FINGOLIMOD EDEST 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fingolimod Edest0.5mg hard capsules EFG

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

• Keep this package leaflet, 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fingolimod Edest and what is it used for
2. What you need to know before you take Fingolimod Edest
3. How to take Fingolimod Edest
4. Possible side effects
5. Storing Fingolimod Edest
6. Package Contents and Additional Information

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

What is Fingolimod Edest

This medicine contains the active substance fingolimod.

What Fingolimod Edest is used for

This medicine 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 that causes attacks, or flare-ups), particularly in:

• Patient who do not respond to treatment despite MS treatment.
• Patient who rapidly develop severe MS.

Fingolimod does not cure MS, but it helps to reduce the number of flare-ups and slow 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 includes the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS and prevents the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (flare-ups) of neurological symptoms that reflect the inflammation occurring in the CNS. The symptoms vary from one patient to another, but usually include difficulty walking, loss of sensation in a part of the body (numbness), vision problems, or balance disorders. The symptoms of a flare-up may disappear completely when the flare-up is over, but some problems may persist.

How Fingolimod Edest works

Fingolimod 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 the nerve damage attributed to multiple sclerosis. Fingolimod also reduces some of the immune responses of your body.

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

Do not take Fingolimod Edest

• you have a weakened immune system(due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• you have a severe active infection or a chronic active infectionsuch as hepatitis or tuberculosis.
• you have active cancer.
• you have severe liver problems. If, in the last 6 months, you have had a heart attack, chest pain, stroke, or warning of a stroke, or any type of heart failure.
• you have any type of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Edest.
• you are taking or have recently taken medications for an irregular heartbeat (of the heart) such as quinidine, disopyramide, amiodarone, or sotalol. If you are pregnant or if you are a woman of childbearing age and do not use an effective contraceptive method.
• you are allergicto fingolimod or to any of the other components of this medication (included in section 6).

If any of the above cases apply to you, tell your doctor without takingFingolimod Edest.

Warnings and precautions

Consult your doctor before starting to take this medication

• you have severe respiratory problems when you sleep (severe sleep apnea).

• you have been told that you have an abnormal electrocardiogram.
• you have symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations).

you are taking or have recently taken medications that slow down your heart rate (such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).

• you have a history of sudden loss of consciousness or fainting (syncope).
• you are planning to get vaccinated.
• you have never had chickenpox.
• you have or have had disorders or other signs of inflammation in the central vision area (the macula) of the eye fundus (a eye disorder known as macular edema, see below) or an inflammation or infection of the eye (uveitis) or if you havediabetes (which can cause you eye problems).
• you have liver problems.
• you have high blood pressure that cannot be controlled with medication.
• you have severe lung problemsor "smoker's cough).

If any of the above cases apply to you, tell your doctor before takingFingolimod Edest.

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 changed the previous dose of 0.25 mg once a day, with other medications that contain fingolimod that are available in a lower concentration, fingolimod produces a decrease in heart rate. As a result, you may feel dizzy or tired, you may be aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, tell your doctor as you may need immediate treatment.Fingolimod can also make your heartbeats become irregular, especially after the first dose. The irregular heartbeats usually normalize in less than a day. The slow heart rate usually normalizes within a month.

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 or after taking the first dose of 0.5 mg, in the case that you have changed the previous dose of 0.25 mg once a day with other medications that contain fingolimod that are available in a lower concentration, so that the necessary 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 fingolimod 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 anomalies, you will need to be monitored for a longer period (at least 2 hours more and possibly during the night, until this is resolved). The same may apply if you are resuming fingolimod after a pause in treatment, depending on both the duration of the pause and how long you were taking fingolimod 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 may not be suitable for you.

If you have suffered from sudden fainting in the past or a decrease in heart rate, fingolimod may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with fingolimod, including monitoring during the night.

If you are taking other medications that can slow down your heart rate, fingolimod may not be suitable for you. It is necessary for a cardiologist to evaluate you and decide if you can change to alternative medications that do not decrease the heart rate to allow treatment with fingolimod. If the aforementioned change is impossible, the cardiologist will advise you on how to start treatment with fingolimod, 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. If so, your doctor will delay the start of treatment with fingolimod for one month after completing the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with fingolimod (and up to two months after you stop treatment), you may be more likely to get infections. You may even get worse 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. If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, tell your doctor immediately, because they can 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 assess the need to perform a magnetic resonance imaging (MRI) scan to evaluate your condition and decide if you need to stop taking fingolimod.

It has been reported that patients treated with fingolimod have had human papillomavirus (HPV) infections, including papilloma, dysplasia, warts, and HPV-associated cancer. 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 HPV screenings.

Macular edema

Before starting treatment with fingolimod, 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 fundus, an inflammation or infection of the eye (uveitis), or diabetes.

After starting treatment with fingolimod, 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 can cause inflammation of the macula, and this disorder is known as macular edema. The inflammation usually occurs within the first four months of treatment with fingolimod.

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.

Macular edema can cause the same visual symptoms as those produced by an MS attack (optic neuritis). At first, you may not have symptoms. It is necessary that you communicate any changes you notice in your vision to your doctor. Your doctor may want to perform an eye examination, especially if:

• The center of your field of vision becomes blurry or has 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. This medication 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, abnormally 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, 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 if the results of your tests indicate a problem with your liver.

High blood pressure

Since fingolimod can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

Fingolimod 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 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, tell your doctor that you are taking fingolimod, as if you do not, your doctor may not understand the results of the tests. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with fingolimod, 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 interrupt treatment with fingolimod.

Posterior reversible encephalopathy syndrome (PRES)

A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely described in patients with multiple sclerosis treated with fingolimod. The symptoms can include a sudden and intense onset of headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment with fingolimod because it can be serious.

Cancer

In patients with MS who have been treated with fingolimod, cases of skin cancer have been reported. 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. The 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, a skin examination is required to check if you have any nodules on the skin. Your doctor will also perform periodic skin checks during treatment with fingolimod. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is important to visit you regularly.

In patients with MS who have been treated with fingolimod, a type of cancer of the lymphatic system (lymphoma) has been reported.

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 suitable protective clothing.
• applying a sunscreen with a high UV protection index regularly.

Unusual brain lesions associated with MS relapses

There have been reports of rare cases of large and unusual brain lesions associated with MS relapses in patients treated with fingolimod. In the case of severe relapses, your doctor will assess the need to perform a magnetic resonance imaging (MRI) scan to evaluate your condition and decide if you need to stop taking fingolimod.

Switching from other treatments to Fingolimod Edest

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod 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.

To switch from teriflunomide, your doctor may advise you to wait for a period of time 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 is suitable for you.

Women of childbearing age

If fingolimod is used during pregnancy, it can be harmful to the fetus. Before starting treatment with fingolimod, your doctor will explain the risks and ask you to take a pregnancy test to ensure that you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking fingolimod. It also explains what you should do to avoid becoming pregnant while taking fingolimod. 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 Edest

Do not stop taking fingolimod or change the dose that you have been 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, as it can be serious (see section 3 "If you stop treatment with Fingolimod Edest" and also section 4 "Possible side effects").

Elderly

Experience with fingolimod in elderly patients (over 65 years) is limited. If in doubt, consult your doctor.

Children and adolescents

Fingolimod 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, 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 Fingolimod Edest.

The first time you take fingolimod, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg with other medications that contain fingolimod that are available in a lower concentration, 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, tell your doctor.
• If you suffer from depression or anxiety or if during treatment with fingolimod you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medications andFingolimod Edest

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Tell your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use Fingolimod Edest with these medications because it could intensify the effect on the immune system (see also "Do not use Fingolimod Edest").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with Fingolimod Edest and up to two months after stopping treatment, you should not receive certain types of vaccines (live attenuated virus vaccines) because they can cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not have the desired effect if administered during this period.
• Medications that slow down the heart rate(such as beta-blockers, e.g., atenolol). The use of Fingolimod Edest with these medications can intensify the effect on the heart rate during the first days after starting treatment with Fingolimod Edest.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, do not take Fingolimod Edest.

3. How to take Fingolimod Edest

Treatment with this medication will be supervised by a doctor with experience in treating multiple sclerosis.

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

The recommended dose is:

Adults:

The dose is one 0.5mg capsule per day.

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

The dose depends on body weight:

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

The use of this medication in children and adolescents with a body weight equal to or less than 40 kg is not appropriate. Other medications containing fingolimod with a lower concentration (such as 0.25 mg capsules) are available.

• Children and adolescents with a weight greater than 40kg: one 0.5 mg capsule per day.

For children and adolescents who start with a 0.25 mg capsule per day with other medications containing fingolimod that are available in a lower concentration and later reach a stable weight greater than 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 first-dose observation period.

Do not exceed the recommended dose. This medication is taken orally.

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

Taking fingolimod 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 Edest than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Fingolimod Edest

If you have been taking fingolimod 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 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 Edest

Do not stop taking fingolimod or change the dose to be taken without discussing it with your doctor first.

Fingolimod 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 fingolimod, you may have to wait for 6-8 weeks before starting a new treatment with EM.

If you need to resume treatment with fingolimod 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 in the doctor's office to restart treatment. Do not restart treatment with fingolimod after stopping it for more than 2 weeks without consulting your doctor first.

Your doctor will decide if it is necessary to monitor you after stopping treatment with fingolimod and how to do it. Inform your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod, as it could be serious.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious

Common(may affect up to 1 in 10 people):

• 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 skin pain, 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 heartbeat (bradycardia), irregular heartbeat
• 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 these have also 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 (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 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 normally 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 people):

• 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, a crusty ulcer, or a new sore on an existing scar. Squamous cell carcinoma can also appear as a firm, painless nodule or mass.

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

• Abnormality in the electrocardiogram (T-wave inversion)
• 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 are more likely to appear on the day treatment with fingolimod 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 abdomen, dark urine (brown color), decreased appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant.
• 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 experience 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

• 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 or mass, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm, 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, 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 people):

• 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 people):

• Pityriasis versicolor (fungal skin infection)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (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 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 (neutrophils)
• Depressive mood
• Nausea

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

• Cancer of the lymphatic system (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish system for monitoring drug side effects: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod Edest

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the aluminum blister after CAD/EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Do not use any packaging that is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy or in any other medication waste collection system. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Edest

• The active ingredient is fingolimod.

Fingolimod Edest 0.5 mg hard capsules EFG

• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are:

Capsule content: pregelatinized cornstarch, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Black printing ink: shellac (E-904), anhydrous alcohol (E-1510), isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), concentrated ammonia solution (E-527), potassium hydroxide (E-525), black iron oxide (E-172).

Yellow printing ink: shellac (E-904), anhydrous alcohol (E-1510), isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), concentrated ammonia solution (E-527), potassium hydroxide (E-525), yellow iron oxide (E-172).

Appearance of the product and package contents

Fingolimod Edest 0.5 mg hard capsules EFG

Hard gelatin capsule, size "3", opaque, strong yellow/white, with the inscription "FO 0.5 mg" on the cap and two radial bands on the body of the capsule with yellow ink, containing white to off-white powder.

Fingolimod Edest 0.5 mg hard capsules are available in packs of 7, 28, or 98 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Intas. Third Party Sales 2005, S.L.

World Trade Center Building

Moll de Barcelona S/N

08039 Barcelona

Spain

Manufacturer

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Fingolimod Edest 0.5 mg hard capsules

France: Fingolimod Edest 0.5 mg, capsule

Spain: Fingolimod Edest 0.5 mg hard capsules EFG

Germany: Fingolimod Edest 0.5 mg Hartkapseln

Date of last revision of this leaflet

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.