Revolade – Eltrombopag uses, dose and side effects

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Revolade 12.5 mg film-coated tabletsRevolade 25 mg film-coated tabletsRevolade 50 mg film-coated tabletsRevolade 75 mg film-coated tablets
eltrombopag

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 increase the number of platelets in your blood. Platelets are blood cells that help reduce or prevent bleeding.

  • Revolade is used to treat a bleeding disorder called immunological (primary) thrombocytopenia (ITP) in patients from 1 year of age who have already taken other medicines ( corticosteroids or immunoglobulins) that have not worked.
    ITP is caused by a low platelet count ( thrombocytopenia ). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may notice include petechiae (needle-sized, flat, round, red marks under the skin), bruising, nosebleeds, bleeding gums, and bleeding that does not stop if they cut or injure themselves.
  • Revolade can also be used to treat low platelet counts ( thrombocytopenia ) in adults with hepatitis C virus ( HCV ) infection if they have had problems with the side effects of interferon therapy. Many people with hepatitis C may have low platelet counts, not only as a result of the disease but also because of some of the antiviral drugs used to treat it. Taking Revolade may make it easier to complete an entire course of antiviral medicine (peginterferon and ribavirin).
  • Revolade can 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, causing a lack of red blood cells ( anemia ), white blood cells ( leukopenia ), and platelets ( thrombocytopenia ).

What you need to know before you take Revolade

Do not take Revolade

if you are allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under “ Contents of contents” ).

  • Check with your doctor if you think this is true for you.

Warnings and cautions

Talk to your doctor before taking Revolade:

  • if you have liver problems. If you have a low number of platelets and at the same time an advanced chronic (long-term) liver disease, the risk of side effects is greater, including life-threatening liver damage and blood clots. If your doctor considers that the benefits of taking Revolade outweigh the risks, you will be closely monitored during treatment.
  • if there is a risk of getting a blood clot in your veins or arteries or if you know that a clot is common in your family.
    You may have a higher risk of blood clots:
  • as you get older
  • if you have had to lie in bed for a long time
  • if you have cancer
  • if you are taking birth control pills or hormone replacement therapy
  • if you have recently had surgery or been physically injured
  • if you are very overweight
  • if you smoke
  • if you have advanced chronic liver disease.
  • If any of these apply to you, tell your doctor before starting treatment. You should not take Revolade unless your doctor thinks that the expected benefits outweigh the risk of blood clots.
  • if you have cataracts (cloud of the lens of the eye)
  • if you have any other blood disease, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check that you do not have this blood disorder before starting Revolade. If you have MDS and are taking Revolade, your MDS may worsen.
  • Tell your doctor if any of these apply to you.

Eye examinations

Your doctor will recommend that you be checked for cataracts. If you do not go for routine eye examinations, your doctor should arrange regular examinations. You can also be checked for the presence of bleeding in and around the retina (the photosensitive layer of cells in the back of the eye).

You need to take samples regularly

Before you start taking Revolade, your doctor will take blood samples to check your blood cells, including platelets. These tests are repeated at regular intervals while you are taking the medicine.

Blood tests to check liver function

Revolade may cause your liver tests to show signs of liver damage – and an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminases. Taking interferon-based medicines with Revolade to treat low platelet counts due to hepatitis C may make certain liver problems worse.

You will be given blood tests to check your liver function before you start taking Revolade and at certain intervals while you are taking it. You may need to stop taking Revolade if the amount of these substances increases too much or if you get other signs of liver damage.

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

Blood tests to check the number of platelets

If you stop taking Revolade, you will likely get a low platelet count again after several days. The platelet count will be checked and your doctor will discuss appropriate precautions with you.

A very high number of platelets can increase the risk of blood clots. However, blood clots can form even with normal or even low platelet counts. Your doctor will adjust your Revolade dose so that your platelet count does not become too high.

Seek medical attention immediately if you have any of these signs of blood clots: swelling, pain or tenderness in a leg sudden shortness of breath, especially with severe chest pain or rapid breathing abdominal pain, enlarged abdomen, blood in the stool

Control of your bone marrow

In people with bone marrow problems, medicines such as Revolade can make the problems worse. Signs of bone marrow changes may show abnormal results on your blood tests. Your doctor may also perform tests to directly check your bone marrow during treatment with Revolade.

Controls for stomach bleeding

If you are taking interferon-based treatments with Revolade, you will be followed up for any signs of bleeding in the stomach or intestines after stopping Revolade.

Cardiac monitoring

Your doctor may consider it necessary to monitor your heart during treatment with Revolade and examine your heart with an ECG ( electrocardiogram ).

Elderly people (65 years and older)

There are limited data on the use of Revolade in patients 65 years of age and older. Caution should be exercised when using Revolade if you are 65 years of age or older.

Children and young people

Revolade is not recommended for children under 1 year who have ITP. It is also not recommended for people under the age of 18 who have low platelet counts due to hepatitis C or severe aplastic anemia.

Other drugs and Revolade

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter ones and vitamins.

Some common medicines work with Revolade – these are prescription and over-the-counter medicines and minerals. These include:

  • antacids to treat an upset stomach, heartburn, or stomach ulcer (see also “ When to take it ” in section 3)
  • drugs called statins, to lower cholesterol
  • certain medicines to treat HIV infection such as lopinavir and/or ritonavir
  • ciclosporin is used in transplants or immune diseases
  • minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc which may be present in vitamin and mineral supplements (see also ” When to take it “ in section 3)
  • drugs such as methotrexate and topotecan, to treat cancer
  • Tell your doctor if you are taking any of these. Some of them should not be taken with Revolade. Dosage may need to be adjusted or you may need to change the time you take them. The doctor will review the medicines you are taking and suggest appropriate reimbursements if needed.

If you are also taking medicines that prevent blood clots, the risk of bleeding is greater. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine, you may need to take lower doses or stop taking them while you are taking Revolade.

Revoluted with food and drink

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

Pregnancy and breastfeeding

Do not use Revolade if you are pregnant unless your doctor specifically recommends it. The effect of Revolade during pregnancy is unknown.

  • Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
  • Use a reliable method of contraception while taking Revolade to prevent pregnancy.
  • If you become pregnant during treatment with Revolade, tell your doctor.

Do not breastfeed while taking Revolade. It is not known if Revolade passes into breast milk.

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

Driving and using machines

Revolade can make you dizzy and cause other side effects that may make you less alert.

  • Do not drive or use machines unless you are sure you are unaffected.

Revolade contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Revolade

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Do not change the dose or dosing schedule for taking Revolade unless your doctor or pharmacist recommends that you do so. While taking Revolade you will be under the supervision of a doctor with specialist knowledge in the treatment of your disease.

How much to take

For ITP

For adults and children (6-17 years) – the usual starting dose for ITP is one 50 mg tablet of Revolade a day. If you are of East / Southeast Asian descent, you may need to start with a lower dose of 25 mg.

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

For hepatitis C

For adults – the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day. If you are of East / Southeast Asian descent, start with the same 25 mg dose.

For SAA

For adults – the usual starting dose for SAA is one 50 mg tablet of Revolade a day. If you are of East / Southeast Asian descent, you may need to start with a lower dose of 25 mg.

It may take 1 to 2 weeks for Revolade to start working. Depending on how you react to Revolade, your doctor may recommend that your daily dose be changed.

How to take the tablets

Swallow the tablet whole with a little water.

When to take it

Make sure you below

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

do not eat or drink any of the following:

  • dairy products such as cheese, butter, yogurt, or ice cream
  • milk or milkshake, beverages containing milk, yogurt, or cream
  • antacids, a type of medicine for heartburn and heartburn
  • certain mineral and vitamin supplements, e.g. iron, calcium, magnesium, aluminum, selenium, and zinc.

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

Ta Revolade

Talk to your doctor if you want more advice on proper food and drink.

If you take more Revolade than you should

Contact a doctor or pharmacist immediately. Show them the package or this leaflet if possible.

You will be monitored for any signs or symptoms of side effects and receive appropriate treatment immediately.

If you forget to take Revolade

Take the next dose at the usual time. Do not take more than one dose of Revolade in one 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 platelets will be checked weekly for four weeks. See also “ Bleeding or bruising after stopping treatment ” in section 4.

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

Possible side effects

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

Symptoms that need treatment: see a doctor

People taking Revolade for either ITP or low platelet counts due to hepatitis C may experience signs of potentially serious side effects. You must tell your doctor if you develop such symptoms.

Higher risk of blood clots

Some people may have a higher risk of blood clots and medications like Revolade can make the problem worse. Sudden blockage of a blood vessel due to a blood clot is an uncommon side effect and can occur in up to 1 in 100 people.

Seek medical attention immediately if you get any signs or symptoms of a blood clot, such as:
 swelling, pain, heat, redness, or tenderness in a leg sudden shortness of breath, especially with severe chest pain or rapid breathing abdominal pain, enlarged abdomen, and blood in the stool.

Liver problem

Revolt can cause changes that show up in blood tests and can be a sign of liver damage. Liver problems (elevated enzyme levels in blood samples) are common and may affect up to 1 in 10 people. Other liver problems are less common and can 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)
  • unusually dark-colored urine
  • Tell your doctor immediately if you get any of these symptoms.

Bleeding or bruising after stopping treatment

Within two weeks of stopping Revolade, your platelet count usually returns to what it was before you started taking Revolade. The lower platelet count may increase the risk of bleeding and bruising. Your doctor will check your platelet count for at least 4 weeks after you stop taking Revolade.

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

Some people may have problems with bleeding in the digestive system when they have stopped taking peginterferon, ribavirin, and Revolade. The symptoms are:

  • black tar-like stools (discolored stools are a less common side effect that can occur in up to 1 in 100 people)
  • blood in the stool
  • vomiting or vomiting that looks like coffee grounds.
  • Tell your doctor immediately if you get any of these symptoms.

The following adverse reactions have been reported to be associated with Revolade treatment in adult patients with ITP:

Very common side effects are

These can occur in more than 1 in 10 people:

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

Very common side effects that may appear on blood tests:

  • elevated liver enzymes ( alanine aminotransferase ( ALT ))

Common side effects are

These can occur in up to 1 in 10 people:

  • muscle pain, muscle spasm, muscle weakness
  • skeletal pain
  • heavy menstrual bleeding or prolonged menstruation
  • sore throat and discomfort when swallowing
  • eye problems include an abnormal vision tests, dry eyes, eye pain, and blurred vision
  • vomiting
  • influenza
  • cold sores
  • pneumonia
  • irritation and inflammation (swelling) of the sinuses
  • inflammation (swelling) and infection of the tonsils
  • infection of the lungs, sinuses, nose, and throat
  • gingivitis
  • loss of appetite
  • tingling or numbness in the hands or feet
  • decreased skin sensitivity
  • drowsiness
  • ear pain
  • pain, swelling, and tenderness in one leg (usually the calf) with hot skin in the affected area (signs of a blood clot in a deep vein)
  • local, blood-filled swelling due to a ruptured blood vessel (hematoma)
  • hot flashes
  • mouth problems, including dry mouth or sores in the mouth, sensitive tongue, bleeding gums, cold sores
  • Runny nose
  • toothache
  • abdominal pain
  • abnormal liver function
  • skin changes, including heavy sweating, itchy raised rashes, red spots, altered appearance
  • hair loss
  • frothy, frothy urine or urine with visible bubbles (signs of protein in the urine)
  • fever, feeling hot
  • chest pain
  • feel weak
  • sleep problems, depression
  • migraine
  • impaired vision
  • fainting (dizziness)
  • indigestion / gas

Common side effects that may show up in blood tests:

  • decreased number of red blood cells ( anemia )
  • decreased platelet count ( thrombocytopenia )
  • decreased white blood cell count
  • decreased hemoglobin level
  • increased number of eosinophils
  • increased white blood cell count ( leukocytosis )
  • increased levels of uric acid
  • decreased levels of potassium
  • increased levels of creatinine
  • increased levels of alkaline phosphatase
  • increase in liver enzymes ( aspartate aminotransferase ( ASAT ))
  • increase in bilirubin (a substance produced in the liver) in the blood
  • increased levels of certain proteins

Uncommon side effects are

These can occur in up to 1 in 100 people:

  • allergic reaction
  • interrupted blood supply to a part of the heart
  • sudden shortness of breath, especially with concomitant severe pain in the chest and/or rapid breathing, which may be a sign of a blood clot in the lungs (see “ Higher risk of blood clots ” earlier in section 4)
  • lost function in a part of the lung caused by a blockage in the pulmonary artery
  • possible pain, swelling, and/or redness around a vein, which may be a sign of a blood clot in a vein
  • yellowing of the skin and/or abdominal pain, which may be a sign of a blockage in the bile ducts, liver damage, or liver damage due to inflammation (see “ Liver problems ” earlier in section 4)
  • liver damage due to medication
  • rapid heartbeat, irregular heartbeat, blue discoloration of the skin, and disturbances of heart rhythm ( QT prolongation) which may be signs of disturbances related to the heart and blood vessels
  • blood clot
  • redness
  • painful, swollen joints caused by uric acid ( gout )
  • lack of interest, mood swings, crying that is difficult to stop or occurs at unexpected times
  • problems with balance, speech and nerve function, tremors
  • painful and abnormal skin sensitivity
  • paralysis of one side of the body
  • migraine with aura
  • nerve damage
  • dilation or swelling of blood vessels causing headaches
  • eye problems including increased production of tears, the cloudy lens in the eye (cataracts), bleeding in the retina, dry eyes
  • problems with the nose, throat, and sinuses, breathing problems when sleeping
  • mouth and throat blisters/sores
  • decreased appetite
  • problems with the digestive system, including frequent bowel movements, food poisoning, blood in the stool, vomiting of blood
  • bleeding from the rectum, change in color of stool, bloated stomach, constipation
  • problems with the mouth, including dry mouth or sores in the mouth, tongue pain, bleeding gums, discomfort in the mouth
  • sunburn
  • feel warm, feel anxious
  • redness or swelling around wounds
  • bleeding in the skin around a catheter (if any)
  • the feeling of foreign objects in the body
  • kidney problems, including inflammation of the kidneys, increased need to urinate at night, kidney failure, white blood cells in the urine
  • cold sweats
  • general malaise
  • skin infection
  • skin changes including skin discoloration, exfoliation (peeling), redness, itching, and sweating
  • muscle weakness
  • cancer of the rectum and colon

Uncommon side effects that may show up in laboratory tests:

  • changes in the form of red blood cells
  • presence of developing white blood cells that may indicate certain diseases
  • increased platelet count
  • decreased levels of calcium
  • decreased number of red blood cells ( anemia ) caused by excessive destruction of red blood cells ( hemolytic anemia )
  • increased number of myelocytes
  • increased number of band neutrophils
  • increased level of blood urea
  • increased level of protein in the urine
  • increased levels of blood albumin
  • increased levels of total protein
  • decreased levels of blood albumin
  • increased pH in the urine
  • increased levels of hemoglobin

The following additional side effects have been reported to be associated with treatment with Revolade in children (aged 1 to 17 years) with ITP:

If these side effects become severe, consult your doctor, pharmacist, or nurse.

Very common side effects are

These can occur in 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
  • fever
  • nausea

Common side effects are

These can occur in up to 1 in 10 children

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

The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:

Very common side effects are

These can occur in more than 1 in 10 people

  • headache
  • appetite
  • cough
  • nausea, diarrhea
  • muscle pain, muscle weakness
  • itching
  • feel tired
  • fever
  • unusual hair loss
  • feel weak
  • flu-like illness
  • swelling in hands or feet
  • overindulge

Very common side effects that may show up in blood tests:

  • decreased number of red blood cells ( anemia )

Common side effects are

These can occur in up to 1 in 10 people

  • urinary tract infection
  • inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dry mouth, sores or inflamed mouth, toothache
  • weight loss
  • sleep disorders, abnormal sleepiness, depression, anxiety
  • dizziness, problems with attention and memory, change in mood
  • decreased brain function caused by liver damage
  • tingling or numbness in the hands or feet
  • fever, headache
  • eye problems, including cloudy lens in the eye (cataracts), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
  • bleeding in the retina
  • fainting (dizziness)
  • rapid or irregular heartbeat (palpitations), shortness of breath
  • cough leading to mucus, runny nose, flu, cold sores, sore throat, and swallowing discomfort
  • gastrointestinal disorders, including vomiting, stomach pain, indigestion, constipation, bloating, taste disturbances, hemorrhoids, discomfort/stomach pain, swollen blood vessels, and bleeding esophagus
  • toothache
  • liver problems, including tumors in the liver, yellowing of the whites of the eyes or skin (jaundice), and liver damage due to medication (see “Liver problems” earlier in section 4)
  • skin changes, including rash, dry skin, eczema, reddening of the skin, itching, excessive sweating, unusual skin growths, hair loss
  • joint pain, back pain, skeletal pain, pain in the extremities (arms, legs, hands, or feet), muscle spasms
  • irritability, general nausea, skin reactions such as redness or swelling and pain at the injection site, chest pain, and discomfort, accumulation of fluid in the body or extremity causing swelling
  • infection of the nose, sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membranes of the bronchi
  • depression, anxiety, sleep problems, nervousness

Common side effects that may show up in blood tests:

  • increased level of blood sugar ( glucose )
  • decreased white blood cell count
  • decreased number of neutrophils
  • decreased level of blood albumin
  • decreased level of hemoglobin
  • increased levels of bilirubin in the blood (a substance produced in the liver)
  • changes in enzymes that control blood coagulation

Uncommon side effects are

These can occur in up to 1 in 10 people

  • painful urination
  • heart rhythm disorders ( QT prolongation)
  • gastric flu ( gastroenteritis ), sore throat
  • mouth blisters / – sores, gastritis
  • skin changes including discoloration, exfoliation, redness, itching, skin change, and night sweats
  • blood clots in a vein in the liver (possible liver and/or digestive system damage)
  • abnormal blood clot formation in small blood vessels with renal failure
  • rash, bruising at the injection site, chest discomfort
  • decreased number of red blood cells ( anemia ) caused by excessive destruction of red blood cells ( hemolytic anemia )
  • confusion, agitation
  • liver failure

The following adverse reactions have been reported to be associated with Revolade treatment in patients with severe aplastic anemia (SAA):

If these side effects become severe, consult your doctor, pharmacist, or nurse.

Very common side effects are

These can occur in more than 1 in 10 people

  • cough
  • headache
  • mouth and throat pain
  • diarrhea
  • feel sick, (nausea)
  • joint pain ( arthralgia )
  • pain in the extremities (arms, legs, hands, and feet)
  • dizziness
  • feeling very tired
  • fever
  • overindulge
  • itchy eyes
  • blisters in the mouth
  • bleeding in the gums
  • abdominal pain
  • muscle twitching

Very common side effects that may show up in blood tests:

  • abnormal changes in the cells of the bone marrow
  • increased levels of liver enzymes ( aspartate aminotransferase ( ASAT ))

Common side effects are

These can occur in up to 1 in 10 people

  • anxiety
  • Depression
  • feel cold (freeze)
  • generally feel bad
  • eye problems, including vision problems, blurred vision, the cloudy lens in the eye (cataracts), spots or deposits in the vitreous of the eye (spots in the field of vision ), dry eyes, itchy eyes, yellowing of the whites of the eyes or skin
  • nosebleeds
  • bleeding gums
  • digestive problems, including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloating, gas, constipation, disturbances of bowel movements that can cause constipation, bloating, diarrhea, and/or the above symptoms, change in color of stools
  • fainting
  • skin problems including small red or purple spots caused by bleeding in the skin ( petechiae ) rash, itching, hives, skin damage
  • back pain
  • muscle pain
  • skeletal pain
  • weakness ( asthenia )
  • swelling in the lower extremity is due to the accumulation of fluids
  • abnormally colored urine
  • interruption of blood supply to the spleen (splenic infarction)
  • Runny nose

Common side effects that may show up in blood tests:

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

Side effects are with unknown frequency

The frequency can not be calculated from the available data

  • discoloration of the skin
  • darker skin tone
  • liver damage due to medication

How to store Revolade

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

Do not use this medicine after the expiry date which is stated on the carton and blister.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance in Revolade is eltrombopag

12.5 mg film-coated tablets

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

25 mg film-coated tablets

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

50 mg film-coated tablets

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

75 mg film-coated tablets

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

The other ingredients are hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, and 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) and yellow iron oxide (E172).

Revolade 75 mg film-coated tablets also contain red iron oxide (E172) and black iron oxide (E172).

What the medicine looks like and the contents of the pack

Revolte 12.5 mg film-coated tablets are round, biconvex, white, and punched with “GS MZ1” and “12.5” on one side.

Revolte 25 mg film-coated tablets are round, biconvex, white, and punched with “GS NX3” and “25” on one side.

Revolte 50 mg film-coated tablets are round, biconvex, brown, and punched with “GS UFU” and “50” on one side.

Related 75 mg film-coated tablets are round, biconvex, pink, and punched with “GS FFS” and “75” on one side.

They are delivered in aluminum blisters in a carton containing 14 or 28 film-coated tablets and multiple packs containing 84 (3 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek dd

Verovskova Ulica 57

Ljubljana 1526

Slovenia

Novartis Pharmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Glaxo Wellcome SA

Avenida de Extremadura, 3

09400 Aranda de Duero

Burgos

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12AustriaNovartis Ph arma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
.ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370

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