Fingolimod Viatris Pharmaceuticals 0.5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fingolimod Viatris Pharmaceuticals 0.5 mg hard capsules EFG

fingolimod

Read all of this 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 effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Fingolimod Viatris Pharmaceuticals is and what it is used for

What Fingolimod Viatris Pharmaceuticals is

The active substance in this medicine is fingolimod.

What Fingolimod Viatris Pharmaceuticals is used for

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

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

Patients who rapidly develop severe MS.

Fingolimod Viatris Pharmaceuticals does not cure MS, but it 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 sheath (called myelin) that surrounds the nerves in the CNS, impairing normal 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 residual problems may persist.

How Fingolimod Viatris Pharmaceuticals works

This medicine 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 Viatris Pharmaceuticals

Do not take Fingolimod Viatris Pharmaceuticals

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 you have been diagnosed with PML.
if you have an active serious or 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 whose 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 method of contraception.
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 Viatris Pharmaceuticals.

Warnings and precautions

Talk to your doctor 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 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 disorders or other signs of inflammation in the central vision area (the macula) of the back of the eye (a condition 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 or you are unsure, inform your doctor before taking Fingolimod Viatris Pharmaceuticals.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, if your previous dose was changed from 0.25 mg once daily, fingolimod may cause 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 pronounced, 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 normalizes within one month. During this period, 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 after taking the first 0.5 mg dose if your previous daily dose was changed from 0.25 mg, so that appropriate measures can be taken if adverse effects occur at the start of treatment. You will need to have an electrocardiogram (ECG) before the 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 your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours and 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 break.

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 Viatris Pharmaceuticals 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 may 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 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 suspect you have an infection, have a fever, flu-like symptoms, herpes, or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), contact your doctor immediately, as this could be serious 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 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 perform magnetic resonance imaging (MRI) scans before starting treatment and during treatment to monitor the risk of PML.

If you think your 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 immediately. 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 treatment with Fingolimod Viatris Pharmaceuticals will be stopped. Some people experience an inflammatory reaction when Fingolimod Viatris Pharmaceuticals 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 treatment, your doctor may request 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 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 may cause inflammation of the macula, a condition known as macular edema. This inflammation usually occurs within the first four months of 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 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 initially. You must report any changes in your vision to your doctor. 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 should not take fingolimod. Fingolimod may 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 unexplained nausea and vomiting, 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 counts

The expected effect of fingolimod treatment is a reduction in 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 results correctly. For certain blood tests, your doctor may need more blood than usual.

Before starting fingolimod treatment, your doctor will confirm that you have sufficient white blood cells and may want to repeat blood counts 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 fingolimod 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. Before starting fingolimod treatment, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If any skin problems arise, your doctor may refer you to a dermatologist, who may decide if 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 exposure to sunlight and UV rays 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. In the case of severe relapses, your doctor will assess whether an MRI scan is needed to evaluate your condition and decide whether you should stop taking fingolimod.

Switching from other treatments to Fingolimod Viatris Pharmaceuticals

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. When switching from teriflunomide, your doctor may advise waiting or performing 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 appropriate 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 you should do to prevent pregnancy. During treatment and for 2 months after stopping treatment, you must use an effective method of contraception (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping Fingolimod Viatris Pharmaceuticals

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

Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment, as it may be serious (see section 3 “If you stop taking Fingolimod Viatris Pharmaceuticals” and section 4 “Possible side effects”).

Elderly population

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

Children and adolescents

Fingolimod must not be given to children under 10 years of age, as it has not been studied in this age group in patients with MS.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children, adolescents, and their caregivers:

Before starting fingolimod treatment, your doctor will check your vaccination status. If you have not received certain vaccines, you may need to get them before starting fingolimod treatment.
The first time you take fingolimod, or when switching from a daily dose of 0.25 mg to 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the section above “Slow heart rate (bradycardia) and irregular heartbeats”).
If you have seizures or convulsions before or while taking fingolimod, inform your doctor.
If you have depression or anxiety, or if you feel depressed or anxious during fingolimod treatment, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Viatris Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Tell your doctor if you are taking any of the following:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use fingolimod with these medicines, as this could intensify the effect on the immune system (see also “Do not take Fingolimod Viatris Pharmaceuticals”).
Corticosteroids, due to an additive effect on the immune system.
Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and for up to two months after stopping, you should not receive certain types of vaccines (live attenuated virus vaccines), as they may cause the infections they are meant to prevent. Other vaccines may not work as well if given during this period.
Medicines that slow the heart rate (e.g., beta-blockers such as atenolol). Using fingolimod with these medicines may intensify the effect on heart rate during the first few days after starting fingolimod.
Medicines for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you take any of these medicines, you must not use fingolimod, as this could intensify the effect on irregular heartbeats (see also the section “Do not take Fingolimod Viatris Pharmaceuticals”).
Other medicines:
protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of fingolimod).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not use fingolimod during pregnancy, if you plan to become pregnant, or if you are a woman of childbearing potential and are not using an effective method of contraception. Fingolimod may harm the fetus if used during pregnancy. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately twice that observed in the general population (where the rate of congenital malformations is about 2–3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal abnormalities.

Therefore, if you are a woman of childbearing potential:

before starting fingolimod treatment, your doctor will inform you of the risk to the fetus and request a pregnancy test to confirm you are not pregnant,

and,

during treatment with fingolimod and for two months after stopping, you must use an effective method of contraception to prevent pregnancy. Discuss reliable contraceptive methods with your doctor.

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

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

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

3. How to take Fingolimod Viatris Pharmaceuticals

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

Follow exactly the dosing instructions for this medicine as provided by your doctor. If you have any doubts, 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 on a 0.25 mg capsule per day and later reach a stable weight above 40 kg, your doctor will instruct you to 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.

Fingolimod Viatris Pharmaceuticals is administered orally.

Take Fingolimod Viatris Pharmaceuticals once daily with a glass of water. The capsules must always be swallowed whole and must not be opened. You may take Kinelimod with or without food.

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

If you have any doubts about how long you should continue treatment with this medicine, consult your doctor or pharmacist.

If you take more Fingolimod Viatris Pharmaceuticals 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fingolimod Viatris Pharmaceuticals

If you have been taking fingolimod for less than 1 month and you 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 you miss your treatment 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 your 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 Viatris Pharmaceuticals

Do not stop taking fingolimod or change your 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 in your blood (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 need to restart fingolimod after a break of more than two weeks, the effect on heart rate that may occur at the start of treatment could reappear, and you will need to be monitored by your doctor when restarting treatment. Do not restart fingolimod after having stopped it for more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up is needed after stopping fingolimod treatment and how this should be managed. 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 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, red spots, 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
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 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 (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 scabbed 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 (ECG) (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 (brown-colored) urine, reduced appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could require liver transplantation
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble those of an MS relapse. Other symptoms may go unnoticed, such as changes in mood or behavior, memory loss, or speech and communication difficulties, 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 Viatris Pharmaceuticals (known as immune reconstitution inflammatory syndrome or IRIS)
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless 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 influence the risk of developing Merkel cell carcinoma
After stopping fingolimod treatment, MS symptoms may return 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 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

Frequent (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 levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, skin redness, 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 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: www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fingolimod Viatris Pharmaceuticals

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Do not use any product container that is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Fingolimod Viatris Pharmaceuticals

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

Capsule contents: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

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

Description of the product and package contents

Fingolimod Viatris Pharmaceuticals 0.5 mg hard capsules EFG have an opaque yellow cap and an opaque white body.

Fingolimod Viatris Pharmaceuticals 0.5 mg hard capsules EFG are available in pack sizes of 7, 28, 84 (3 packs of 28 capsules) or 98 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this summary: April 2025

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