GILENYA 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gilenya 0.25mg hard capsules

Gilenya 0.5mg hard capsules

fingolimod

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the package leaflet

1. What is Gilenya and what is it used for
2. What you need to know before you take Gilenya
3. How to take Gilenya
4. Possible side effects
5. Storing Gilenya
6. Package contents and further information

1. What is Gilenya and what is it used for

What is Gilenya

Gilenya contains the active substance fingolimod.

What is Gilenya used for

Gilenya is used in adults and in children and adolescents (from 10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (a disease where symptoms periodically occur), particularly in:

• Patient who do not respond to treatment despite MS treatment.

or

• Patient who rapidly develop severe MS.

Gilenya does not cure MS, but it helps to reduce the number of relapses and slow down the progression of physical disabilities due to 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 covering (called myelin) that surrounds the nerves in the CNS, preventing the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect the inflammation occurring in the CNS. Symptoms vary from one patient to another, but usually include difficulties walking, loss of sensation in some part of the body (numbness), vision problems, or balance disorders. The symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Gilenya works

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

2. What you need to know before starting to take Gilenya

Do not take Gilenya

• Ifyou have a weakened immune system(due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• Ifyour doctor suspects that you may have a rare brain infection known as progressive multifocal leukoencephalopathy (PML) or if you have been confirmed to have PML.
• Ifyou have a severe active or chronic active infectionsuch as hepatitis or tuberculosis.
• Ifyou have active cancer.
• Ifyou have severe liver problems.
• If, in the last 6months, you have had a heart attack, chest pain, stroke, or stroke warning, or any type of heart failure.
• Ifyou have any type of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Gilenya.
• If you are taking or have recently taken medications for an irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.
• If you are pregnantor if you are a woman of childbearing age and are not using an effective contraceptive method.
• If you are allergicto fingolimod or to any of the other components of this medication (included in section 6).

If any of the above cases apply to you or if you are unsure, tell your doctor before taking Gilenya.

Warnings and precautions

Consult your doctor before starting to take Gilenya:

• If you have severe respiratory problems when sleeping (severe sleep apnea).
• If you have been told that you have an abnormal electrocardiogram.
• If you have symptoms of a slow heart rate (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, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• If you have a history of sudden loss of consciousness or fainting (syncope).
• If you plan to get vaccinated.
• If you have never had chickenpox.
• If you have or have haddisordersor other signs of inflammation in the central vision area (the macula) of the eye (a condition known as macular edema, see below) or an eye infection (uveitis) or if you havediabetes (which can 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 problemsor "smoker's cough."

If any of the above cases apply to you or if you are unsure, tell your doctor before taking Gilenya.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that you have changed from a previous dose of 0.25 mg once a day, Gilenya causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop. If these effects are severe, tell your doctor, as you may need immediate treatment. Gilenya can also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal in less than a day. The slow heart rate usually returns to normal within a month. During this period, no clinically significant effect on heart rate is usually expected.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Gilenya or after taking the first dose of 0.5 mg, in the case that you have changed from a previous dose of 0.25 mg once a day, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You will need to have an electrocardiogram before the first dose of Gilenya and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight, until this is resolved). The same may apply if you are restarting Gilenya after a pause in treatment, depending on both the duration of the pause and how long you were taking Gilenya before the pause.

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

If you have suffered from sudden fainting in the past or a slow heart rate, Gilenya may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you 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. You need to be evaluated by a cardiologist, who will assess whether you can switch to alternative medications that do not slow the heart rate to allow treatment with Gilenya. If such a switch is not possible, the cardiologist will advise you 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 against the virus, you will likely need to be vaccinated before starting treatment with Gilenya. If so, your doctor will delay the start of treatment with Gilenya for one month after completing the vaccination cycle.

Infections

Gilenya reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with Gilenya (and up to two months after stopping treatment), you may be more likely to get infections. You may even have a worsening of an infection you already have. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately, as it can be serious and life-threatening.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, has been reported in patients treated with Gilenya. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have regular HPV checks.

PML

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

If you think your multiple sclerosis (MS) is getting worse or if you notice any new symptoms, such as changes in your mood or behavior, worsening or appearance of weakness on one side of the body, changes in vision, confusion, memory problems, or difficulties with speech and communication, tell your doctor as soon as possible. These can be symptoms of PML. Also, talk to your family members or caregivers about your treatment. Symptoms may appear without you realizing it.

If you develop PML, it can be treated, and your treatment with Gilenya will be stopped. Some people have an inflammatory reaction when Gilenya is removed from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can cause a worsening of your disease, including a worsening of brain function.

Macular edema

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

After starting treatment with Gilenya, your doctor may request an eye examination after 3 or 4 months of treatment.

The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colors, and details clearly and sharply. Gilenya can cause inflammation of the macula, and this condition is known as macular edema. The inflammation usually occurs in the first four months of treatment with Gilenya.

If you have diabetesor have had an eye infection known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you to have regular eye checks to detect macular edema.

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

Macular edema can cause the same visual symptoms as those produced in an MS attack (optic neuritis). At first, you may not have symptoms. You should inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

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

Liver function tests

If you have severe liver problems, you should not take Gilenya. Gilenya can affect liver function. You may not notice any symptoms, but if you notice a yellowish tone to your skin or the white part of your eyes, unusually dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, tell your doctor immediately.

If you have any of these symptoms after starting treatment with Gilenya, tell your doctor immediately.

Before, during, and after treatment, your doctor will request blood tests to check your liver function. You may need to interrupt treatment if the results of your blood tests indicate a problem with your liver.

High blood pressure

Since Gilenya can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

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

Blood count

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

Before starting treatment with Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to interrupt treatment with Gilenya.

Posterior reversible encephalopathy syndrome (PRES)

A condition known as posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with multiple sclerosis treated with Gilenya. Symptoms can include sudden and severe headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment with Gilenya, as it can be serious.

Cancer

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

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

Sun exposure and sun protection

Fingolimod weakens your immune system, which increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by:

• using suitable protective clothing.
• applying a sunscreen with a high UV protection index regularly.

Unusual brain lesions associated with MS relapses

Rare cases of large and 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 the need to perform an MRI scan to evaluate your condition and decide whether you need to 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 treatment-related abnormalities. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with Gilenya. To switch from teriflunomide, your doctor may advise you to wait for a period or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is necessary, and you should discuss it with your doctor to decide whether Gilenya is suitable for you.

Women of childbearing age

If Gilenya is used during pregnancy, it may harm the fetus. Before starting treatment with Gilenya, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking Gilenya and what you should do to avoid becoming pregnant while taking Gilenya. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Gilenya

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

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with Gilenya, as it can be serious (see section 3 "If you stop taking Gilenya" and also section 4 "Possible side effects").

Elderly patients

Experience with Gilenya in elderly patients (over 65 years) is limited. If in doubt, consult your doctor.

Children and adolescents

Gilenya should not be administered to children under 10 years of age, as it has not been studied in patients with MS in this age group.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children and adolescents and their caregivers:

• Before starting treatment with Gilenya, your doctor will check your vaccination status. If you have not received certain vaccinations, you may need to receive them before you can start treatment with Gilenya.
• The first time you take Gilenya, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or attacks before taking or while taking Gilenya, tell your doctor.
• If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with Gilenya, tell your doctor. You may need closer monitoring.

Other medications and Gilenya

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Tell your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use Gilenya with these medications, as it may enhance the effect on the immune system (see also "Do not take Gilenya").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with Gilenya and up to two months after stopping treatment, you should not receive certain types of vaccines (live attenuated virus vaccines), as they may cause the infections they are intended to prevent. Other vaccines may not have the desired effect if administered during this period.
• Medications that slow the heart rate

3. How to take Gilenya

Treatment with Gilenya will be supervised by a doctor with experience in treating multiple sclerosis.

Follow your doctor's instructions for taking this medication exactly. 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 (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a weight of 40 kg or less: one 0.25 mg capsule per day.
• Children and adolescents with a weight over 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 over 40 kg, the doctor will instruct them to switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Do not exceed the recommended dose.

Gilenya is taken orally.

Take Gilenya once a day with a glass of water. Gilenya capsules should always be swallowed whole, without opening them. You can take Gilenya with or without food.

Taking Gilenya at the same time every day will help you remember when to take the medication.

If you have doubts about the duration of treatment with Gilenya, 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 forget to take 1 dose during the day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Gilenya for at least 1 month and have forgotten to take your treatment for more than 2 weeks, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have forgotten to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

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

If you stop taking Gilenya

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

Gilenya will remain in your body for up to 2 months after stopping treatment. The number of white blood cells in your blood (lymphocyte count) may remain low during this period, and it is possible that side effects may still occur. After stopping treatment with Gilenya, you may need to wait for 6-8 weeks before starting a new treatment with another medication.

If you need to restart treatment with Gilenya after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur, and you will need to be monitored in the doctor's office to restart treatment. Do not restart treatment with Gilenya after stopping it for more than 2 weeks without consulting your doctor.

Your doctor will decide if it is necessary to monitor you after stopping treatment with Gilenya and how to do so. Inform your doctor immediately if you think your multiple sclerosis is getting worse after stopping treatment with Gilenya, as this could be serious.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious

Common(may affect up to 1 in 10 patients)

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may experience include fever and weakness in the early stage of the infection, followed by numbness, itching, or red spots with severe pain
• Slow heart rate (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC) that often appears as a pearl-like nodule, although it can also have other forms
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and 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 (inflammation in the central vision area of the retina in the eye) with symptoms such as shadows or a blind spot or loss of vision in the field of vision, blurred vision, problems seeing colors or details
• Decreased number of blood platelets, which increases 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 change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate
• Seizures, attacks (more frequent in children and adolescents than in adults)

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

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

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

• Abnormality in the electrocardiogram (inversion of the T wave)
• Tumor related to human herpesvirus 8 infection (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 starts
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark urine (brown color), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of a multiple sclerosis relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication problems, which your doctor may need to investigate further to rule out PML. Therefore, if you think your multiple sclerosis is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible
• Immune reconstitution inflammatory syndrome (IRIS) after stopping treatment with Gilenya (a condition in which the immune system reacts to a previously acquired infection)
• 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 red-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can 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, multiple sclerosis symptoms may recur and may be worse than they were 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, inform your doctor immediately.

Other side effects

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

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

Common(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 white blood cell count (lymphocytes, leukocytes)
• Weakness
• Rash with itching, redness of the skin, and burning (eczema)
• Itching
• Increased blood levels of certain lipids (triglycerides)
• Hair loss
• Breathing difficulties
• Depression
• Blurred vision (see also the section on macular edema under the heading "Some side effects can 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)
• Depressive mood
• Nausea

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

• Lymphatic system cancer (lymphoma)

Frequency not known(cannot be estimated from available data)

• Peripheral inflammation

If you consider any of the side effects you are experiencing to be serious, inform your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gilenya

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

Do not use this medication after the expiration date stated on the carton after "EXP" and on the blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from moisture.

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

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Gilenya Composition

• The active ingredient is fingolimod.

Gilenya 0.25 mg hard capsules

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

Capsule content: 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), ammonia solution, concentrated (E527).

Gilenya 0.5 mg hard capsules

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

Capsule content: 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, ammonia solution, concentrated (E527), potassium hydroxide, black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), dimethicone.

Product Appearance and Package Contents

Gilenya 0.25 mg hard capsules have an opaque ivory-colored body and cap. The cap has a black printing mark "FTY 0.25mg" and the body has a black radial band.

Gilenya 0.5 mg hard capsules have an opaque white-colored body and an opaque bright yellow-colored cap. The cap has a black printing mark "FTY0.5mg" and the body has two yellow radial bands printed with ink.

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

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

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

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

België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
	Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Ceská republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
Ελλάδα Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma – Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1	Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Κύπρος Novartis Pharma Services Inc. Τηλ: +357 22 690 690	Sverige Novartis Sverige AB Tel: +46 8 732 32 00
Latvija SIA Novartis Baltics Tel: +371 67 887 070

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

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