Fingolimod Glenmark 0.5 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fingolimod Glenmark 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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What Fingolimod Glenmark is

The active substance of this medicine is fingolimod.

What Fingolimod Glenmark is used for

This medicine is used in adults and in children and adolescents (aged 10 years and older) with a body weight above 40 kg 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 affecting 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 generally 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 Glenmark 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, thereby preventing them from reaching 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 starting Fingolimod Glenmark

Do not take Fingolimod Glenmark

if you have a reduced immune response (due to an immunodeficiency syndrome, a disease, 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, within the last 6 months, you have had a heart attack, angina, stroke, transient ischemic attack (TIA), or any type of heart failure.
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows QT interval prolongation before starting fingolimod treatment.
if you are taking or have recently taken medications for irregular heartbeat (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 any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor before starting this medicine:

if you have severe breathing problems during sleep (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you have symptoms of a slow heartbeat (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 visual disorders or other signs of inflammation in the central area of vision (the macula) at 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 can 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 situations 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 dose of 0.5 mg, or 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 fatigued, become aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, 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 typically 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 monitoring of your pulse and blood pressure, after taking the first dose of fingolimod or the first 0.5 mg dose if switching from 0.25 mg once daily, so appropriate measures can be taken if adverse effects occur at treatment initiation. You will have an electrocardiogram (ECG) before the first dose and again after the 6-hour monitoring period. Your doctor may also 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 restarting fingolimod after a treatment interruption, depending on the duration of the break and how long you had previously taken fingolimod.

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 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 may consider switching you 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 initiate 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, 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), you may be more susceptible to infections. An existing infection may worsen. Infections can be serious and potentially fatal. If you suspect you have an infection, have a fever, flu-like symptoms, herpes (shingles), or headache with neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits), contact your doctor immediately, as these may be symptoms of fungal or herpes virus meningitis and/or encephalitis, which can be severe and life-threatening.

Infections with human papillomavirus (HPV), including warts, dysplasia, 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 the risk of PML.

If you feel your MS is worsening or notice 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 speech and communication difficulties, inform your doctor immediately. These may be signs of PML. Also, talk to your family members or caregivers about your treatment, as symptoms may appear without you noticing them.

If you develop PML, treatment will be initiated 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 order an eye examination if you have or have had visual disorders, signs of inflammation in the central vision area (the macula) at 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 into 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, 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 these cases, your doctor may recommend regular eye exams to detect macular edema.

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

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

The center of your vision becomes blurry or has shadows;
A blind spot appears in the center of your vision;
You have difficulty seeing colors or fine details.

Liver function tests

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

If you experience any of these symptoms after starting fingolimod, contact 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 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 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 adequate white blood cell levels and may repeat tests regularly. If your white blood cell count is too low, you may need to stop fingolimod treatment.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, a condition called posterior reversible encephalopathy syndrome (PRES) 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

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

wearing appropriate protective clothing.
regularly applying a high-SPF sunscreen.

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 cases of severe relapses, your doctor will assess whether an MRI is needed to evaluate your condition and decide whether to stop fingolimod.

Switching from other treatments to Fingolimod Glenmark

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Glenmark if there are no signs of abnormalities from prior 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 Glenmark. 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 needed to determine if Fingolimod Glenmark 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 perform 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 Glenmark, inform your doctor immediately. Your doctor will decide to stop treatment (see section 3 “If you stop taking Fingolimod Glenmark” and section 4 “Possible side effects”). You will receive specific prenatal follow-up.

Breastfeeding

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

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

3. How to take Fingolimod Glenmark

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

Always follow exactly your doctor's instructions for taking this medicine. If you are unsure, 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.

Children and adolescents who initially received a 0.25 mg capsule per day and later reach a stable weight above 40 kg should switch to a 0.5 mg capsule per day, as directed by their physician. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose. Fingolimod is administered 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 your dose. If you have any questions about the duration of treatment with fingolimod, consult your doctor or pharmacist.

If you take more Fingolimod Glenmark than you should

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

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

If you forget to take Fingolimod Glenmark

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 observe you when you take the next dose.

If you have been taking fingolimod for at least 1 month and have missed treatment for more than 2 weeks, speak with your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed treatment 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 Glenmark

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

Fingolimod remains 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 fingolimod treatment, you may need to wait 6–8 weeks before starting a new treatment for MS.

If you restart fingolimod after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear. Therefore, medical monitoring will be necessary when restarting treatment. Do not restart fingolimod after a break of more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up after stopping fingolimod treatment is needed 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 using 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

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

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 part of the body or face. Other symptoms may include fever and weakness in the early phase of the infection, followed by numbness, tingling, red rashes, or severe 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
It is known that patients with multiple sclerosis have a higher frequency of depression and anxiety; these have also been reported in pediatric patients treated with fingolimod
Weight loss

Uncommon (may affect up to 1 in 100 patients):

Pneumonia, with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the area of central vision 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 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 patients):

A condition called reversible posterior encephalopathy syndrome (RPES). Symptoms may include sudden and 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 crusted sore, or a new sore on an existing scar

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

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 of 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 mood or behavioral changes, 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 reappear and may be worse than 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 experience any of these symptoms, contact your doctor immediately.

Other adverse effects

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

Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
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 patients):

Pityriasis versicolor (fungal infection of the skin)
Dizziness
Severe headache, usually accompanied by nausea, vomiting, and light sensitivity (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, skin redness, and burning (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 patients):

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

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

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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fingolimod Glenmark Storage

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

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

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Unused packs and medicines should be handed over at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fingolimod Glenmark

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

Capsule contents: calcium phosphate and stearic acid.

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

Printing ink: shellac (E904) and black iron oxide (E172).

Appearance of the product and contents of the pack

Fingolimod Glenmark 0.5 mg hard capsules EFG are presented as hard gelatin capsules with an opaque yellow cap and an opaque white body; 15.9 ± 0.3 mm in length, with "0.5 mg" printed on the cap in black ink.

Fingolimod Glenmark 0.5 mg hard capsules EFG are packed in cardboard boxes containing the appropriate number of PVC/PE/PVDC/aluminum foil blisters or perforated unit-dose PVC/PE/PVDC/aluminum foil blisters with the appropriate number of capsules and the package leaflet.

Pack sizes:

Carton packs containing 7, 7x1, 28, 28x1, 98 or 98x1 capsules, or multipacks containing 84 capsules (3 packs of 28 capsules).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Pharmathen International, S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

Pharmathen S.A.
Dervenakion 6
Pallini Attiki, 15351
Greece

Glenmark Pharmaceuticals S.R.O.
Fibichova 143
Vysoke Mýto 566 17
Czech Republic

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

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the EEA Member States under the following names:

Denmark: Fingolimod Glenmark
Czech Republic: Fingolimod Glenmark
Germany: Fingolimod Glenmark 0,5 mg Hartkapseln
Netherlands: Fingolimod Glenmark 0,5 mg harde capsules
Poland: Fingolimod Glenmark
Slovakia: Fingolimod Glenmark 0,5 mg tvrdé kapsuly
Spain: Fingolimod Glenmark 0,5 mg cápsulas duras EFG
Sweden: Fingolimod Glenmark
United Kingdom: Fingolimod Glenmark 0.5 mg hard capsules

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

Detailed 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/)