Revolve 50 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Revolade 12.5 mg film-coated tablets

Revolade 25 mg film-coated tablets

Revolade 50 mg film-coated tablets

Revolade 75 mg film-coated tablets

eltrombopag

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child, even though the leaflet refers to "you".

Leaflet Contents

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, 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 disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already received other medications (corticosteroids or immunoglobulins) that were ineffective.

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

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

• Revolade may also be used in patients with low blood cell counts due to severe aplastic anaemia (SAA). SAA is a condition in which the bone marrow is damaged, leading to a deficiency of red blood cells (anaemia), white blood cells (leucopenia), 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 the heading "Composition of Revolade").

Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take Revolade:

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

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

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

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

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

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

Eye examinations

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

You will need regular blood tests

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

Blood tests to monitor liver function

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

You will have blood tests before starting Revolade and regularly during treatment to monitor your liver function. You may need to stop treatment with Revolade if these markers increase significantly or if you develop any other signs of liver damage.

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

Blood tests to monitor platelet count

If you stop taking Revolade, your platelet count is likely to drop again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the necessary precautions.

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

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

• swelling, pain, or tenderness in one leg
• sudden shortness of breath, occasionally accompanied by sharp chest pain or rapid breathing
• abdominal pain, swollen abdomen, or blood in the stool.

Examination of bone marrow

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

Monitoring for gastrointestinal bleeding

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

Heart monitoring

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

Older people (65 years and over)

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

Children and adolescents

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

Other medicines and Revolade

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

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

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

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

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

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

Taking Revolade with food and drink

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

Pregnancy and breastfeeding

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

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

Driving and using machines

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

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

Revolade contains sodium

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

3. How to take Revolade

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

How much to take

For ITP

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

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

For Hepatitis C

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

For SAA

Adults – the usual starting dose for SAA is one 50 mg tablet of Revolade per day. If you are of East Asian or Southeast Asian ancestry, you may need to start treatment with a lower dose of 25 mg.

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

How to take the tablets

Swallow the tablet whole with water.

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:

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

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

For further information on which foods and drinks are suitable, 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 signs or symptoms of adverse effects and will be given appropriate treatment immediately.

If you forget to take Revolade

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

If you stop taking Revolade

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

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

4. Possible adverse effects

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

Symptoms to which you need to pay attention: consult your doctor

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

Increased risk of blood clots

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

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

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

Liver problems

Revolade may cause changes detectable in blood tests, which could indicate liver damage. Liver problems (increased liver enzymes in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.

If you have any signs of liver problems:

• yellowing of the skin or the white part of the eyes (jaundice)
• unusually dark-colored urine

contact your doctor immediately

Bleeding or bruising after stopping treatment

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

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

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

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

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

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

Very common adverse effects

May affect more than 1 in 10 people

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

Very common adverse effects detectable in blood tests

• increase in the liver enzyme alanine aminotransferase (ALT)

Common adverse effects

May affect up to 1 in 10 people

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

Common adverse effects detectable in blood tests:

• decrease in the number of red blood cells (anemia)
• decrease in the number of platelets (thrombocytopenia)
• decrease in the number of white blood cells
• decrease in hemoglobin levels
• increase in eosinophils
• increase in the number of white blood cells (leukocytosis)
• 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 bilirubin in blood (a substance produced by the liver)
• increase in certain protein levels

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction

• interruption of blood supply to parts of the heart

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

• partial loss of lung function caused by blockage in the pulmonary artery

• possible pain, swelling, and/or redness around a vein, which could be signs of blood clots in a vein

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

• liver damage due to medication

• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, heart rhythm disturbances (prolongation of QT interval), which could indicate a heart- or blood vessel-related disorder

• blood clots

• hot flushes

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

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

• balance problems, speech and nerve function disturbances, tremors

• pain or abnormal sensations in the skin

• paralysis on one side of the body

• migraine with aura

• nerve pain

• dilation or swelling of blood vessels causing headache

• eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eye

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

• blisters/pain in mouth and throat

• loss of appetite

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

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

• mouth problems, including dryness or irritation in the mouth, tongue pain, bleeding gums, mouth discomfort

• sunburn

• feeling hot, sensation of anxiety

• redness or inflammation around wounds

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

• sensation of a foreign body

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

• cold sweat

• general feeling of discomfort

• skin infection

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

• muscle weakness

• rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in neutrophils
• increase in blood urea levels
• increase in protein 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 hemoglobin levels

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

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

Very common adverse effects

May affect more than 1 in 10 children

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

Common adverse effects

May affect up to 1 in 10 children

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

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

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects detectable in blood tests:

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

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection

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

• weight loss

• sleep disorders, abnormal drowsiness, depression, anxiety

• dizziness, attention and memory problems, mood changes

• decreased brain function due to liver damage

• tingling or numbness in hands and feet

• fever, headache

• eye problems, including clouding of the eye lens (cataracts), dry eye, small yellow deposits in the retina, yellowish discoloration of the white part of the eyes

• retinal bleeding

• sensation of spinning

• rapid and irregular heartbeats (palpitations), difficulty breathing

• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and discomfort when swallowing

• digestive system disorders, including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste alterations, hemorrhoids, abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (esophagus)

• toothache

• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage due to medication (see "Liver problems" above in section 4)

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

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

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

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

• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating

• heart rhythm disturbances (prolongation of QT interval)

• stomach flu (gastroenteritis), sore throat

• blisters/pain in the mouth, stomach inflammation

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

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

• poor clotting in small blood vessels with kidney failure

• itching and bruising at injection site, chest discomfort

• decrease in the number of red blood cells (anemia) caused by massive destruction of red blood cells (hemolytic anemia)

• confusion, agitation

• liver failure

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

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

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects detectable in blood tests

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

Common adverse effects

May affect up to 1 in 10 people:

• anxiety

• depression

• feeling cold

• general feeling of discomfort

• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eye, itchy eyes, yellowing of the whites of the eyes or skin

• nosebleeds

• digestive problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, flatulence/gas, constipation, intestinal motility changes that may cause constipation, bloating, diarrhea, and/or the above-mentioned symptoms, changes in stool color

• fainting

• skin problems including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions

• bleeding gums

• back pain

• muscle pain

• bone pain

• weakness (asthenia)

• swelling of the lower limbs due to fluid accumulation

• abnormal urine color

• interruption of blood flow to the spleen (splenic infarction)

• runny nose

Common adverse effects detectable in blood tests

• increase in certain enzymes due to muscle breakdown (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycemia)
• increase in bilirubin in blood (a substance produced by the liver)
• decrease in the number of white blood cells

Adverse effects with unknown frequency

Frequency cannot be estimated from available data

• skin discoloration

• darkening of the skin

• liver damage due to medication

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Revolade

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after «CAD/EXP».

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Revolade

The active substance in Revolade is eltrombopag.

12.5 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.

25 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

50 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other components are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethyl starch, 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), black iron oxide (E172).

Nature of the product and pack contents

Revolade 12.5 mg film-coated tablets are white, round, biconvex, engraved with ‘GS MZ1’ and ‘12.5’ on one side.

Revolade 25 mg film-coated tablets are white, round, biconvex, engraved with ‘GS NX3’ and ‘25’ on one side.

Revolade 50 mg film-coated tablets are brown, round, biconvex, engraved with ‘GS UFU’ and ‘50’ on one side.

Revolade 75 mg film-coated tablets are pink, round, biconvex, engraved with ‘GS FFS’ and ‘75’ on one side.

The tablets are supplied in aluminium blisters within a carton containing 14 or 28 film-coated tablets, and multiple packs containing 84 film-coated tablets (3 packs of 28).

Only certain pack sizes may be marketed.

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

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

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

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50
	Luxembourg/Luxembourg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) A.E.B.E. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu.