FINGOLIMOD PHARMATHEN 0.5 mg HARD CAPSULES

Introduction

Package Leaflet:information for the user

Fingolimod Pharmathen 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 Pharmathen and what is it used for
2. What you need to know before taking Fingolimod Pharmathen
3. How to take Fingolimod Pharmathen
4. Possible side effects
5. Storage of Fingolimod Pharmathen
6. Contents of the pack and further information

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

What is Fingolimod Pharmathen

Fingolimod Pharmathen contains the active substance fingolimod.

What is Fingolimod Pharmathen used for

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

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

or

• Patient who rapidly develop severe MS.

Fingolimod does not cure MS, but it helps 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, 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 patient to patient but usually include difficulty walking, loss of sensation in a part 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 Pharmathen works

This medication helps combat the immune system's attacks 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. This medication also reduces some of the immune responses of your body.

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

Do not take Fingolimod Pharmathen

• if you have a weakened immune system(due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have a severe active or chronic infectionsuch 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 this medication.
• if you are taking or have recently taken medications for an irregular heartbeat(of the heart) such as quinidine, disopyramide, amiodarone, or sotalol.
• if you are pregnantor if you are a woman of childbearing age and are not using an effective contraceptive method.
• if you are allergicto 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 not sure, tell your doctor before taking Fingolimod Pharmathen.

Warnings and precautions

Consult your doctor before starting to take this medication:

• if you have severe respiratory problems when you sleep (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 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 disordersor other signs of inflammation in the central vision area (the macula) of the eye (a condition known as macular edema, see below) or 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 problemsor "smoker's cough."

If any of the above cases apply to you or if you are not sure, tell your doctor before taking Fingolimod Pharmathen.

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 changed the previous dose of 0.25 mg once a day, this medication produces a decrease in heart rate. As a result, you may feel dizzy or tired, you may be aware of your heartbeat, or your blood pressure may drop. If these effects are severe, tell your doctor immediately, as you may need immediate treatment.This medication 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 this medication, 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 Pharmathen 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 resuming Fingolimod Pharmathen after a pause in treatment, depending on both the duration of the pause and how long you were taking Fingolimod Pharmathen 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 nighttime 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 change is not possible, the cardiologist will advise you on how to start treatment with fingolimod, including nighttime 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 this medication. If so, your doctor will delay the start of treatment with fingolimod for one 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 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, as 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 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 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 checks.

Macular edema

Before starting treatment with this medication, 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 condition is known as macular edema. 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 by an MS attack (optic neuritis). At first, you may not have symptoms. You should 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. 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, unusually 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 check your liver function. You may need to interrupt treatment with fingolimod 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 regular blood pressure checks.

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 a reduction in 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 your doctor 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, your doctor will check if 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, as 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 your 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 if you have any nodules on your skin. Your doctor will also perform regular skin checks during treatment with fingolimod. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is 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 suitable protective clothing.
• regularly applying a sunscreen with a high UV protection index.

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 Pharmathen

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 of time 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 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 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 Pharmathen

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 treatment with Fingolimod Pharmathen" and also section 4 "Possible side effects").

Elderly population

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, 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 receive them before you can start treatment with this medication.
• The first time you take fingolimod, your doctor will check 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 you feel depressed or anxious during treatment with fingolimod, tell your doctor. You may need closer monitoring.

Other medications and Fingolimod Pharmathen

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Tell your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system,including other medicationsused to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use fingolimod with these medications because it could intensify the effect on the immune system (see also "Do not take Fingolimod Pharmathen").
• 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 (vaccines made with live attenuated viruses) 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 the heart rate(e.g., beta-blockers such as atenolol). Using fingolimod with these medications can intensify the effect on the heart rate during the first few days after starting treatment with fingolimod.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use fingolimod, as it could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Pharmathen").
• Other medications:
• • protease inhibitors, anti-infective agents such as

3. How to take Fingolimod Pharmathen

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

Follow the instructions for administering this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

Use inadults

The recommended dose is one hard capsule per day.

Use in children and adolescents (from 10 years of age and older)

The dose depends on body weight:

In children and adolescents with a body weight over 40 kg, the recommended dose is one hard capsule per day.

There are other pharmaceutical forms of this medicine more suitable for children and adolescents aged 10 or older whose body weight is 40 kg or less; ask your doctor or pharmacist about the availability of other doses of fingolimod in hard capsules.

Do not exceed the recommended dose.

Fingolimod Pharmathen is for oral use.

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

Taking Fingolimod Pharmathen 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 this medicine, consult your doctor or pharmacist.

If you take moreFingolimod Pharmathenthan 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 medicine and the amount ingested.

If you forget to take Fingolimod Pharmathen

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.

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Fingolimod Pharmathen

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 2 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 2 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 2 weeks without consulting your doctor.

Your doctor will decide if it is necessary to monitor you after stopping treatment with fingolimod and how. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 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 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 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
• Decreased 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 can 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 over an existing scar. Squamous cell carcinoma can also appear as a firm and painless nodule or mass.

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

• Abnormality 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 the 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 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), 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). The symptoms of PML can be similar to those of a multiple sclerosis relapse. You may also have 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 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 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. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• 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
• Feeling 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 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 the available data):

• Peripheral inflammation

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

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Fingolimod Pharmathen

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Pharmathen

• The active ingredient is fingolimod.

Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).

• Other ingredients are:

Contents of the capsule:tricalcium phosphate, stearic acid

Capsule coating:gelatin, titanium dioxide (E171), yellow iron oxide (E172)

Printing ink:Shellac lacquer, black iron oxide (E172)

Appearance of the product and package contents

Fingolimod Pharmathen 0.5 mg hard capsules EFG are presented in the form of a white to off-white powder, in a hard gelatin capsule No. 3, with an opaque yellow cap and an opaque white body, with a length of 15.9 ± 0.3 mm, with "0.5 mg" printed on the cap in black ink.

Fingolimod Pharmathen 0.5 mg hard capsules EFG are packaged in a cardboard box containing the corresponding number of aluminum-PVC/PE/PVDC blisters with the corresponding number of capsules and a leaflet.

Presentation:

Containers containing 7, 28 or 98 tablets.

It is possible that only some pack sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

Tel.: +30 210 66 04 300

Fax: +30 210 66 66 749

E-mail: info@pharmathen.com

Manufacturer

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

or

Pharmaselect International Beteiligungs GmbH

Ernst-Melchior-Gasse 20,

A-1020 Vienna,

Austria

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

Denmark	Fingolimod Pharmathen 0.5 mg hard capsules
Austria	Fingolimod Pharmathen 0.5 mg Hartkapseln
Belgium	Fingolimod Pharmathen 0.5 mg hard capsules
Finland	Fingolimod Ailon 0.5 mg hard capsules
France	FINGOLIMOD PHARMATHEN 0.5 mg, hard capsules
Germany	Fingolimod Pharmathen 0.5 mg Hartkapseln
Greece	FINGOLIMOD PHARMATHEN 0.5 mg σκληρ? καψ?κια
Cyprus	FINGOLIMOD PHARMATHEN 0.5 mg σκληρ? καψ?κια
Ireland	Fingolimod Pharmathen 0.5 mg hard capsules
Italy	Fingolimod Pharmathen 0.5 mg hard capsules
Netherlands	Fingolimod Pharmathen 0.5 mg hard capsules
Norway	Fingolimod Pharmathen 0.5 mg hard capsules
Sweden	Fingolimod Unimedic Pharma 0.5 mg hard capsules
Portugal	Fingolimod Pharmathen 0.5 mg capsules

Date of last revision of thisleaflet:April 2022

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