Gilenya 0.5 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gilenya 0.25 mg hard capsules

Gilenya 0.5 mg hard capsules

fingolimod

Read this entire leaflet carefully before you start taking 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 give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Gilenya is and what it is used for

What Gilenya is

Gilenya contains the active substance fingolimod.

What Gilenya is used for

Gilenya is used in adults and in children and adolescents (aged 10 years and older) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• Patients who do not respond to treatment despite receiving therapy for MS.

or

• Patients who rapidly develop severe MS.

Gilenya does not cure MS, but it helps reduce the number of relapses and slows the progression of physical disability caused by MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that surrounds the nerves in the CNS, impairing proper nerve function. This process is known as demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms reflecting inflammation occurring in the CNS. Symptoms vary from patient to patient, but typically include difficulty walking, loss of sensation in parts of the body (numbness), vision problems, or balance disorders. Symptoms of a relapse may completely disappear when the attack ends, although some problems may persist.

How Gilenya works

Gilenya helps combat immune system attacks on the CNS by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body, preventing them from reaching the brain and spinal cord. This limits nerve damage caused by multiple sclerosis. Gilenya also reduces some of the body's immune responses.

2. What you need to know before taking Gilenya

Do not take Gilenya

• if you have a reduced immune response (due to an immunodeficiency syndrome, an illness, or medications that suppress the immune system).
• if your doctor suspects you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML), or if you have been diagnosed with PML.
• if you have a severe active infection or an active chronic infection such as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if, within the past 6 months, you have had a heart attack, angina, stroke, transient ischemic attack (TIA), or any type of heart failure.
• if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows QT interval prolongation before starting treatment with Gilenya.
• if you are taking or have recently taken medications for irregular heartbeat (of the heart) such as quinidine, disopyramide, amiodarone, or sotalol.
• if you are pregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method.
• if you are allergic to fingolimod or any of the other components of this medicine (listed in section 6).

If any of the above conditions apply to you or you are unsure, inform your doctor before taking Gilenya.

Warnings and precautions

Talk to your doctor before starting Gilenya:

• if you have severe breathing problems while sleeping (severe sleep apnea).
• if you have been told you have an abnormal electrocardiogram (ECG).
• if you have symptoms of a slow heartbeat (e.g., dizziness, nausea, or palpitations).
• if you are taking or have recently taken medications that slow your heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• if you have a history of sudden loss of consciousness or fainting (syncope).
• if you are planning to get vaccinated.
• if you have never had chickenpox.
• if you have or have had disorders or other signs of inflammation in the central area of vision (the macula) at the back of the eye (a condition known as macular edema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause eye problems).
• if you have liver problems.
• if you have high blood pressure that cannot be controlled with medication.
• if you have severe lung problems or "smoker's cough."

If any of the above conditions apply to you or you are unsure, inform your doctor before taking Gilenya.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first 0.5 mg dose—especially if you have switched from a previous dose of 0.25 mg once daily—Gilenya causes a temporary decrease in heart rate. As a result, you may feel dizzy or fatigued, become aware of your heartbeat, or experience a drop in blood pressure. If these effects are severe, inform your doctor immediately, as you may require immediate treatment. Gilenya may also cause irregular heartbeats, particularly after the first dose. Irregular heartbeats usually return to normal within less than a day. The slow heart rate typically normalizes within one month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly monitoring of your pulse and blood pressure, after taking your first dose of Gilenya or your first 0.5 mg dose if you have switched from 0.25 mg once daily. This is to allow appropriate measures to be taken if adverse effects occur at the start of treatment. You will have an electrocardiogram (ECG) before your first dose and again after the 6-hour monitoring period. Your doctor may also monitor your ECG continuously during this time. If, after the 6-hour period, your heart rate is very slow or decreasing, or if your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours, possibly overnight) until the issue resolves. The same may apply if you restart Gilenya after a treatment interruption, depending on the duration of the interruption and how long you had been taking Gilenya before the break.

If you have or are at risk of having irregular or abnormal heartbeats, if your ECG is abnormal, or if you have heart disease or heart failure, Gilenya may not be suitable for you.

If you have previously experienced sudden fainting or a slow heart rate, Gilenya may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start treatment with Gilenya, including overnight monitoring.

If you are taking other medications that can slow your heart rate, Gilenya may not be suitable for you. A cardiologist must evaluate you and consider whether you can switch to alternative medications that do not slow the heart rate to allow Gilenya treatment. If such a switch is not possible, the cardiologist will advise on how to start treatment with Gilenya, including overnight monitoring.

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected, you may need to be vaccinated before starting Gilenya. If so, your doctor will delay starting Gilenya by one month after completing the vaccination series.

Infections

Gilenya reduces the number of white blood cells in the blood (especially lymphocyte count). White blood cells fight infections. During treatment with Gilenya (and for up to two months after stopping treatment), you may be more susceptible to infections. An existing infection may also worsen. Infections can be serious and potentially life-threatening. If you suspect you have an infection, have a fever, flu-like symptoms, herpes (shingles), or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits)—which may be signs of meningitis and/or encephalitis caused by a fungal or herpes virus infection—contact your doctor immediately, as this could be serious and life-threatening.

Infections with human papillomavirus (HPV), including papilloma, dysplasia, warts, and HPV-related cancers, have been reported in patients treated with Gilenya. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screening.

PML

PML is a rare brain disorder caused by an infection that can lead to severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) scans before and during treatment to monitor for the risk of PML.

If you think your MS is worsening or you notice any new symptoms—such as changes in mood or behavior, worsening or new weakness on one side of the body, vision changes, confusion, memory problems, or difficulty speaking or communicating—inform your doctor as soon as possible. These may be symptoms of PML. Also, talk to your family members or caregivers about your treatment, as symptoms may appear without your awareness.

If you develop PML, it can be treated, and your Gilenya treatment will be stopped. Some people experience an inflammatory reaction when Gilenya is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may worsen your condition, including brain function.

Macular edema

Before starting Gilenya, your doctor may recommend an eye examination if you have or have had visual disorders or other signs of inflammation in the central area of vision (the macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting Gilenya, your doctor may recommend an eye examination after 3 to 4 months of treatment.

The macula is a small area of the retina at the back of the eye that allows you to see shapes, colors, and fine details clearly. Gilenya may cause inflammation of the macula, a condition known as macular edema. This usually occurs within the first four months of treatment.

If you have diabetes or have previously had eye inflammation (uveitis), you are at higher risk of macular edema. In these cases, your doctor may recommend regular eye exams to detect macular edema.

If you have had macular edema, discuss this with your doctor before continuing Gilenya treatment.

Macular edema may cause visual symptoms similar to those of an MS attack (optic neuritis). You may not have symptoms at first. Report any changes in vision to your doctor. Your doctor may recommend an eye examination, especially if:

• The center of your visual field becomes blurry or contains shadows;
• A blind spot appears in the center of your visual field;
• You have difficulty seeing colors or fine details.

Liver function tests

If you have severe liver problems, you must not take Gilenya. Gilenya may affect liver function. You may not notice any symptoms, but if you develop yellowing of the skin or whites of the eyes, abnormally dark (brown-colored) urine, pain in the upper right side of your abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.

If you experience any of these symptoms after starting Gilenya, inform your doctor immediately.

Before, during, and after treatment, your doctor will order blood tests to monitor your liver function. You may need to stop treatment if test results indicate liver problems.

High blood pressure

Since Gilenya may cause a slight increase in blood pressure, your doctor will want to monitor your blood pressure regularly.

Lung problems

Gilenya has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to experience adverse effects.

Blood counts

Gilenya is expected to reduce the number of white blood cells in your blood. This effect usually resolves within 2 months after stopping treatment. If you have blood tests, inform the doctor that you are taking Gilenya, as otherwise the doctor may not interpret the results correctly. For certain blood tests, your doctor may need more blood than usual.

Before starting Gilenya, your doctor will confirm that you have an adequate white blood cell count and may repeat monitoring regularly. If your white blood cell count is too low, you may need to stop treatment with Gilenya.

Reversible posterior encephalopathy syndrome (RPES)

Rarely, a condition called reversible posterior encephalopathy syndrome (RPES) has been reported in multiple sclerosis patients treated with Gilenya. Symptoms may include sudden, severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Gilenya, as it may be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with Gilenya. Inform your doctor immediately if you notice any skin nodules (e.g., shiny, pearl-like nodules), spots, or open sores that do not heal for weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change in color, shape, or size over time. Before starting Gilenya, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If skin problems arise, your doctor may refer you to a dermatologist, who may decide whether regular visits are necessary.

A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with Gilenya.

Sun exposure and sun protection

Fingolimod weakens your immune system, increasing the risk of cancer, especially skin cancer. You should limit sun and UV exposure by:

• wearing appropriate protective clothing;
• regularly applying sunscreen with a high UV protection factor.

Unusual brain lesions associated with MS relapses

Rare cases of large, unusual brain lesions associated with MS relapses have been reported in patients treated with Gilenya. In the case of severe relapses, your doctor will assess whether an MRI scan is needed to evaluate your condition and decide whether you should stop taking Gilenya.

Switching from other treatments to Gilenya

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Gilenya if there are no signs of abnormalities from the previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting Gilenya. When switching from teriflunomide, your doctor may advise waiting or undergoing an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is required, and you should discuss with your doctor whether Gilenya is suitable for you.

Women of childbearing potential

Gilenya may harm the fetus if used during pregnancy. Before starting treatment, your doctor will explain the risks and request a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking Gilenya and what steps to take to avoid pregnancy. During treatment and for 2 months after stopping, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

If you become pregnant while taking Gilenya, inform your doctor immediately. Your doctor will decide whether to stop treatment (see section 3 “If you stop taking Gilenya” and section 4 “Possible side effects”). You will receive specific prenatal follow-up.

Breastfeeding

You must not breastfeed during treatment with Gilenya. Gilenya passes into breast milk and may cause serious adverse effects in the infant.

Driving and using machines

Your doctor will advise whether your condition allows you to drive vehicles—including bicycles—and safely operate machinery. Gilenya is not expected to affect your ability to drive or operate machinery.

However, at the start of treatment, you must remain at the clinic or hospital for 6 hours after taking your first dose of Gilenya. During this time and possibly afterward, your ability to drive and operate machinery may be impaired.

3. How to take Gilenya

Treatment with Gilenya will be supervised by a doctor experienced in the treatment of multiple sclerosis.

Always follow exactly the instructions for using this medicine given by your doctor. If you are unsure, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (from 10 years of age onwards):

The dose depends on body weight:

• Children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day.
• Children and adolescents weighing more than 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start with a 0.25 mg capsule per day and later reach a stable weight above 40 kg, the doctor will instruct them to switch to a 0.5 mg capsule per day. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.

Gilenya is taken orally.

Take Gilenya once daily with a glass of water. Gilenya capsules must always be swallowed whole and must not be opened. You may take Gilenya with or without food.

Taking Gilenya at the same time each day will help you remember when to take the medicine.

If you have any doubts about how long Gilenya treatment should last, consult your doctor or pharmacist.

If you take more Gilenya than you should

If you have taken more Gilenya than you should, inform your doctor immediately.

If you forget to take Gilenya

If you have been taking Gilenya for less than 1 month and miss a dose for a full day, speak with your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose.

If you have been taking Gilenya for at least 1 month and you miss your treatment for more than 2 weeks, speak with your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose. However, if you miss your treatment for up to 2 weeks, you may take the next dose as scheduled.

Never take a double dose to make up for a missed dose.

If you stop taking Gilenya

Do not stop taking Gilenya or change your dose without first discussing it with your doctor.

Gilenya will remain in your body for up to two months after stopping treatment. The number of white blood cells (lymphocyte count) may remain low during this period, and adverse effects described in this leaflet may still occur. After stopping Gilenya treatment, you may need to wait 6–8 weeks before starting a new treatment for MS.

If you restart Gilenya treatment after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and it will be necessary for you to be monitored by a doctor when restarting treatment. Do not restart Gilenya treatment after a break of more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up is needed after stopping Gilenya treatment and how this should be managed. Inform your doctor immediately if you think your MS is worsening after stopping Gilenya, as this could be serious.

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

4. Possible adverse effects

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

Some adverse effects may be serious or potentially serious

Frequent (may affect up to 1 in 10 patients)

• Cough with sputum (phlegm), chest discomfort, fever (signs of lung disorders)
• Infection with herpes virus (shingles or herpes zoster), with symptoms such as blisters, stinging, itching, or pain of the skin, especially on the upper part of the body or face. Other symptoms may include fever and weakness in the early phase of infection, followed by numbness, itching, or red spots with severe pain
• Slow heartbeat (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other forms
• It is known that people with multiple sclerosis have depression and anxiety more frequently; these have also been reported in pediatric patients treated with Gilenya
• Weight loss

Uncommon (may affect up to 1 in 100 patients)

• Pneumonia, with symptoms such as fever, cough, difficulty breathing
• Macular edema (swelling in the area of central vision of the retina at the back of the eye), with symptoms such as shadows or a blind spot or loss of vision in the center of the visual field, blurred vision, problems seeing colors or details
• Decrease in the number of blood platelets, increasing the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change over time in size, shape, thickness, or color, or the formation of new moles. Moles may itch, bleed, or ulcerate
• Seizures, fits (more frequent in children and adolescents than in adults)

Rare (may affect up to 1 in 1,000 patients)

• A condition called reversible posterior encephalopathy syndrome (PRES). Symptoms may include sudden and severe headache, confusion, seizures and/or visual disturbances
• Lymphoma (a type of cancer affecting the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that may appear as a firm red nodule, a crusted sore, or a new sore on an existing scar

Very rare (may affect up to 1 in 10,000 patients)

• Abnormality in the electrocardiogram (ECG) (T-wave inversion)
• Tumor associated with infection by human herpesvirus 8 (Kaposi’s sarcoma)

Frequency not known (cannot be estimated from available data)

• Allergic reactions, including symptoms such as rash or hives with itching, swelling of lips, tongue or face, which are more likely to occur on the day treatment with Gilenya is started
• Signs of liver disease (including liver failure), such as yellowing of the skin or the whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark urine (brown-colored), loss of appetite, fatigue, and abnormal results in liver function tests. In a small number of cases, liver failure could require a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. Other symptoms may also occur that you might not notice yourself, such as changes in mood or behavior, memory loss, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening or if you or people close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible
• Inflammatory disorder after stopping treatment with Gilenya (known as immune reconstitution inflammatory syndrome or IRIS)
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless flesh-colored or bluish-red nodule, usually on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may affect the risk of developing Merkel cell carcinoma
• After stopping treatment with Gilenya, MS symptoms may reappear and may be worse than before or during treatment
• Autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia)

If you experience any of these symptoms, contact your doctor immediately.

Other adverse effects

Very frequent (may affect more than 1 in 10 patients)

• Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Feeling of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test showing abnormal liver enzyme levels
• Cough

Frequent (may affect up to 1 in 10 patients)

• Pityriasis versicolor (fungal skin infection)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low levels of white blood cells (lymphocytes, leukocytes)
• Weakness
• Itchy rash, redness and burning of the skin (eczema)
• Itching
• Increased blood levels of certain lipids (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema under the heading "Some adverse effects may be serious or potentially serious")
• Hypertension (Gilenya may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon (may affect up to 1 in 100 patients)

• Low levels of certain white blood cells (neutrophils)
• Depressed mood
• Nausea

Rare (may affect up to 1 in 1,000 patients)

• Cancer of the lymphatic system (lymphoma)

Frequency not known (cannot be estimated from available data)

• Peripheral inflammation

If you consider any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

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

5. Storage of Gilenya

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

Do not use this medicine after the expiry date stated on the carton after "CAD" and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gilenya

• The active substance is fingolimod.

Gilenya 0.25 mg hard capsules

• Each capsule contains 0.25 mg of fingolimod (as hydrochloride).
• The other components are:

Capsule contents: mannitol, hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Printing ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520), ammonium solution, concentrated (E527).

Gilenya 0.5 mg hard capsules

• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other components are:

Capsule contents: mannitol, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Printing ink: shellac (E904), anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol (E1520), purified water, ammonium solution, concentrated (E527), potassium hydroxide, black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), dimethicone.

Nature of the product and pack size

Gilenya 0.25 mg hard capsules have an opaque ivory-colored body and cap. The cap bears a black printed mark “FTY 0.25mg” and the body has a single radial black band.

Gilenya 0.5 mg hard capsules have an opaque white body and an opaque bright yellow cap. The cap bears a black printed mark “FTY0.5mg” and the body has two radial bands marked with yellow ink.

Gilenya 0.25 mg capsules are available in packs containing 7 or 28 capsules. In your country, only certain pack sizes may be marketed.

Gilenya 0.5 mg capsules are available in packs containing 7, 28 or 98 capsules, or in multiple packs containing 84 capsules (3 packs of 28 capsules). In your country, only certain pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Lek Pharmaceuticals d.d.
Verovskova Ulica 57
Ljubljana, 1526
Slovenia

Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia

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 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. Tel/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 ‑ Pharmaceutical Products, 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 Tel/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:

Other sources of information

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