Patient Information Leaflet: Information for the User

Gilenya 0.25 mg hard capsules, 0.5 mg hard capsules

Fingolimod
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 others, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Gilenya is and what it is used for
What you need to know before taking Gilenya
How to take Gilenya
Possible side effects
How to store Gilenya
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 children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

Patients who have not responded to therapy with a treatment for MS, or
Patients with rapidly evolving severe MS.

Gilenya does not cure MS, but helps reduce the number of relapses and slows down 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 includes the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS, impairing normal nerve function. This process is known as demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms reflecting an inflammatory state of the central nervous system. Symptoms vary from patient to patient, but usually include difficulty walking, numbness, vision problems, or balance disturbances. Symptoms of a relapse may completely disappear once the relapse has ended, although some impairments may persist.
How Gilenya works
Gilenya helps protect the nervous system from attacks by the immune system by reducing the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body, thereby preventing them from reaching the brain and spinal cord. This limits nerve damage caused by MS. Gilenya also reduces some of the body's immune responses.

2. What you should know before taking Gilenya

Do not take Gilenya

if you have a reduced immune response (due to 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 PML has been confirmed.
if you currently have a severe infection or a chronic ongoing infection, such as hepatitis or tuberculosis.
if you have active cancer.
if you suffer from severe liver problems.
if, within the last 6 months, you have had a heart attack, angina, stroke, or a transient ischemic attack (TIA), or certain types of heart failure.
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Gilenya.
if you are taking or have recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol.
if you are pregnant or are a woman of childbearing potential who is not using effective contraception.
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these situations apply to you or you are unsure, talk to your doctor before taking Gilenya.

Warnings and precautions
Talk to your doctor before taking Gilenya:

if you have severe breathing problems during sleep (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you experience symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations).
if you are taking or have recently taken medications that slow the heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase drugs, or pilocarpine).
if you have previously experienced episodes 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 had vision disorders or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular edema, see below), if you have or have had eye inflammation or infection (uveitis), or if you have diabetes (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 problems or if you have a smoker's cough. If any of these situations apply to you or you are unsure, talk to your doctor before taking Gilenya.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment, or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg, Gilenya causes a slowing of the heart rate. As a result, you may experience dizziness, fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, contact your doctor immediately, as immediate treatment may be necessary. Gilenya may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate typically returns to normal within one month. During this period, clinically significant effects on heart rate are generally not expected.
Your doctor will ask you to remain in the clinic or hospital for at least 6 hours after taking the first dose of Gilenya, or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if adverse effects occur at the start of treatment. You must have an electrocardiogram (ECG) performed before the first dose of Gilenya and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after 6 hours, your heart rate is very low or continues to decrease, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, possibly until the next morning), until these issues resolve. The same may apply if you restart Gilenya after an interruption in treatment, depending on how long the interruption was and how long you had been taking Gilenya before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your ECG is abnormal, or if you have heart disorders or heart failure, Gilenya may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Gilenya may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with Gilenya, including monitoring until the next morning.
If you are taking medications that can reduce heart rate, Gilenya may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medications that do not reduce heart rate, allowing you to start treatment with Gilenya. If such a change is not possible, the cardiologist will advise you on how to start treatment with Gilenya, including monitoring until the next morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be necessary before starting treatment with Gilenya. In such cases, your doctor will delay the start of Gilenya treatment until one month after completing the full vaccination course.

Infections
Gilenya reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Gilenya (and up to 2 months after stopping treatment), you may be more susceptible to infections. Any existing infection may worsen. Infections can be severe and life-threatening. If you think you have an infection, have a fever, flu-like symptoms, shingles (herpes zoster), or a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (these may be symptoms of meningitis and/or encephalitis caused by fungal or herpes viral infection), contact your doctor immediately, as it could be serious and life-threatening.
Human papillomavirus (HPV) infection, including warts, dysplasia, condylomas, and HPV-related cancers, has 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 HPV screening.

PML
PML is a rare brain disease caused by an infection that can lead to severe disability or death. Your doctor will schedule magnetic resonance imaging (MRI) scans before starting treatment and during treatment to monitor the risk of PML.
If you believe your multiple sclerosis (MS) is worsening or if you notice new symptoms, such as mood or behavior changes, new or worsening weakness on one side of the body, vision changes, confusion, memory lapses, or language and communication difficulties, speak to your doctor as soon as possible. These may be symptoms of PML. Also talk to your partner or caregiver and inform them about your treatment. They may notice symptoms you might not recognize yourself.
If you develop PML, it can be treated, and 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) can lead to worsening of symptoms, including worsening brain function.

Macular edema
Before starting treatment with Gilenya, if you have or have had vision disorders or other signs of swelling in the central vision area (macula) at the back of the eye, if you have or have had eye inflammation or infection (uveitis), or if you have diabetes, your doctor may ask you to undergo an eye examination.
Your doctor may also ask you to have an eye examination 3–4 months after starting Gilenya 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 fine details clearly. Gilenya can cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Gilenya.
The risk of macular edema is higher if you have diabetes or have had eye inflammation called uveitis. In these cases, your doctor will want to perform regular checks to detect early signs of macular edema.
If you have previously had macular edema, talk to your doctor before restarting Gilenya treatment.
Macular edema can cause some of the visual symptoms (optic neuritis) that also occur during MS attacks. In the early stages, there may be no symptoms. Make sure to inform your doctor of any changes in vision. Your doctor may ask you to undergo an eye examination, especially if:

the central area of vision is blurred or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colors or fine details.

Liver function tests
You must not take Gilenya if you have severe liver problems. Treatment with Gilenya may affect your liver function. You may not notice any symptoms, but if you observe yellowing of the skin or whites of the eyes, abnormally dark-colored urine (brown), pain on the right side of the abdomen, fatigue, unusual loss of appetite, or unexplained nausea and vomiting, contact your doctor immediately.
If you experience any of these symptoms after starting Gilenya treatment, contact your doctor immediately.
Before, during, and after treatment, your doctor will ask you to have blood tests to monitor liver function. If test results indicate a liver problem, treatment with Gilenya may need to be stopped.

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

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

Blood count
The intended effect of Gilenya treatment is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking Gilenya. Otherwise, your doctor may not correctly interpret the test results, and for certain types of tests, your doctor may need to draw more blood than usual.
Before starting Gilenya treatment, your doctor will confirm that your white blood cell count is adequate and may ask you to have regular blood counts. If your white blood cell count is too low, treatment with Gilenya may need to be stopped.

Reversible posterior encephalopathy syndrome (PRES)
Rare cases of reversible posterior encephalopathy syndrome (PRES) have been reported in patients with multiple sclerosis treated with Gilenya. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Contact your doctor immediately if you experience any of these symptoms during treatment with Gilenya, as it could be serious.

Cancer
Skin tumors have been reported in patients with MS treated with Gilenya. Contact your doctor immediately if you notice any new skin nodules (e.g., shiny, pearly nodules), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin (e.g., unusual moles) with changes in color, thickness, or size over time. A skin examination is required before starting Gilenya treatment to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Gilenya. If skin problems occur, your doctor may refer you to a dermatologist who may recommend regular follow-up visits.
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. This increases the risk of developing tumors, particularly skin tumors. You should limit sun and UV exposure:

by wearing appropriate protective clothing.
by regularly applying sunscreen with high UV protection.

Unusual brain lesions associated with an MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with Gilenya. In the event of a severe relapse, your doctor will assess whether an MRI is needed to evaluate this condition and decide whether you should stop taking Gilenya.

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

Women of childbearing potential
Gilenya may harm the unborn child if used during pregnancy. Before starting treatment, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a reminder card explaining why you should not become pregnant while taking Gilenya and what you should do to avoid pregnancy. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping Gilenya treatment
Do not stop taking Gilenya or change your dose without first talking to your doctor.
Contact your doctor immediately if you think your multiple sclerosis is worsening after stopping Gilenya treatment. This can be serious (see “If you stop taking Gilenya” in section 3 and section 4, “Possible side effects”).

Use in the elderly
Experience with Gilenya in patients over 65 years of age is limited. If you have any concerns, consult your doctor.

Children and adolescents
Gilenya is not intended for use in children under 10 years of age, as it has not been studied in pediatric patients with MS in this age group.
The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children, adolescents, and their caregivers:

Before starting Gilenya treatment, your doctor will check your vaccination status. If you have not received certain vaccinations, they may need to be administered before starting Gilenya.
The first time you take Gilenya or when switching from the daily dose of 0.25 mg to the daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeat (see above “slow heart rate (bradycardia) and irregular heartbeat”).
If you experience seizures or epileptic fits before or while taking Gilenya, inform your doctor.
If you suffer from depression or anxiety, or become depressed or anxious during Gilenya treatment, inform your doctor. You may need closer monitoring.

Other medicines and Gilenya
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking any of the following:

Medicines that suppress or modify the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use Gilenya with these medicines, as the effect on the immune system may be intensified (see also “Do not take Gilenya”).
Corticosteroids, due to possible additive effects on the immune system.
Vaccines. If you need to be vaccinated, consult your doctor first. During and up to 2 months after treatment with Gilenya, you must not receive certain types of vaccines (live attenuated vaccines), as they may trigger the infection they are meant to prevent. Other vaccines may not work as well during this period.
Medicines that slow the heart rate (such as beta-blockers, e.g., atenolol). Concomitant use of Gilenya with these medicines may intensify the effect on heart rate in the first days of treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Gilenya if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take Gilenya”).
Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced efficacy of Gilenya).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Do not use Gilenya during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential not using effective contraception. If Gilenya is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in infants exposed to Gilenya during pregnancy is approximately twice the rate observed in the general population (in which the rate of congenital malformations is about 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal malformations.
Therefore, if you are a woman of childbearing potential:

before starting Gilenya treatment, your doctor will inform you of the risks to the unborn child and ask you to take a pregnancy test to ensure you are not pregnant, and
you must use effective contraception during treatment with Gilenya and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a reminder 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 “If you stop taking Gilenya” in section 3 and section 4, “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed while being treated with Gilenya. Gilenya is excreted in breast milk and may cause serious adverse effects in the infant.

Driving and using machines
Your doctor will advise you whether your condition allows you to safely drive vehicles, including bicycles, and use machinery. Gilenya should not affect your ability to drive or use machines.
However, at the start of treatment, you will need to remain at your doctor’s office or in the hospital for 6 hours after taking the first dose of Gilenya. Your ability to drive and use machines may be impaired during this time and potentially afterward.

3. How to take Gilenya

Treatment with Gilenya will be supervised by a physician experienced in the treatment of multiple sclerosis.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

Recommended dose:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
The dose is based on body weight:

Children and adolescents with body weight less than or equal to 40 kg: one 0.25 mg capsule daily.
Children and adolescents with body weight greater than 40 kg: one 0.5 mg capsule daily.
Children and adolescents who start treatment with one 0.25 mg capsule daily and subsequently reach a stable body weight above 40 kg will be instructed by the doctor to switch to one 0.5 mg capsule daily. In this case, repeat the first-dose observation period is recommended.

Do not exceed the recommended dose.
Gilenya is for oral use.
Take Gilenya once daily with a glass of water. Gilenya capsules must always be swallowed whole, without opening them. Gilenya may be taken with or without food.
Taking Gilenya at the same time each day will help you remember to take your medicine.
If you have any questions about how long your treatment with Gilenya should last, consult your doctor or pharmacist.

If you take more Gilenya than you should
If you have taken too many Gilenya capsules, inform your doctor immediately.

If you forget to take Gilenya
If you have been taking Gilenya for less than 1 month and you miss a dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.
If you have been taking Gilenya for at least 1 month and you have missed taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as scheduled.
Never take a double dose to make up for a forgotten dose.

If you stop taking Gilenya
Do not stop taking Gilenya or change the dose without first consulting your doctor.
Gilenya will remain in your body for up to 2 months after stopping treatment. The number of white blood cells (lymphocytes) may remain low during this time, and the side effects described in this leaflet may still occur. After stopping Gilenya, you may need to wait 6–8 weeks before starting a new treatment for multiple sclerosis.
If you need to restart Gilenya after a treatment interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may occur again: therefore, restarting treatment will require observation in a clinic or hospital setting. Do not restart Gilenya after an interruption of more than two weeks without consulting your doctor.
Your doctor will decide whether and how monitoring is needed after stopping Gilenya treatment. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping Gilenya. This may be serious.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be or become serious.

Common (may affect up to 1 in 10 people)

Cough with phlegm, chest discomfort, fever (signs of lung disorders)
Herpes virus infection (shingles or herpes zoster), with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper part of the body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with severe pain
Slow heart rate (bradycardia), irregular heartbeat
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other appearances
Depression and anxiety are known to occur more frequently in the population with MS and have been reported in pediatric patients treated with Gilenya
Weight loss

Uncommon (may affect up to 1 in 100 people)

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the central vision area of the retina, at the back of the eye) with symptoms such as shadows or blind spots in the center of vision, blurred vision, problems distinguishing colors or details
Reduction in platelets in the blood, 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 in size, shape, thickness, or color over time, or new moles. Moles may itch, bleed, or ulcerate
Seizures, epileptic fits (more frequent in children and adolescents than in adults)

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

A condition called reversible posterior encephalopathy syndrome. Symptoms may include sudden onset of 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, an ulcerated lesion with a crust, or a new ulceration on a pre-existing scar

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

Abnormality on electrocardiogram (T-wave inversion)
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma)

Not known (frequency cannot be estimated from the available data)

Allergic reactions, including symptoms such as rash or hives, swelling of the lips, tongue, or face, which are more likely to occur on the first day of treatment with Gilenya
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach area (abdomen), dark urine (brown-colored), unusual loss of appetite, fatigue, and abnormal liver function tests. In a very limited number of cases, liver failure may lead to liver transplantation.
Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may also occur that you may not notice yourself, such as changes in mood or behavior, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important that you contact your doctor as soon as possible
Inflammatory disease 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 painless flesh-colored or bluish-red nodules, often on the face, head, or neck. Merkel cell carcinoma may also present as a hard, painless nodule or mass. Long-term sun exposure and a weakened immune system may influence the risk of developing Merkel cell carcinoma.
After stopping treatment with Gilenya, MS symptoms may reappear and possibly worsen compared to before or during treatment.
Autoimmune form of anemia (reduction in red blood cells) where red blood cells are destroyed (autoimmune hemolytic anemia)

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

Other side effects

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

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 tests showing higher levels of liver enzymes
Cough

Common (may affect up to 1 in 10 people)

Ringworm, a fungal skin infection (pityriasis versicolor)
Dizziness
Severe headache often accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells in the blood (lymphocytes, leukocytes)
Weakness
Skin rash with itching, redness, and burning (eczema)
Itching
Increased blood levels of fats (triglycerides)
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema “Some side effects may be or become serious”)
Hypertension (Gilenya may cause a slight increase in blood pressure)
Muscle pain
Joint pain

Uncommon (may affect up to 1 in 100 people)

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

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

Cancer of the lymphatic system (lymphoma)

Not known (frequency cannot be estimated from the available data)

Peripheral swelling

If any of these side effects become severe, contact your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Gilenya

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
“Exp.”/“EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gilenya contains

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). 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 components are: Capsule contents: mannitol, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). 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.

Description of the appearance of Gilenya and package contents
Gilenya 0.25 mg hard capsules have an opaque ivory-colored body and cap. The black inscription "FTY 0.25mg" is printed on the cap and a black circular band is printed on the body.
Gilenya 0.5 mg hard capsules have an opaque white body and an opaque bright yellow cap. The black inscription "FTY0.5mg" is printed on the cap and two yellow bands are printed on the body.
Gilenya 0.25 mg capsules are available in packs containing 7 or 28 capsules. Not all 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). Not all 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 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu