FINGOLIMOD MYLAN 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fingolimod Mylan 0.5 mg Hard Capsules

fingolimod

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fingolimod Mylan and what is it used for
2. What you need to know before you take Fingolimod Mylan
3. How to take Fingolimod Mylan
4. Possible side effects
5. Storage of Fingolimod Mylan
6. Contents of the pack and further information

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

What is Fingolimod Mylan

Fingolimod Mylan contains the active substance fingolimod.

What is Fingolimod Mylan used for

Fingolimod Mylan is used in adults and in children and adolescents (from 10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (a disease where symptoms periodically occur), particularly in:

• Patient who do not respond to treatment despite MS treatment.

or

• Patient who rapidly develop severe MS.

Fingolimod Mylan does not cure MS, but helps reduce the number of relapses and slows down the progression of physical disabilities caused by MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that covers the nerves in the CNS, preventing the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect inflammation occurring in the CNS. Symptoms vary from one patient to another, but usually include difficulties walking, loss of sensation in some parts of the body (numbness), vision problems, or balance disorders. The 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 multiple sclerosis. This medicine also reduces some of the immune responses of your body.

2. What you need to know before starting to take Fingolimod Mylan

Do not take Fingolimod Mylan

• to fingolimod or to any of the other components of this medicine (listed in section 6).
• (due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• .
• such as hepatitis or tuberculosis.
• .
• .
• .
• (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval.
• (of the heart) such as quinidine, disopyramide, amiodarone, or sotalol.
• or if you are a woman of childbearing age and are not using an effective contraceptive method.

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

Warnings and precautions

Consult your doctor before starting to take Fingolimod Mylan

• .
• .
• (e.g., dizziness, nausea, or palpitations).
• (such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• .
• .
• .
• or other signs of inflammation in the central vision area (the macula) of the eye (a condition known as macular edema, see below) or an inflammation or infection of the eye (uveitis) or if you have diabetes(which can cause eye problems).
• .
• .
• or "smoker's cough).

If any of the above cases apply to you or if you are unsure, tell 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 that 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, tell your doctor as you may need immediate treatment. This medicine can also cause your heartbeats to become irregular, especially after the first dose. Irregular heartbeats usually return to normal in less than a day. The slow heart rate usually returns to normal within a month. During this period, it is generally not expected to have any clinically significant effect on the heart rate.

Your doctor will ask you to stay in the office or hospital for at least 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 that you have been changed from a previous dose of 0.25 mg once a day, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You should 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 overnight, until this is resolved). The same may apply if you are resuming Fingolimod Mylan after a pause in treatment, depending on both the duration of the pause and how long you were taking it before the pause.

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

If you have suffered from sudden fainting in the past or a decrease in 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. It is necessary for a cardiologist to evaluate you and determine if you can switch to alternative medications that do not decrease the heart rate to allow treatment with Fingolimod Mylan. If the aforementioned change is not possible, 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, you will likely need to be vaccinated before starting treatment with Fingolimod Mylan. If so, your doctor will delay the start of treatment for a month after completing the vaccination cycle.

Infections

Fingolimod Mylan reduces the number of white blood cells in the blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medicine (and up to two months after stopping treatment), you may be more likely to get infections. You may even have a worsening of an infection that you already have. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, rash, and/or confusion or convulsions (seizures) (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately because it can be serious and life-threatening.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, has been reported in patients treated with Fingolimod Mylan. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have regular HPV check-ups.

PML

PML is a rare brain disorder caused by an infection that can cause severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) before starting treatment and during treatment to monitor the risk of PML.

If you think your MS is getting worse or if you notice any new symptoms, such as changes in your mood or behavior, worsening or appearance of weakness on one side of the body, changes in vision, confusion, memory problems, or difficulties with speech and communication, tell your doctor as soon as possible. These can be symptoms of PML. Also, talk to your family members or caregivers to inform them about your treatment. Symptoms may appear without you realizing it.

If you develop PML, it can be treated, and your treatment with Fingolimod Mylan will be interrupted. Some people have an inflammatory reaction when Fingolimod Mylan is removed from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can cause a worsening of your disease, including a worsening of brain function.

Macular edema

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

After starting treatment with Fingolimod Mylan, your doctor may request an eye examination after 3 or 4 months of treatment.

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

If you have diabetesor have had an eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you 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 those produced in an MS attack (optic neuritis). At first, you may not have symptoms. It is necessary that you inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• The center of your field of vision becomes blurry or contains shadows.
• A blind spot appears in the center of your field of vision.
• You have problems 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 tone to your skin or the white part of your eyes, unusually dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, you have less appetite than usual, or you have nausea and vomiting without apparent cause, tell your doctor immediately.

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

Before, during, and after treatment, your doctor will request blood tests to check your liver function. You may need to interrupt treatment with Fingolimod Mylan if the results of your tests indicate a problem with your liver.

High blood pressure

Since Fingolimod Mylan causes a slight increase in blood pressure, your doctor will want you to have your blood pressure checked 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 returns to normal during the 2 months after stopping treatment. If you need to have blood tests, tell your doctor that you are taking this medicine, as they may not understand the results of the tests if you do not. For certain blood tests, your doctor may need more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

A condition called PRES has been rarely reported in MS patients treated with fingolimod. Symptoms can include sudden and severe headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment, as it can be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Tell your doctor immediately if you notice any nodules on the skin (e.g., shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. Symptoms of skin cancer can 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, a skin examination is required to check if you have any nodules on the skin. Your doctor will also perform regular skin checks during treatment. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is important to visit you regularly.

A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with fingolimod.

Sun exposure and sun protection

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

• using adequate protective clothing.
• applying a high UV protection sunscreen regularly.

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 assess the need to perform an MRI to evaluate 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 treatment-related abnormalities. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with Fingolimod Mylan. To switch from teriflunomide, your doctor may advise you to wait for a period or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is necessary, and you should discuss it with your doctor to decide if Fingolimod Mylan is suitable for you.

Women of childbearing age

If Fingolimod Mylan is used during pregnancy, it may harm the fetus. Before starting treatment, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking Fingolimod Mylan. It also explains 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").

MS worsening 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.

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

Elderly patients

Experience with fingolimod in elderly patients (over 65 years) is limited. If in doubt, 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 received certain vaccinations, it may be necessary to administer them before you can start treatment with this medicine.
• The first time you take Fingolimod Mylan, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or attacks before taking or while taking Fingolimod Mylan, tell your doctor.
• If you suffer from depression or anxiety or if during treatment with Fingolimod Mylan you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medicines and Fingolimod Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. Tell 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 it can enhance the effect on the immune system (see also "Do not use Fingolimod Mylan").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with Fingolimod Mylan and up to two months after stopping treatment, you should not receive certain types of vaccines (live attenuated vaccines).

3. How to take Fingolimod Mylan

Treatment with Fingolimod Mylan will be supervised by a doctor with experience in the treatment of multiple sclerosis.

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

Adults

The dose is one 0.5 mg capsule per day.

Children and adolescents (from 10 years of age and older)

The dose depends on body weight:

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

For children and adolescents who start with a 0.25 mg capsule per day and later reach a stable weight over 40 kg, the doctor will indicate that they switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period of the first dose.

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

Other medicines 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 should always be swallowed whole, without opening them. You can take this medicine with or without food.

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

If you have doubts about the duration of treatment with this medicine, 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 medicine for less than 1 month and forget to take 1 dose during a whole 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 have forgotten 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 have forgotten 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 make up for forgotten doses.

If you stop treatment with Fingolimod Mylan

Do not stop taking this medicine or change the dose to be taken without consulting your doctor first.

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

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

Your doctor will decide if it is necessary to monitor you after stopping treatment with Fingolimod Mylan and how to do it. 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 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 can be serious or potentially serious:

Common(may affect up to 1 in 10 patients)

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or pain of the skin, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stage 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 appears 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

Uncommon(may affect up to 1 in 100 patients)

• Pneumonia, 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 no vision in the field of vision, blurred vision, problems seeing colors or details
• Decreased number of 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 change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate
• 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 sudden and severe 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 appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar

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

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

Frequency not known(cannot be estimated from available data)

• Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which is more likely to occur on the day treatment with Fingolimod Mylan starts.
• 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 abdominal area, dark urine (brown color), decreased appetite, 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). The symptoms of PML can be similar to those of an MS relapse. You may also have symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication difficulties, 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 close to you notice any new or unusual symptoms, it is very important that you inform your doctor as soon as possible.
• Inflammatory disorder after stopping treatment with Fingolimod Mylan (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 the formation of a painless nodule of flesh or red-blue color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with Fingolimod Mylan, MS symptoms may recur and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

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

Other side effects

Very common(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 abnormal liver enzyme levels
• Cough

Common(may affect up to 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

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

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

• Lymphatic system cancer (lymphoma)

Frequency not known(cannot be estimated from available data)

• Peripheral inflammation

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

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fingolimod Mylan

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

• Do not use this medicine after the expiry date stated on the packaging and on the aluminum/polypropylene blister after EXP. The expiry date is the last day of the month stated.
• Do not store above 25°C.
• Store in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or has signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of Fingolimod Mylan

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

• Capsule content: calcium hydrogen phosphate dihydrate, glycine, colloidal anhydrous silica, and magnesium stearate.
• Capsule shell: 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 and container contents of the product

Hard capsule with an opaque brown-orange cap and an 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

Multipacks containing 3 boxes, each with 28 hard capsules

Calendar packs containing 28 or 84 hard capsules

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

Bottles containing 90 or 100 hard capsules

Only some pack sizes may be marketed.

Marketing authorization holder

Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturers

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

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Marketing authorization holder:

Date of the last revision of this prospectus:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.