Package Insert: Information for the Patient

Fingolimod SUN 0.5 mg Hard Capsules EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Fingolimod SUN and how is it used

2. What you need to know before starting to take Fingolimod SUN

3. How to take Fingolimod SUN

4. Possible adverse effects

5. Storage of Fingolimod SUN

6. Contents of the package and additional information

The active ingredient of Fingolimod SUN is fingolimod.

What is Fingolimod SUN used for

Fingolimod SUN is used in adults, in children and adolescents (10 years of age and older, with a body weight of more than 40 kg) to treat relapsing-remitting multiple sclerosis (EM), particularly in:

-patients who do not respond to treatment despite treatment for EM

or

-patients who rapidly develop severe EM.

Fingolimod SUN does not cure EM, but helps to reduce the number of relapses and slow down the progression of physical disabilities due to EM.

What is multiple sclerosis

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

Relapsing-remitting EM 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 persist.

How Fingolimod SUN works

Fingolimod SUN 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 preventing them from reaching the brain and spinal cord. This limits nerve damage attributed to multiple sclerosis. Fingolimod also reduces some of the immune responses of your body.

Do not take Fingolimod SUN

• if you have a weakened immune response (due to immunodeficiency syndrome, a disease, or medications that suppress the immune system)
• if you have an active severe infection or an active chronic infection such as hepatitis or tuberculosis
• if you have an active cancer
• if you have severe liver problems
• if, in the last 6 months, you have had a heart attack, angina, stroke, or transient ischemic attack or any type of heart failure
• if you have any type of irregular or abnormal heart rhythm (arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with this medication
• if you are taking or have recently taken medications for irregular heart rhythms such as quinidine, disopyramide, amiodarone, or sotalol
• if you are pregnant or if you are a fertile woman and do not use an effective contraceptive method.
• if you are allergic to fingolimod or to any of the other components of this medication (including those listed in section 6).

If any of the above cases apply to you, inform your doctor without takingFingolimod SUN.

Warnings and precautions

Consult your doctor before starting to take Fingolimod SUN:

• if you have severe respiratory problems when sleeping (severe sleep apnea)
• if you have been told that you have an abnormal electrocardiogram
• if you have symptoms of slow heart rhythm (e.g., dizziness, nausea, or palpitations)
• if you are taking or have recently taken medications that slow your heart rate (such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine)
• if you have a history of sudden loss of consciousness or fainting (syncope)
• if you plan to get vaccinated
• if you have never had chickenpox
• if 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 have diabetes (which can cause eye problems)
• if you have liver problems
• if you have high blood pressure that cannot be controlled with medications
• if you have severe lung problems or "smoker's cough."

If any of the above cases apply to you, inform your doctor before takingFingolimod SUN.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of Fingolimod SUN 0.5 mg, in the case that you have been switched from other medications containing fingolimod available to a lower dose (daily dose of 0.25 mg), 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 as you may need immediate treatment.Fingolimod also may make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize in less than a day. The slow heart rate usually normalizes within a 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 or hospital for a minimum of 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Fingolimod SUN or after taking the first dose of Fingolimod SUN 0.5 mg, in the case that you have been switched from a previous dose of 0.25 mg once a day, so that appropriate measures can be taken if adverse effects appear at the start of treatment. You will need to 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 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 appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with fingolimod, including monitoring during the night.

If you are taking other medications 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 switch to alternative medications 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 monitoring during the night.

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 fingolimod for a month after completing 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 for up to 2 months after you stop treatment), you may be more susceptible to infections. You may even have a worsening of an existing infection. Infections can be severe and potentially life-threatening. If you think you have contracted 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 as it can be severe and life-threatening.

If you think your MS is worsening (e.g., weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as 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 this medication.

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 Fingolimod SUN, your doctor may request that you have an eye examination if you have or have had eye problems 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 request that you 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 may cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first four months of treatment with fingolimod.

If you have diabetes or 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 communicate any changes you notice in your vision to your doctor. 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 problems seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take fingolimod. Fingolimod can affect liver function. You may not perceive any symptoms, but if you notice a yellowish tint to your skin or the white part of your eyes, abnormally dark urine (brown), pain in your right side of your stomach (abdomen), fatigue, decreased 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.

Before, during, and after treatment, your doctor will request blood tests to monitor your liver function. You may need to stop treatment if the results of your blood tests indicate a liver problem.

High blood pressure

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

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 normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking fingolimod, as if you do not, the doctor may not understand the results of the blood tests. For certain blood tests, your doctor may need to take more blood than usual.

Before starting treatment with Fingolimod SUN, 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 this medication.

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, as it can be severe.

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 nodules on your skin (e.g., shiny nodules with a pearl-like appearance), spots, or open wounds that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that over time change color, shape, or size. Before starting treatment with fingolimod, a skin examination is required to check if you have any nodules on your 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 see you regularly.

In patients with MS who have been treated with fingolimod, a type of lymphatic system cancer (lymphoma) has been reported.

Exposure to the sun and sun protection

Fingolimod weakens your immune system, increasing 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 SUN. 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 medication.

Switching from other treatments to Fingolimod SUN

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, a thorough evaluation is required, and you should discuss this with your doctor to decide if fingolimod is suitable for you.

Women of childbearing age

If fingolimod is used during pregnancy, it may be harmful to the fetus. Before starting treatment with Fingolimod SUN, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant.

During treatment with Fingolimod SUN and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking this medication. They will also explain what you should do to avoid becoming pregnant while taking this medication.

Worsening of MS after stopping treatment with Fingolimod SUN

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

Inform your doctor immediately if you think your MS is worsening after stopping treatment with this medication, as it can be severe (see section 3 "If you stop treatment with fingolimod" and also section 4 "Possible side effects").

Older adults

The experience with fingolimod in older adults (over 65 years) is limited. If you have any doubts, consult your doctor.

Children and adolescents

Fingolimod 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.

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 Fingolimod SUN, your doctor will check your vaccination status. If you have not been vaccinated, you may need to have the vaccinations before starting treatment with Fingolimod SUN.
• The first time you take Fingolimod SUN, or when switching from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor 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 Fingolimod SUN, inform your doctor.
• If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with Fingolimod SUN, inform your doctor. You may need closer monitoring.

Other medications and Fingolimod SUN

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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 SUN with these medications because this could intensify the effect on the immune system (see also "Do not take Fingolimod SUN").
• corticosteroids due to an added effect on the immune system.
• vaccines. If you need a vaccine, inform your doctor first. During treatment with Fingolimod SUN and for 2 months after stopping treatment, 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 may be possible that other vaccines will not have the desired effect if given during this period of time.
• medications that slow your heart rate (e.g., beta-blockers such as atenolol). The use of Fingolimod SUN with these medications may intensify the effect on your heart rate during the first few days after starting treatment with this medication.
• medications for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medications, you should not use Fingolimod SUN, as this could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod SUN").
• other medications:

• or 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 lactation

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

Pregnancy

Do not take Fingolimod SUN during pregnancy, or if you are planning to become pregnant, or if you are a woman who may become pregnant and do not use an effective contraceptive method. If this medication is used during pregnancy, there is a risk of harming 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 fertile woman:

• before starting treatment with Fingolimod SUN, your doctor will inform you about the risk to the fetus and will ask you to have a pregnancy test to ensure you are not pregnant,

and,

• during treatment with Fingolimod SUN and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss contraceptive options with your doctor.

Information card

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

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

Lactation

Do not breastfeed during treatment with Fingolimod SUN.This medication passes into breast milk, and there is a risk of severe adverse effects in the baby.

Driving and operating machinery

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

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

Fingolimod SUN containspotassium

Patients with renal insufficiency or those on low-potassium diets should note that this medication contains 0.013 mmol (or 0.515 mg) of potassium per capsule/daily maximum dose.

Fingolimod SUN containssodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free."

The treatment with Fingolimod SUN will be supervised by a doctor with experience in treating multiple sclerosis.

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

The recommended dose is

Adults

The dose is one hard capsule of Fingolimod SUN 0.5 mg per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children and adolescents with a body weight equal to or less than 40 kg: one capsule of 0.25 mg per day.Fingolimod SUN 0.5 mg hard capsules are not suitable for pediatric patients with a body weight ≤40 kg. Other medications containing fingolimod are available in lower doses (such as 0.25 mg capsules).
• children and adolescents with a body weight greater than 40 kg: one hard capsule of Fingolimod SUN 0.5 mg per day.

Children and adolescents who start treatment with 0.25 mg capsules of other medications containing fingolimod and subsequently reach a stable body weight greater than 40 kg will be instructed by their doctor to switch to a 0.5 mg fingolimod capsule per day. In this case, it is recommended to repeat the same monitoring as the first dose.

Do not exceed the recommended dose.

Fingolimod SUN is used orally.

Take Fingolimod SUN once a day with a glass of water. Fingolimod SUN capsules must always be swallowed whole, without opening. You can take Fingolimod SUN with or without food.

Taking Fingolimod SUN 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 SUN, consult your doctor or pharmacist.

If you take more Fingolimod SUN than you should

If you have taken more Fingolimod SUN than you should, inform your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fingolimod SUN

If you have been taking Fingolimod SUN 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 at the time you take the next dose.

If you have been taking Fingolimod SUN 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 at the time 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 compensate for missed doses.

If you interrupt treatment with Fingolimod SUN

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

Fingolimod SUN 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 prospectus may still occur. After discontinuing treatment with Fingolimod SUN, you may need to wait 6-8 weeks before starting a new treatment with EM.

If you need to restart treatment with Fingolimod SUN 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 this medication and how. Inform your doctor immediately if you think your MS is worsening after discontinuing treatment with Fingolimod SUN, 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 (can affect up to 1 in 10 people):

• Cough with phlegm, chest discomfort, fever (signs of lung 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 take other forms
• It is known that people with multiple sclerosis have depression and anxiety more frequently, and it has also been reported in pediatric patients treated with fingolimod
• Weight loss.

Less frequent (can 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 (can affect up to 1 in 1,000 people):

• A disease called reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms can 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 (can 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 are more likely to appear the day treatment with fingolimod 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 can 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 (can 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 altered liver enzyme levels
• Cough.

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

• Tinea, a fungal infection of the skin (tinea versicolor)
• 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)
• Itching
• Increased levels of certain blood lipids (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema under the title "Some side effects can be serious or potentially serious")
• Hypertension (this medicine can cause a slight increase in blood pressure)
• Muscle pain
• Joint pain.

Poorly frequent (can affect up to 1 in 100 people):

• Low levels of certain white blood cells (neutrophils)
• Depressive mood
• Nausea.

Rare (can 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and in the blisterpack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. In case of doubt,ask your pharmacisthow to dispose ofthe packaging and themedications that you no longerneed. By doing so, you will help protect the environment.

Composition of Fingolimod SUN

• The active ingredient is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other componentsare:
• 1. Hard capsule content: magnesium stearate (E470b), potassium polacrilex(see section 2), crospovidone (E1202), anhydrous colloidal silica (E551)
  2. Hard capsule coating:

Cap: yellow iron oxide (E172), titanium dioxide (E171), gelatin (E441), sodium lauryl sulfate

Body of the capsule:titanium dioxide (E171), gelatin, sodium lauryl sulfate

Printing ink:shellac (E904), propylene glycol (E1520), potassium hydroxide(E525), black iron oxide (E172)

Appearance of the product and contents of the pack

Fingolimod SUN 0.5 mg hard capsules EFG have an opaque yellow cap and an opaque white body, printed axially with '064' in black ink.

Fingolimod SUN is presented in pre-cut blister packs of single-dose units

Packs containing 7 x 1, 28 x 1, 56 x 1 or 98 x 1 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Cluj County

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:Fingolimod Basics

Spain:Fingolimod SUN 0.5 mg hard capsules EFG

France:Fingolimod SUN

Italy:Fingolimod SUN

Netherlands:Fingolimod SUN

Poland:Fingolimod SUN

United Kingdom (Northern Ireland):Fingolimod SUN

Last update of thisleaflet: August 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/