Package Insert: Information for the Patient

Fingolimod Mylan 0.5 mg Hard Capsules

fingolimod

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Fingolimod Mylan

Fingolimod Mylan contains the active ingredient fingolimod.

What is Fingolimod Mylan used for

Fingolimod Mylan is used in adults and in children and adolescents (10 years of age and older) to treat relapsing-remitting multiple sclerosis (RRMS) (that occurs with relapses), particularly in:

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

or

• Patients who rapidly develop severe RRMS.

Fingolimod Mylan does not cure RRMS, but helps to reduce the number of relapses and slow the progression of physical disabilities due to RRMS.

What is multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects the central nervous system (CNS), consisting of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS and prevents nerves from functioning correctly. This process is called demyelination.

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

How Fingolimod Mylan works

Fingolimod Mylan helps combat the attacks of the immune system on the CNS by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and preventing them from reaching the brain and spinal cord. This limits nerve damage attributed to MS. This medication also reduces some of the immune responses of your body.

Do not take Fingolimod Mylan

• if you are allergicto fingolimod or to any of the other ingredients of this medicine (listed in section 6).
• if you have aweakened immune response(due to immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have aserious active infection or a chronic active infectionsuch as hepatitis or tuberculosis.
• if you have anactive cancer.
• if you havesevere liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke, or warning of a stroke, or any type of heart failure.
• if you have any type ofirregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you arepregnantor if you are a woman of childbearing potential and do not use an effective contraceptive method.

If any of the above cases apply to you or you are unsure,inform your doctor before taking Fingolimod Mylan.

Warnings and precautions

Consult your doctor before starting to take Fingolimod Mylan

• if you have severe respiratory problems when sleeping (severe sleep apnea).
• if you have been told you have an abnormal electrocardiogram.
• if you have symptoms of slow heart rhythm (e.g. dizziness, nausea, or palpitations).
• if you are taking or have recently taken medications that slow your heart rate(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• if you have a history of sudden loss of consciousness or fainting (syncope).
• if you plan to be vaccinated.
• if you have never had chickenpox.
• if you have or have had eye inflammation or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as macular edema, see below) or if you have uveitis or diabetes(which can cause eye problems).
• if you have liver problems.
• if you havehigh blood pressure that cannot be controlled with medication.
• if you havesevere lung problemsor "smoker's cough."

If any of the above cases apply to you or you are unsure,inform your doctor before taking Fingolimod Mylan.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case where you have been changed from a previous dose of 0.25 mg once a day, Fingolimod Mylan causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop.If these effects are severe, inform your doctor as you may need immediate treatment.This medicine can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within a day. Slow heart rate usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation or hospital for a minimum of 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Fingolimod Mylan or after taking the first dose of 0.5 mg, in the case where you have been changed from a previous dose of 0.25 mg once a day, to take the necessary measures if any adverse effects appear at the start of treatment. You will need to have an electrocardiogram before the first dose of this medicine and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly throughout the night, until this is resolved). The same may apply if you are restarting Fingolimod Mylan after a treatment break, depending on the duration of the break and how long you were taking it before the break.

If you have, or are at risk of having, irregular or abnormal heartbeats, if your electrocardiogram is abnormal, or if you have a heart disease or heart failure, Fingolimod Mylan may not be suitable for you.

If you have had sudden fainting spells in the past or decreased heart rate, Fingolimod Mylan may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment, including monitoring during the night.

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

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, your doctor will probably delay starting treatment with Fingolimod Mylan until you have completed the vaccination cycle.

Infections

Fingolimod Mylan reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medicine (and for up to 2 months after you stop treatment), you may be more susceptible to infections. You may even worsen an existing infection. Infections can be serious and potentially life-threatening. If you think you have contracted an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or convulsions (seizures) (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or herpes virus), contact your doctor immediately, as it can be serious and life-threatening.

If you think your MS is worsening (e.g. weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, in patients treated with Fingolimod Mylan. Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema

Before starting treatment with Fingolimod Mylan, your doctor may ask you to have an eye examination if you have or have had eye problems or other signs of inflammation in the central vision area (macula) of the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting treatment with Fingolimod Mylan, your doctor may ask you to have an eye examination 3 or 4 months after starting treatment.

The macula is a small area of the retina at the back of the eye that allows you to see shapes, colors, and details clearly and clearly. Fingolimod Mylan can cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first four months of treatment.

If you havediabetesor have had eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want to have regular eye checks to detect macular edema.

If you have had macular edema, consult your doctor before continuing treatment with Fingolimod Mylan.

Macular edema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may not have any symptoms. You need to inform your doctor of any changes you notice in your vision. Your doctor may want to have an eye examination, especially if:

• You notice a blurry or shadowy area in the center of your visual field.
• You notice a blind spot in the center of your visual field.
• You have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take Fingolimod Mylan. It can affect liver function. You may not notice any symptoms, but if you notice a yellowish tint to your skin or the white part of your eyes, abnormally dark urine (brown), pain in your right side of your abdomen, fatigue, decreased appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

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

Your doctor will ask you to have blood tests to check your liver function before, during, and after treatment. You may need to stop treatment with Fingolimod Mylan if the test results indicate a liver problem.

High blood pressure

As Fingolimod Mylan can cause a slight increase in blood pressure, your doctor will want to check your blood pressure regularly.

Lung problems

Fingolimod Mylan has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to develop adverse effects.

Blood count

The expected effect of treatment with Fingolimod Mylan is to reduce the number of white blood cells in your blood. This effect usually normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking this medicine, as if you do not, the doctor may not understand the test results. For certain blood tests, your doctor may need to take more blood than usual.

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

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS has been rarely reported in patients with MS treated with fingolimod. Symptoms may include sudden and intense headache, confusion, convulsions, and changes in vision. Inform your doctor immediately if you experience any of these symptoms during treatment, as it can be serious.

Cancer

In patients with MS who have been treated with fingolimod, cases of skin cancer have been reported. Inform your doctor immediately if you notice any new skin nodules (e.g. shiny nodules with a pearl-like appearance), skin lesions, or open sores that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g. unusual moles) that change color, shape, or size over time. Before starting treatment with Fingolimod Mylan, you will need to have a skin examination to check for any skin nodules. Your doctor will also want to check your skin regularly during treatment. If you notice any skin problems, your doctor may refer you to a dermatologist, who may decide if you need regular check-ups.

In patients with MS who have been treated with fingolimod, a type of lymphoma has been reported.

Sun exposure and sun protection

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

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

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In the case of severe relapses, your doctor will evaluate the need for an MRI scan to assess your condition and decide if you need to stop treatment.

Switching from other treatments to Fingolimod Mylan

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Mylan if there are no signs of abnormalities caused by previous treatment. Your doctor may need to have a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with Fingolimod Mylan. To switch from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if Fingolimod Mylan is suitable for you.

Women of childbearing potential

If Fingolimod Mylan is used during pregnancy, it may be harmful to the fetus. Before starting treatment, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking Fingolimod Mylan. They will also explain what you should do to avoid becoming pregnant while taking this medicine. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod Mylan

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

Inform your doctor immediately if you think your MS is worsening after stopping treatment with Fingolimod Mylan, as it can be serious (see section 3 "If you stop treatment with Fingolimod Mylan" and also section 4 "Possible side effects").

Older adults

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

Children and adolescents

Fingolimod Mylan should not be administered to children under 10 years of age, as it has not been studied in patients with MS in this age group.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children and adolescents and their caregivers:

• Before starting treatment with Fingolimod Mylan, your doctor will check your vaccination status. If you have not been given certain vaccinations, you may need to have them before you can start treatment with this medicine.
• The first time you take Fingolimod Mylan, or when you change from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will check your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or convulsions before taking or while taking Fingolimod Mylan, inform your doctor.
• If you experience depression or anxiety, or if you feel depressed or anxious during treatment with Fingolimod Mylan, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Mylan

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

• Medicines that suppress or modulate the immune system, including other medicines used to treat MS,such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use Fingolimod Mylan with these medicines because this could intensify the effect on the immune system (see also "Do not take Fingolimod Mylan").
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with Fingolimod Mylan and for up to 2 months after stopping treatment, you should not be given certain types of vaccines (vaccines made with live, attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. Other vaccines may not be effective if given during this period of time.
• Medicines that slow heart rate(e.g. beta-blockers such as atenolol). The use of Fingolimod Mylan with these medicines may intensify the effect on heart rate during the first few days after starting treatment.
• Medicines for irregular heartbeats,such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medicines, you should not use Fingolimod Mylan, as this may intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Mylan").

• Other medicines:

• protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (Hypericum perforatum) (potential risk of reduced efficacy of Fingolimod Mylan).

Pregnancy and breastfeeding

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

Pregnancy

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

Therefore, if you are a woman of childbearing potential:

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

and

• during treatment with this medicine and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss the reliable contraceptive methods with your doctor.

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

If you become pregnant while taking Fingolimod Mylan, inform your doctor immediately.Your doctor will decide to stop treatment (see section 3 "If you stop treatment with Fingolimod Mylan" and also section 4 "Possible side effects"). You will have a specific prenatal follow-up.

Breastfeeding

Do not breastfeed during treatment with Fingolimod Mylan.Fingolimod Mylan passes into breast milk and there is a risk of serious adverse effects in the baby.

Driving and operating machinery

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

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

The treatment with Fingolimod Mylan will be monitored by a doctor with experience in treating multiple sclerosis.

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

The recommended dose is:

Adults

The dose is one capsule of 0.5 mg per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

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

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

Fingolimod Mylan is only available in hard capsules of 0.5 mg that are not suitable for children and adolescents with a body weight equal to or less than 40 kg.

Other medications containing fingolimod with a concentration of 0.25 mg are available. Consult your doctor or pharmacist.

Do not exceed the recommended dose.

Fingolimod Mylan is taken orally.

Take Fingolimod Mylan once a day with a glass of water. The capsules must always be swallowed whole, without opening. You can take this medication with or without food.

Taking Fingolimod Mylan every day at the same time will help you remember when to take the medication.

If you have doubts about the duration of treatment with this medication, consult your doctor or pharmacist.

If you take more Fingolimod Mylan than you should

If you have taken more than you should, inform your doctor immediately.

If you forget to take Fingolimod Mylan

If you have been taking this medication for less than 1 month and forget to take 1 dose for an entire day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Fingolimod Mylan for at least 1 month and forget to take your treatment for more than 2 weeks, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you forget to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

Never take a double dose to compensate for missed doses.

If you interrupt treatment with Fingolimod Mylan

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

Fingolimod Mylan will remain in your body for up to 2 months after treatment is stopped. The number of white blood cells in the blood (lymphocyte count) may remain low during this period and it is possible that the adverse effects described in this leaflet will still occur. After stopping treatment with this medication, you may need to wait 6-8 weeks before starting a new treatment for MS.

If you need to resume treatment with Fingolimod Mylan after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur and you will need to be monitored by your doctor to resume treatment. Do not restart treatment with this medication after stopping it for more than 2 weeks without consulting your doctor.

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

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

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

Some side effects can be serious or potentially serious:

Frequent(may affect up to 1 in 10 patients)

• Cough with mucus production (sputum), chest discomfort, fever (signs of respiratory changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may experience are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain
• Slow heart rate (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC) that often presents as a pearl-like nodule, although it can also have other forms
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and it has also been reported in pediatric patients treated with fingolimod
• Weight loss

Frequent(may affect up to 1 in 10 patients)

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

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

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include the sudden and intense onset of headache, confusion, seizures, and/or visual disturbances
• Lymphoma (a type of cancer that affects the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that can present as a firm, red nodule, a sore with a scab, or a new sore over an existing scar

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

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

Frequency unknown(cannot be estimated from available data)

• Allergic reactions, including symptoms of rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day treatment with Fingolimod Mylan begins.
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those around you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless, flesh-colored or red-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm, painless nodule or mass. Long-term exposure to sunlight and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with Fingolimod Mylan, MS symptoms may reappear and may be worse than they were before or during treatment.
• Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed.

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

Other side effects

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

• Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Sensation of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test with alterations in liver enzyme levels
• Cough

Frequent(may affect up to 1 in 10 patients)

• Pityriasis versicolor (fungal infection of the skin)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching
• Increased levels of certain lipids in the blood (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see the section on macular edema under the title "Some side effects can be serious or potentially serious")
• Hypertension (Fingolimod Mylan may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Poorly frequent(may affect up to 1 in 100 patients)

• Low levels of certain white blood cells (neutrophils)
• Depressive mood
• Nausea

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

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

Frequency unknown(cannot be estimated from available data)

• Peripheral inflammation

If you consider that any of the side effects you are experiencing are serious,inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the packaging and on the aluminum blister/funnel after CAD/EXP. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25 °C.
• Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Fingolimod Mylan

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

• Capsule content: calcium dihydrogen phosphate, glycine, anhydrous colloidal silica, and magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Appearance of the product and contents of the package

Hard capsule with opaque brown-orange cap and opaque white body, with the imprint "MYLAN" over "FD 0.5" in black ink on the cap and body.

Fingolimod Mylan 0.5 mg capsules are available in:

Blister packs containing 28, 30, 84, or 98 hard capsules

Multi-packs containing 3 boxes, each with 28 hard capsules

Calendar packs containing 28 or 84 hard capsules

Single-dose blister packs containing 7 x 1, 28 x 1, 90 x 1, or 98 x 1 hard capsules

Jars containing 90 or 100 hard capsules

Only some package sizes may be marketed.

Marketing Authorization Holder

Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland.

Manufacturer(s)

Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900, Hungary

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Marketing Authorization Holder:

Last review date of this leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.