FINGOLIMOD STADA 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for theuser

Fingolimod Stada 0.5 mg hard capsules EFG

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

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

Contents of the package leaflet

1. What is Fingolimod Stada and what is it used for
2. What you need to know before taking Fingolimod Stada
3. How to take Fingolimod Stada
4. Possible side effects
5. Storage of Fingolimod Stada
6. Package contents and additional information

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

What isFingolimod Stada

The active ingredient of Fingolimod Stada is fingolimod.

What Fingolimod Stada is used for

Fingolimod is used in adults, adolescents, and children aged 10 years and older with a body weight >40 kg to treat relapsing-remitting multiple sclerosis (MS) (with relapses), particularly in:

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

or

• patients 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 due to 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 sheath (called myelin) that covers the nerves in the CNS and prevents the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect the inflammation occurring in the CNS. Symptoms vary from patient to patient but usually include difficulties 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 ends, but some problems may persist.

How Fingolimod Stada works

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

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

Do not take Fingolimod Stada if

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

If any of the above cases apply to you or if you are unsure, tell your doctor before taking fingolimod.

Warnings and precautions

Consult your doctor before starting to take fingolimod if:

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

If any of the above cases apply to you or if you are unsure, tell your doctor before taking fingolimod.

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 you have been changed from a previous dose of 0.25 mg once a day, fingolimod causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, tell your doctor as you may need immediate treatment.Fingolimod can also cause irregular heartbeats, 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, no clinically significant effect on heart rate is usually expected.

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

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

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

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

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, you will likely need to be vaccinated before starting treatment with fingolimod. If so, your doctor will delay the start of treatment with fingolimod for one 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 stopping treatment), you may be more likely to get infections. You may even have a worsening of an infection you already have. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately because it can be serious and life-threatening. If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, tell your doctor immediately, as they can be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will assess the need for an MRI scan to evaluate your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, 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.

Macular edema

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

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

The macula is a small area of the retina 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 condition is known as macular edema. The inflammation usually occurs within the first four months of treatment with fingolimod.

If you have diabetesor 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. You must 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 has 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. 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 eye, dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, tell your doctor immediately.

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

Before, during, and after treatment, your doctor will 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 you to have your blood pressure checked regularly.

Lung problems

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

Blood count

The expected effect of treatment with fingolimod is to reduce the number of white blood cells in your blood. This effect usually normalizes within two months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking fingolimod, as they may not understand the results of the tests otherwise. For certain blood tests, your doctor may need to take more blood than usual.

Before starting treatment with fingolimod, your doctor will confirm whether 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 called 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.

Tell your doctor immediately if you experience any of these symptoms during treatment with fingolimod because it can be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Tell your doctor immediately if you notice any nodules on the skin (e.g., shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. Symptoms of skin cancer can include abnormal growth or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Before starting treatment with fingolimod, a skin examination is required to check for any skin nodules. 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 whether it is important to visit you regularly.

There have been reports of a type of cancer of the lymphatic system (lymphoma) 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 for an MRI scan to evaluate your condition and decide if you need to stop taking fingolimod.

Switching from other treatments to fingolimod

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

Women of childbearing age

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

Worsening of MS after stopping treatment with fingolimod

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

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

Elderly patients

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

Children and adolescents

Fingolimod should not be administered to children under 10 years of age and weighing less than 40 kg, 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, you may need to be vaccinated before you can start treatment with fingolimod.
• The first time you take fingolimod, 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 seizures or attacks before taking or while taking fingolimod, tell your doctor.
• If you suffer from depression or anxiety or if during treatment with fingolimod you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medicines and Fingolimod Stada

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

• Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use fingolimod with these medicines because it could intensify the effect on the immune system (see also "Do not take fingolimod").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell 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 have the desired effect if administered during this period.
• Medicines that slow the heart rate(e.g., beta-blockers such as atenolol). The use of fingolimod with these medicines can intensify the effect on the heart rate during the first days after starting treatment with fingolimod.
• Medicines for treating irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medicines, you should not use fingolimod, as it could intensify the effect on irregular heartbeats (see also the section "Do not take fingolimod").
• Other medicines:

or protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.

or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (potential risk of reduced efficacy of fingolimod).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

3. How to take Fingolimod Stada

Treatment with fingolimod will be supervised by a doctor with experience in the treatment of multiple sclerosis.

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, 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 and with a body 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.

Children and adolescents (10 years of age and older and with a body weight of 40 kg or less): Fingolimod 0.5 mg hard capsules are not suitable for pediatric patients with a body weight of 40 kg or less. Other medications containing a lower dose of fingolimod (such as 0.25 mg capsules) are available.

Do not exceed the recommended dose.

Method of administration

Fingolimod is taken orally.

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

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

Duration of treatment

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

If you take more Fingolimod Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fingolimod Stada

If you have been taking fingolimod 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 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 Stada

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

Fingolimod 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, you may have 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 recur, 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 follow-up is necessary after stopping treatment with fingolimod and how it will be done. 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 the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects 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 experience are fever and weakness in the early stage 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 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
• 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 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 cause itching, bleeding, or ulceration
• 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 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 appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar

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

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

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

• Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which are more likely to appear on the day that 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 abdominal area, dark urine (brown color), decreased appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to those of a multiple sclerosis relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech and 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 that you inform your doctor as soon as possible
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless nodule of flesh or blue-red color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass
• After stopping treatment with fingolimod, multiple sclerosis 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 blood levels of certain lipids (triglycerides)
• Hair loss
• Breathing difficulties
• Depression
• Blurred vision (see also the section on macular edema under the heading "Some side effects can be serious or potentially serious")
• Hypertension (fingolimod may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon(may affect up to 1 in 100 people):

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

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

• Lymphatic system cancer (lymphoma)

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

• Peripheral inflammation

If you 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 Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Fingolimod Stada

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.

Do not store above 25°C.

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

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Stada

The active ingredient is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).

The other ingredients are:

• Capsule content: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
• Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Appearance of the product and package contents

Fingolimod 0.5 mg are hard capsules, size 3, with an opaque yellow cap and an opaque white body.

Fingolimod 0.5 mg is available in blister packs containing 7, 28, 30, 56, 84, 98, or 100 capsules, or in single-dose blister packs containing 7x1, 28x1, 30x1, 56x1, 84x1, 98x1, 100x1 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Haupt Pharma Amareg GmbH

Donaustaufr Str. 378

93055 Regensburg

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road Clonmel 3

Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

This medication is authorized in the Member States of the European Economic Area with the following names:

Austria: Fingolimod STADA 0.5 mg Hartkapseln

Belgium: Fingolimod EG 0.5 mg hard capsules

Cyprus: FINGOLIMOD/STADA

Czech Republic: Fingolimod STADA

Denmark: Fingolimod STADA

Estonia: Fingolimod STADA

Germany: Fingolimod STADA 0.5 mg Hartkapseln

Greece: FINGOLIMOD/STADA

Spain: Fingolimod Stada 0.5 mg hard capsules EFG

Finland: Fingolimod STADA 0.5 mg kapseli, kova

France: FINGOLIMOD EG 0.5 mg, gélule

Croatia: Fingolimod STADA 0.5 mg tvrde kapsule

Hungary: Fingolimod Stada 0.5mg kemény kapszula

Ireland: Fingolimod Clonmel 0.5 mg hard capsules

Iceland: Fingolimod STADA 0.5 mg hörð hylki

Italy: FINGOLIMOD EG

Latvia: Fingolimod STADA 0.5 mg cietas kapsulas

Lithuania: Fingolimod STADA 0.5 mg kietosios kapsulės

Luxembourg: Fingolimod EG 0.5 mg gélules

Netherlands: Fingolimod CF 0.5 mg, harde capsules

Norway: Fingolimod STADA

Poland: Fingolimod Stada

Portugal: Fingolimod Stada

Sweden: Fingolimod STADA 0.5 mg hårda kapslar

Slovenia: Fingolimod STADA 0.5 mg trde kapsule

Slovakia: Fingolimod STADA 0.5mg tvrdé kapsuly

Date of last revision of this leaflet:April 2021

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