Revolade 25 mg comprimidos recubiertos con pelicula

Patient Information Leaflet

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

Please read this leaflet carefully before you start to take this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Revolade contains eltrombopag, which belongs to a group of medications called thrombopoietin receptor agonists,which is 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), purpura, 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 C have low platelet levels, not only due to the disease, but also due to the antiviral treatments used to treat it. Taking Revolade may help you complete the antiviral treatment cycle (peginterferon and ribavirin).

Revolade may also be used in patients with low blood cell levels 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 to 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 the appearance of blood clots is 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 damage
• if you have a lot of excess weight (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 have a check-up to see if you have cataracts. If you do not have routine eye checks, your doctor will ask you to have them. They should also check 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 you start taking Revolade, your doctor will perform a blood test to see how your blood cells, including platelets, are. These blood tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Revolade may cause your blood test results to indicate liver damage - an increase in some liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, a treatment given together with Revolade to treat low platelet counts due to hepatitis C, some liver problems may worsen.

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 levels of these markers increase too much or if you have any other signs of liver damage.

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

Blood tests to check platelet levels

If you stop taking Revolade, it is likely that you will have low platelet levels (thrombocytopenia) a few days later. Your platelet levels will be checked, and your doctor will tell you what precautions you need to take.

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

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

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

Bone marrow examination

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 in your blood tests. Your doctor may also perform tests to check your bone marrow directly during treatment with Revolade.

Review of gastrointestinal bleeding

If you are taking interferon, a treatment given together with Revolade, you will be monitored to detect any signs of bleeding in your stomach or intestines after you stop taking Revolade.

Heart monitoring

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

People over 65 years old

There are few 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 due to 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 to treatindigestion,heartburn, orstomach ulcers(see also section3 “When to take it”).
• medicines called statins, tolower cholesterol
• some medicines to treatHIV infection, such as lopinavir and/or ritonavir
• ciclosporin, used intransplantsor inimmune system disorders
• minerals such as iron, calcium, magnesium, aluminium, 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 the dose or change the times you take them. 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/orazathioprinetogether with Revolade, you may need to reduce the dose or stop taking these medicines.

Taking Revolade with food and drinks

Do not take Revolade with food or milk products, as the calcium in milk 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.

Inform your doctorif you are breastfeeding or plan to breastfeed.

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.

Revolade contains sodium

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

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 do so. 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 17 years old) - the usual initial dose for PTI is one 50 mg tablet of Revolade per day. If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25 mg.

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

For Hepatitis C

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

For AAG

Adults– the usual initial dose for AAG is one 50 mg tablet of Revolade per day. If you are of East or Southeast Asian descent, 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 changing your daily dose.

How to take the tablets

Swallow the tablet whole, with water

When to take it

Make sure that –

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

do not consume:

• Dairy productssuch as cheese, butter, yogurt, or ice cream
• Milk or milkshakes, beverages made with milk, yogurt, or cream
• Antacids, a type of medication for indigestion 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 beverages, 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 receive 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 consulting your doctor first. If your doctor advises you to stop treatment, your platelet levels will be monitored every week for four weeks. See also “Bleeding or bruising after stopping treatment” in section 4.

If you have any other questions about the use of 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 a blood clot, such as:

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

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 Revolade treatment, 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 Revolade treatment.

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

Some peoplehavegastrointestinal bleedingafter stopping peginterferon,ribavirin, andRevolade.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 stools
• 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 PTI treated with Revolade

Very common side effects

Can affect more than 1 in 10 people

• Cold
• Feeling dizzy (nausea)
• Diarhea
• Cough
• Upper respiratory tract infection (infection of the nose, sinuses, throat, and airways)
• 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
• Swollen or inflamed breasts
• Swollen or inflamed tonsils
• Respiratory tract infection, sinus, throat, and nasal passages
• Swollen or inflamed gums
• Loss of appetite
• Itching, tingling, 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 problems, including dry mouth, mouth irritation, tongue sensitivity, gum bleeding, and mouth ulcers
• Coughing up mucus
• Toothache
• Abdominal pain
• Abnormal liver function
• Changes in the skin, including excessive sweating, itching, red patches, changes in skin appearance
• 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(a substance produced by the liver)
• 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 severe chest pain and/or rapid breathing, which may be signs of a pulmonary embolism (see “Increased risk of thrombosis” earlier in section4)

• 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 a blood clot in a vein
• Yellow skin and/or abdominal pain that may be signs of a bile duct obstruction, liver injury, or liver damage due to inflammation (see “Liver problems” earlier in section4)
• Liver damage due to medication
• Fast heart rate, 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.
• Blood clots
• Seizures
• Joint pain and swelling due to uric acid (gout)
• 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
• Swollen or dilated blood vessels that cause headache
• Eye problems, including increased tear production, blurred vision, cataracts, retinal hemorrhage, or dry eyes
• Nose, throat, and sinus problems, sleep apnea
• Ulcers or pain in the 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 dry mouth, mouth irritation, tongue sensitivity, gum bleeding, and mouth ulcers
• Sunburn
• Feeling hot, anxiety
• Redness or swelling around wounds
• Bleeding around a catheter (if you have one) in the skin
• Feeling like a foreign body is present
• Kidney problems, including inflammation of the kidneys, excessive nighttime urination, kidney failure, 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 in urine
• Increased total protein levels
• Decreased albumin levels in the blood
• Increased pH 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, common cold (infection of the upper respiratory tract)
• Diarhea
• Abdominal pain
• Cough
• Elevated body temperature
• Feeling dizzy (nausea)

Common side effects

Can affect up to 1 in 10 children

• Difficulty sleeping (insomnia)
• Toothache
• Sore throat and nasal congestion
• Itching, runny nose, or stuffiness
• 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 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 dizzy (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, sinusitis, and tonsillitis, symptoms similar to the flu, dry mouth, mouth irritation, or inflammation, toothache
• Weight loss
• Sleep disorders, abnormal drowsiness, depression, anxiety
• Dizziness, attention and memory problems, mood changes
• Decreased brain function due to liver damage
• Itching or numbness in hands and feet
• Fever, headache
• Eye problems, includingcataracts, dry eyes, small yellow deposits in the retina, yellowing of the white part of the eyes
• Retinal hemorrhage
• Feeling like everything is spinning
• Irregular heartbeat, difficulty breathing
• Coughing up mucus, runny nose, flu (influenza), herpes labialis, throat irritation, and difficulty swallowing
• Abdominal problems, including vomiting, stomach pain, indigestion, constipation, swollen stomach, altered taste, hemorrhoids, abdominal pain or discomfort, swollen blood vessels, and bleeding in the esophagus
• Toothache
• Liver problems, including liver tumors, yellowing of the white part of the eyes or skin (jaundice), and liver damage due to medication (see “Liver problems” earlier in section4)
• Changes in the skin, including rashes, 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, 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 blood clotting enzymes

Rare side effects

Can affect up to 1 in 100 people:

• Difficulty urinating
• 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

• Blood clots in the liver veins (possible liver and/or digestive system damage)
• Poor blood clotting in small blood vessels with kidney failure
• Redness or swelling and pain 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 reported 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 dizzy (nausea)
• Joint pain (arthritis)
• Pain in the extremities (arms, legs, hands, and feet)
• Dizziness
• Fever
• Chills
• Itchy eyes
• Ulcers in the mouth
• Gum bleeding
• Abdominal pain
• Muscle spasms

Very common side effects that may appear in blood tests:

• 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, yellow deposits in the eye (cupid's bow), eye dryness, itchy eyes, yellowing of the white part of the eyes or skin
• Nosebleeds
• Abdominal problems, including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain or discomfort, swollen stomach, gas, constipation, diarrhea, and/or the aforementioned symptoms, changes in stool color
• Fainting
• Skin problems, including red or purple patches due to bleeding under the skin (petechiae), rashes, 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 blood tests:

• Increased 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

• Medication-induced liver damage

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the national reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about 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 in the blister.

This medication does not require special storage conditions.

Medicines 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. In this way, you will help protect the environment.

Composition of Revolade

The active ingredient of Revolade is eltrombopag.

Coated tablets of 12.5 mg

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

Coated tablets of 25 mg

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

Coated tablets of 50 mg

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

Coated tablets of 75 mg

Each 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 carboxymethylcellulose, titanium dioxide (E171).

Revolade 12.5 mg and 25 mg coated tablets also contain polysorbate 80 (E433).

Revolade 50 mg coated tablets also contain: iron oxide red (E172), iron oxide yellow (E172).

Revolade 75 mg coated tablets also contain: iron oxide red (E172), iron oxide black (E172).

Appearance of the product and contents of the pack

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

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

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

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

They are supplied in aluminium blisters in a carton containing 14 or 28 coated tablets and multiple packs containing 84 coated tablets (3 packs of 28).

Only some pack sizes may be marketed.

Marketing authorisation 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 Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Glaxo Wellcome S.A.

Avenida de Extremadura 3

09400 Aranda de Duero

Burgos

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

For detailed information about this medicinal product, please visit the website of the European Medicines Agency http://www.ema.europa.eu.