Prospecto: information for the user

Fingolimod Zentiva 0.5mg hard capsules EFG

fingolimod

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isFingolimod Zentivaand for what it is used

2. What you need to know before starting to takeFingolimod Zentiva

3. How to takeFingolimod Zentiva

4. Possible adverse effects

5. Storage ofFingolimod Zentiva

6. Contents of the package and additional informationl

Fingolimod Zentiva contains the active ingredient fingolimod.

What Fingolimod Zentiva is used for

This medicine is used in adults and in children and adolescents (from 10 years of age and older, and with a body weight >40 kg) to treat relapsing-remitting multiple sclerosis (that occurs with relapses) (MS), particularly in:

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

Or

• Patients who rapidly develop severe MS.

This medicine does not cure MS, but helps to reduce the number of relapses and to reduce the speed of physical disability progression 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 covering (called myelin) that surrounds the nerves in the CNS and prevents nerves from functioning correctly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of CNS symptoms that are a reflection of the inflammation that occurs in the CNS. Symptoms vary from patient to patient, but usually consist of difficulties walking, numbness in some part of the body (tingling), vision problems or balance disorders. The symptoms of a relapse may disappear completely when the relapse ends, but some problems may remain.

How Fingolimod Zentiva works

This medicine helps to 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 by preventing them from reaching the brain and spinal cord. This limits nerve damage attributed to MS. This medicine also reduces some of the immune responses of your body.

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 aweakened immune response(due to a syndrome of immunodeficiency, a disease, or to medicines that suppress the immune system).
• you have aserious active infection or a chronic active infectionsuch as hepatitis or tuberculosis.
• you haveactive cancer.
• you haveserious liver problems.
• in the last 6 months, you have had a heart attack, angina, stroke, or transient ischemic attack or any type of heart failure.
• you have any type ofirregular or abnormal heart rhythm(arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with this medicine.
• you are taking or have recently taken medicines for irregular heart rhythmsuch as quinidine, disopyramide, amiodarone, or sotalol.
• you arepregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method.

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

Warnings and precautions

Consult your doctor before starting to take this medicine if:

• you have severe sleep apnea.
• you have been told that you have an abnormal electrocardiogram.
• you have symptoms of slow heart rhythm (e.g. dizziness, nausea, or palpitations).
• you are taking or have recently taken medicines 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 plan to be vaccinated.
• you have never had chickenpox.
• you have or have had eye inflammation or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as macular edema, see below) or if you havediabetes (which can cause eye problems).
• you have liver problems.
• you havehigh blood pressure that cannot be controlled with medicines.
• you haveserious lung problemsor "smoker's cough."

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

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5mg, in the case that you have been changed from a previous dose of 0.25mg once a day, 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, inform your doctor or you may need immediate treatment.Fingolimod can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize in less than 1 day. The slow heart rate usually normalizes within 1 month.

During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation room 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 0.5mg, in the case that you have been changed from a previous dose of 0.25mg once a day, to take the necessary measures if any adverse effects appear 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 treatment break, depending on both the duration of the break and how long you were taking fingolimod before the break.

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

If you have had sudden fainting spells in the past or decreased 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 monitoring overnight.

If you are taking other medicines that can slow your heart rate, fingolimod may not be suitable for you. It is necessary for a cardiologist to evaluate you, and it is they who will decide if you can change to alternative medicines that do not slow your heart rate to allow treatment with fingolimod. If this change is impossible, 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, your doctor will probably delay starting treatment with this medicine for 1 month after completing the vaccination course.

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 for up to 2 months after stopping treatment), you may be more susceptible to infections. You may even have a worsening of an existing infection. Infections can be serious and potentially life-threatening. If you think you have caught an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or the herpes virus), contact your doctor immediately because it can be serious and life-threatening. If you think your MS is getting worse (e.g. weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, because they may 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 evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, in patients treated with fingolimod. Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend regular HPV checks.

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 disturbances or other signs of inflammation in the central vision area (macula) of the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting treatment with fingolimod, your doctor may ask you to have an eye examination 3 or 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 clearly. Fingolimod can cause inflammation of the macula and this condition is known as macular edema. Inflammation usually occurs in the first four months of treatment with this medicine.

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

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

A macular edema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may not have any symptoms. It is necessary to inform your doctor of any changes you notice in your vision. Your doctor may want to have 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 trouble seeing colors or small details.

Liver function tests

If you have serious 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 color of the skin or the white part of your eyes, abnormally dark urine (brown), abdominal pain on the right side, fatigue, loss of appetite, nausea, and vomiting without apparent cause,inform your doctor immediately.

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

Your doctor will ask you to have blood tests before, during, and after treatment to monitor your liver function. You may need to stop treatment with this medicine if the test results indicate a liver problem.

High blood pressure

As fingolimod causes a slight increase in blood pressure, your doctor will want to monitor your blood pressure regularly.

Lung problems

Fingolimod has a mild effect on lung function. Patients with serious 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 normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking this medicine, as if you do not, the doctor may not understand the test results. For certain blood tests, your doctor may need to take more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

In patients with MS who have been treated with fingolimod, cases of skin cancer have been reported. Inform your doctor immediately if you notice any new skin nodules (e.g. shiny nodules with a pearl-like appearance), moles, or open sores that do not heal within weeks. Symptoms of skin cancer may 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, you will need to have a skin examination to check if you have any skin nodules. Your doctor will also perform regular skin checks during treatment with fingolimod. If you notice any skin problems, your doctor may refer you to a dermatologist, who may decide if you need regular follow-up appointments.

In patients with MS who have been treated with fingolimod, a type of lymphoma has been reported.

Exposure to the sun 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:

• wearing protective clothing.
• regularly applying a high-protection sunscreen.

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 evaluate the need for an MRI scan to assess 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 abnormalities caused by previous treatment. Your doctor may need to have a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with fingolimod. To switch from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if fingolimod is suitable for you.

Women of childbearing potential

If fingolimod is used during pregnancy, it may be harmful to 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 explaining why you should not become pregnant while taking fingolimod. They will also explain what you should 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").

Worsening of MS after stopping treatment with fingolimod

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

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

Older adults

The experience of fingolimod in patients over 65 years old is limited. If you have any doubts, consult your doctor.

Children and adolescents

This medicine should not be administered 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 >40kg. Children with aweight ≤40kg 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:

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

Other medicines and Fingolimod Zentiva

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

• Medicines that suppress or modulate the immune system, includingother medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use fingolimod with these medicines because it could intensify the effect on the immune system (see also "Do not take Fingolimod Zentiva").
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and for up to 2 months after stopping treatment, you should not be given certain types of vaccines (vaccines made with live, attenuated viruses) because they may cause the infections that these vaccines are meant to prevent. It is possible that other vaccines may not have the desired effect if given during this period of time.
• Medicines that slow heart rate(e.g. beta-blockers such as atenolol). The use of fingolimod with these medicines may intensify the effect on heart rate during the first few days after starting treatment with fingolimod.
• Medicines for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medicines, you should not use fingolimod, as it may intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Zentiva").
• Other medicines:

• protease inhibitors, antifungals such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (potential risk of reduced fingolimod efficacy).

Pregnancy and breastfeeding

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

Pregnancy

Do not use this medicine during pregnancy, or if you are planning to become pregnant, or if you are a woman who may become pregnant and are not using 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 heart, kidney, and musculoskeletal malformations.

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 fetus and ask you to have a pregnancy test to ensure you are not pregnant, and,
• during treatment with fingolimod and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss effective contraceptive methods with your doctor.

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

If you become pregnant while taking this medicine, inform your doctor immediately.Your doctor will decide to stop treatment (see section 3 "If you stop taking Fingolimod Zentiva" and also section 4 "Possible side effects"). You will have a specific prenatal follow-up.

Breastfeeding

During treatment withfingolimod, you should not breastfeed. Fingolimod passes into breast milk and there is a risk that the baby may have serious adverse effects.

Driving and using machines

Your doctor will inform you if your disease allows you to drive vehicles, including bicycles, and use machines safely. There is no expected influence of this medicine on your ability to drive and use machines.

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

The treatment with this medication will be supervised by a doctor with experience in the treatment of multiple sclerosis.

Follow exactly the administration instructions for fingolimod indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one capsule of 0.5mg per day.

Children and adolescents (10 years of age and older): The dose depends on body weight:

• Children and adolescents with a weight above 40kg should takeone capsule of 0.5mg per day.
• Children and adolescents with a weight equal to or less than 40kg should useother suitable formulations.

To children and adolescents who start with one capsule of 0.25mg per day and later reach a stable weight above 40kg, the doctor will instruct them to change to one capsule of 0.5mg 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 must always be swallowed whole, without opening. You can take this medication with or without food.

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

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Fingolimod Zentiva

If you have been taking this medication for less than 1 month and forget to take 1 dose for an entire 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 forget 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 forget 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 compensate for missed doses.

If you interrupt treatment with Fingolimod Zentiva

Do not stop taking this medication or change the dose you should take without consulting your doctor first.

This medication will remain in your body for up to 2 months after treatment is discontinued. The number of white blood cells in the blood (lymphocyte count) may remain low during this period and it is possible that the adverse effects described in this leaflet will still occur. After discontinuing treatment with fingolimod, you may need to wait 6-8 weeks before starting a new treatment with EM.

If you need to restart treatment with this medication after a pause of more than 2 weeks, the effect on heart rhythm that may occur at the start of treatment may recur and you will need to be monitored by your doctor to restart treatment. Do not restart treatment with this medication after you have discontinued it for more than 2 weeks without consulting your doctor.

Your doctor will decide if you need to be followed up after discontinuing treatment with fingolimod and how. Inform your doctor immediately if you think your MS is worsening after discontinuing treatment with fingolimod, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Some side effects can be serious or potentially serious

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

• Cough with mucus (phlegm), chest discomfort, fever (signs of respiratory changes).
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, prickling, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain.
• Slow heart rate (bradycardia), irregular heart rhythm.
• A type of skin cancer known as basal cell carcinoma (BCC) that often presents 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 it has also been reported in pediatric patients treated with fingolimod.
• Weight loss.

Less frequent(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 center of the visual field, blurred vision, problems seeing colors or details.
• Decreased platelet count, 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 over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can cause itching, bleeding, or ulceration.
• Seizures, attacks (more common 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 the sudden and intense onset of 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 present as a firm, red nodule, a sore with a crust, or a new sore over an existing scar.

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

• Electrocardiogram anomaly (T wave inversion).
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma).

Frequency unknown(cannot be estimated from available data):

• Allergic reactions, including symptoms such as rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day treatment with this medicine begins.
• 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 stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, 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, flesh-colored or red-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm or painless nodule or mass. Long-term exposure to sunlight and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with fingolimod, MS symptoms may reappear and may be worse than they were before or during treatment.
• Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed.

If you have any of these symptoms,inform your doctor immediately.

Other side 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.
• Sensation of pressure or pain in the cheeks and forehead (sinusitis).
• Headache.
• Diarrhea.
• Back pain.
• Blood test with alterations in liver enzyme levels.
• Cough.

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

• Pityriasis versicolor (fungal infection of the skin).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine).
• Low white blood cell count (lymphocytes, leukocytes).
• Weakness.
• Itching.
• Redness of the skin and burning (eczema).
• Increased levels of certain blood lipids (triglycerides).
• Hair loss.
• Difficulty breathing.
• Depression.
• Blurred vision (see the section on macular edema under the title "Some side effects can be serious or potentially serious").
• Hypertension (fingolimod can cause a slight increase in blood pressure).
• Muscle pain.
• Joint pain.

Less frequent(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):

• Lymphoma (a type of cancer that affects the lymphatic system).

Frequency unknown(cannot be estimated from available data):

• Peripheral inflammation.

If you consider that any of the side effects you are experiencing are serious,inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 to protect it from moisture.

Do not use any packaging that is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fingolimod Zentiva

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

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

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

Appearance of the product and contents of the package

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

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

It may be that only some package sizes are marketed in your country.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing

S.C. ZENTIVA S.A.

Theodor Pallady Blvd. no. 50, Sector 3

Bucharest, cod 032266

Romania

or

LABORMED-PHARMA S.A.

Theodor Pallady Blvd. no. 44B, sector 3,

Bucharest, cod 032266

Romania

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

Last review date of this leaflet:November 2023

More detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.