Revolade 25 mg polvo para suspension oral

Patient Information Leaflet

Revolade 25mg Oral Powder for Suspension

eltrombopag

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Revolade is and what it is used for

2.What you need to know before you start taking Revolade

3.How to take Revolade

4.Possible side effects

5.Storage of Revolade

6.Contents of the pack and additional information

Instructions for use

Revolade contains eltrombopag, which belongs to a group of medications calledthrombopoietin receptor agonists,used to help increase the number of platelets in the blood. Platelets are cells present in the blood that help reduce or prevent bleeding.

• Revolade is used to treat a blood disorder called immune thrombocytopenia (primary) (PTI) in patients over 1year of age who have already taken other medications (corticosteroids or immunoglobulins) that have not worked.

PTI is caused by a low platelet count (thrombocytopenia). People with PTI have a higher risk of bleeding. Symptoms that patients with PTI may notice are petechiae (small, round, flat red spots under the skin), ecchymoses, nosebleeds, bleeding gums, and inability to control bleeding if they cut or injure themselves.

• Revolade may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus infection (HCV), in cases where they have had problems with the side effects of interferon treatment. Many people with hepatitis have low platelet levels, not only due to the disease, but also due to antiviral treatments used to treat it. Taking Revolade may help you complete your antiviral treatment cycle (peginterferon and ribavirin).

• Revolade may also be used in 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).

Do not take Revolade

• if you are allergicto eltrombopag or any of the other ingredients of this medicine (listed in section6 under the title “Composition of Revolade”).

Consult your doctorif you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take Revolade:

• if you haveliver problems. People who have a low platelet count and a chronic advanced liver disease (for a long time) have a higher risk of adverse effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefits of Revolade outweigh the risks, they will closely monitor you during treatment.
• if you havea risk of suffering a blood clotin veins or arteries, or if you know that blood clots are a common occurrence in your family.

The risk of suffering a blood clot may be higherin the following circumstances:

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking the contraceptive pill or hormone replacement therapy
• if you have recently undergone surgery or have suffered physical trauma
• if you are significantly overweight (obesity)
• if you are a smoker
• if you have a chronic and advanced liver disease.

If you find yourself in any of these situations,inform your doctorbefore starting treatment.You should not take Revolade unless your doctor considers that the expected benefits outweigh the risk of blood clots.

• if you havecataracts(the lens of the eye becomes cloudy).
• if you have anotherblood disorder, such as myelodysplastic syndrome (MDS). Before starting to take Revolade, your doctor will perform tests to check that you do not have this disease. If you have MDS and take Revolade, MDS may worsen.

Inform your doctorif you find yourself in any of these situations.

Eye examinations

Your doctor will recommend that you undergo a check-up to see if you have cataracts. If you do not have regular eye check-ups, your doctor will ask you to have them done. They will also examine your retina (the layer of light-sensitive cells at the back of the eye) to see if there is bleeding in the retina or around it.

You will need to have regular blood tests

Before starting to take Revolade, your doctor will perform a blood test to see how your blood cells, including platelets, are doing. These blood tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Revolade may cause abnormal results on your blood tests that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, a treatment used in combination with Revolade to treat low platelet counts caused by hepatitis C, it may worsen some liver problems.

You will have blood tests before starting to take Revolade and frequently while you are taking it to check your liver function. You may need to stop taking Revolade if your liver enzyme levels become too high or if you have any other signs of liver damage.

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

Blood tests for platelet count

If you stop taking Revolade, it is likely that your platelet count will drop again a few days later (thrombocytopenia). Your doctor will monitor your platelet count and advise you on the precautions you need to take.

Very high platelet counts may increase the risk of blood clots. However, blood clots can also form with normal or low platelet counts. Your doctor will adjust your Revolade dose to ensure that your platelet count does not become too high.

Seek medical help immediatelyif you experience any of the following signs of ablood clot:

• swelling, painor sensitivityin a leg
• sudden difficulty breathing, occasionally accompanied by severe chest pain or rapid breathing
• abdominal pain(stomach), enlarged abdomen, blood in the stool.

Blood tests to examine your bone marrow

In people with bone marrow disorders, medicines like Revolade can worsen the disorders. Signs of changes in the bone marrow may appear as abnormal results on your blood tests. Your doctor may also perform tests to directly examine your bone marrow during treatment with Revolade.

Review of gastrointestinal bleeding

If you are taking interferon, a treatment used in combination with Revolade, you will be monitored for any signs of bleeding in your stomach or intestines after you stop taking Revolade.

Cardiac monitoring

Your doctor may consider, if necessary, monitoring your heart while you are taking Revolade using an electrocardiogram.

People over 65 years old

There is little data on the use of Revolade in patients aged 65 years or older. If you are 65 years or older, you should be careful when using Revolade.

Children and adolescents

Revolade is not recommended for use in children under 1 year old with PTI. It is also not recommended for children under 18 years old with low platelet counts caused by hepatitis C or severe aplastic anemia.

Other medicines and Revolade

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

Some common medicines may interact with Revolade(including prescription medicines, non-prescription medicines, and minerals). These include:

• medicines for indigestionand heartburn, orstomach ulcers(see also section3 “When to take it”).
• medicines called statins, tolower cholesterol
• some medicines for treating HIV infection, such as lopinavir and/or ritonavir
• ciclosporin, used intransplantsor inimmune system disorders
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be present invitamin and mineral supplements(see also section3 “When to take it”).
• medicines such as methotrexate and topotecan, used to treatcancer

Consult your doctorif you are taking any of these medicines. Some should not be taken with Revolade, you may need to adjust your dose or take them at different times. Your doctor will review the medicines you are taking and recommend alternatives if necessary.

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

If you are takingcorticosteroids, danazol, and/orazathioprinewith Revolade, you may need to reduce your dose or stop taking these medicines.

Taking Revolade with food and drinks

Do not take Revolade with milk or milk products, as the calcium in these products affects the absorption of the medicine. For more information, see section3, “When to take it”.

Pregnancy and breastfeeding

Do not take Revolade if you are pregnantunless your doctor specifically recommends it. The effect of Revolade during pregnancy is unknown.

• Inform your doctorif you are pregnant, think you may be pregnant, or plan to become pregnant.
• Use a reliable method of contraceptionto prevent pregnancy while taking Revolade.
• If you become pregnant while taking Revolade, inform your doctor.

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

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

Driving and operating machines

Revolade may cause dizzinessand other side effects that make you less alert.

Do not drive or operate machinesunless you are sure that Revolade does not affect you.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not change the dose or treatment schedule with Revolade unless your doctor or pharmacist advises you to. While taking Revolade, you will be under the supervision of a specialist doctor with experience in treating your disease.

How much to take

For PTI

Adults and children(6 to 17years old) - the usual initial dose for PTI is two packets of 25mgof Revolade per day. If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25mg.

Children(1 to 5years old) - the usual initial dose for PTI is one packet of 25mgof Revolade per day.

For Hepatitis C

Adults- the usual initial dose for hepatitis C is one packet of 25mgof Revolade per day. If you are of East or Southeast Asian descent, start treatment with the same dose of 25mg.

For AAG

Adults– the usual initial dose for AAG is two packets of 25mgof Revolade per day. If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25mg.

Revolade may take 1 to 2 weeks to take effect. Depending on your response to Revolade, your doctor may recommend changing your daily dose.

How to take a dose of the medication

The oral suspension powder is found in the packets, whose contents you will need to mix before you can take the medication. After section6 of the leaflet are theInstructions for Usethat explain how to mix and administer the medication. If you have doubts or do not understand the Instructions for Use, consult your doctor, nurse or pharmacist.

IMPORTANT – Use the medication immediatelyafter mixing it with water. If you do not useit within 30minutesfrom mixing, you will need to prepare a new dose. Do not reuse the oral dosing syringe. Use a new oral dosing syringe each time you prepare a new dose of Revolade oral suspension.

When to take it

Make sure that –

• 4hours beforetaking Revolade
• and 2hours aftertaking Revolade

do notconsume:

• Dairy productssuch as cheese, butter, yogurt or ice cream
• Milk or milkshakes, beverages made with milk, yogurt or cream
• Antacids, a type of medication forindigestion and heartburn
• somevitamin and mineral supplements, including iron, calcium, magnesium, aluminum, selenium and zinc.

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

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

If you take more Revolade than you should

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

If you forget to take Revolade

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

If you interrupt treatment with Revolade

Do not stop taking Revolade without first consulting your doctor. If your doctor advises you to stop treatment, you will be monitored for platelet levels every week for four weeks. See also “Bleeding or bruising after stopping treatment” in section4.

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

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

Symptoms to watch for: consult your doctor

People taking Revolade for both PTI and low platelet counts associated with hepatitis C may experience signs related to possible severe side effects.It is essential to inform your doctor if you develop symptoms.

Increased risk of thrombosis

Some people may be at a higher risk of developing a blood clot, and medicines like Revolade may worsen this problem. The sudden blockage of a blood vessel by a clot is a rare side effect that can affect up to 1 in 100 people.

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

• Swelling, pain, heat, redness, or sensitivity in a leg
• Sudden difficulty breathing, occasionally accompanied by sharp chest pain or agitated breathing.
• Abdominal pain (stomach), enlarged abdomen, blood in your stool.

Liver problems

Revolade may cause changes that appear in blood tests, which may be signs of liver damage. Liver problems (elevated liver enzymes in blood tests) are common and can affect up to 1 in 10 people. Other liver problems are rare and can affect up to 1 in 100 people.

If you have any of the signs of liver problems:

• Yellowing of the skin or white part of the eyes (jaundice)
• Dark-colored urine.

• Contact your doctor immediately

Bleeding or hematomas after treatment interruption

Two weeks after stopping treatment with Revolade, your platelet levels will usually return to similar levels to those before starting Revolade. A decrease in platelet levels may increase the risk of bleeding or hematomas. Your doctor will check your platelet levels for at least 4 weeks after stopping treatment with Revolade.

Contact your doctorif you experience bleeding or hematomas after stopping Revolade.

Some peopleexperience bleeding in thedigestive systemafter stopping peginterferon, ribavirin, and Revolade.The symptoms include:

• Black, tar-like stools (the discoloration of stools is a rare side effect that can affect up to 1 in 100 people).
• Blood in your stool.
• Vomiting blood or something that looks like coffee grounds.

Contact your doctor immediatelyif you experience any of these symptoms.

The following side effects have been reported in patients with adult PTI treated with Revolade

Very common side effects

Can affect more than 1 in 10 people

• Cold
• Feeling of dizziness (nausea)
• Diarhea
• Cough
• Upper respiratory tract infection, including common cold, sinusitis, pharyngitis, and bronchitis
• Back pain

Very common side effects that may appear in blood tests

• Elevated liver enzymes (alanine aminotransferase (ALT))

Common side effects

Can affect up to 1 in 10 people

• Muscle pain, muscle spasms, muscle weakness
• Bone pain
• Heavy menstrual bleeding
• Sore throat and difficulty swallowing
• Eye problems, including abnormal eye test results, dry eyes, eye pain, and blurred vision
• Vomiting
• Flu
• Herpes labialis
• Pneumonia
• Mastitis and breast inflammation
• Pharyngitis and tonsillitis
• Pulmonary, nasal, sinus, and throat infections
• Gingivitis
• Loss of appetite
• Itching, prickling, or numbness
• Decreased skin sensitivity
• Drowsiness
• Ear pain
• Pain, swelling, and sensitivity in one leg (usually the calf), with warm skin in the affected area (signs of a deep vein thrombosis)
• Localized swelling filled with blood from a broken blood vessel (hematoma)
• Seizures
• Mouth and throat problems, including dry mouth, mouth irritation, tongue sensitivity, gum bleeding, and mouth ulcers
• Runny nose
• Toothache
• Abdominal pain
• Abnormal liver function
• Changes in the skin, including excessive sweating, rash with itching, red spots, and skin discoloration
• Hair loss
• Foamy or bubbly urine (signs of protein in the urine)
• Elevated body temperature, feeling hot
• Chest pain
• Feeling weak
• Difficulty sleeping, depression
• Migraine
• Decreased vision
• Feeling like everything is spinning (vertigo)
• Gas

Common side effects that may appear in blood tests:

• Decreased red blood cell count (anemia)
• Decreased platelet count (thrombocytopenia)
• Decreased white blood cell count
• Decreased hemoglobin levels
• Increased eosinophil count
• Increased white blood cell count (leukocytosis)
• Increased uric acid levels
• Decreased potassium levels
• Increased creatinine levels
• Increased alkaline phosphatase levels
• Increased liver enzymes (aspartate aminotransferase (AST))
• Increased bilirubin levels in the blood
• Increased levels of certain proteins

Rare side effects

Can affect up to 1 in 100 people:

• Allergic reaction
• Interruption of blood supply to parts of the heart

• Sudden difficulty breathing, especially when accompanied by sharp chest pain and/or agitated breathing, which may be signs of a pulmonary embolism (see “Increased risk of thrombosis” earlier in section 4)

• Partial loss of lung function caused by a blockage in the pulmonary artery
• Possible pain, swelling, and/or redness around a vein that may be signs of deep vein thrombosis
• Yellow skin and/or abdominal pain that may be signs of a bile duct obstruction, liver injury, or drug-induced liver damage (see “Liver problems” earlier in section 4)
• Drug-induced liver damage
• Fast or irregular heartbeat, blue discoloration of the skin, abnormal heart rhythm (prolonged QT interval) that may be a sign of a heart and blood vessel disorder.
• Coagulation disorders
• Seizures
• Gout (joint pain and swelling due to uric acid)
• Loss of interest, changes in mood, difficult-to-calming crying, or unexpected crying
• Balance problems, abnormal speech and nervous system function, tremors
• Pain or abnormal sensations in the skin
• Paralysis of one side of the body
• Migraine with aura
• Neuralgia
• Swelling or dilation of blood vessels causing headache
• Eye problems, including increased tear production, blurred vision, cataracts, retinal hemorrhage, or dry eyes
• Nasal, throat, and sinus problems, sleep apnea
• Ulcers or pain in the mouth and throat
• Loss of appetite
• Digestive system problems, including frequent bowel movements, food poisoning, blood in stool, vomiting blood
• Rectal bleeding, changes in stool color, abdominal swelling, constipation
• Mouth and throat problems, including dry mouth, mouth irritation, tongue sensitivity, gum bleeding, and mouth ulcers
• Sunburn
• Feeling hot, anxiety
• Redness or inflammation around wounds
• Bleeding around a catheter (if you have one) in the skin
• Feeling of a foreign body
• Kidney problems, including kidney inflammation, nocturia (increased need to urinate at night), renal failure, and white blood cells in urine
• Cold sweats
• General feeling of discomfort

• Skin infection
• Changes in the skin, including skin discoloration, peeling, redness, itching, and excessive sweating
• Muscle weakness
• Colon and rectal cancer

Rare side effects that may appear in blood tests:

• Changes in the shape of white blood cells
• Presence of immature white blood cells that may be indicative of certain diseases
• Increased platelet count
• Decreased calcium levels
• Decreased red blood cell count (anemia) due to excessive destruction of red blood cells (hemolytic anemia)
• Increased myelocyte count
• Increased neutrophil count
• Increased urea levels in the blood
• Increased protein levels in urine
• Increased total protein levels
• Decreased albumin levels in the blood
• Increased pH levels in urine
• Increased hemoglobin levels

The following side effects have been reported in children (1 to 17 years old) with PTI treated with Revolade

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

Very common side effects

Can affect more than 1 in 10 children

• Upper respiratory tract infection, including common cold, sinusitis, pharyngitis, and bronchitis
• Diarhea
• Abdominal pain
• Cough
• Elevated body temperature
• Feeling of dizziness (nausea)

Common side effects

Can affect up to 1 in 10 children

• Difficulty sleeping (insomnia)
• Toothache
• Sore throat and nasal pain
• Itching, runny nose, or nasal congestion
• Irritation of the throat, runny nose, congestion, and sneezing
• Mouth problems, including dry mouth, mouth irritation, tongue sensitivity, gum bleeding, and mouth ulcers

The following side effects have been reported in patients with chronic hepatitis C treated with Revolade in combination with peginterferon and ribavirin

Very common side effects

Can affect more than 1 in 10 people:

• Headache
• Loss of appetite
• Cough
• Feeling of dizziness (nausea), diarrhea
• Muscle pain, muscle weakness
• Itching
• Feeling tired
• Fever
• Hair loss
• Feeling weak
• Flu-like symptoms
• Swelling of hands or feet
• Chills

Very common side effects that may appear in blood tests:

• Decreased red blood cell count (anemia)

Common side effects

Can affect up to 1 in 10 people:

• Urinary tract infection
• Pharyngitis and tonsillitis, sinusitis, and nasal congestion, symptoms similar to the flu, dry mouth, mouth irritation, and inflammation of the mouth, toothache
• Weight loss
• Sleep disorders, abnormal drowsiness, depression, anxiety
• Dizziness, attention and memory problems, changes in mood
• Decreased brain function due to liver damage
• Itching or numbness in hands and feet
• Fever, headache
• Eye problems, including blurred vision, cataracts, dry eyes, small yellow deposits in the retina, yellowing of the white part of the eyes
• Retinal bleeding
• Feeling like everything is spinning
• Irregular heartbeat (palpitations), difficulty breathing
• Cough with mucus, runny nose, flu (influenza), herpes labialis, throat irritation, and difficulty swallowing
• Digestive system problems, including vomiting, stomach pain, indigestion, constipation, bloated stomach, altered taste, hemorrhoids, abdominal pain or discomfort, swelling of blood vessels, and bleeding in the esophagus
• Toothache
• Liver problems, including liver tumor, yellowing of the white part of the eyes or skin (jaundice), and drug-induced liver damage (see “Liver problems” earlier in section 4)
• Changes in the skin, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating, unusual skin growth, hair loss
• Joint pain, back pain, bone pain, pain in the extremities (arms, legs, hands, and feet), muscle spasms
• Irritability, feeling unwell, skin reactions such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid retention in the body or extremities causing swelling

• Upper respiratory tract infection, including common cold, sinusitis, pharyngitis, and bronchitis

• Depression, anxiety, sleep disorders, nervousness

Common side effects that may appear in blood tests:

• Increased blood sugar levels
• Decreased white blood cell count
• Decreased neutrophil count
• Decreased albumin levels in the blood
• Decreased hemoglobin levels
• Increased bilirubin levels in the blood (a substance produced by the liver)
• Changes in clotting factors

Rare side effects

Can affect up to 1 in 100 people:

• Urinary pain
• Abnormal heart rhythm (prolonged QT interval)

• Stomach flu (gastroenteritis), sore throat
• Ulcers or pain in the mouth, inflammation of the stomach
• Changes in the skin, including changes in color, peeling, redness of the skin, itching, lesions, and night sweats

• Coagulation disorders in the liver (possible liver damage and/or digestive system damage)
• Poor blood clotting in small blood vessels with renal failure
• Pruritus and bruising at the injection site, chest pain
• Decreased red blood cell count (anemia) due to massive destruction of red blood cells (hemolytic anemia)

• Confusion, agitation
• Liver failure

The following side effects have been observed in patients with severe aplastic anemia (SAA) treated with Revolade

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

Very common side effects

Can affect more than 1 in 10 people:

• Cough
• Headache
• Pain in the mouth and throat
• Diarhea
• Feeling of dizziness (nausea)
• Joint pain (arthritis)
• Pain in the extremities (arms, legs, hands, and feet)
• Dizziness
• Feeling tired
• Fever
• Chills
• Itchy eyes
• Ulcers in the mouth
• Gum bleeding
• Abdominal pain
• Muscle spasms

Very common side effects that may appear in a blood test:

• Abnormal changes in bone marrow cells
• Increased liver enzymes (aspartate aminotransferase (AST))

Common side effects

Can affect up to 1 in 10 people:

• Anxiety
• Depression
• Feeling cold
• General feeling of discomfort
• Eye problems, including vision problems, cataracts, small yellow deposits in the eye (vitreous floaters), dry eyes, itchy eyes, yellowing of the white part of the eyes or skin
• Nasal bleeding
• Digestive system problems, including difficulty swallowing, pain in the mouth, swollen tongue, vomiting, loss of appetite, stomach pain or discomfort, bloated stomach, gas, constipation, diarrhea, and/or the aforementioned symptoms, changes in stool color
• Fainting
• Skin problems, including red or purple spots due to bleeding under the skin (petechiae), rash, itching, urticaria, skin lesions
• Back pain
• Muscle pain
• Bone pain
• Weakness (asthenia)
• Swelling of the lower extremities due to fluid accumulation
• Abnormal urine color
• Interruption of blood flow to the spleen (splenic infarction)
• Runny nose

Common side effects that may appear in a blood test:

• Increased levels of certain enzymes due to muscle degradation (creatinine phosphokinase)
• Iron overload in the body (iron overload)
• Decreased blood sugar levels (hypoglycemia)
• Increased bilirubin levels in the blood (a substance produced by the liver)
• Decreased white blood cell count

Side effects of unknown frequency

Cannot be estimated from available data:

• Skin discoloration
• Skin darkening
• Drug-induced liver damage

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the overwrap.

This medication does not require special storage conditions.

Do not open the overwrap until you are ready to use it. Once mixed, Revolade should be administered immediately, but it may be stored for no more than 30minutes at room temperature.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Revolade

25 mg powder for oral suspension

The active ingredient of Revolade is eltrombopag. Each pack contains a powder to reconstitute that releases 32 mg of eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.

The other components are: mannitol (E421), sucralose, and xanthan gum.

Appearance of the product and contents of the pack

Revolade 25 mg powder for oral suspension is available in a kit that contains 30 sachets; each sachet contains a brownish-red to yellow powder. The kit also includes a reusable mixing vial with a cap and plug and 30 oral dosing syringes for single use.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

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 Nürnberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of the leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

INSTRUCTIONS FOR USE

Revolade®25 mg powder for oral suspension

(eltrombopag)

Read and follow the instructions below to prepare a dose of Revolade and administer it to the patient. If you have any questions, or if you are damaged or lost any component of the kit, consult your doctor, nurse or pharmacist.

Before starting

Read these messages first

• Revolade powder must be mixed only withwaterat room temperature.

Administer the medicine to the patient immediately after mixing the powder with water. If you do not use the medicinewithin 30 minutes, you will need to prepare a new dose.

Dispose of the unwanted mixture in the trash,do not pour it down the drain.

• Try to keep the medicine from touching your skin. If this happens, wash the area immediately with water and soap. If you have an allergic reaction or are unsure, contact your doctor.
• If you spill the powder or liquid, wipe it clean with a damp cloth (see step 14 of these instructions).
• Be careful thatchildren do not play with the vial, cap, plug, or syringes there is a risk of suffocation if children put them in their mouth.

What you need

Each kit of Revolade powder for oral suspension contains:

To prepare and give the dose of Revolade, you need:

• The correct number of sachets that your doctor has prescribed (included in the kit)
• 1 reusable mixing vial with cap and plug (included in the kit)
• 1 oral dosing syringe for single use (included in the kit)
• 1 clean glass or cup with water (not included)
• Scissors to cut the sachet (not included)

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