Label: information for the user

Gilenya 0.25mg hard capsules

Gilenya 0.5mg hard capsules

fingolimod

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section4.

What is Gilenya

Gilenya contains the active ingredient fingolimod.

What is Gilenya used for

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

-Patients who do not respond to treatment despite treatment for RRMS.

or

-Patients who rapidly develop severe RRMS.

Gilenya does not cure RRMS, but helps to reduce the number of relapses and slow the progression of physical disabilities caused by RRMS.

What is multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects the central nervous system (CNS), consisting 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 correctly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of CNS symptoms that are a reflection of the inflammation that occurs in the CNS. Symptoms vary from patient to patient, but generally include difficulties walking, numbness in some part of the body (tingling), vision problems, or balance disorders. Symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Gilenya works

Gilenya helps combat the immune system's attacks 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 nerve damage attributed to MS. Gilenya also reduces some of the body's immune responses.

Do not take Gilenya

• if you have a weakened immune system(due to a condition known as immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if your doctor suspects that you may havea rare brain infection known as progressive multifocal leukoencephalopathy (PML) or if you have been confirmed to have PML.
• if you have an active severe infection or an active chronic infectionsuch as hepatitis or tuberculosis.
• if you haveactive cancer.
• if you havesevere liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke, or transient ischemic attack or any type of heart failure.
• if you have any type ofirregular or abnormal heart rhythm(arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with Gilenya.
• if you are taking or have recently taken medications for irregular heart rhythmssuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you arepregnantor if you are a woman of childbearing potential and do not use an effective contraceptive method.
• if you are allergicto fingolimod or to any of the other components of this medication (including those 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

Consult your doctor before starting to take Gilenya:

• if you have severe sleep apnea.
• if you have been told that you have an abnormal electrocardiogram.
• if you have symptoms of 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 hadinflammation or other signs of inflammation in the central vision area (macula) of the back of the eye(a condition known as macular edema, see below)or if you have uveitis or diabetes (which can cause eye problems).
• if you have liver problems.
• if you havehigh blood pressure that cannot be controlled with medication.
• if you havesevere lung problemsor“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 dose of 0.5 mg, in the case that you have been 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 have a decrease in blood pressure.If these effects are severe, inform your doctor as you may need immediate treatment.Gilenya can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within a day. Slow heart rate usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation 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 been changed from a previous dose of 0.25 mg once a day, to take the necessary measures if any adverse effects 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). This may also 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 heartbeats, if your electrocardiogram is abnormal, or if you have a heart disease or heart failure, Gilenya may not be suitable for you.

If you have had sudden fainting spells in the past or a decrease in 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 monitoring during the night.

If you are taking other medications that can slow your heart rate, Gilenya may not be suitable for you. It is necessary for a cardiologist to evaluate you, and it is they who will decide if you can switch to alternative medications that do not slow your heart rate to allow treatment with Gilenya. If this change is impossible, the cardiologist will advise you on how to start treatment with Gilenya, including monitoring during the night.

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, your doctor will probably delay starting treatment with Gilenya for a month after completing the vaccination course.

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 for up to two months after stopping treatment), you may be more susceptible to infections. You may even exacerbate an existing infection. Infections can be severe and potentially life-threatening. If you think you have contracted an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or the herpes virus), contact your doctor immediately as it may be severe and life-threatening.

A 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 regular HPV checks.

PML

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

Sif you think your EM is getting worse or if you notice any new symptoms, such as changes in your mood or behavior, worsening or new weakness on one side of your body, changes in vision, confusion, memory lapses, or difficulty speaking and communicating, inform your doctor as soon as possible.These may be symptoms of PML.Also, inform your family members or caregivers about your treatment.Symptoms can appear without you realizing it.

If you contract PML, it can be treated, and your treatment with Gilenya will be stopped. Some people have an inflammatory reaction when Gilenya is eliminated 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 disturbances or other signs of inflammation in the central vision area (macula) of the back of the eye, uveitis, or diabetes.

After starting treatment with Gilenya, your doctor may request an eye examination 3-4 months after starting 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. Inflammation usually occurs within the first four months of treatment with Gilenya.

If you havediabetesor have had uveitis, you are more likely to develop macular edema. In these cases, your doctor will want to perform 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 an MS attack (optic neuritis). At first, you may not have any symptoms. It is essential to 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 visual field becomes blurry or contains shadows;
• a blind spot appears in the center of your visual field;
• you have trouble 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 tint to your skin or the white part of your eyes, abnormally dark urine (brown), right-sided abdominal pain, fatigue, decreased appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

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

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

High blood pressure

As Gilenya causes a slight increase in blood pressure, your doctor will want to regularly monitor your blood pressure.

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 normalizes within two months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking Gilenya, as if you do not, the doctor may not understand the test results. For certain blood tests, your doctor may need to take more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Cases of skin cancer have been reported in patients with MS treated with Gilenya. Inform your doctor immediately if you notice any new skin nodules (e.g., shiny nodules with a pearl-like appearance), moles, or open sores that do not heal within weeks. Symptoms of skin cancer may 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, your doctor will perform a skin examination 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 if you need regular follow-up appointments.

Cases of lymphoma, a type of cancer of the lymphatic system, have been reported in patients with MS treated with Gilenya.

Sun exposure and sun protection

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

• wearing protective clothing.
• regularly applying a high-protection sunscreen.

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 for an MRI to evaluate your condition and decide if 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 abnormalities caused by previous treatment. Your doctor may need to perform a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with Gilenya. To switch from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if Gilenya is suitable for you.

Women of childbearing potential

If Gilenya is used during pregnancy, it may be harmful to 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 explaining why you should not become pregnant while taking Gilenya. They will also explain what you should do to avoid becoming pregnant while taking Gilenya. During treatment and for two months after stopping treatment, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

Stopping treatment with Gilenya

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

Inform your doctor immediately if you think your MS is getting worse after stopping treatment with Gilenya, as it may be severe (see section 3 “If you stop treatment with Gilenya” and also section 4 “Possible side effects”).

Older patients

The experience with Gilenya in patients over 65 years old is limited. If you have any doubts, consult your doctor.

Children and adolescents

Gilenya should not be administered to children under 10 years old 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 been vaccinated against certain diseases, you may need to have them before starting treatment with Gilenya.
• The first time you take Gilenya, or when you change 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 on “Slow heart rate (bradycardia) and irregular heartbeats”).
• If you have seizures or convulsions before taking or while taking Gilenya, inform your doctor.
• If you experience depression or anxiety, or if you feel depressed or anxious during treatment with Gilenya, inform your doctor. You may need closer monitoring.

Other medications and Gilenya

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

• Medications that suppress or modulate the immune system, includingother 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 intensify the effect on the immune system (see also “Do not use Gilenya”).
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with Gilenya and for up to two months after stopping treatment, you should not be given certain types of vaccines (vaccines made with live, attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not be effective if given during this period of time.
• Medications that slow heart rate(e.g., beta-blockers such as atenolol). The use of Gilenya with these medications may intensify the effect on heart rate during the first few days after starting treatment with Gilenya.
• Medications for irregular heartbeats,such as quinidine, disopyramide, amiodarone, or sotalol.Do not use Gilenya with these medications as it may intensify the effect on irregular heartbeats (see also the section “Do not use Gilenya”).
• Other medications:

• protease inhibitors, antifungal medications such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (potential risk of reduced efficacy of Gilenya).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Do not use Gilenya during pregnancy, or if you are planning to become pregnant, or if you are a woman who may become pregnant and do not use an effective contraceptive method. If Gilenya is used during pregnancy, there is a risk of harming the fetus. The rate of congenital malformations observed in babies exposed to Gilenya during pregnancy is approximately twice that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included heart, kidney, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing potential:

• before starting treatment with Gilenya, your doctor will inform you about the risk to the fetus and request a pregnancy test to ensure you are not pregnant,

and,

• during treatment with Gilenya and for two months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss contraceptive options with your doctor.

Your doctor will give you a card explaining why you should not become pregnant while taking Gilenya.

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

Breastfeeding

Do not breastfeedduring treatment with Gilenya. Gilenya passes into breast milk, and there is a risk of severe adverse effects in the baby.

Driving and operating machinery

Your doctor will inform you if your disease allows you to drive vehicles, including bicycles, and use machines safely. Gilenya is not expected to affect your ability to drive and use machines.

However, after taking the first dose of Gilenya, you will need to stay in the consultation or hospital for at least 6 hours. During this period and possibly afterwards, your ability to drive and use machines may be impaired.

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one capsule of 0.5mg per day.

Children and adolescents (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a weight equal to or less than 40kg:one capsule of 0.25mg per day.
• Children and adolescents with a weight greater than 40kg:one capsule of 0.5mg per day.

To children and adolescents who start with one capsule of 0.25mg per day and later reach a stable weight greater than 40kg, the doctor will instruct them to change to one capsule of 0.5mg per day. In this case, it is recommended to repeat the observation period of the first dose.

Do not exceed the recommended dose.

Gilenya is used orally.

Take Gilenya once a day with a glass of water.The Gilenya capsules must always be swallowed whole, without openingGilenya can be taken with or without food.

Taking Gilenya every day at the same time 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 forgot to take Gilenya

If you have been taking Gilenya for less than 1 month and forget to take 1 dose for an entire 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 forget 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 forget 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 compensate for missed doses.

If you interrupt treatment with Gilenya

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

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

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

Your doctor will decide if you need to be followed up after stopping treatment with Gilenya and how.Inform your doctor immediately if you think your MS is worsening after stopping treatment with Gilenya, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects,although not everyone will experience them.

Some side effects may be serious or potentially serious

Common(may affect up to 1 in 10patients)

• Cough with mucus (phlegm), chest discomfort, fever (signs of respiratory changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain
• Slow heart rate (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC) that often presents 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 it has also been reported in pediatric patients treated with Gilenya
• Weight loss

Uncommon(may affect up to 1in 100patients)

• Pneumonia, with symptoms such as fever, cough, difficulty breathing
• Macular edema (inflammation in the central vision area of the retina in the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the central field of vision, blurred vision, problems seeing colors or details
• Decreased platelet count, which increases the risk of bleeding or hematomas
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can cause itching, bleeding, or ulceration
• Seizures, attacks (more common in children and adolescents than in adults)

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

• A condition called reversible posterior leukoencephalopathy syndrome (RPLS).Symptoms may include the sudden and intense onset of 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 present as a firm, red nodule, a sore with a scab, or a new sore over an existing scar

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

• Electrocardiogram anomaly (T wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency not known(cannot be estimated from available data)

• Allergic reactions, including symptoms of rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day treatment with Gilenya begins
• 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 on the right side of the stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those around you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible
• Inflammatory reconstitution syndrome (IRIS) after interrupting treatment with Gilenya
• 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, red or pinkish nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm or soft nodule. 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 they were before or during treatment
• Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed

If you have any of these symptoms,inform your doctor immediately.

Other side effects

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

• 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
• Blood test with altered liver enzyme levels
• Cough

Common(may affect up to 1in 10patients)

• Pityriasis versicolor (fungal infection of the skin)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching rash, skin redness, and burning (eczema)
• Itching
• Increased levels of certain lipids in the blood (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema under the title«Some side 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 1in 100patients)

• Low neutrophil count
• Depressive mood
• Nausea

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

• Lymphoma (a type of cancer that affects the lymphatic system)

Frequency not known(cannot be estimated from available data)

• Peripheral inflammation

If you consider that any of theside effectsyou are experiencing are serious,inform your doctor.

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 thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on 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 box after “CAD” and on the blister pack 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 it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Gilenya

• The active ingredient is fingolimod.

Gilenya 0.25mg hard capsules

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

Capule content: mannitol, hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate.

Capule coating: gelatin, titanium dioxide (E171),yellow iron oxide (E172).

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

Gilenya 0.5mg hard capsules

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

Capule content: mannitol, magnesium stearate.

Capule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

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

Appearance of the product and contents of the pack

Gilenya 0.25mg hard capsules have an opaque white body and an opaque ivory cap. The cap has a black printing mark “FTY0.25mg” and the body has a radial black band.

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

Gilenya 0.25mg hard capsules are available in packs containing7or 28capsules.They may only be marketed in certain pack sizes in your country.

Gilenya0.5mg hard capsules are available in packs containing 7, 28 or 98capsules or in multiple packs containing 84capsules (3packs of 28capsules). They may only be marketed in certain pack sizes in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Alemania

Lek Pharmaceuticals d.d.

Verovskova Ulica 57

Ljubljana, 1526

Eslovenia

Novartis Pharmaceutical Manufacturing LLC

VerovskovaUlica57

Ljubljana, 1000

Eslovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu

.