Fingolimod Sun 0.5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fingolimod SUN 0.5 mg hard capsules EFG

Read the 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Fingolimod SUN is fingolimod.

What Fingolimod SUN is used for

Fingolimod SUN is used in adults, children and adolescents (aged 10 years and older, with body weight above 40 kg) to treat relapsing-remitting multiple sclerosis (MS) (characterised by relapses), particularly in:

patients who do not respond to treatment despite receiving therapy for MS

patients who rapidly develop severe MS.

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

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS, impairing proper nerve function. This process is known as demyelination.

Relapsing-remitting MS is characterised by repeated attacks (relapses) of neurological symptoms reflecting inflammation occurring in the CNS. Symptoms vary from patient to patient, but typically include difficulty walking, loss of sensation in parts of the body (numbness), vision problems, or balance disorders. Symptoms of a relapse may completely disappear when the relapse ends, although some problems may persist.

How Fingolimod SUN works

Fingolimod SUN helps combat immune system attacks on the CNS by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and preventing them from reaching the brain and spinal cord. This limits nerve damage caused by multiple sclerosis. Fingolimod also reduces some of the body's immune responses.

2. What you need to know before taking Fingolimod SUN

Do not take Fingolimod SUN

if you have a weakened immune response (due to an immunodeficiency syndrome, an illness, or medications that suppress the immune system)
if your doctor suspects you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML), or if PML has been confirmed
if you have a serious active infection or an active chronic infection such as hepatitis or tuberculosis
if you have active cancer
if you have severe liver problems
if you have had a heart attack, angina, stroke, transient ischemic attack (TIA), or any type of heart failure within the past 6 months
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows QT interval prolongation before starting treatment with this medicine
if you are taking or have recently taken medications for irregular heartbeats (such as quinidine, disopyramide, amiodarone, or sotalol)
if you are pregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method
if you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6).

If any of the above apply to you, inform your doctor before taking Fingolimod SUN.

Warnings and precautions

Talk to your doctor before starting Fingolimod SUN:

if you have severe breathing problems while sleeping (severe sleep apnea)
if you have been told you have an abnormal electrocardiogram (ECG)
if you have symptoms of a slow heart rate (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, ivabradine, digoxin, anticholinesterase agents, or pilocarpine)
if you have a history of sudden loss of consciousness or fainting (syncope)
if you are planning to get vaccinated
if you have never had chickenpox
if you have or have had disorders or other signs of inflammation in the central vision area (the macula) of the back of the eye (an eye disorder known as macular edema, see below), eye inflammation or infection (uveitis), or if you have diabetes (which may cause eye problems)
if you have liver problems
if you have high blood pressure that cannot be controlled with medication
if you have severe lung problems or "smoker's cough."

If any of the above apply to you, inform your doctor before taking Fingolimod SUN.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of Fingolimod SUN 0.5 mg, or after switching from other fingolimod-containing medicines available at a lower dose (0.25 mg daily dose) to Fingolimod SUN 0.5 mg, fingolimod causes a decrease in heart rate. As a result, you may feel dizzy or tired, become aware of your heartbeat, or your blood pressure may drop. If these effects are severe, inform your doctor immediately, as you may require immediate treatment. Fingolimod may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. The slow heart rate usually normalizes within one month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly pulse and blood pressure checks, after taking your first dose of Fingolimod SUN or after taking your first dose of Fingolimod SUN 0.5 mg if you have switched from a previous 0.25 mg once-daily dose, so that appropriate measures can be taken if adverse effects occur at the start of treatment. You will have an electrocardiogram (ECG) before your first dose of fingolimod and again after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours, possibly overnight), until the issue resolves. The same may apply if you are restarting fingolimod after a treatment interruption, depending on the duration of the interruption and how long you had been taking fingolimod before the interruption.

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

If you have previously experienced sudden fainting or a slow heart rate, fingolimod may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start treatment with fingolimod, including overnight monitoring.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. A cardiologist must evaluate you and consider whether you can switch to alternative medications that do not slow the heart rate to allow fingolimod treatment. If such a switch is not possible, the cardiologist will advise on how to start fingolimod treatment, including overnight monitoring.

If you have never had chickenpox

If you have never had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, you may need to be vaccinated before starting fingolimod treatment. If so, your doctor will delay the start of fingolimod treatment by one month after completing the vaccination series.

Infections

Fingolimod reduces the number of white blood cells in the blood (especially lymphocytes). White blood cells fight infections. During treatment with fingolimod (and for up to two months after stopping treatment), you may be more susceptible to infections. An existing infection may even worsen. Infections can be serious and potentially fatal. If you think you have an infection, have a fever, flu-like symptoms, herpes (shingles), or a headache with neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits) (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infections), contact your doctor immediately, as this could be serious and life-threatening.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-related cancer, has been reported in patients treated with fingolimod. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screening.

PML

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

If you think your MS is worsening or if you notice any new symptoms, such as mood or behavior changes, new or worsening weakness on one side of the body, vision changes, confusion, memory lapses, or difficulty speaking and communicating, consult your doctor as soon as possible. These could be symptoms of PML. Talk also with your partner or caregivers and inform them about your treatment. They may notice symptoms you are not aware of.

If you develop PML, it will be treated and your fingolimod treatment will be stopped. Some people experience an inflammatory reaction as fingolimod is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may worsen your condition, including worsening brain function.

Macular edema

Before starting Fingolimod SUN, 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 back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting fingolimod treatment, your doctor may request an eye examination 3 to 4 months after starting 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, a condition known as macular edema. This inflammation usually occurs within the first four months of fingolimod treatment.

If you have diabetes or have had eye inflammation known as uveitis, you are at higher risk of developing macular edema. In these cases, your doctor may recommend regular eye examinations to detect macular edema.

If you have had macular edema, discuss this with your doctor before continuing fingolimod treatment.

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

the center of your visual field becomes blurry or contains shadows
a blind spot appears in the center of your visual field
you have difficulty seeing colors or small details.

Liver function tests

If you have severe liver problems, you must not take fingolimod. Fingolimod can affect liver function. You may not experience any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark (brown-colored) urine, pain in the right side of your abdomen, fatigue, loss of appetite, or nausea and vomiting without apparent cause, inform your doctor immediately.

If you experience any of these symptoms after starting fingolimod treatment, inform your doctor immediately.

Before, during, and after treatment, your doctor will order blood tests to monitor your liver function. You may need to stop treatment if test results indicate a liver problem.

High blood pressure

Since fingolimod causes a slight increase in blood pressure, your doctor will want you to have your blood pressure monitored 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 fingolimod treatment is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you have blood tests, inform your doctor that you are taking fingolimod, as otherwise your doctor may not interpret the test results correctly. For certain blood tests, your doctor may need more blood than usual.

Before starting Fingolimod SUN, your doctor will confirm you have sufficient white blood cells in your blood and may want to repeat blood counts regularly. If you do not have enough white blood cells, you may need to stop treatment with this medicine.

Reversible posterior encephalopathy syndrome (RPES)

Rarely, a condition called reversible posterior encephalopathy syndrome (RPES) has been reported in multiple sclerosis patients treated with fingolimod. Symptoms may include sudden, severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during fingolimod treatment, as it could be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Inform your doctor immediately if you notice any skin nodules (e.g., shiny, pearl-like nodules), spots, or open sores that do not heal for weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change in color, shape, or size over time. Before starting fingolimod treatment, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during fingolimod treatment. If any skin problems arise, your doctor may refer you to a dermatologist, who may decide whether regular visits are necessary.

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, increasing the risk of developing cancer, especially skin cancer. You should limit your sun and UV exposure by:

wearing appropriate protective clothing
regularly applying sunscreen with a high UV protection factor.

Unusual brain lesions associated with MS relapses

Rare cases of large, unusual brain lesions associated with MS relapses have been reported in patients treated with Fingolimod SUN. In the case of severe relapses, your doctor will assess the need for a magnetic resonance imaging (MRI) scan to evaluate your condition and decide whether you need to stop taking this medicine.

Switching from other treatments to Fingolimod SUN

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod if there are no signs of abnormalities caused by the previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting fingolimod treatment. When switching from teriflunomide, your doctor may advise waiting or undergoing an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is required, and you should discuss with your doctor whether fingolimod is suitable for you.

Women of childbearing age

If fingolimod is used during pregnancy, it may harm the fetus. Before starting Fingolimod SUN, your doctor will explain the risks and request a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking this medicine and what steps to take to avoid pregnancy. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide to stop treatment (see section 3 “If you stop taking Fingolimod SUN” and section 4 “Possible side effects”). You will receive specific prenatal follow-up.

Breastfeeding

You must not breastfeed during treatment with Fingolimod SUN. This medicine passes into breast milk and there is a risk that the baby may experience serious adverse effects.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive vehicles, including bicycles, and safely operate machinery. This medicine is not expected to affect your ability to drive or use machines.

However, at the start of treatment, you must remain at the medical clinic or hospital for 6 hours after taking the first dose of this medicine. During this time and possibly afterward, your ability to drive and use machines may be impaired.

Fingolimod SUN contains potassium

Patients with renal impairment or on potassium-restricted diets should be aware that this medicine contains 0.013 mmol (or 0.515 mg) of potassium per capsule/daily maximum dose.

Fingolimod SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free.”

3. How to take Fingolimod SUN

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

Always follow exactly the instructions for use given by your doctor. If in doubt, consult your doctor again.

The recommended dose is

Adults

The dose is one hard capsule of Fingolimod SUN 0.5 mg per day.

Children and adolescents (aged 10 years and above)

The dose depends on body weight:

Children and adolescents weighing ≤ 40 kg: one 0.25 mg capsule per day. Fingolimod SUN 0.5 mg hard capsules are not suitable for pediatric patients with body weight ≤ 40 kg. Other medicines containing fingolimod are available in lower doses (such as 0.25 mg capsules).
Children and adolescents weighing more than 40 kg: one hard capsule of Fingolimod SUN 0.5 mg per day.

Children and adolescents who start treatment with 0.25 mg capsules of other fingolimod-containing medicines and later reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg fingolimod capsule per day. In this case, repeat monitoring after the first dose is recommended.

Do not exceed the recommended dose.

Fingolimod SUN is administered orally.

Take Fingolimod SUN once daily with a glass of water. Fingolimod SUN capsules must always be swallowed whole, without opening them. You may take Fingolimod SUN with or without food.

Taking Fingolimod SUN at the same time each day will help you remember when to take your medicine.

If you have any questions about how long treatment with Fingolimod SUN should continue, consult your doctor or pharmacist.

If you take more Fingolimod SUN than you should

If you have taken more Fingolimod SUN than you should have, inform your doctor immediately or call the Spanish Poison Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Fingolimod SUN

If you have been taking Fingolimod SUN for less than 1 month and forget to take one dose for a whole day, speak with your doctor before taking the next dose. Your doctor may decide to monitor you at the time you take the next dose.

If you have been taking Fingolimod SUN for at least 1 month and have missed taking your medicine for more than 2 weeks, speak with your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose. However, if you have missed taking your medicine for up to 2 weeks, you may take the next dose as originally scheduled.

Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod SUN

Do not stop taking Fingolimod SUN or change your dose without first discussing it with your doctor.

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

If you need to restart treatment with Fingolimod SUN after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and it will be necessary for you to be monitored by your doctor when restarting treatment. Do not restart treatment with this medicine after having stopped it for more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up monitoring is needed after stopping treatment with this medicine and how it should be carried out. Inform your doctor immediately if you think your MS is worsening after stopping treatment with Fingolimod SUN, as this could be serious.

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

4. Possible adverse effects

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

Some adverse effects may be serious or potentially serious

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

cough with phlegm, chest discomfort, fever (signs of pulmonary disorders)
herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, stinging, itching, or skin pain, especially on the upper body or face. Other symptoms may include fever and weakness in the early phase of infection, followed by numbness, itching, or red patches with severe pain.
slow heart rate (bradycardia), irregular heart rhythm
a type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other forms
depression and anxiety are known to occur more frequently in people with multiple sclerosis, and 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 (swelling in the central vision area of the retina at 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
decrease in the number of blood platelets, increasing the risk of bleeding or bruising
malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change over time in size, shape, thickness, or color, or the development of new moles. Moles may itch, bleed, or ulcerate.
seizures, fits (more frequent in children and adolescents than in adults).

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

a condition called reversible posterior encephalopathy syndrome (PRES). Symptoms may include sudden and severe onset of headache, confusion, seizures, and/or visual disturbances
lymphoma (a type of cancer affecting the lymphatic system)
squamous cell carcinoma: a type of skin cancer that may appear as a firm red nodule, a crusted sore, or a new sore developing on an existing scar.

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

abnormal electrocardiogram (ECG) finding (T-wave inversion)
tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma).

Frequency not known (cannot be estimated from available data):

allergic reactions, including symptoms such as rash or hives with itching, swelling of lips, tongue, or face, which are more likely to occur on the day treatment with fingolimod is started
signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark urine (brown-colored), loss of appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could require a liver transplant.
risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory loss, or difficulties with speech and communication, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening, or if you or people close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
inflammatory disorder after stopping treatment with fingolimod (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, light sensitivity, 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 reddish-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
after stopping treatment with fingolimod, MS symptoms may reappear and may be worse than they were before or during treatment.
autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you have any of these symptoms, contact your doctor immediately.

Other adverse effects

Very common (may affect more than 1 in 10 people):

influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
feeling of pressure or pain in the cheeks and forehead (sinusitis)
headache
diarrhea
back pain
blood tests showing abnormal liver enzyme levels
cough.

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

tinea, a fungal skin infection (pityriasis versicolor)
dizziness
severe headache, usually accompanied by nausea, vomiting, and light sensitivity (migraine)
low levels of white blood cells (lymphocytes, leukocytes)
weakness
itchy rash, redness and burning of the skin (eczema)
itching
increased blood levels of certain lipids (triglycerides)
hair loss
difficulty breathing
depression
blurred vision (see also the section on macular edema under the heading "Some adverse effects may be serious or potentially serious")
hypertension (this medicine 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)
depressed 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 any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fingolimod SUN Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fingolimod SUN

The active substance is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are:
1. Capsule contents: magnesium stearate (E470b), potassium polacrilin (see section 2), crospovidone (E1202), colloidal anhydrous silica (E551)
2. Capsule shell:

Capsule cap: yellow iron oxide (E172), titanium dioxide (E171), gelatin (E441), sodium lauryl sulfate

Capsule body: titanium dioxide (E171), gelatin, sodium lauryl sulfate

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)

Nature of the product and pack contents

Fingolimod SUN 0.5 mg hard capsules EFG have an opaque yellow cap and an opaque white body, printed axially with '064' in black ink.

Fingolimod SUN is available in single-dose pre-cut blister packs.

Pack sizes containing 7 x 1, 28 x 1, 56 x 1 or 98 x 1 hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Germany: Fingolimod Basics

Spain: Fingolimod SUN 0.5 mg hard capsules EFG

France: Fingolimod SUN

Italy: Fingolimod SUN

The Netherlands: Fingolimod SUN

Poland: Fingolimod SUN

United Kingdom (Northern Ireland): Fingolimod SUN

Date of the most recent review of this summary: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Detailed and up-to-date information on this product is also available by scanning the QR code included in the package leaflet using a smartphone. The same information is also available at the following link: (the link must be included) (and the NCA website)

Include the QR code and the link