Fingolimod Zentiva 0.5 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fingolimod Zentiva 0.5 mg hard capsules EFG

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 further 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 could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Fingolimod Zentiva contains the active substance fingolimod.

What Fingolimod Zentiva is used for

This medicine is used in adults and in children and adolescents (aged 10 years and older, and with a body weight >40 kg) 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.

This medicine does not cure MS, but 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, preventing nerves from functioning properly. 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 Zentiva works

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

2. What you need to know before starting Fingolimod Zentiva

Do not take Fingolimod Zentiva if:

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

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

Warnings and precautions

Talk to your doctor before starting this medicine if:

you have severe breathing problems while sleeping (severe sleep apnea).
you have been told you have an abnormal electrocardiogram (ECG).
you have symptoms of a slow heartbeat (e.g., dizziness, nausea, or palpitations).
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).
you have a history of sudden loss of consciousness or fainting (syncope).
you are planning to get vaccinated.
you have never had chickenpox.
you have or have had disorders or other signs of inflammation in the central vision area (the macula) at the back of the eye (a condition known as macular edema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause eye problems).
you have liver problems.
you have uncontrolled high blood pressure despite medication.
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 this medicine.

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 0.25 mg once-daily dose—fingolimod causes a decrease in heart rate. As a result, you may feel dizzy or tired, become aware of your heartbeat, or experience a drop in blood pressure. If these effects are severe, inform your doctor immediately, as you may require urgent treatment. Fingolimod may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than 1 day. Slow heart rate typically normalizes within 1 month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will require you to remain at the clinic or hospital for at least 6 hours after taking your first dose of fingolimod or your first 0.5 mg dose (if switching from 0.25 mg once daily), with hourly pulse and blood pressure checks, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. An electrocardiogram (ECG) will be performed before your first dose and again after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate or if your ECG shows abnormalities, you will need extended monitoring (at least 2 additional hours, and possibly overnight) until the issue resolves. The same may apply if you restart 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 consider switching 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 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 will likely need to be vaccinated before starting treatment with this medicine. If so, your doctor will delay the start of fingolimod treatment by 1 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 up to 2 months after stopping treatment), you may be more susceptible to infections. An existing infection may also worsen. Infections can 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.

Human papillomavirus (HPV) infections—including papillomas, dysplasia, warts, 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 and during treatment to monitor for the risk of PML.

If you think your MS is worsening or 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 and communicating—inform your doctor immediately. These could 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, 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 treatment with this medicine, your doctor may request an eye examination if you have or have had visual disorders or other signs of inflammation in the central vision area (the macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting fingolimod treatment, your doctor may request an eye examination after 3 to 4 months.

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 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 previously had eye inflammation known as uveitis, you are at higher risk of developing macular edema. In such 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 can cause visual symptoms similar to those of an MS attack (optic neuritis). You may not have symptoms at first. Inform your doctor immediately of any changes in your vision.

Your doctor may recommend 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 fine details.

Liver function tests

If you have severe liver problems, you must not take this medicine. 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 taking this medicine 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 count

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 need blood tests, inform your doctor that you are taking this medicine, as otherwise your doctor may misinterpret the test results. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment, your doctor will confirm you have sufficient 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.

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 wounds 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 treatment, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during fingolimod treatment. If skin problems arise, your doctor may refer you to a dermatologist, who may decide on regular follow-up visits.

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 the need for a magnetic resonance imaging (MRI) scan to evaluate your condition and decide whether you should stop taking this medicine.

Switching from other treatments to Fingolimod Zentiva

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

Women of childbearing potential

If fingolimod is used during pregnancy, it may harm the fetus. Before starting treatment, your doctor will explain the risks and perform a pregnancy test to ensure 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 treatment, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping fingolimod treatment

Do not stop taking this medicine 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 this could be serious (see section 3 “If you stop taking Fingolimod Zentiva” and section 4 “Possible side effects”).

Elderly patients

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

Children and adolescents

This medicine should not be given to children under 10 years of age, as it has not been studied in this age group of MS patients.

This product is administered to children with a body weight >40 kg. Children with a body weight ≤40 kg should take other suitable formulations.

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

Other medicines and Fingolimod Zentiva

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

Medicines that suppress or modulate the immune system, including other medicines used for the treatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use fingolimod together with these medicines, as this could intensify the effect on the immune system (see also “Do not use Fingolimod Zentiva”).
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 it, certain types of vaccines (those made with live attenuated viruses) should not be administered, as they may cause the infections they are intended to prevent. Other vaccines may also not work as effectively if given during this time.
Medicines that slow down the heart rate, such as beta-blockers (e.g. atenolol). Using fingolimod with these medicines may intensify the effect on heart rate during the first few days after starting fingolimod treatment.
Medicines used to treat irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medicines, you must not use fingolimod, as this could intensify the effect on irregular heartbeats (see also section “Do not take Fingolimod Zentiva”).
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 efficacy of fingolimod).

Pregnancy and breastfeeding

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

Pregnancy

Do not use this medicine 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. If fingolimod is used during pregnancy, there is a risk of causing harm to the unborn baby. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately 2 times higher than that observed in the general population (where the rate of congenital malformations is approximately 2–3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal abnormalities.

Therefore, if you are a woman of childbearing potential:

before starting treatment with this medicine, your doctor will inform you about the risk to the unborn baby and will request a pregnancy test to confirm that you are not pregnant; and
during treatment with fingolimod and for 2 months after stopping it, you must use an effective method of contraception to prevent pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a card explaining why you must not become pregnant while taking this medicine.

If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide to discontinue treatment (see section 3 “If you stop taking Fingolimod Zentiva” and section 4 “Possible side effects”). You will be offered specific prenatal monitoring.

Breastfeeding

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

Driving and use of machines

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

However, at the start of treatment, you will need to remain at the doctor's office or hospital for 6 hours after taking your first dose of fingolimod. During this time, and possibly afterwards, your ability to drive and operate machinery may be impaired.

3. How to take Fingolimod Zentiva

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

Follow exactly the fingolimod dosing instructions provided 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 above): The dose depends on body weight:

Children and adolescents weighing more than 40 kg should take one 0.5 mg capsule per day.
Children and adolescents weighing 40 kg or less should use other suitable formulations.

For children and adolescents who initially started on a 0.25 mg capsule per day and later reach a stable weight above 40 kg, the doctor will instruct them to switch to a 0.5 mg capsule per day. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.

This medicine is for oral use.

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

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

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

If you take more Fingolimod Zentiva 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 Zentiva

If you have been taking this medicine 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 this medicine for at least 1 month and have missed taking 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 planned.

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

If you stop taking Fingolimod Zentiva

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

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

If you need to restart treatment with this medicine 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 this medicine after stopping it for more than two weeks without 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 treatment, as this could be serious.

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

4. Possible adverse effects

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

Some adverse effects may be serious or potentially serious

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 patches with 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 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 people):

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 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 this medicine 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 lead to the need for a liver transplant.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to an MS relapse. Other symptoms may not be noticeable 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 influence 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, inform your doctor immediately.

Other adverse effects

Very frequent (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, 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, pharmacist, or nurse, 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 Zentiva

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

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

Store below 25°C.

Keep in the original blister to protect from moisture.

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

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

6. Contents of the pack and other information

Composition of Fingolimod Zentiva

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

Capsule contents: microcrystalline cellulose 101 and 102, anhydrous calcium hydrogen phosphate, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172) (only in the capsule cap).

Appearance of the product and pack contents

Fingolimod Zentiva 0.5 mg hard capsules have a size “3” capsule (15.8±0.4 mm) filled with white or almost white free granular powder, with an opaque white body and an opaque bright yellow cap.

Fingolimod Zentiva 0.5 mg hard capsules are available in packs containing 7, 28, 30, 56, 90 or 98 capsules.

In your country, only some pack sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

S.C. ZENTIVA S.A.

B-dul Theodor Pallady nr. 50, Sector 3

Bucharest, code 032266

Romania

LABORMED-PHARMA S.A.

Bd. Theodor Pallady nr. 44B, sector 3,

Bucharest, code 032266

Romania

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Germany	Fingolimod Zentiva
Austria	Fingolimod Zentiva
Bulgaria	Финголимод Зентива 0,5 mg твърди капсули
Denmark	Fingolimod Zentiva
Slovakia	Fingolimod Zentiva 0,5 mg
Spain	Fingolimod Zentiva 0,5 mg hard capsules EFG
Estonia	Fingolimod Zentiva
Finland	Fingolimod Zentiva
France	Fingolimod Zentiva 0,5 mg, capsule
Iceland	Fingolimod Zentiva
Italy	Fingolimod Zentiva
Latvia	Fingolimod Zentiva 0,5 mg cietas kapsulas
Lithuania	Fingolimod Zentiva 0,5 mg kietosios kapsulės
Norway	Fingolimod Zentiva
Poland	Fingolimod Zentiva
Portugal	Fingolimod Zentiva
United Kingdom (Northern Ireland)	Fingolimod Zentiva
Czech Republic	Fingolimod Zentiva
Romania	Fingolimod Zentiva 0,5 mg capsule
Sweden	Fingolimod Zentiva

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

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