GILENYA 0.5 MG Hard capsules

Зміст інструкції

1. Gilenya 0.25 mg hard capsules, 0.5 mg hard capsules
   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. How to store Gilenya
   6. Contents of the pack and other information

Gilenya 0.25 mg hard capsules, 0.5 mg hard capsules

Fingolimod

Read this leaflet carefully before you start to take this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What 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 children and adolescents (10 years of age and over) for the treatment
of relapsing-remitting multiple sclerosis (RRMS), 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 to reduce the number of relapses and to slow 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 sheath (called
myelin) that covers the nerves in the CNS and prevents the nerves from functioning as they should. This
process is called demyelination.
Relapsing-remitting MS is characterized by relapsing attacks (relapses) of neurological symptoms
that reflect an inflammatory state of the central nervous system. Symptoms vary from patient to
patient, but usually involve difficulty walking, numbness, visual disturbances or
balance problems. The symptoms of a relapse may disappear completely when the relapse is
over, but some disturbances may persist.

How does Gilenya work
Gilenya helps to protect the nervous system from attacks by the immune system, reducing the
ability of some white blood cells (lymphocytes) to circulate freely within the body and preventing
them from reaching the brain and spinal cord. This limits the damage to the nerves caused
by MS. Gilenya also reduces some of the body's immune responses.

2. What you need to know before you take Gilenya

Do not take Gilenya

• if you have a reduced immune response(due to an immunodeficiency syndrome, a disease or medications that suppress the immune system).
• if your doctor suspects you may have a rare brain infection calledprogressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.
• if you have a serious ongoing infection or a chronic ongoing infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you suffer from severe liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke or warning signs of a stroke orcertain 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 heartbeatsuch as quinidine, disopyramide, amiodarone or sotalol.
• if you are pregnantor are a woman of childbearing potential who is not using effective contraception.
• if you are allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these apply to you or you are not sure, talk to your doctor before takingGilenya.

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 that you have an abnormal electrocardiogram.
• if you experience symptoms of a slow heart rate (e.g., dizziness, nausea or palpitations).
• if you are taking or have recently taken medicines that slow down the heartbeat(such as beta blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesterase drugs or pilocarpine).
• if you have had episodes of sudden loss of consciousness or fainting (syncope) in the past.
• if you are planning to get vaccinated.
• if you have never had chickenpox.
• if you have or have had vision problemsor other signs of swelling in the central vision area (macula) in the back of the eye (a condition known as macular edema, see below), if you have or have had inflammation or infection of the eye (uveitis), or if you suffer from diabetes(which can cause eye problems).
• if you suffer from liver problems.
• if you suffer from high blood pressure that cannot be controlled with medicines.
• if you suffer from severe lung problemsor if you have a smoker's cough. If any of these apply to you or you are not sure, talk to your doctor before takingGilenya.

Slow heartbeat (bradycardia) and irregular heartbeat
At the beginning of treatment or, when switching from a daily dose of 0.25 mg to
administration of the first 0.5 mg dose, Gilenya causes a slowing of the heart rate.
As a result, you may experience dizziness or fatigue, awareness of your
heartbeat or a drop in blood pressure. If these effects are severe, contact your
doctor, as immediate treatment may be necessary.Gilenya can also cause an
irregular heartbeat, especially after the first dose. The irregular heartbeat usually returns
to normal in less than a day. The slow heart rate usually returns to normal within
a month. During this period, clinically significant effects on heart rate are not expected.
The doctor will ask you to remain in the outpatient clinic or hospital for at least 6 hours after
administration of the first dose of Gilenya or, when switching from a daily dose of
0.25 mg, to administration of the first 0.5 mg dose, during which your pulse and blood pressure will be measured every
hour: in this way, appropriate measures can be taken in case of
adverse effects that occur at the beginning of treatment. You must have an
electrocardiogram performed before the administration of the first dose of Gilenya and at the end
of the 6 hours of monitoring. The doctor may continuously monitor your electrocardiogram
during this period. If after 6 hours your heart rate is very low or is
decreasing, or if your electrocardiogram shows abnormalities, you may need to
remain under observation for a longer period (at least for another 2 hours and
possibly until the next morning), until these problems have resolved. The same may
happen if you resume Gilenya after an interruption of treatment, depending on how long
the interruption has been and how long you have been taking Gilenya before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your electrocardiogram is
abnormal, or if you have heart problems or heart failure, Gilenya may not be suitable for you.
If you have had episodes of sudden loss of consciousness or reduced heart rate in the past,
Gilenya may not be suitable for you. You will be visited by a cardiologist (heart specialist) who will give you
instructions on how you should start treatment with Gilenya, including monitoring until the next morning.
If you are taking medicines that can cause a decrease in heart rate, Gilenya
may not be suitable for you. You will be visited by a cardiologist who will assess whether you can take, as
an alternative, medicines that do not decrease the heart rate and allow you to start
treatment with Gilenya. If this change of therapy is not possible, the cardiologist will give you
instructions on how you should 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 to 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. If this situation occurs, your doctor will postpone the start of
treatment with Gilenya until one month after completion of the entire vaccination cycle.
Infections
Gilenya reduces the number of white blood cells (especially lymphocytes). White blood cells fight
infections. While taking Gilenya (and up to 2 months after stopping treatment), you may be more likely to get infections.
Any ongoing infection may worsen. Infections can be serious and life-threatening. If you think you have an infection,
if you have a fever, if you have flu-like symptoms, have shingles or have a headache accompanied by stiffness of the
neck, sensitivity to light, nausea, rash and/or confusion or convulsions (seizures) (these
can be symptoms of meningitis and/or encephalitis caused by a fungal or viral infection with herpes),
contact your doctor immediately, as it may be serious and life-threatening.
In patients treated with Gilenya, human papillomavirus (HPV) infection has been reported, including
papilloma, dysplasia, genital warts and HPV-related cancer. The doctor will assess whether you need
HPV vaccination before starting treatment. If you are a woman, your doctor will also
recommend that you undergo HPV screening.
PML
PML is a rare brain disease caused by an infection that can lead to severe disability or death. The doctor will plan magnetic resonance imaging (MRI) scans before starting treatment and
during treatment to monitor the risk of PML.
If you think that the MS is worsening or if you notice any new symptoms, such as changes
in mood or behavior, new or worsening weakness on one side of the body, changes
in vision, confusion, memory lapses or difficulty with speech and communication, talk to
your doctor as soon as possible. These may be symptoms of PML. Also talk to your partner or caregiver and inform them of the treatment. They may experience symptoms that you may not be aware of yourself.
If you contract PML, it can be treated and treatment with Gilenya will be discontinued. Some
people experience an inflammatory reaction when Gilenya is removed from the body. This
reaction (known as immune reconstitution inflammatory syndrome or IRIS) can lead to
worsening of conditions, including worsening of brain function.
Macular edema
Before starting treatment with Gilenya, if you have or have had vision problems or other signs of swelling
in the central vision area (macula) in the back of the eye, if you have or have had
inflammation or infection of the eye (uveitis) or if you suffer from diabetes, your doctor may ask
you to undergo an eye examination.
The doctor may ask you to undergo an eye examination 3-4 months after starting treatment
with Gilenya.
The macula is a small area of the retina located in the back of the eye that allows you to
see shapes, colors and details clearly. Gilenya can cause swelling of the macula, a
condition that is known as macular edema. Swelling usually occurs within the first 4 months of
treatment with Gilenya.
The possibility of macular edema occurring is greater if you suffer from diabetesor if you have
had an inflammation of the eye called uveitis. In these cases, your doctor will want to subject you to
regular checks to detect the first signs of macular edema.
If you have suffered from macular edema, tell your doctor before resuming treatment with Gilenya.
Macular edema can cause some of the visual symptoms (optic neuritis) that occur during
MS attacks. There may be no symptoms in the early stages. Be sure to tell your doctor
of any changes in vision. The doctor may ask you to undergo an eye examination,
especially if:

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

Liver function tests
If you have severe liver problems, you should not take Gilenya. Treatment with Gilenya may affect
your liver function. You probably won't notice any symptoms, but if you notice yellowing of the
skin or whites of the eyes, abnormally dark urine (brown in color), pain on the right side of the stomach area (abdomen), fatigue, unusual feeling of loss of appetite
or unexplained nausea and vomiting, tell your doctor immediately.
If you experience any of these symptoms after starting treatment with Gilenya, tell your
doctor immediately.
Before, during and after treatment, your doctor will ask you to have blood tests to
check your liver function. If the results indicate a liver problem, it may
be necessary to stop treatment with Gilenya.
High blood pressure
Because Gilenya causes a slight increase in blood pressure, your doctor may subject you to regular
blood pressure checks.
Lung problems
Gilenya has a weak effect on lung function. In patients with severe lung problems
or with a smoker's cough, side effects may occur more easily.
Blood count
The desired effect of treatment with Gilenya is to reduce the number of white blood cells in
the blood. These usually return to normal values within 2 months of stopping treatment. If
you need to undergo blood tests, tell your doctor that you are taking Gilenya. Otherwise, it may not be possible for the doctor to correctly evaluate the test results, and for some
types of tests, the doctor may need to draw more blood than usual.
Before starting treatment with Gilenya, your doctor will confirm whether your number of white blood cells is sufficient, and may ask you to repeat the count regularly. If you do not have
enough white blood cells, it may be necessary to stop treatment with Gilenya.
Reversible posterior encephalopathy syndrome (PRES)
Reversible posterior encephalopathy syndrome (PRES), a syndrome
rarely reported in patients with multiple sclerosis treated with Gilenya. Symptoms may include sudden onset
of severe headache, confusion, seizures and changes in vision. Tell
your doctor immediately if you experience any of these symptoms during treatment with Gilenya because
it can be serious.
Cancer
Skin cancers have been reported in patients with MS treated with Gilenya. See your doctor immediately
if you notice the appearance of any skin nodule (e.g., pearly and shiny nodule), spot or
open sore that does not heal within a few weeks. Symptoms of skin cancer can
include abnormal growths or changes in skin tissue (e.g., unusual moles) with changes in
color, thickness or size over time. Before starting treatment with Gilenya, a
skin check is necessary to check for skin nodules. The doctor will also perform periodic
skin checks during treatment with Gilenya. If you experience skin problems, the doctor
may send you to a dermatologist who, after the visit, may decide that it is important for you to be
visited 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. This increases the risk of developing cancer, in
particular skin cancer. You must limit exposure to the sun and UV rays:

• by wearing appropriate protective clothing.
• by regularly applying sun creams with a high degree of UV protection.

Unusual brain lesions associated with an MS relapse
Rare cases of unusually extensive brain lesions associated with an MS relapse have been reported in patients treated with Gilenya. In case of a severe relapse, the doctor will assess whether to perform an MRI
to evaluate this condition and decide whether it is necessary for you to stop taking Gilenya.
Switching from other treatments to Gilenya
The doctor may switch you directly from treatment with interferon-beta, glatiramer acetate or
dimethyl fumarate to treatment with Gilenya if there are no signs of abnormalities caused by the previous
treatment. The doctor may have you undergo a blood test to rule out such abnormalities. After stopping natalizumab, it may be necessary to wait 2-3 months before
starting treatment with Gilenya. For switching from teriflunomide, the doctor may advise you to
wait for a certain period of time or to proceed with an accelerated elimination
procedure. If you have been treated with alemtuzumab, a careful assessment and
discussion with your doctor is necessary to decide whether Gilenya is suitable for you.
Women of childbearing potential
If you use

zato durante la gravidanza, Gilenya può danneggiare il nascituro. Prima di iniziare il
trattamento con Gilenya, il medico le spiegherà il rischio e le chiederà di sottoporsi ad un test di
gravidanza per assicurarsi che non ci sia una gravidanza in corso. Il medico le consegnerà un
promemoria che spiega perchè non deve iniziare una gravidanza mentre assume Gilenya. Spiega anche
cosa deve fare per evitare una gravidanza mentre assume Gilenya. Deve usare misure contraccettive
efficaci durante il trattamento e per 2 mesi dopo l’interruzione del trattamento (vedere paragrafo
“Gravidanza e allattamento”).
Peggioramento della SM dopo l’interruzione del trattamento con Gilenya
Non interrompa l’assunzione di Gilenya nè cambi la sua dose senza averne parlato prima con il
medico.
Informi immediatamente il medico se pensa che la sua sclerosi multipla stia peggiorando dopo aver
interrotto il trattamento con Gilenya. Ciò può essere grave (vedere “Se interrompe il trattamento con
Gilenya” al paragrafo 3 e anche il paragrafo 4, “Possibili effetti indesiderati”).

Uso negli anziani
L'esperienza con Gilenya in pazienti anziani di età superiore ai 65 anni è limitata. Se ha qualsiasi
dubbio si rivolga al medico.

Bambini e adolescenti
Gilenya non è destinato per un utilizzo nei bambini sotto i 10 anni di età in quanto non è stato studiato
nei pazienti con SM in questo gruppo di età.
Le avvertenze e precauzioni elencate sopra si applicano anche ai bambini e agli adolescenti. Le
seguenti informazioni sono di particolare importanza per i bambini e adolescenti e per le persone che li
assistono:

• Prima di iniziare il trattamento con Gilenya, il medico controllerà lo stato delle sue vaccinazioni. Se non ha effettuato certe vaccinazioni, può essere necessario che le siano somministrate prima dell’inizio del trattamento con Gilenya.
• La prima volta che assume Gilenya oppure quando passa dalla dose giornaliera di 0,25 mg alla dose giornaliera di 0,5 mg, il medico controllerà la frequenza cardiaca e il battito cardiaco (vedere sopra “bassa frequenza cardiaca (bradicardia) e battito cardiaco irregolare”).
• Se manifesta convulsioni o crisi epilettiche prima di assumere o mentre sta assumendo Gilenya, informi il medico.
• Se soffre di depressione o ansia oppure se diventa depresso o ansioso durante la terapia con Gilenya, informi il medico. Può aver bisogno di essere controllato più attentamente.

Altri medicinali e Gilenya
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale. Informi il medico se sta assumendo uno dei seguenti farmaci:

• Medicinali che sopprimono o modificano il sistema immunitario, inclusi altri medicinaliutilizzati per il trattamento della SM,quali interferone beta, glatiramer acetato, natalizumab, mitoxantrone, teriflunomide, dimetilfumarato o alemtuzumab. Non deve usare Gilenya con questi medicinali poichè si può intensificare l’effetto sul sistema immunitario (vedere anche “Non prenda Gilenya”).
• Corticosteroidi, a causa del possibile effetto additivo sul sistema immunitario.
• Vaccini. Se deve fare una vaccinazione, chieda prima consiglio al medico. Durante e fino a 2 mesi dopo il trattamento con Gilenya, non deve ricevere alcuni tipi di vaccini (vaccini vivi attenuati) in quanto possono innescare l'infezione che avrebbero dovuto prevenire. Altri vaccini possono non funzionare bene come al solito se somministrati in questo periodo.
• Medicinali che rallentano il battito cardiaco(quali i beta-bloccanti, come ad esempio atenololo). L'uso concomitante di Gilenya con questi medicinali può intensificare l'effetto sul battito cardiaco nei primi giorni del trattamento con Gilenya.
• Medicinali per il battito cardiaco irregolare, quali chinidina, disopiramide, amiodarone o sotalolo. Non deve usare Gilenya se sta assumendo questo tipo di medicinali perchè possono intensificare l’effetto sul battito cardiaco irregolare (vedere anche ‘Non prenda Gilenya’).
• Altri medicinali: o inibitori delle proteasi, antiinfettivi quali chetoconazolo, antifungini azolici, claritromicina o telitromicina. o carbamazepina, rifampicina, fenobarbitale, fenitoina, efavirenz o erba di San Giovanni (potenziale rischio di ridotta efficacia di Gilenya).

Gravidanza e allattamento
Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza o se sta allattando con latte
materno, chieda consiglio al medico prima di prendere questo medicinale.
Gravidanza
Non usi Gilenya durante la gravidanza, se sta pianificando una gravidanza o se è una donna in età
fertile e non sta usando misure contraccettive efficaci. Se Gilenya è usato durante la gravidanza, vi è il
rischio di danni per il nascituro. Il tasso di malformazioni congenite osservato in neonati esposti a
Gilenya durante la gravidanza è circa 2 volte il tasso osservato nella popolazione generale (nella quale
il tasso di malformazioni congenite è di circa 2-3%). Le malformazioni più frequentemente riportate
includono malformazioni cardiache, renali e muscoloscheletriche.
Pertanto se lei è una donna in età fertile:

• prima di iniziare il trattamento con Gilenya, il medico la informerà sul rischio per il nascituro e le chiederà di sottoporsi ad un test di gravidanza per assicurarsi che non ci sia una gravidanza in corso, e
• deve usare misure contraccettive efficaci durante l’assunzione di Gilenya e per due mesi dopo l’interruzione del trattamento per evitare una gravidanza. Parli con il suo medico dei metodi di contraccezione affidabili.

Il medico le consegnerà un documento promemoria che spiega perchè non deve iniziare una
gravidanza mentre assume Gilenya.

Se inizia una gravidanza durante il trattamento con Gilenya, informi il medico immediatamente.
Il medico deciderà di interrompere il trattamento (vedere “Se interrompe il trattamento con Gilenya” al
paragrafo 3 e anche il paragrafo 4, “Possibili effetti indesiderati”). Dovrà anche sottoporsi a controlli
prenatali specializzati
Allattamento

Non allatti con latte materno durante il trattamento con Gilenya. Gilenya viene escreto nel latte
materno con il rischio di gravi effetti indesiderati per il neonato.

Guida di veicoli e utilizzo di macchinari
Il medico le dirà se la sua malattia le permette di guidare veicoli, compresa la bicicletta, e di usare
macchinari in modo sicuro. Gilenya non dovrebbe influire sulla capacità di guidare veicoli e sull'uso di
macchinari.
Comunque, all’inizio del trattamento dovrà trattenersi presso l’ambulatorio del medico o in ospedale
per 6 ore dopo aver preso la prima dose di Gilenya. La capacità di guidare veicoli e usare macchinari
può essere compromessa in questo intervallo di tempo e potenzialmente anche dopo.

3. How to take Gilenya

Treatment with Gilenya will be supervised by a doctor experienced in the treatment of multiple
sclerosis.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor.
The recommended dose is:

Adults:
The dose is one 0.5 mg capsule once a day.
Children and adolescents (10 years of age and over):
The dose depends on body weight:

• Children and adolescents with a body weight equal to or less than 40 kg: one 0.25 mg capsule per day.
• Children and adolescents with a body weight greater than 40 kg: one 0.5 mg capsule per day. Children and adolescents who start treatment with a 0.25 mg capsule per day and subsequently reach a stable body weight above 40 kg will be instructed by the doctor to switch to treatment with 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 for oral use.
Take Gilenya once a day with a glass of water. Gilenya capsules must always be
swallowed whole, without opening them. Gilenya can be taken with or without food.
Taking Gilenya every day at the same time will help you remember when to take the medicine.
If you have any doubts about the duration of treatment with Gilenya, ask 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 forget to take 1 dose for a whole day, contact
your doctor before taking the next dose. The doctor may decide to observe you when you take the next
dose.
If you have been taking Gilenya for at least 1 month and have forgotten to take the medicine for more than
2 weeks, contact your doctor before taking the next dose. The doctor may decide to
observe you when you take the next dose. However, if you have forgotten to take the
medicine for 2 weeks or less, you can take the next dose as planned.
Never take a double dose to make up for a missed dose.

If you stop taking Gilenya
Do not stop taking Gilenya and do not change the dose without first contacting your doctor.
Gilenya will remain in the body for up to 2 months after stopping treatment. The number of white
blood cells (lymphocytes) may remain low during this period and the undesirable effects described in this
leaflet may still occur. After stopping treatment with Gilenya, you may need to wait 6-8 weeks before
starting a new treatment for multiple sclerosis.
If it is necessary to restart taking Gilenya after more than 2 weeks of interruption of
treatment, the effect on heart rate that normally occurs at the beginning of treatment
may occur again: to restart treatment, it will therefore be necessary to stay in
outpatient or hospital under observation. Do not restart treatment with Gilenya after
stopping it for more than two weeks without consulting your doctor.
The doctor will decide whether and how you need to be monitored after stopping treatment with
Gilenya. Immediately inform your doctor if you think there is a worsening of multiple
sclerosis after stopping treatment with Gilenya. This may be serious.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 problems)
• 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 on the face. Other symptoms may include fever and weakness in the early stages of the infection, followed by numbness, itching or red spots with severe pain
• Slow heartbeat (bradycardia), irregular heartbeat
• A type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, although it can also take on other appearances
• Depression and anxiety are known to occur with increased frequency in the population affected by 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 area of central vision 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
• Reduced platelets in the blood, 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 may change in size, shape, thickness or color over time, or new moles. Moles may itch, bleed or ulcerate
• Convulsions, epileptic seizures (more frequent in children and adolescents than in adults)

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

• A syndrome called reversible posterior encephalopathy syndrome. Symptoms may include sudden onset of severe headache, confusion, convulsions 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 hard, red nodule, an ulcer with a crust, or a new ulcer on a pre-existing scar

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

• Abnormality on the electrocardiogram (T-wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

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

• Allergic reactions, including symptoms of skin 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 upper part of the abdomen, dark urine (brown in color), unusual feeling of 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). The symptoms of PML may be similar to an MS relapse. Symptoms that you may not be personally aware of may also occur, such as changes in mood or behavior, memory lapses, difficulty with speech and communication, which may require further medical evaluation to rule out the risk of PML. Therefore, if you feel that your MS is worsening or if you or someone close to you notices any new or unusual symptoms, it is very important that you see 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 stiff neck, 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 can also appear as a painless hard nodule or a mass. Long-term sun exposure and a weakened immune system can influence the risk of developing Merkel cell carcinoma.
• After stopping treatment with Gilenya, the symptoms of MS may reappear and possibly worsen compared to how they were before or during treatment.
• Autoimmune form of anemia (decrease in red blood cells) where red blood cells are destroyed (autoimmune hemolytic anemia).

If any of these side effects occur, tell 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)

• Tinea, 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 levels of fats (triglycerides) in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the paragraph regarding macular edema “Some side effects may be or become serious”)
• High blood pressure (Gilenya can cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon(may affect up to 1 in 100 people)

• Low levels of some 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 edema

If any of these side effects occur severely, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you 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 package and blister after
“Scad.”/“EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Store in the original package to protect the medicine from moisture.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gilenya contains

• The active ingredient is fingolimod.

Gilenya hard capsules 0.25 mg

• Each capsule contains 0.25 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule contents: mannitol, hydroxypropylcellulose, hydroxypropyl betadex, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). Ink: lacquer (E904), black iron oxide (E172), propylene glycol (E1520), ammonia solution, concentrated (E527).

Gilenya hard capsules 0.5 mg

• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule contents: mannitol, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). Ink: lacquer (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 Gilenya and contents of the pack
Gilenya 0.25 mg hard capsules have an opaque ivory-colored body and cap. The inscription
“FTY 0.25mg” in black color is engraved on the cap and a black circular band on the body.
Gilenya 0.5 mg hard capsules have an opaque white body and an opaque intense yellow cap.
The inscription “FTY0.5mg” in black color is engraved on the cap and two yellow bands are engraved 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
multipacks containing 84 capsules (3 packs of 28 capsules). Not all pack sizes may be marketed.

Marketing Authorisation 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, contact the local representative of the marketing
authorisation 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

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká 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

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

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

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