• The information in this leaflet is intended for you or for the child, but the text will refer only to “you”.

Contents of this leaflet

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

1. What Revolade is and what it is used for

Revolade 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.

• Revolade 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 medicines (corticosteroids or immunoglobulins) that were not effective.

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

• Revolade may also be used to treat low platelet counts (thrombocytopenia) in patients with hepatitis C virus (HCV) who have experienced problems due to adverse reactions during interferon therapy. Many people with hepatitis C have low platelet counts not only as a result of the disease itself but also due to certain antiviral medicines used to treat it. Taking Revolade may make it easier for you to complete a full course of antiviral treatment (peginterferon and ribavirin).

• Revolade may also be used to treat adult patients with low blood cell counts caused by severe aplastic anemia (SAA). SAA is a condition in which the bone marrow is damaged, leading to a deficiency of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).

2. What you should know before taking Revolade

Do not take Revolade

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

Warnings and precautions
Talk to your doctor before taking Revolade:

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

Eye examination
Your doctor will recommend regular checks for cataracts. If you do not routinely have eye examinations, your doctor will schedule regular eye exams. 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 Revolade, your doctor will perform blood tests to monitor your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Revolade may alter blood test results, which could indicate liver damage – such as an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate aminotransferase. If you are receiving interferon-based treatments in combination with Revolade for low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to check liver function before starting Revolade and during treatment. You may need to stop taking Revolade if levels of these enzymes rise 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 Revolade, your platelet count will likely decrease again within a few days. Your platelet count will be monitored, and your doctor will advise you on appropriate precautions.
A very high platelet count may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust your Revolade dose 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 shortness of breath, especially along with sharp chest pain or rapid breathing
• abdominal pain, abdominal swelling, blood in stools

Tests to monitor bone marrow
In people who may have bone marrow problems, medicines like Revolade could worsen these issues. Signs of bone marrow changes may appear as abnormalities in blood test results. Your doctor may perform tests to directly monitor your bone marrow during treatment with Revolade.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Revolade, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Revolade.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Revolade and may perform an electrocardiogram (ECG).
Elderly patients (65 years and older)
There is limited data on the use of Revolade in patients aged 65 years and older. Exercise caution when taking Revolade if you are aged 65 or older.
Children and adolescents
Revolade is not recommended for children under 1 year of age with ITP. Also, it is not recommended for people under 18 years of age with low platelet count due to hepatitis C or severe aplastic anemia.
Other medicines and Revolade
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 Revolade – including prescription and over-the-counter medicines and minerals. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also ‘ When to take it ’ in section 3)

• medicines called statins, used to lower cholesterol

• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir

• cyclosporine, used in transplants and immune disorders

• minerals 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 Revolade, or you may need to adjust your dose, or it may be necessary to change the timing of administration. Your doctor will review all the medicines you are taking and, if needed, suggest appropriate substitutions.
  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 Revolade.
  Revolade with food and drink
  Do not take Revolade with dairy products or beverages containing milk or 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 Revolade during pregnancy unless specifically recommended by your doctor. The effects of Revolade during pregnancy are not known.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.

• Use a reliable method of contraception while taking Revolade to prevent pregnancy.

• If you become pregnant during treatment with Revolade, inform your doctor.

Do not breastfeed while taking Revolade. It is not known whether Revolade passes into breast milk.
➔ If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Revolade may cause dizziness and other side effects that reduce alertness.
➔  Do not drive or operate machinery unless you are certain you are not affected.

3. How to take Revolade

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist. Do not change the dose or dosing schedule of Revolade unless your doctor or
pharmacist advises you to do so. While you are taking Revolade, 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 two 25 mg sachets of
Revolade per day. 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 sachet of Revolade per
day.

For Hepatitis C
Adults – the recommended starting dose for hepatitis C is one 25 mg sachet of Revolade per day.
If you are of East or Southeast Asian origin, you will start with the same dose of 25 mg.

For SAA
Adults – the recommended starting dose for SAA is two 25 mg sachets of Revolade per day. If you are of
East or Southeast Asian origin, you may need to start with a lower dose of 25 mg.

Revolade may take 1 to 2 weeks to start working. Depending on your response to Revolade, your doctor may
recommend adjusting the daily dose.

How to take a dose of the medicine
The oral suspension powder comes in sachets, whose contents must be reconstituted before taking the
medicine. Instructions for Use on how to reconstitute and administer the medicine can be found after section 6
of this leaflet. If you have any questions or do not understand the Instructions for Use, consult your doctor,
nurse, or pharmacist.

IMPORTANT – Administer the medicine immediately after reconstituting the powder with
water. If not used within 30 minutes of reconstitution, a new dose must be prepared. Do not reuse the oral
dosing syringe. A new single-use oral syringe must be used to prepare each dose of Revolade oral suspension.

When to take it
Make sure that—

• in the 4 hours before taking Revolade
• and in the 2 hours after taking Revolade

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based smoothies, milk-containing beverages, 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 Revolade than you should
Contact your doctor or pharmacist immediately. If possible, show them the packaging 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 Revolade
Take the next dose at your usual time. Do not take more than one dose of Revolade in a day.

If you stop taking Revolade
Do not stop taking Revolade without talking to your doctor. If your doctor advises you to stop treatment, your
platelet count will be monitored weekly for four weeks. See also ‘Bleeding or bruising after you have stopped treatment’ in section 4.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms requiring attention: consult a doctor
People who take Revolade for ITP or low platelet count due to hepatitis C may develop signs of potentially serious side effects. It is important to inform your doctor
if you develop any of these symptoms.

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

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

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

Liver problems
Revolade may cause changes detectable in blood tests, which 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 have any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine that is unusually dark in colour ➔ - Inform your doctor immediately.

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

• dark stools (change in stool colour is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or material resembling coffee grounds ➔ - Inform your doctor immediately if you experience any of these symptoms.

The following side effects have been reported in association with Revolade treatment in
adults with ITP:

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

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

Very common side effects that may be detected by blood tests:

• increase in the liver enzyme 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 when swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain, blurred vision
• vomiting
• influenza
• herpes labialis (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
• sensation of tingling, prickling, or numbness, commonly known as "pins and needles"
• decreased skin sensitivity
• feeling drowsy
• earache
• 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
• liver function abnormalities
• skin changes including excessive sweating, irregular itchy rash, red spots, changes in skin appearance
• hair loss
• urine that appears foamy, frothy, or fizzy (signs of protein in the urine)
• high temperature, feeling hot
• chest pain
• feeling weak
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (dizziness)
• gas/bloating due to digestion

Common side effects that may be detected by blood tests:

• decrease in red blood cell count (anaemia)
• decrease in platelet count (thrombocytopenia)
• decrease in white blood cell count
• decrease in haemoglobin levels
• increase in eosinophil count
• increase in white blood cell count (leucocytosis)
• increase in uric acid levels
• decrease in potassium levels
• increase in creatinine levels
• increase in alkaline phosphatase levels
• increase in the liver enzyme aspartate aminotransferase (AST)
• increase in blood bilirubin levels (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 acute chest pain and/or rapid breathing, which may indicate a blood clot in the lungs (see 'Higher risk of blood clots' at the beginning of section 4)
• loss of function in part of the lung caused by blockage of the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could indicate blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which could indicate bile duct obstruction, liver injury, or liver damage due to inflammation (see 'Liver problems' at the beginning of section 4)
• drug-induced liver injury
• rapid heartbeat, irregular heartbeat, bluish skin discolouration, heart rhythm disorders (QT prolongation), which could indicate a heart or blood vessel 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 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 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 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
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweat
• general feeling of malaise
• skin infection
• skin changes including skin discolouration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon side effects that may be detected by laboratory tests:

• changes in red blood cell shape
• presence of white blood cell development suggestive of certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increase in myelocytes
• increase in band neutrophils
• increase in blood urea levels
• increase in protein levels in urine
• increase in albumin levels in blood
• increase in total protein levels
• decrease in albumin levels in blood
• increase in urine pH
• increase in haemoglobin level

The following side effects have been reported in association with Revolade 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, sneezing
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported in association with Revolade treatment 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 weak
• flu-like illness
• swelling of hands or feet
• chills

Very common side effects that may be detected by blood tests:

• decrease in red blood cell count (anaemia)

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

• urinary tract infections
• inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
• weight loss
• sleep disturbances, 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
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat and discomfort when swallowing
• digestive system problems including vomiting, stomach ache, indigestion, constipation, stomach swelling, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus
• toothache
• liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (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, feet), muscle spasms
• irritability, general feeling of malaise, skin reaction such as redness or swelling and pain, 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 mucous lining of the bronchi
• depression, anxiety, sleep disturbances, nervousness

Common side effects that may be detected by blood tests:

• increase in blood sugar (glucose)
• reduction in white blood cell count
• reduction in neutrophil count
• reduction in blood albumin
• reduction in haemoglobin level
• increase in blood bilirubin (a substance produced by the liver)
• changes in enzymes controlling blood clotting

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

• pain during urination
• heart rhythm disorders (QT interval prolongation)
• stomach 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 cell count (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported in association with Revolade treatment in
patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.

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

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

Very common side effects that may be detected by blood tests:

• abnormal changes in bone marrow cells
• increase in the liver enzyme aspartate aminotransferase (AST)

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

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eyes, itchy eyes, 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 ache/discomfort, stomach swelling, gas during digestion, constipation, intestinal motility disorder that may cause constipation, bloating, diarrhoea and/or the above-mentioned symptoms, change in stool colour
• fainting
• skin problems including small red or purple spots caused by bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• bleeding gums
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of lower limbs due to fluid accumulation
• abnormally coloured urine
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects that may be detected by blood tests:

• increase in enzymes due to muscle injury (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increase in blood bilirubin (a substance produced by the liver)
• reduction in white blood cell count

Side effects with unknown frequency
Frequency cannot be estimated from the available data:

• skin discolouration
• dark skin
• drug-induced liver injury

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

5. How to store Revolade

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 sachets after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not open the sachets until the time of use. After reconstitution, Revolade oral suspension must be administered immediately, but may be stored for up to 30 minutes at room temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Revolade contains
25 mg oral suspension powder
After reconstitution, equivalent to 25 mg of eltrombopag free acid.
The other excipients are: mannitol, sucralose and xanthan gum.

Description of the appearance of Revolade and contents of the pack
Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a brownish-red to yellow powder. Each pack contains 30 sachets, a reusable 40 ml reconstitution bottle with a screw cap and lid, and 30 single-use oral dosing syringes for administration.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Lek d.d
Verovskova Ulica 57
Ljubljana 1526
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana 1000
Slovenia
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

INSTRUCTIONS FOR USE

Revolade 25 mg oral suspension powder

(eltrombopag)
Read and follow these instructions to prepare a dose of Revolade and administer it to the patient. If
you have any doubts or if you damage or lose any component of your kit, consult your doctor, nurse, or
pharmacist for advice.
Before you start
Read these messages first

• Revolade powder must be reconstituted only with water at room temperature

Administer the medicine to the patient immediately after reconstituting the powder with
water. If the medicine is not administered within 30 minutes of reconstitution, you must prepare a
new dose.
Dispose of unused reconstituted medicine in household waste; do not pour it down the drain.

• Avoid letting the medicine come into contact with the skin. If this occurs, wash immediately with soap and water. If a skin reaction occurs, or if you have any doubts, contact your doctor.
• If you spill any powder or liquid, clean it up with a damp cloth (see point 14 of the instructions).
• Be careful that children do not play with the bottle, cap, lid, or syringes – if children put them in their mouth, there is a risk of choking.

What you need
Each Revolade oral suspension powder kit contains:

30 sachets of powder

1 reusable reconstitution vial with
lid and cap ( note — the reconstitution vial may become stained )

30 single-use oral dosing syringes
To prepare and administer a dose of Revolade, you will need:

• The exact number of sachets prescribed by the doctor (supplied in the kit)
• 1 reusable reconstitution vial with lid and cap (supplied in the kit)
• 1 single-use oral dosing syringe (supplied in the kit)
• 1 clean glass or cup filled with drinking water (not supplied)
• scissors to cut the sachet (not supplied)

15. Clean the reconstitution equipment.

• Dispose of the syringe used for administration. A new single-use oral syringe must be used to prepare each dose of Revolade oral suspension.
• Rinse the reconstitution vial and cap under running water (the reconstitution vial may become stained due to the medicine. This is normal.).
• Allow all equipment to air dry.
• Wash hands with water and soap. After using all 30 sachets in the kit, discard the vial. Always start with a new complete kit for each set of 30 sachets.

Keep Revolade powder for oral suspension, including the dosing kit, and all medicines out of the reach and sight of children.