FINGOLIMOD 0.5 MG Капсулы твердые

Содержание инструкции

1. Fingolimod Mylan Italia 0,5 mg hard capsules
   1. What is Fingolimod Mylan Italia and what it is used for
   2. What you need to know before taking Fingolimod Mylan Italia
   3. How to take Fingolimod Mylan Italia
   4. Possible side effects
   5. How to store Fingolimod Mylan Italia
   6. Contents of the pack and other information

Fingolimod Mylan Italia 0,5 mg hard capsules

Generic medicine
Read this leaflet carefully before taking 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 they have the same symptoms as you, as it could 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 Fingolimod Mylan Italia is and what it is used for
• 2. What you need to know before you take Fingolimod Mylan Italia
• 3. How to take Fingolimod Mylan Italia
• 4. Possible side effects
• 5. How to store Fingolimod Mylan Italia
• 6. Contents of the pack and other information

1. What is Fingolimod Mylan Italia and what it is used for

What isFingolimod Mylan Italia
Fingolimod Mylan Italia contains the active substance fingolimod.

What is Fingolimod Mylan Italia used for
Fingolimod Mylan Italia 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 a treatment for MS or
• Patients with rapidly evolving severe MS.

Fingolimod Mylan Italia 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 or balance disturbances. The symptoms of a relapse
may disappear completely when the relapse is over, but some disorders may persist.

How does Fingolimod Mylan Italia work
Fingolimod Mylan Italia 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. Fingolimod
Mylan Italia also reduces some of the body's immune reactions.

2. What you need to know before taking Fingolimod Mylan Italia

Do not take Fingolimod Mylan Italia

• if you have a reduced immune response (due to an immunodeficiency syndrome, a disease or medications that suppress the immune system).
• if you have a serious ongoing infection or a chronic ongoing infection such as hepatitis or tuberculosis.
• if you have an 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 or certain types of heart failure.
• if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Mylan Italia.
• 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 contraceptive measures.
• if you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6). If any of these applies to you, talk to your doctor before taking Fingolimod Mylan Italia.

Warnings and precautions
Talk to your doctor before taking Fingolimod Mylan Italia:

• 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 intend to get vaccinated.
• if you have never had chickenpox.
• if you have or have had visual disturbances or other signs of swelling in the central area of vision (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 by medicines.
• if you suffer from severe lung problems or if you have a smoker's cough. If any of these apply to you, tell your doctor before taking Fingolimod Mylan Italia.

Slow heartbeat (bradycardia) and irregular heartbeat
At the beginning of treatment or when switching from a daily dose of 0.25 mg to the administration of the
first 0.5 mg dose, Fingolimod Mylan Italia 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. Fingolimod Mylan Italia can also cause an irregular heartbeat, especially after the first
dose. The irregular heartbeat usually returns to normal within 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 the administration
of the first dose of Fingolimod Mylan Italia or when switching from a daily dose of 0.25 mg to the
administration of the first 0.5 mg dose, during which your pulse and blood pressure will be measured hourly:
this will allow appropriate measures to 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 Fingolimod Mylan Italia and at the end of the 6-hour monitoring period. The doctor may monitor your
electrocardiogram continuously during this period. If after 6 hours your heart rate is very
low or is decreasing, or if your electrocardiogram shows abnormalities, it may be
necessary for you 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
Fingolimod Mylan Italia after an interruption of treatment, depending on how long the interruption was and
how long you had been taking Fingolimod Mylan Italia 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, Fingolimod Mylan Italia may not be suitable for you.
If you have had episodes of sudden loss of consciousness or reduced heart rate in the past, Fingolimod
Mylan Italia may not be suitable for you. You will be visited by a cardiologist (heart specialist) who will give you
instructions on how to start treatment with Fingolimod Mylan Italia, including monitoring until
the next morning.
If you are taking medicines that can cause a decrease in heart rate, Fingolimod Mylan Italia
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 Fingolimod
Mylan Italia. If this change of therapy is not possible, the cardiologist will give you instructions on how to
start treatment with Fingolimod Mylan Italia, 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
Fingolimod Mylan Italia. If this situation occurs, your doctor will postpone the start of treatment with
Fingolimod Mylan Italia until one month after completion of the entire vaccination cycle.
Infections
Fingolimod Mylan Italia reduces the number of white blood cells (especially lymphocytes). White blood cells
fight infections. While taking Fingolimod Mylan Italia (and up to 2 months after stopping the
treatment), you may be more likely to get infections. Any existing 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, shingles, or headache accompanied by stiff neck, sensitivity to light,
nausea, rash and/or confusion or convulsions (seizures) (these may be symptoms of meningitis and/or
encephalitis caused by a fungal or viral infection), contact your doctor immediately, as it may be
serious and life-threatening.
If you think that the MS is getting worse (for example, if you experience weakness or vision problems) or if you notice any
new symptoms, see your doctor immediately as these may be symptoms of a rare brain disorder caused by an infection and called progressive multifocal leukoencephalopathy (PML). PML is a
serious condition that can lead to severe disability or death. Your doctor will consider performing
an MRI to assess this condition and decide whether you should stop taking Fingolimod Mylan Italia.
In patients treated with fingolimod, human papillomavirus (HPV) infection has been reported, including papilloma,
dysplasia, condyloma and HPV-related cancer. Your doctor will assess whether you need vaccination against
HPV before starting treatment. If you are a woman, your doctor will also recommend that you undergo HPV screening.
Macular edema
Before starting treatment with Fingolimod Mylan Italia, if you have or have had visual disturbances or other signs of swelling
in the central area of vision (macula) in the back of the eye, if you have or have had inflammation or
eye infection (uveitis) or if you suffer from diabetes, your doctor may ask you to have an eye examination.
The doctor may ask you to have an eye examination 3-4 months after starting treatment with Fingolimod
Mylan Italia.
The macula is a small area of the retina located in the back of the eye. Fingolimod Mylan Italia can
cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Fingolimod Mylan Italia.
The likelihood of macular edema is higher if you suffer from diabetesor have had an 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 suffered from macular edema, tell your doctor before resuming treatment with Fingolimod Mylan Italia.
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 about any changes in
vision. The doctor may ask you to have 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 trouble distinguishing colors or fine details.

Liver function tests
If you have severe liver problems, you should not take Fingolimod Mylan Italia. Treatment with Fingolimod Mylan
Italia may affect your liver function. You may not notice any symptoms, but if you notice yellowing
of the skin or the whites of your eyes, abnormally dark urine (brown in color), pain in the
right side of the abdomen, fatigue, an 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 Fingolimod Mylan Italia, 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 discontinue treatment with Fingolimod Mylan Italia.
High blood pressure
Because Fingolimod Mylan Italia causes a slight increase in blood pressure, your doctor may perform regular checks
of your blood pressure.
Lung problems
Fingolimod Mylan Italia has a weak effect on lung function. Adverse effects may occur more easily in patients with severe
lung problems or with smoker's cough.
Blood count
The desired effect of treatment with Fingolimod Mylan Italia is to reduce the number of white blood cells in
the blood. These usually return to normal values within 2 months of the end of treatment. If you need to
undergo blood tests, tell your doctor that you are taking Fingolimod Mylan Italia. Otherwise, it may not be possible for the doctor to correctly assess the test results, and for some types of tests the doctor may
need to draw more blood than usual.
Before starting treatment with Fingolimod Mylan Italia, 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 discontinue treatment with Fingolimod Mylan Italia.
Reversible posterior encephalopathy syndrome (PRES)
A syndrome called reversible posterior encephalopathy syndrome (PRES) has been rarely reported in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden onset of severe headache,
confusion, seizures, and visual disturbances. Tell your doctor immediately if you experience any of these symptoms during treatment with
Fingolimod Mylan Italia, as it may be serious.
Cancer
Skin cancers have been reported in patients with MS treated with fingolimod. 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 may 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 Fingolimod Mylan Italia, a skin check should be performed to check for
skin nodules. Your doctor will also perform periodic skin checks during treatment with Fingolimod
Mylan Italia. If you have skin problems, your doctor may refer 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 fingolimod.
Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing cancer, especially skin cancer. You must limit exposure to the sun and UV rays:

• by wearing appropriate protective clothing.
• by regularly applying sunscreens 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 fingolimod. In case of a severe relapse, the doctor will assess whether to perform an MRI to assess this
condition and decide whether it is necessary to stop taking Fingolimod Mylan Italia.
Switching from other treatments to Fingolimod Mylan Italia
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate or dimethyl fumarate to
treatment with Fingolimod Mylan Italia if there are no signs of abnormalities caused by the previous treatment. Your 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 fingolimod. For switching
from teriflunomide, your 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 Fingolimod Mylan Italia is suitable for you.
Women of childbearing potential
If used during pregnancy, Fingolimod Mylan Italia can harm the unborn child. Before starting
treatment with Fingolimod Mylan Italia, your doctor will explain the risk to you and ask you to undergo a pregnancy test to make sure there is no pregnancy in progress

The doctor will give you a reminder explaining
why you should not become pregnant while taking Fingolimod Mylan Italia. It also explains what you should do to
avoid pregnancy while taking Fingolimod Mylan Italia. You must use effective contraceptive measures during
treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).
Worsening of MS after stopping treatment with Fingolimod Mylan Italia
Do not stop taking Fingolimod Mylan Italia or change your dose without first talking to your
doctor.
Immediately inform your doctor if you think your multiple sclerosis is worsening after stopping
treatment with Fingolimod Mylan Italia. This may be serious (see “If you stop taking Fingolimod
Mylan Italia” in section 3 and also section 4, “Possible side effects”).

Use in the elderly
Experience with Fingolimod Mylan Italia in elderly patients over 65 years of age is limited. If you have any
doubts, consult your doctor.

Children and adolescents
Fingolimod Mylan Italia is not intended for use in children under 10 years of age as it has not been
studied in 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 and adolescents and for those who care for them:

• Before starting treatment with Fingolimod Mylan Italia, your doctor will check your vaccination status. If you have not had certain vaccinations, you may need to be given them before starting treatment with Fingolimod Mylan Italia.
• The first time you take Fingolimod Mylan Italia or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will check your heart rate and heartbeat (see above “slow heart rate (bradycardia) and irregular heartbeat”).
• If you have seizures or convulsions before taking or while taking Fingolimod Mylan Italia, tell your doctor.
• If you suffer from depression or anxiety or become depressed or anxious during therapy with Fingolimod Mylan Italia, tell your doctor. You may need to be monitored more closely.

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

• Medicines that suppress or modify the immune system, including other medicines used for thetreatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate or alemtuzumab. You should not use Fingolimod Mylan Italia with these medicines as it may intensify the effect on the immune system (see also “Do not take Fingolimod Mylan Italia”).
• Corticosteroids, due to the possible additive effect on the immune system.
• Vaccines. If you need to be vaccinated, ask your doctor for advice first. During and up to 2 months after treatment with Fingolimod Mylan Italia, you should not receive certain types of vaccines (live attenuated vaccines) as they may trigger the infection they were intended to prevent. Other vaccines may not work as well as usual if given during this period.
• Medicines that slow down the heartbeat(such as beta-blockers, for example atenolol). Concomitant use of Fingolimod Mylan Italia with these medicines may intensify the effect on the heartbeat in the first few days of treatment with Fingolimod Mylan Italia.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. You should not use Fingolimod Mylan Italia if you are taking these medicines because they may intensify the effect on irregular heartbeat (see also ‘Do not take Fingolimod Mylan Italia’).
• Other medicines:
• protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz or St John's wort (potential risk of reduced efficacy of Fingolimod Mylan Italia).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, ask your
doctor for advice before taking this medicine.
Pregnancy
Do not use Fingolimod Mylan Italia during pregnancy, if you are planning a pregnancy or if you are a woman of
childbearing potential and are not using effective contraceptive measures. If Fingolimod Mylan Italia is used during pregnancy, there is a
risk of harm to the unborn child. The rate of congenital malformations observed in newborns exposed to fingolimod
during pregnancy is approximately 2 times the rate observed in the general population (in which the rate of
congenital malformations is approximately 2-3%). The most frequently reported malformations include heart, kidney and musculoskeletal
malformations.
Therefore, if you are a woman of childbearing potential:

• before starting treatment with Fingolimod Mylan Italia, your doctor will inform you about the risk to the unborn child and ask you to undergo a pregnancy test to make sure you are not pregnant, and
• you must use effective contraceptive measures while taking Fingolimod Mylan Italia and for two months after stopping treatment to avoid pregnancy. Talk to your doctor about reliable methods of contraception.

Your doctor will give you a reminder document explaining why you should not become pregnant while
taking Fingolimod Mylan Italia.

If you become pregnant during treatment with Fingolimod Mylan Italia, tell your doctor
immediately.The doctor will decide to stop treatment (see “If you stop taking Fingolimod
Mylan Italia” in section 3 and also section 4, “Possible side effects”). You will also
need to have specialized prenatal check-ups.
Breastfeeding

Do not breastfeed during treatment with Fingolimod Mylan Italia. Fingolimod is excreted into
breast milk with the risk of serious side effects for the newborn.

Driving and using machines
Your doctor will tell you if your illness allows you to drive vehicles, including bicycles, and use machines in a
safe manner. Fingolimod Mylan Italia should not affect your ability to drive vehicles and use
machines.
However, at the beginning of treatment you should remain at the doctor's office or in hospital for 6 hours after
taking the first dose of Fingolimod Mylan Italia. The ability to drive vehicles and use machines may be
impaired during this time and potentially also afterwards.

3. How to take Fingolimod Mylan Italia

Treatment with Fingolimod Mylan Italia 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 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. Other medicines containing fingolimod with a lower dosage (e.g. 0.25 mg capsules) are available on the market.
• 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.
Fingolimod Mylan Italia is for oral use.
Take Fingolimod Mylan Italia once a day with a glass of water. The Fingolimod Mylan Italia capsules
must always be swallowed whole, without opening them. Fingolimod Mylan Italia can be taken with or without food.
Taking Fingolimod Mylan Italia every day at the same time will help you remember when to take the medicine.
If you have doubts about the duration of treatment with Fingolimod Mylan Italia, ask your doctor or pharmacist.

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

If you forget to take Fingolimod Mylan Italia
If you have been taking Fingolimod Mylan Italia for less than 1 month and forget to take 1 dose for an entire 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 Fingolimod Mylan Italia 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 a
maximum of 2 weeks, you can take the next dose as planned.
Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Mylan Italia
Do not stop taking Fingolimod Mylan Italia or change the dose without first contacting your
doctor.
Fingolimod Mylan Italia 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 Fingolimod Mylan Italia, you may need to
wait 6-8 weeks before starting a new treatment for multiple sclerosis.
If it is necessary to restart taking Fingolimod Mylan Italia 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 remain in the outpatient clinic or hospital under
observation. Do not restart treatment with Fingolimod Mylan Italia after interrupting 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 Fingolimod
Mylan Italia. Immediately inform your doctor if you think there is a worsening of multiple sclerosis after
stopping treatment with Fingolimod Mylan Italia. This may be serious.
If you have any questions about 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 everybody 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 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
• It is known that depression and anxiety occur with an increased frequency in the population affected by MS and have been reported in pediatric patients treated with fingolimod
• 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 (PRES). 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 may 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 is more likely to occur on the first day of treatment with Fingolimod Mylan Italia
• Signs of liver disease (including liver failure), such as yellowing of the skin or the whites of the eyes (jaundice), nausea or vomiting, pain in the upper right part of the stomach (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). PML symptoms 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 gaps, difficulty with speech and communication, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think your MS is getting worse 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
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiffness of the 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 lumps, often on the face, head or neck. Merkel cell carcinoma may 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 Fingolimod Mylan Italia, the symptoms of MS may return 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 (Fingolimod Mylan Italia 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 (swelling)

If any of these side effects become severe, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fingolimod Mylan Italia

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 on the blister after “Exp.”. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30ºC.
Store in the original package to protect the medicine from moisture.
Do not use damaged packages or those showing signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fingolimod Mylan Italia contains

• The active ingredient is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule contents: potassium citrate monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate Capsule shell: gelatin, titanium dioxide (E171) Capsule cap: gelatin, titanium dioxide (E171), yellow iron oxide (E172)

Description of the appearance of Fingolimod Mylan Italia and contents of the pack
The hard capsules of Fingolimod Mylan Italia 0.5 mg (16 mm, size 3) have a white body and a yellow cap.
The hard capsules of Fingolimod Mylan Italia 0.5 mg are available in packs containing 28 capsules.

Marketing Authorisation Holder
Mylan S.p.A., via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
Synthon Hispania S.L., C/ Castelló no 1, Pol. Las Salinas, 08830 Sant Boi de Llobregat, Barcelona, Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
NL: Fingolimod Viatris
IT: Fingolimod Mylan Italia