Fingolimod Aurovitas 0.5 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fingolimod Aurovitas 0.5 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What Fingolimod Aurovitas is

This medicine contains the active substance fingolimod.

What Fingolimod Aurovitas is used for

Fingolimod is used in adults and in children and adolescents (aged 10 years and older) to treat relapsing-remitting multiple sclerosis (MS) (characterized by relapses), particularly in:

• Patients who do not respond to treatment despite receiving therapy for MS.

or

• Patients who rapidly develop severe MS.

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

What multiple sclerosis is

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 surrounds the nerves in the CNS, impairing proper nerve function. This process is known as demyelination.

Relapsing-remitting MS is characterized 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 Aurovitas works

Fingolimod 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 by preventing them from entering the brain and spinal cord. This limits nerve damage caused by multiple sclerosis. Fingolimod also reduces some of the immune responses in your body.

2. What you need to know before taking Fingolimod Aurovitas

Do not take Fingolimod Aurovitas

• 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 known as progressive multifocal leukoencephalopathy (PML), or if you have been diagnosed with PML.
• if you have an active serious 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, or transient ischemic attack (mini-stroke), or any type of heart failure within the last 6 months.
• if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows QT interval prolongation before starting fingolimod treatment.
• 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 or you are unsure, inform your doctor before taking fingolimod.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine.

• 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), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause eye problems).
• if you have liver problems.
• if you have uncontrolled high blood pressure.
• if you have severe lung problems or smoker’s cough.

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

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first 0.5 mg dose—especially if you have switched from a previous dose of 0.25 mg once daily—fingolimod causes a temporary 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 need urgent 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 typically returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly monitoring of your pulse and blood pressure, after taking your first dose of fingolimod or after taking the first 0.5 mg dose if you have switched from 0.25 mg once daily. This is to allow appropriate measures to 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 perform continuous ECG monitoring 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 restart fingolimod after a treatment interruption, depending on the length of the interruption and how long you had been taking fingolimod before the break.

If you have or are at risk of 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 fingolimod treatment, including whether overnight monitoring is needed.

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 reduce heart rate to allow fingolimod treatment. If such a switch is not possible, the cardiologist will advise on how to start fingolimod treatment, including whether overnight monitoring is needed.

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, 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 your 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 also worsen. Infections may be serious and potentially fatal. If you suspect you have an infection, have a fever, flu-like symptoms, herpes (shingles), or a headache accompanied by 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.

Infections with human papillomavirus (HPV), including warts, dysplasia, papillomas, and HPV-related cancers, have 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 may 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 perform magnetic resonance imaging (MRI) scans before and during treatment to monitor your risk of PML.

If you think your multiple sclerosis (MS) is worsening or you notice any new symptoms—such as changes in mood or behavior, worsening or new weakness on one side of the body, vision changes, confusion, memory problems, or difficulty speaking or communicating—inform your doctor as soon as possible. These may be symptoms of PML. Also, talk to your family members or caregivers about your treatment, as symptoms may appear without your awareness.

If you develop PML, it can be treated and your fingolimod treatment will be stopped. Some people experience an inflammatory reaction when 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, your doctor may arrange for an eye examination if you have or have had visual disorders or 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, your doctor may schedule an eye examination 3 to 4 months after starting treatment.

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

If you have diabetes or have had eye inflammation (uveitis), you are at higher risk of macular edema. In such cases, your doctor may recommend regular eye check-ups to detect macular edema.

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

Macular edema may cause visual symptoms similar to those of an MS attack (optic neuritis). You may not have symptoms at first. Report any changes in your vision to your doctor. Your doctor may recommend an eye examination, especially if:

• the center of your visual field becomes blurry or shadowy;
• a blind spot appears in the center of your visual field;
• you have difficulty seeing colors or fine details.

Liver function tests

Do not take fingolimod if you have severe liver problems. Fingolimod may affect liver function. You may not notice any symptoms, but if you develop yellowing of the skin or whites of the eyes, abnormally dark (brown-colored) urine, pain in the upper right side of your abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.

If you experience any of these symptoms after starting fingolimod, 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 liver problems.

High blood pressure

Since fingolimod may cause 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 experience adverse effects.

Blood counts

Fingolimod is expected 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 misinterpret the results. For certain blood tests, your doctor may need more blood than usual.

Before starting fingolimod, your doctor will confirm you have enough white blood cells and may repeat blood counts regularly. If your white blood cell count is too low, you may need to stop fingolimod treatment.

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 treatment, as it may be serious.

Cancer

Skin cancer cases have been reported in MS patients treated with fingolimod. Inform your doctor immediately if you notice skin nodules (e.g., shiny, pearl-like lumps), spots, or open sores that do not heal for weeks. Signs 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. A skin examination is required before starting fingolimod to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may decide if regular visits are needed.

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

• wearing appropriate protective clothing;
• regularly applying sunscreen with high UV protection.

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. In the case of severe relapses, your doctor will assess whether an MRI is needed to evaluate your condition and whether you should stop taking fingolimod.

Switching from other treatments to fingolimod

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod if there are no signs of abnormalities from your 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. 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 potential

Fingolimod may harm the fetus if used during pregnancy. Before starting treatment, 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 fingolimod and what steps to take to avoid pregnancy. During treatment and for 2 months after stopping, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

If you become pregnant while taking fingolimod, inform your doctor immediately. Your doctor will decide to stop treatment (see section 3 “If you stop taking Fingolimod Aurovitas” and section 4 “Possible side effects”). You will receive specific prenatal monitoring.

Breastfeeding

You must not breastfeed during treatment with fingolimod. Fingolimod passes into breast milk and may cause serious adverse effects in the baby.

Driving and using machines

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

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

Fingolimod Aurovitas contains maltodextrin (glucose)

Maltodextrin is absorbed as glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Fingolimod Aurovitas contains sodium

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

3. How to take Fingolimod Aurovitas

Treatment with fingolimod will be supervised by a physician experienced in the treatment of multiple sclerosis.

Follow exactly the administration instructions given 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 (aged 10 years and older):

The dose depends on body weight:

• Children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day.
• Children and adolescents weighing more than 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start with one 0.25 mg capsule per day and later reach a stable weight above 40 kg, the doctor will instruct them to switch to one 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.

Fingolimod is taken orally.

Take fingolimod once daily with a glass of water. Fingolimod capsules must always be swallowed whole and must not be opened. Fingolimod may be taken with or without food.

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

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

If you take more Fingolimod Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fingolimod Aurovitas

If you have been taking fingolimod for less than 1 month and miss a dose for a full day, speak with 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 missed taking your medication for more than 2 weeks, speak with 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 missed taking your medication for up to 2 weeks, you may take the next dose as scheduled.

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

If you stop taking Fingolimod Aurovitas

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

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

If you need to restart treatment with fingolimod 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 in a medical setting when restarting treatment. Do not restart treatment with fingolimod after having stopped it for more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up after stopping fingolimod treatment is necessary and how it should be conducted. Inform your doctor immediately if you think your MS is worsening after stopping fingolimod, 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 produce adverse effects, although not everyone will experience them.

Some adverse effects may be serious or potentially serious

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

• Cough with sputum (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 spots with intense pain.
• Slow heartbeat (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 patients 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 in size, shape, thickness, or color over time, or the formation 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 (RPES). Symptoms may include sudden, severe headache, confusion, seizures and/or visual disturbances.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that may appear as a firm red nodule, a scaly sore, or a new sore developing on an existing scar.

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

• Abnormality in the electrocardiogram (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 results in liver function tests. 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 bluish-red 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 return and may be worse than 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, 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 levels of liver enzymes.
• Cough.

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

• Tinea versicolor (fungal skin infection).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting, and light sensitivity (migraine).
• Low levels of white blood cells (lymphocytes, leukocytes).
• Weakness.
• Itchy rash, redness of the skin and burning sensation (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 (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).
• 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fingolimod Aurovitas Storage

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

Do not use this medicine after the expiry date stated on the outer packaging and blister, following “EXP”. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. 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 Aurovitas

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

• The other components are:

Contents of the capsule: maltodextrin, talc, sodium stearyl fumarate.

Components of the capsule:

-Cap: titanium dioxide (E171), yellow iron oxide (E172) and gelatin.

-Body: titanium dioxide (E171), black iron oxide (E172) and gelatin.

-Printing ink: shellac, black iron oxide (E172), potassium hydroxide.

Appearance of the product and contents of the pack

Hard gelatin capsule of size “3”, with a shiny yellow cap and grey body, printed with “FGL 05” on the cap in black ink, filled with a white or almost white powder.

Fingolimod Aurovitas 0.5 mg is available in blister packs containing 7, 28, 56, 84 and 98 hard capsules and in perforated unit dose blister packs containing 28 × 1 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorised in the European Economic Area Member States under the following names:

Germany: Fingolimod PUREN 0.5 mg Hard Capsules

Belgium: Fingolimod AB 0.5 mg hard capsules/gélules/Hartkapseln

Spain: Fingolimod Aurovitas 0.5 mg hard capsules EFG

France: Fingolimod Arrow 0.5 mg, gélule

Italy: Fingolimod Aurobindo

Netherlands: Fingolimod Aurobindo 0.5 mg, hard capsules

Poland: Fingolimod Aurovitas

Portugal: Fingolimod Generis

Date of the most recent review of this leaflet: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).