FINGOLIMOD SALA 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fingolimod Sala 0.5 mg Hard Capsules EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fingolimod Sala and what is it used for
2. What you need to know before you take Fingolimod Sala
3. How to take Fingolimod Sala
4. Possible side effects
5. Storing Fingolimod Sala
6. Package Contents and Further Information

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

What is Fingolimod Sala

Fingolimod Sala contains the active substance fingolimod.

What is Fingolimod Sala used for

This medicine is used in adults and in children and adolescents (from 10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (a disease that causes symptoms to appear, then disappear, and then appear again), particularly in:

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

or

• Patient who rapidly develop severe MS.

Fingolimod does not cure MS, but it helps to reduce the number of relapses and slow down the progression of physical disabilities caused by MS.

What is Multiple Sclerosis

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

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

How Fingolimod Sala works

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

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

Do not take Fingolimod Sala

• if you have a weakened immune system (due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if your doctor suspects that you may have a rare brain infection known as progressive multifocal leukoencephalopathy (PML) or if you have been confirmed to have PML.
• if you have a severe active infection or a chronic active infection such as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if, in the last 6 months, you have had a heart attack, chest pain, stroke, or warning signs of a stroke, or any type of heart failure.
• if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with fingolimod.
• if you are taking or have recently taken medications for an irregular heartbeat (such as quinidine, disopyramide, amiodarone, or sotalol).
• if you are pregnant or if you are a woman of childbearing age and are not using an effective contraceptive method.
• if you are allergic to fingolimod or to any of the other components of this medication (included in section 6).

If any of the above cases apply to you or if you are unsure, inform your doctor before taking Fingolimod Sala.

Warnings and precautions

Consult your doctor before starting to take Fingolimod Sala:

• 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 a slow heart rate (e.g., dizziness, nausea, or palpitations).
• if you are taking or have recently taken medications that slow down 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 disorders or other signs of inflammation in the central vision area (the macula) of the eye, an inflammation or infection of the eye (uveitis), 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 medication.
• if you have severe lung problems or "smoker's cough."

If any of the above cases apply to you or if you are unsure, inform your doctor before taking Fingolimod Sala.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once a day has been changed, fingolimod produces 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 Sala may also cause your heartbeats to become 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, it is generally not expected to have any clinically significant effect on the heart rate.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Fingolimod Sala or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once a day has been changed, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You should have an electrocardiogram before the first dose of Fingolimod Sala 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 anomalies, 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 resuming Fingolimod Sala after a pause in treatment, depending on both the duration of the pause and how long you were taking Fingolimod Sala before the pause.

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

If you have suffered from sudden fainting in the past or a decrease in heart rate, Fingolimod Sala 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 Sala, including monitoring during the night.

If you are taking other medications that can slow down your heart rate, Fingolimod Sala may not be suitable for you. It is necessary for a cardiologist to evaluate you and determine if you can switch to alternative medications that do not decrease the heart rate to allow treatment with Fingolimod Sala. If such a change is not possible, the cardiologist will advise you on how to start treatment with Fingolimod Sala, 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, you will likely need to be vaccinated before starting treatment with Fingolimod Sala. If so, your doctor will delay the start of 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 up to two months after interrupting treatment), you may be more likely to contract infections. You may even experience a worsening of an infection you already have. Infections can be severe and potentially life-threatening. If you think you have contracted an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, rash, and/or confusion or convulsions (seizures) (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately as it may be serious and life-threatening.

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

PML

PML is a rare brain disorder caused by an infection that can cause severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) before starting treatment and during treatment to monitor the risk of PML.

If you think your MS is getting worse or if you notice any new symptoms, such as changes in your mood or behavior, worsening or appearance of weakness on one side of the body, changes in vision, confusion, memory problems, or difficulties with speech and communication, inform your doctor as soon as possible. These may be symptoms of PML. Also, talk to your family members or caregivers to inform them about your treatment. Symptoms may appear without you realizing it.

If you contract PML, it can be treated, and your treatment with Fingolimod Sala will be interrupted. Some people have an inflammatory reaction when Fingolimod Sala is eliminated from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can cause a worsening of your disease, including a worsening of brain function.

Macular edema

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

After starting treatment with fingolimod, your doctor may request an eye examination after 3 or 4 months 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 sharply. Fingolimod can cause inflammation of the macula, and this disorder is known as macular edema. The inflammation usually occurs within the first four months of treatment with fingolimod.

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

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

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

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

Liver function tests

If you have severe liver problems, you should not take Fingolimod Sala. Fingolimod can affect liver function. You may not notice any symptoms, but if you notice a yellowish tone to your skin or the white part of your eyes, unusually dark urine (brown-colored), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or 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 interrupt treatment if the results of your tests indicate a problem with your liver.

High blood pressure

Since fingolimod can cause 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 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 interrupting treatment. If you need to have blood tests, inform your doctor that you are taking Fingolimod Sala, as they may not understand the results of the tests otherwise. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with Fingolimod Sala, your doctor will confirm that you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to interrupt treatment with fingolimod.

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

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

A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with fingolimod.

Sun exposure and sun protection

Fingolimod weakens your immune system, 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.
• applying a high-UV-protection sunscreen regularly.

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In the case of severe relapses, your doctor will assess the need to perform an MRI to evaluate your condition and decide if you need to stop taking Fingolimod Sala.

Switching from other treatments to Fingolimod Sala

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Sala if there are no signs of treatment-related anomalies. Your doctor may need to perform a blood test to rule out such anomalies. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with Fingolimod Sala. To switch from teriflunomide, your doctor may advise you to wait for a period or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is necessary, and you should discuss it with your doctor to decide if Fingolimod Sala is suitable for you.

Women of childbearing age

If Fingolimod Sala is used during pregnancy, it may be harmful to the fetus. Before starting treatment with fingolimod, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking Fingolimod Sala and what you should do to avoid becoming pregnant while taking Fingolimod Sala. 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 Sala

Do not stop taking Fingolimod Sala or change the dose prescribed by your doctor without discussing it with your doctor first.

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

Elderly

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

Children and adolescents

Fingolimod Sala 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, your doctor will check your vaccination status. If you have not received certain vaccinations, it may be necessary to administer them before you can start treatment with Fingolimod Sala.
• The first time you take Fingolimod Sala, or when you switch 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 had seizures or attacks before taking or while taking Fingolimod Sala, inform your doctor.
• If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with Fingolimod Sala, inform your doctor. You may need closer monitoring.

Other medications and Fingolimod Sala

Inform your doctor or pharmacist if you are taking, have recently taken, 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 Sala with these medications because it could intensify the effect on the immune system (see also "Do not use Fingolimod Sala").
• Corticosteroids due to an added effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and up to two months after stopping treatment, you should not receive certain types of vaccines (live attenuated virus vaccines) because they can cause the infections they are intended to prevent. Other vaccines may not be effective if administered during this period.
• Medications that slow down your heart rate (such as beta-blockers, e.g., atenolol). The use of fingolimod with these medications can intensify the effect on the heart rate during the first days after starting treatment.

3. How to take Fingolimod Sala

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

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a weight of 40 kg or less: one 0.25 mg capsule per day. Other medicines with fingolimod with a lower dose (0.25 mg capsules) are available.
• Children and adolescents with a weight over 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start with a 0.25 mg capsule per day and later reach a stable weight over 40 kg, the doctor will indicate that they switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Do not exceed the recommended dose.

Fingolimod Sala is taken orally.

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

Taking Fingolimod Sala every day at the same time will help you remember when to take the medicine.

If you have doubts about the duration of treatment with Fingolimod Sala, consult your doctor or pharmacist.

If you take more Fingolimod Sala than you should

If you have taken more Fingolimod Sala than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Fingolimod Sala

If you have been taking Fingolimod Sala for less than 1 month and you forget to take 1 dose during a whole day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Fingolimod Sala for at least 1 month and you have forgotten to take your treatment for more than 2 weeks, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have forgotten to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

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

If you stop treatment with Fingolimod Sala

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

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

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

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

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

4. Possible side effects

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

Some side effects can be serious or potentially serious

Common(may affect up to 1 in 10 people)

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stage of the infection, followed by numbness, itching, or red spots with intense pain
• Slow heartbeat (bradycardia), irregular heartbeat
• A type of skin cancer known as basal cell carcinoma (BCC) that often appears as a pearl-like nodule, although it can also have other forms
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and it has also been reported in pediatric patients treated with Fingolimod Sala.
• 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 at the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the field of vision, blurred vision, problems seeing colors or details
• Decrease in the number of blood platelets, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate
• Seizures, attacks (more frequent in children and adolescents than in adults)

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

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

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

• Abnormality in the electrocardiogram (T-wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency not known(cannot be estimated from available data)

• Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which is more likely to occur on the day treatment with Fingolimod Sala starts
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdominal area, dark urine (brown color), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. You may also have symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible
• Inflammatory disorder after stopping treatment with Fingolimod Sala (known as immune reconstitution inflammatory syndrome or IRIS)
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiffness in the neck, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless nodule or mass, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm or hard nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with Fingolimod Sala, MS symptoms may recur and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these symptoms, 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 abnormal liver enzyme levels
• Cough

Common(may affect up to 1 in 10 people)

• Pityriasis versicolor (fungal skin infection)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low level of white blood cells (lymphocytes, leukocytes)
• Weakness
• Rash with itching, redness of the skin, and burning (eczema)
• Itching
• Increased levels of certain lipids (triglycerides) in the blood
• Hair loss
• Breathing difficulties
• Depression
• Blurred vision (see also the section on macular edema under the heading "Some side effects can be serious or potentially serious")
• Hypertension (fingolimod may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon(may affect up to 1 in 100 people)

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

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

• Lymphatic system cancer (lymphoma)

Frequency not known(cannot be estimated from available data)

• Peripheral inflammation

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fingolimod Sala

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

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

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine if you notice that the packaging is damaged or has signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Sala

• The active ingredient is fingolimod.

• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• Other ingredients are:

Capsule content: Potassium citrate monohydrate, anhydrous colloidal silica, magnesium stearate.

Capsule shell: Gelatin, titanium dioxide (E171)

Capsule cap: Gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and package contents

Fingolimod Sala 0.5 mg hard capsules (16 mm, size 3) have a white body and a yellow cap.

Fingolimod Sala 0.5 mg hard capsules are available in packs containing 7, 28, or 98 capsules.

Fingolimod Sala 0.5 mg hard capsules are available in packs with unit-dose blisters containing 7x1, 28x1, 98x1, or 100x1 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Synthon Hispania S.L.

C/ Castelló 1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

This medicine is authorized in the EEA Member States and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Fingolimod Synthon 0.5 mg, hard capsules

Croatia: Fingolimod Alpha-Medical 0.5 mg hard capsules

Estonia: Fingolimod Norameda

Finland: Fingolimod Avansor

France: Fingolimod Synthon 0.5 mg, gel capsule

Germany: Fingolimod Holsten 0.5 mg hard capsules

Hungary: Fingolimod-Q Pharma 0.5 mg hard capsules

Iceland: Fingolimod WH

Latvia: Fingolimod Norameda 0.5 mg hard capsules

Lithuania: Fingolimod Norameda 0.5 mg hard capsules

Poland: Fingolimod Symphar

Portugal: Fingolimod Reig Jofre

Spain: Fingolimod Sala 0.5 mg hard capsules EFG

Sweden: Fingolimod Avansor

United Kingdom (Northern Ireland): Fingolimod 0.5 mg, hard capsules

Date of last revision of this leaflet:April 2024

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