FINGOLIMOD ZENTIVA 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fingolimod Zentiva 0.5mg hard capsules EFG

fingolimod

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Fingolimod Zentiva contains the active substance fingolimod.

What Fingolimod Zentiva is used for

This medication 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) (with relapses), particularly in:

• Patient who do not respond to treatment despite MS treatment.

Or

• Patient who rapidly develop severe MS.

This medication does not cure MS, but it helps reduce the number of relapses and slow the progression of physical disabilities due to MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), consisting of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that covers the nerves in the CNS, preventing the nerves from functioning properly. This process is called demyelination.

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

How Fingolimod Zentiva works

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

2. What you need to know before taking Fingolimod Zentiva

Do not take Fingolimod Zentiva if

• you are allergicto fingolimod or to any of the other ingredients of this medicine (listed in section 6).
• you have a weakened immune system(due to an immune deficiency syndrome, a disease, or medications that suppress the immune system).
• you have a severe active or chronic infectionsuch as hepatitis or tuberculosis.
• you have active cancer.
• you have severe liver problems.
• in the last 6 months, you have had a heart attack, chest pain, stroke, or stroke warning signs or any type of heart failure.
• you have any type of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with this medicine.
• you are taking or have recently taken medications for irregular heartbeatssuch as quinidine, disopyramide, amiodarone, or sotalol.
• you are pregnant or are a woman of childbearing age and are not using an effective contraceptive method.

If any of the above applies to you or if you are not sure, tell your doctor before takingthis medicine.

Warnings and precautions

Consult your doctor before starting to take this medicine if:

• you have severe respiratory problems when sleeping (severe sleep apnea).
• you have been told you have an abnormal electrocardiogram.
• you have symptoms of a slow heart rate (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, or 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 disordersor other signs of inflammation in the central vision area (macula) of the eye (a condition known as macular edema, see below) or inflammation or infection of the eye (uveitis) or if you havediabetes (which can cause eye problems).
• you have liver problems.
• you have high blood pressure that cannot be controlled with medication.
• you have severe lung problemsor "smoker's cough."

If any of the above applies to you or if you are not sure, tell your doctor before takingthis medicine.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once daily has been changed, fingolimod causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop. If these effects are severe, tell your doctor as you may need immediate treatment.Fingolimod may also cause your heartbeats to become irregular, especially after the first dose. Irregular heartbeats usually return to normal within 1 day. The slow heart rate usually returns to normal within 1 month.

During this period, no clinically significant effect on heart rate is usually expected.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of fingolimod or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once daily has been changed, so that appropriate measures can be taken in case of adverse effects that occur at the start of treatment. You will have an electrocardiogram before the first dose of fingolimod and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight, until this is resolved). The same may apply if you are restarting fingolimod after a pause in treatment, depending on both the duration of the pause and how long you were taking fingolimod before the pause.

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

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

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. You need to be evaluated by a cardiologist, who will assess whether you can switch to alternative medications that do not slow the heart rate to allow treatment with fingolimod. If such a switch is not possible, the cardiologist will advise you on how to start treatment with fingolimod, including overnight monitoring.

If you have never had chickenpox

If you have not 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 will probably need to be vaccinated before starting treatment with this medicine. If so, your doctor will delay the start of treatment with fingolimod for 1 month after completion of the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with fingolimod (and up to 2 months after stopping treatment), you may be more likely to get infections. You may even get worse if you already have an infection. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately because it can be serious and life-threatening. If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, tell your doctor immediately, as they can be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will assess the need for an MRI scan to evaluate your condition and decide if you need to stop taking fingolimod.

Cases of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, have been reported in patients treated with fingolimod. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have regular HPV screenings.

Macular edema

Before starting treatment with this medicine, your doctor may ask you to have an eye examination if you have or have had visual disorders or other signs of inflammation in the central vision area (macula) of the eye, inflammation or infection of the eye (uveitis), or diabetes.

After starting treatment with fingolimod, your doctor may ask you to have an eye examination after 3 or 4 months of treatment.

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

If you have diabetesor have had an eye inflammation known as uveitis, you are more likely to get macular edema. In these cases, your doctor will want you to have regular eye checks to detect macular edema.

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

Macular edema can cause the same visual symptoms as those produced by an MS attack (optic neuritis). At first, you may not have symptoms. You must tell your doctor about any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• The center of your field of vision becomes blurred or contains shadows.
• A blind spot appears in the center of your field of vision.
• You have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take this medicine. Fingolimod can affect liver function. You may not notice any symptoms, but if you notice a yellowish tint to your skin or the white of your eyes, unusually dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, tell your doctor immediately.

If you have any of these symptoms after starting treatment with fingolimod, tell your doctor immediately.

Before, during, and after treatment, your doctor will ask for blood tests to check your liver function. You may need to stop treatment with this medicine if your test results indicate a liver problem.

High blood pressure

Since fingolimod can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

Fingolimod has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to develop adverse effects.

Blood count

The expected effect of treatment with fingolimod is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you need to have blood tests, tell your doctor that you are taking this medicine, as your doctor may not understand the test results if you do not. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with this medicine, your doctor will check if you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to stop treatment with fingolimod.

Posterior reversible encephalopathy syndrome (PRES)

A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in MS patients treated with fingolimod. Symptoms can include sudden and severe headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment with fingolimod because it can be serious.

Cancer

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

Cases of a type of cancer of the lymphatic system (lymphoma) have been reported in MS patients treated with fingolimod.

Sun exposure and sun protection

Fingolimod weakens your immune system, which increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by

• using suitable protective clothing.
• applying a sunscreen with a high UV protection index regularly.

Unusual brain lesions associated with MS relapses

Rare cases of large and 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 an MRI scan to evaluate your condition and decide if you need to 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 treatment-related abnormalities. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with fingolimod. To switch from teriflunomide, your doctor may advise you to wait for a period or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor are necessary to decide if fingolimod is suitable for you.

Women of childbearing age

If fingolimod is used during pregnancy, it may harm the fetus. Before starting treatment with this medicine, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking fingolimod. It also explains what you need to do to avoid becoming pregnant while taking this medicine. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

MS worsening after stopping treatment with fingolimod

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

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod, as it can be serious (see section 3 "If you stop taking Fingolimod Zentiva" and also section 4 "Possible side effects").

Elderly

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 patients with MS in this age group.

This product is administered to children with a weight >40 kg. Children with a 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 and adolescents and their caregivers:

• Before starting treatment with this medicine, your doctor will check your vaccination status. If you have not received certain vaccinations, you may need to be vaccinated before you can start treatment with fingolimod.
• The first time you take this medicine, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will check your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or attacks before taking or while taking this medicine, tell your doctor.
• If you suffer from depression or anxiety or if during treatment with this medicine you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medications and Fingolimod Zentiva

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

• Medications that suppress or modulate the immune system, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use fingolimod with these medications because it could intensify the effect on the immune system (see also "Do not use Fingolimod Zentiva").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and up to two months after its interruption, you should not be given certain types of vaccines (vaccines made with live attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not be effective if administered during this period.
• Medications that slow down the heart rate(e.g., beta-blockers such as atenolol). The use of fingolimod with these medications may intensify the effect on the heart rate during the first days after starting treatment with fingolimod.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use fingolimod, as it could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Zentiva").
• Other medications:

• 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 plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Do not use this medication during pregnancy, or if you plan to become pregnant, or if you are a woman who can become pregnant and do not use an effective contraceptive method. If fingolimod is used during pregnancy, there is a risk of harm to the fetus. 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 malformations.

Therefore, if you are a woman of childbearing age:

• before starting treatment with this medication, your doctor will inform you about the risk to the fetus and ask you to perform a pregnancy test to ensure you are not pregnant, and,
• during treatment with fingolimod and for 2 months after its interruption, you must use an effective contraceptive method to avoid becoming pregnant. Discuss reliable contraceptive methods with your doctor.

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

If you become pregnant during treatment with this medication, inform your doctor immediately.Your doctor will decide whether to interrupt treatment (see section 3 "If you stop treatment with Fingolimod Zentiva" and also section 4 "Possible side effects"). You will receive specific prenatal monitoring.

Breastfeeding

During treatment with fingolimod, you should not breastfeed.Fingolimod passes into breast milk, and there is a risk that the baby may experience serious side effects.

Driving and using machines

Your doctor will inform you if your condition allows you to drive vehicles, including bicycles, and use machines safely. It is not expected that this medication will affect your ability to drive and use machines.

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

3. How to take Fingolimod Zentiva

Treatment with this medication will be supervised by a doctor with experience in treating multiple sclerosis.

Follow your doctor's instructions for taking fingolimod exactly. 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 (10 years of age and older): The dose depends on body weight:

• Children and adolescents weighing more than 40 kg should takeone 0.5 mg capsule per day.
• Children and adolescents weighing 40 kg or less should useother suitable formulations.

For children and adolescents who start with 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, it is recommended to repeat the observation period of the first dose.

Do not exceed the recommended dose.

This medication is taken orally.

Take this medication once a day with a glass of water. Fingolimod capsules should always be swallowed whole, without opening them. You can take this medication with or without food.

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

If you have doubts about the duration of treatment with fingolimod, 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fingolimod Zentiva

If you have been taking this medication for less than 1 month and forget to take 1 dose for a whole day, talk to 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 medication for at least 1 month and have forgotten to take your treatment for more than 2 weeks, talk to 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 forgotten to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

Never take a double dose to make up for forgotten doses.

If you stop treatment with Fingolimod Zentiva

Do not stop taking this medication or change the dose to be taken without discussing it with your doctor first.

This medication will remain in your body for up to two months after treatment is stopped. The number of white blood cells in the blood (lymphocyte count) may remain low during this period, and it is possible that side effects may still occur. After stopping treatment with fingolimod, you may need to wait for 6-8 weeks before starting a new treatment for MS.

If you need to restart treatment with this medication after a pause of more than two weeks, the effect on the heart rate that may occur at the start of treatment may repeat, and you will need to be monitored in the doctor's office to restart treatment. Do not restart treatment with this medication after interrupting it for more than two weeks without consulting your doctor.

Your doctor will decide whether you need to be monitored after stopping treatment with fingolimod and how. Inform your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod, as it could be serious.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects may be serious or potentially serious

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

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders).
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may experience are fever and weakness in the early stage of the infection, followed by numbness, itching, or red spots with severe pain.
• Slow heart rate (bradycardia), irregular heart rhythm.
• A type of skin cancer called basal cell carcinoma (BCC) that often appears as a pearl-like nodule, although it can also have other forms.
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and these 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 (inflammation in the central vision area of the retina in the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the field of vision, blurred vision, problems seeing colors or details.
• Decreased number of blood platelets, which increases 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 in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate.
• Seizures, attacks (more frequent in children and adolescents than in adults).

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

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden and severe headache, confusion, seizures, and/or visual disturbances.
• Lymphoma (a type of cancer that affects the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar.

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

• Abnormality in the electrocardiogram (inversion of the T wave).
• Tumor related to 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 this medication starts.
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdominal area, dark urine (brown color), decreased appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to those of an MS relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
• 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 nodule of flesh-colored or red-blue color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with fingolimod, MS symptoms may recur and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these symptoms, tell your doctor immediately.

Other side 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 with abnormal liver enzyme levels.
• Cough.

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

• 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.
• Rash with itching, redness of the skin, and burning (eczema).
• Itching.
• Increased blood levels of certain lipids (triglycerides).
• Hair loss.
• Breathing difficulties.
• Depression.
• Blurred vision (see also the section on macular edema under the heading "Some side effects can 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).
• Depressive mood.
• Nausea.

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

• Lymphatic system cancer (lymphoma).

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

• Peripheral inflammation.

If you think any of the side effects you are experiencing is serious, tell your doctor.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod Zentiva

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

Do not use this medication after the expiration date stated on the packaging and on the aluminum blister after CAD/EXP. The expiration date is the last day of the month indicated.

Store below 25°C.

Store in the original blister pack to protect it from moisture.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Fingolimod Zentiva

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

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

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

Appearance and Container Content of the Product

Fingolimod Zentiva 0.5 mg hard capsules have a size "3" (15.8±0.4 mm) capsule filled with loose white or off-white granular powder with an opaque white body and an opaque bright yellow cap.

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

Only some pack sizes may be marketed in your country.

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, cod 032266

Romania

or

LABORMED-PHARMA S.A.

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

Bucharest, cod 032266

Romania

You can request more information about this medicinal product by contacting 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:November 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.