Patient Information Leaflet

Fingolimod Krka 0.5 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

2.What you need to know before you start taking Fingolimod Krka

3.How to take Fingolimod Krka

4.Possible side effects

5.Storage of Fingolimod Krka

6.Contents of the pack and additional information

What is Fingolimod Krka

The active ingredient of this medication is fingolimod.

What is Fingolimod Krka used for

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

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

or

-Patients who rapidly develop severe MS.

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

What is multiple sclerosis

MSis a chronic diseasethat 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 properly. This process is called demyelination.

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

How Fingolimod Krka works

This medication 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 MS. Fingolimod also reduces some of the immune responses of your body.

Do not take Fingolimod Krka

• 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 infectionsuch 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 ofirregular 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 rhythmsuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you arepregnantorif you are a woman of childbearing age and do not use an effective contraceptive method.
• if you are allergicto fingolimod or to any of the other components of this medication (including those listed in section6).

If any of the above cases apply to you,inform your doctor before taking this medication.

Warnings and precautions

Consult your doctor before starting to take this medication:

• 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 havediabetes (which can cause eye problems).
• if you have liver problems.
• if you havehigh blood pressure that cannot be controlled with medication.
• if you havesevere lung problemsor“smoker's cough”.

If any of the above cases apply to you,inform your doctor before taking this medication.

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, this medication causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or have a decrease in blood pressure.If these effects are pronounced, inform your doctor, as you may need immediate treatment.This medication can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within less than a day. Slow heart rate usually normalizes within a month.

Your doctor will ask you to stay in the consultation or hospital for at least 6hours, with pulse and blood pressure checks every hour, after taking the first dose of this medication 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 in case of adverse effects that appear at the start of treatment. You will need to have an electrocardiogram before the first dose of this medication 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 this medication after a pause in treatment, depending on the duration of the pause and how long you were taking this medication 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, this medication may not be suitable for you.

If you have had sudden fainting episodes in the past or decreased heart rate, this medication 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 this medication, including monitoring during the night.

If you are taking other medications that can slow your heart rate, this medication may not be suitable for you. A cardiologist will evaluate you, and it will be their decision whether to change to alternative medications that do not slow your heart rate to allow treatment with this medication. If this change is impossible, the cardiologist will advise you on how to start treatment with this medication, 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 this medication for a month after completing the vaccination cycle.

Infections

This medication reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medication (and for up to two months after stopping 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 herpes virus), contact your doctor immediately, as it may 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 whether 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 this medication. Your doctor will evaluate whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema

Before starting treatment with this medication, your doctor may request 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 this medication, your doctor may request an eye examination after 3 or 4months of 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. This medication 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 medication.

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 this medication.

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 essential to inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• You notice a blurry or shadowy area in the center of your visual field.
• You notice a blind spot in the center of your visual field.
• You have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take this medication. Fingolimod can affect liver function. You may not notice 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 the abdomen, fatigue, decreased appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

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

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

High blood pressure

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

Lung problems

This medication 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 this medication is to reduce the number of white blood cells in your blood. This effect usually normalizes within two months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking this medication, 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 medication, your doctor will confirm that 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 this medication. 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 this medication, as it may be severe.

Cancer

In patients with MS who have been treated with this medication, cases of skin cancer have been reported. Inform your doctor immediately if you notice any new skin nodules (e.g., shiny nodules that resemble pearls), 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 medication, you will need a skin examination to check for any skin nodules. Your doctor will also perform regular skin checks during treatment with this medication. If you notice any skin problems, your doctor may refer you to a dermatologist, who may decide whether you need regular follow-up appointments.

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

Sun exposure and sun protection

This medication 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 this medication. In the case of severe relapses, your doctor will evaluate the need for an MRI scan to assess your condition and decide whether you need to stop taking this medication.

Switching from other treatments to Fingolimod

Your doctor may change you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to this medication if there are no signs of abnormalities caused by previous treatment. Your doctor may need to perform a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with this medication. 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 this medication is suitable for you.

Women of childbearing age

If this medication is used during pregnancy, it may be harmful to the fetus. Before starting treatment with this medication, 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 this medication. They will also explain what you should do to avoid becoming pregnant while taking this medication. During treatment and for two months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Talk to your doctor about reliable contraceptive methods.

Worsening of MS after stopping treatment with Fingolimod

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 may be severe (see section 3“Stopping treatment with Fingolimod Krka” and also section 4“Adverse reactions”).

Older patients

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

Children and adolescents

This medication 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 this medication, your doctor will check your vaccination status. If you have not been vaccinated, you may need to have the vaccinations before starting treatment with this medication.
• The first time you take this medication, or when changing 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 section above “Slow heart rate (bradycardia) and irregular heartbeats”).
• If you have seizures or attacks before taking or while taking this medication, inform your doctor.
• If you experience depression or anxiety, or if you feel depressed or anxious during treatment with this medication, inform your doctor. You may need closer monitoring.

Other medications and Fingolimod Krka

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, includingother medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use this medication with these medications, as it may intensify the effect on the immune system (see also “Do not take Fingolimod Krka”).
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with this medication and for up to two 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. Other vaccines may not be effective if given during this period of time.
• Medications that slow heart rate(e.g., beta-blockers such as atenolol). The use of this medication with these medications may intensify the effect on 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 this medication, as it may intensify the effect on irregular heartbeats (see also “Do not take Fingolimod Krka”).

• Other medications:

• 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 efficacy of this medication).

Pregnancy and breastfeeding

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

Pregnancy

Do not use this medication 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 harm to the fetus. The rate of congenital malformations observed in babies exposed to this medication during pregnancy is approximately twice 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 age:

• Before starting treatment with this medication, 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 this medication and for two months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Talk to your doctor about reliable contraceptive methods.

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

If you become pregnant while taking this medication, inform your doctor immediately.Your doctor will decide to stop treatment (see section3 “Stopping treatment with Fingolimod Krka” and also section 4 “Adverse reactions”). You will have a specific prenatal follow-up.

Breastfeeding

During treatment with this medication, you should not breastfeed. This medication passes into breast milk, and there is a risk of severe adverse effects in the baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

However, after taking the first dose of this medication, you will need to stay in the doctor's office or hospital for at least 6hours. During this period and possibly afterwards, your ability to drive and use machinery 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 of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one capsule of 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 weight equal to or less than 40 kg: one capsule of 0.25 mg per day.
• Children and adolescents with a weight greater than 40 kg: one capsule of 0.5 mg per day. To children and adolescents who start with one capsule of 0.25 mg per day and later reach a stable weight greater than 40 kg, the doctor will instruct them to change to one capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period of the first dose.

This medication is not available in 0.25 mg doses. For this dose, other medications containing fingolimod available on the market must be used.

Do not exceed the recommended dose.

This medication is taken orally.

Take this medication once a day with a glass of water. The capsules of this medication 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 this medication, consult your doctor or pharmacist.

If you take more Fingolimod Krka 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 Krka

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 the missed doses.

If you interrupt treatment with Fingolimod Krka

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

This medication will remain in your body for up to two months after treatment interruption. 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 interrupting treatment with this medication, you may need to wait 6-8 weeks before starting a new treatment with EM.

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

Your doctor will decide if you need to be followed up after interrupting treatment with this medication and how. Inform your doctor immediately if you think your EM is worsening after interrupting treatment with this medication, 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 medicinecan 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 mucus (sputum), chest discomfort, fever (signs of respiratory changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, burning, 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 this medicine.
• 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 center of the visual field, blurry vision, problems seeing colors or details.
• Decreased platelet count, which increases the risk of bleeding or hematomas.
• 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 reversible posterior leukoencephalopathy syndrome (RPLS). 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-colored nodule, a sore with a scab, or a new sore over an existing scar

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

-Electrocardiogram anomaly (T wave inversion)

-Kaposi's sarcoma (a type of cancer related to human herpesvirus 8 infection)

Frequency not known(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 occur 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 color), decreased appetite, 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 calledprogressive multifocal leukoencephalopathy (PML). PML symptoms 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 around 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, painless nodule or mass. Long-term exposure to sunlight and a weakened immune system may affect the risk of developing Merkel cell carcinoma

• After stopping treatment with this medicine, 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 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
• Sensation of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test with altered liver enzyme levels
• Cough

Common(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
• 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 may be serious or potentially serious")
• Hypertension (this medicine 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)

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

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

• Peripheral inflammation

If you consider that any of theside effectsyou are experiencing are serious,inform your doctor.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://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 EXP. The expiration date is the last day of the month indicated.

Blisters:

Do not store above 25°C.

Store in the original packaging to protect it from humidity.

Flasks:

Do not store above 25°C.

Keep the flask perfectly closed to protect it from humidity.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Fingolimod Krka

• The active ingredient is fingolimod.Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
• The other components are: microcrystalline cellulose (E460), povidone, magnesium stearate (E470b) in the capsule content and titanium dioxide (E171), carrageenan, potassium chloride, hypromellose, yellow iron oxide (E172) andprinting ink (shellac (E904), , black iron oxide (E172)) on the coating.

Appearance of the product and contents of the package

The capsule cap is brown-yellow with a black mark “F” and “0.5 mg” and with the company's logo in black. The capsule body is white. The capsule content is a white or almost white powder. Capsule length: 15 - 17 mm.

This medicine is available in boxes containing:

• 7, 14, 28, 30, 98 and 100 hard capsules, in non-perforated blisters.
• 30 x 1 and 100 x 1 hard capsules, in perforated unit-dose blisters.
• calendar format: 7 x 1, 14 x 1, 28 x 1 and 98 x 1 hard capsules in perforated unit-dose blisters.

This medicine is available in bottles containing 30 hard capsules in a box.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Ardena Pamplona S.L.,

Polígono Mocholi, C/Noain N°1,

Navarra,

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

Calle de Anabel Segura 10, 28108

Alcobendas, Madrid,

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:June 2021

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