Fingolimod Mylan Italia: detailed information

Package leaflet: Information for the user

Fingolimod Mylan Italia 0.5 mg hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any 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 you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Fingolimod Mylan Italia is and what it is used for
What you need to know before taking Fingolimod Mylan Italia
How to take Fingolimod Mylan Italia
Possible side effects
How to store Fingolimod Mylan Italia
Contents of the pack and other information

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

What Fingolimod Mylan Italia is
Fingolimod Mylan Italia contains the active substance fingolimod.
What Fingolimod Mylan Italia is used for
Fingolimod Mylan Italia 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 another treatment for MS, or
Patients with rapidly evolving severe MS.

Fingolimod Mylan Italia does not cure MS, but helps reduce the number of relapses and slows the progression of physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease affecting 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 the nerves' ability to function properly. 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 involve difficulty walking, numbness, vision or balance problems. Symptoms of a relapse may completely disappear when the relapse ends, although some impairments may persist.
How Fingolimod Mylan Italia works
Fingolimod Mylan Italia 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. Fingolimod Mylan Italia also reduces some of the body's immune responses.

2. What you should know before taking Fingolimod Mylan Italia

Do not take Fingolimod Mylan Italia

if you have a weakened immune response (due to immunodeficiency syndrome, an illness, or medicines 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 have severe liver problems.
if you have had a heart attack, angina, stroke, or a transient ischaemic attack (TIA) within the past 6 months, or certain types of heart failure.
if you have certain types of irregular or abnormal heart rhythm (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Mylan Italia.
if you are taking or have recently taken medicines for irregular heart rhythm 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 apply 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 serious breathing problems during sleep (severe sleep apnoea).
if you have been told you have an abnormal electrocardiogram (ECG).
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 the heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, 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 visual disturbances or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular oedema, 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 serious lung problems or a smoking-related cough. If any of these apply to you, inform your doctor before taking Fingolimod Mylan Italia.

Slow heart rate (bradycardia) and irregular heart rhythm
At the start of treatment, or when switching from the daily 0.25 mg dose to 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 immediately, as immediate treatment may be required. Fingolimod Mylan Italia may also cause an irregular heart rhythm, especially after the first dose. Irregular heart rhythm usually returns to normal within less than a day. The slow heart rate typically returns to normal within one month. During this time, 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 Fingolimod Mylan Italia, or when switching from the daily 0.25 mg dose to the first 0.5 mg dose. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if side effects occur at the beginning of treatment. You must have an electrocardiogram (ECG) performed before the first dose of Fingolimod Mylan Italia and again at the end of the 6-hour monitoring period. Your doctor may monitor your ECG continuously 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 Fingolimod Mylan Italia after a treatment interruption, 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 heart rhythm, if your ECG is abnormal, or if you have heart problems or heart failure, Fingolimod Mylan Italia may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or a slow heart rate, Fingolimod Mylan Italia 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 Fingolimod Mylan Italia, including monitoring until the next morning.
If you are taking medicines that can slow your heart rate, Fingolimod Mylan Italia may not be suitable for you. You will be evaluated by a cardiologist who will determine whether you can switch to alternative medicines that do not slow the heart rate, allowing you to start treatment with Fingolimod Mylan Italia. If such a change in therapy is not possible, the cardiologist will advise you 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 against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be needed before starting treatment with Fingolimod Mylan Italia. If this applies, your doctor will delay the start of treatment with Fingolimod Mylan Italia until one month after completing the full vaccination course.

Infections
Fingolimod Mylan Italia reduces the number of white blood cells (particularly lymphocyte count). White blood cells fight infections. While taking Fingolimod Mylan Italia (and for up to 2 months after stopping treatment), you may be more likely to develop infections. Any existing infection may worsen. Infections can be serious and life-threatening. If you think you have an infection, have a fever, flu-like symptoms, herpes zoster, or have 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 a fungal or herpes viral infection), contact your doctor immediately, as this could be serious and life-threatening.
In patients treated with fingolimod, human papillomavirus (HPV) infection has been reported, including warts, dysplasia, condyloma, and HPV-related cancers. 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 feel that your multiple sclerosis (MS) is worsening or if you notice any new symptoms, such as changes in mood or behaviour, new or worsening weakness on one side of the body, changes in vision, confusion, memory lapses, or language and communication difficulties, speak to your doctor as soon as possible. These may be symptoms of PML. Talk also to your partner or caregiver and inform them about your treatment. They may notice symptoms you might not be aware of.
If you develop PML, it can be treated, and treatment with Fingolimod Mylan Italia will be stopped. Some people experience an inflammatory reaction when Fingolimod Mylan Italia is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may lead to worsening of the condition, including worsening brain function.

Macular oedema
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) 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 have an eye examination.
Your doctor may also 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 at the back of the eye that allows you to see shapes, colours, and fine details clearly. Fingolimod Mylan Italia can cause swelling of the macula, a condition known as macular oedema. Swelling usually occurs within the first 4 months of treatment with Fingolimod Mylan Italia.
The risk of macular oedema is higher if you have diabetes or have previously had eye inflammation called uveitis. In such cases, your doctor may recommend regular check-ups to detect early signs of macular oedema.
If you have previously had macular oedema, talk to your doctor before restarting treatment with Fingolimod Mylan Italia.
Macular oedema can cause some of the visual symptoms (optic neuritis) that also occur during MS relapses. In the early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision. Your 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 difficulty distinguishing colours or fine details.

Liver function tests
You must not take Fingolimod Mylan Italia if you have severe liver problems. 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 whites of the eyes, abnormally dark-coloured urine (brown), pain on the right side of the stomach area (abdomen), fatigue, unusual loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.
If you experience any of these symptoms after starting treatment with Fingolimod Mylan Italia, inform your doctor immediately.
Before, during, and after treatment, your doctor will ask you to have blood tests to monitor liver function. If results indicate a liver problem, treatment with Fingolimod Mylan Italia may need to be stopped.

High blood pressure
Since Fingolimod Mylan Italia causes a slight increase in blood pressure, your doctor may monitor your blood pressure regularly.

Lung problems
Fingolimod Mylan Italia has a mild effect on lung function. Patients with severe lung problems or smoking-related cough may be more likely to experience side effects.

Blood count
The intended effect of treatment with Fingolimod Mylan Italia 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 Fingolimod Mylan Italia. Otherwise, your doctor may not be able to interpret test results correctly, and for some tests, your doctor may need to collect more blood than usual.
Before starting treatment with Fingolimod Mylan Italia, your doctor will confirm that your white blood cell count is sufficient and may ask you to have regular blood counts. If your white blood cell count is too low, treatment with Fingolimod Mylan Italia may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)
PRES has been rarely reported in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Fingolimod Mylan Italia, as it could be serious.

Cancer
Skin tumours have been reported in patients with MS treated with fingolimod. 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 colour, thickness, or size over time. A skin examination is required before starting treatment with Fingolimod Mylan Italia to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may recommend regular follow-up examinations.
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 tumours, particularly skin tumours. You should limit exposure to sunlight and UV rays:

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 fingolimod. In case of a severe relapse, your doctor will assess whether an MRI is needed to evaluate this condition and decide whether you should 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 Fingolimod Mylan Italia if there are no signs of abnormalities caused by 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 fingolimod treatment. For switching from teriflunomide, your doctor may advise you to wait for a certain period or proceed with an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether Fingolimod Mylan Italia is suitable for you.

Women of childbearing potential
Fingolimod Mylan Italia may harm the unborn child if used during pregnancy. Before starting treatment with Fingolimod Mylan Italia, 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 must not become pregnant while taking Fingolimod Mylan Italia 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 treatment with Fingolimod Mylan Italia
Do not stop taking Fingolimod Mylan Italia or change your dose without first talking to your doctor.
Inform your doctor immediately 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 patients aged over 65 years is limited. If you have any concerns, 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 of particular importance for children, adolescents, and their caregivers:

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

Other medicines and Fingolimod Mylan Italia
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 Fingolimod Mylan Italia with these medicines, as this 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 a vaccination, consult your doctor first. During and up to 2 months after treatment with Fingolimod Mylan Italia, 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 Fingolimod Mylan Italia with these medicines may intensify the effect on heart rate in the first days of treatment with Fingolimod Mylan Italia.
Medicines for irregular heart rhythm, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Fingolimod Mylan Italia if you are taking these medicines, as they may intensify the effect on irregular heart rhythm (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 effectiveness of Fingolimod Mylan Italia).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, 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 not using effective contraception. 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 infants exposed to fingolimod during pregnancy is about twice the rate observed in the general population (in which the rate of congenital malformations is approximately 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal abnormalities.
Therefore, if you are a woman of childbearing potential:

before starting treatment with Fingolimod Mylan Italia, your doctor will inform you of the risk 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 Fingolimod Mylan Italia 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 must not become pregnant while taking Fingolimod Mylan Italia.
If you become pregnant while taking Fingolimod Mylan Italia, inform your doctor immediately. Your 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 specialized prenatal monitoring.

Breastfeeding
Do not breastfeed while taking Fingolimod Mylan Italia. Fingolimod Mylan Italia is excreted in breast milk, with a risk of serious side effects for the infant.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive vehicles, including bicycles, and use machines safely. Fingolimod Mylan Italia 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 hospital for 6 hours after taking the first dose of Fingolimod Mylan Italia. Your ability to drive or use machines may be impaired during this time and potentially afterwards.

3. How to take Fingolimod Mylan Italia

Treatment with Fingolimod Mylan Italia must be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents with body weight less than or equal to 40 kg: one 0.25 mg capsule daily. Other medicinal products containing fingolimod at lower strengths (e.g. 0.25 mg capsules) are available on the market.
Children and adolescents with body weight above 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, repeating the first-dose observation period is recommended.
Do not exceed the recommended dose.
Fingolimod Mylan Italia is for oral use.
Take Fingolimod Mylan Italia once daily with a glass of water. Fingolimod Mylan Italia capsules must always be swallowed whole and must not be opened. Fingolimod Mylan Italia may be taken with or without food.
Taking Fingolimod Mylan Italia at the same time each day will help you remember when to take your medicine.
If you have any doubts about how long treatment with Fingolimod Mylan Italia should continue, consult 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 you forget to take one 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 Fingolimod Mylan Italia 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 up to 2 weeks, you may take the next dose as planned.
Never take a double dose to make up for a forgotten dose.
If you stop taking Fingolimod Mylan Italia
Do not stop taking Fingolimod Mylan Italia or change the dose without first consulting your doctor.
Fingolimod Mylan Italia 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 treatment with Fingolimod Mylan Italia, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.
If it is necessary to restart Fingolimod Mylan Italia after an 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 requires observation in an outpatient clinic or hospital setting. Do not restart treatment with Fingolimod Mylan Italia after an interruption of more than two weeks without first consulting your doctor.
Your doctor will decide whether and how monitoring is needed after stopping treatment with Fingolimod Mylan Italia. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Fingolimod Mylan Italia. This may be serious.
If you have any questions about the use of this medicine, consult 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 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 with increased frequency in people with 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 central 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 blood platelets which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that 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 (PRES). 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 hard, 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):

Abnormal electrocardiogram (ECG) (T-wave inversion)
Tumour 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 skin rash or hives, swelling of the lips, tongue or face, which are 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 right side of the abdomen, dark (brown-colored) urine, 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 Fingolimod Mylan Italia (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 appear as a firm, 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 Fingolimod Mylan Italia, MS symptoms may recur 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 levels of blood 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 (Fingolimod Mylan Italia 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 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30ºC.
Store in the original packaging to protect the medicine from moisture.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fingolimod Mylan Italia contains

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

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

Marketing Authorization 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 European Economic Area countries under the following names:
NL: Fingolimod Viatris
IT: Fingolimod Mylan Italia