Prospect: information for theuser

Fingolimod Stada 0.5 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Fingolimod Stada

4.Possible adverse effects

5.Storage of Fingolimod Stada

6.Contents of the package and additional information

What isFingolimod Stada

The active ingredient of Fingolimod Stada is fingolimod.

What is Fingolimod Stada 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 (RRMS) (that occurs with relapses), particularly in:

- patients who do not respond to treatment despite treatment for RRMS.

or

- patients who rapidly develop severe RRMS.

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

What is multiple sclerosis

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

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

How Fingolimod Stada works

Fingolimod helps 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 nerve damage attributed to multiple sclerosis. Fingolimod also reduces some of the body's immune responses.

Do not take Fingolimod Stada if

-you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6).

-you have a weakened immune system (due to a condition called immunodeficiency, a disease, or to medicines that suppress the immune system).

-you have an active serious infection or an active chronic infection such as hepatitis or tuberculosis.

-you have an active cancer.

-you have severe liver problems.

-in the last 6 months, you have had a heart attack, angina, stroke, or transient ischaemic attack or any type of heart failure.

-you have any type of irregular or abnormal heart rhythm (arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with fingolimod.

-you are taking or have recently taken medicines for irregular heart rhythms (such as quinidine, disopyramide, amiodarone, or sotalol).

-you are pregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method.

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

Warnings and precautions

Consult your doctor before starting to take fingolimod if:

-you have severe sleep apnoea.

-you have been told that you have an abnormal electrocardiogram.

-you have symptoms of slow heart rhythm (e.g. dizziness, nausea, or palpitations).

-you are taking or have recently taken medicines that slow down your heart rhythm (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 be vaccinated.

-you have never had chickenpox.

-you have or have had eye problems or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as macular oedema, see below) or if you have diabetes (which can cause eye problems).

-you have liver problems.

-you have high blood pressure that cannot be controlled with medicines.

-you have severe lung problems or "smoker's cough".

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

Slow heart rhythm (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 of this, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop.If these effects are pronounced, inform your doctor as you may need immediate treatment.Fingolimod can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within a day. The slow heart rate usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation or hospital for a minimum of 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of fingolimod 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 if any adverse effects appear at the start of treatment. You will need to have an electrocardiogram before the first dose of fingolimod and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight, until this is resolved). The same may apply if you are restarting fingolimod after a pause in treatment, depending on both the duration of the pause and how long you were taking fingolimod before the pause.

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

If you have had sudden fainting attacks in the past or decreased 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 monitoring during the night.

If you are taking other medicines that can slow down your heart rate, fingolimod may not be suitable for you. It is necessary for a cardiologist to evaluate you, and it is they who will decide if you can change to alternative medicines that do not slow down your heart rate to allow treatment with fingolimod. If this change is impossible, the cardiologist will advise you on how to start treatment with fingolimod, including monitoring during the night.

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, you will probably need to be vaccinated before starting treatment with fingolimod. If so, your doctor will delay starting treatment with fingolimod for a month after completing the vaccination course.

Infections

Fingolimod reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with fingolimod (and for up to 2 months after stopping treatment), you may be more prone to infections. You may even get a worse infection that you already have. Infections can be serious and potentially life-threatening. If you think you have caught an infection, have a fever, have symptoms similar to flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or convulsions (seizures) (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or herpes virus), contact your doctor immediately as it can be serious and life-threatening. If you think your MS is getting worse (e.g. weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, in patients treated with fingolimod. Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend regular HPV checks.

Macular oedema

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

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

The macula is a small area of the retina at the back of the eye that allows you to see shapes, colours, and details clearly and clearly. Fingolimod can cause inflammation of the macula and this condition is known as macular oedema. The inflammation usually occurs in the first 4 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 oedema. In these cases, your doctor will want you to have regular eye checks to detect macular oedema.

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

A macular oedema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may not have any symptoms. It is necessary to inform your doctor of any change you notice in your vision. Your doctor may want to examine your eyes, especially if:

-the centre of your field of vision becomes blurry or contains shadows;

-a blind spot appears in the centre of your field of vision;

-you have problems seeing colours 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 yellow colour in your skin or the white part of your eye, abnormally dark urine (brown), abdominal pain on the right side, tiredness, loss of appetite, nausea, or 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 ask you to have blood tests to check your liver function. You may need to stop treatment if the results of your blood tests indicate a liver problem.

High blood pressure

As fingolimod causes a slight increase in blood pressure, your doctor will want to check 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 stopping treatment. If you need to have blood tests, inform your doctor that you are taking fingolimod, as if you do not, the doctor may not understand the results of the blood tests. For certain blood tests, your doctor may need to take more blood than usual.

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

Reversible posterior leukoencephalopathy syndrome (RPLS)

Rarely, a condition called reversible posterior leukoencephalopathy syndrome (RPLS) has been described in patients with MS treated with fingolimod. Symptoms may include:

a sudden and intense onset of headache, confusion, convulsions, and changes in vision.

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

Cancer

In patients with MS who have been treated with fingolimod, cases of skin cancer have been reported. Inform your doctor immediately if you notice any new skin nodules (e.g. shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g. unusual moles) that change colour, shape, or size over time. Before starting treatment with fingolimod, you will need to have a skin examination to check if you have any skin nodules. Your doctor will also want to check your skin regularly during treatment with fingolimod. If you notice any skin problems, your doctor may refer you to a dermatologist, who may decide if you need regular check-ups.

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

Exposure to the sun and sun protection

Fingolimod weakens your immune system, which increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by:

using protective clothing.

regularly applying a high-protection sunscreen.

Unusual brain lesions associated with MS relapses

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

Changing other treatments to fingolimod

Your doctor may change you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod if there are no signs of abnormalities caused by the previous treatment. Your doctor may need to have a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with fingolimod. To change from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if fingolimod is suitable for you.

Women of childbearing potential

If fingolimod 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 have a pregnancy test to ensure you are not pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking fingolimod. They will also explain what you should do to avoid becoming pregnant while taking fingolimod. 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

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

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

Older patients

The experience with fingolimod in older patients (over 65 years) is limited. If you are unsure, 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 been given certain vaccinations, you may need to have them before you can start treatment with fingolimod.

-The first time you take fingolimod, or when you change from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will check your heart rate and heartbeats (see the section above "Slow heart rhythm (bradycardia) and irregular heartbeats").

-If you have had seizures or convulsions before taking or while taking fingolimod, inform your doctor.

-If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with fingolimod, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Inform your doctor if you are taking any of the following medicines:

• Medicines that suppress or modulate the immune system, includingother 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 this could intensify the effect on the immune system (see also "Do not use fingolimod").
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and for 2 months after stopping treatment, you should not be given certaintypes ofvaccines (vaccines made with live, attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not have the desired effect if given during this period of time.
• Medicines that slow down heart rate(e.g. beta-blockers such as atenolol). The use of fingolimod with these medicines may intensify the effect on heart rate during the first few days after starting treatment with fingolimod.
• Medicines for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medicines, you should not use fingolimod, as this could intensify the effect on irregular heartbeats (see also the section "Do not take fingolimod").
• Other medicines:

orprotease inhibitors, antifungals such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.

orcarbamazepine, 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, or if you think you may be pregnant, consult your doctor before using this medicine.

Pregnancy

Do not use fingolimod during pregnancy, or if you are a woman of childbearing potential and are not using an effective contraceptive method, or if you are a woman who may become pregnant and are not using an effective contraceptive method. If fingolimod is used during pregnancy, there is a risk of harming the fetus. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately 2 times higher than that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included heart, kidney, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing potential:

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

and,

-during treatment with fingolimod and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss the reliable contraceptive methods with your doctor.

Your doctor will give you additional educational material that explains why you should not become pregnant while taking fingolimod.

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

Breastfeeding

Do not breastfeed during treatment with fingolimod.Fingolimod passes into breast milk and there is a risk of serious adverse effects in the baby.

Driving and using machines

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

However, after taking the first dose of fingolimod, you will need to stay in the consultation or hospital for a minimum of 6 hours. During this period and possibly afterwards, your ability to drive and use machines may be affected.

The treatment with fingolimod will be monitored by a doctor with experience in the treatment of multiple sclerosis.

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

The recommended dose is:

Adults:

The dose is one capsule of 0.5 mg per day.

Children and adolescents (10 years of age and older and with a body weight of more than 40 kg):

One capsule of 0.5 mg per day. Children and adolescents who start with a capsule of 0.25 mg per day and later reach a stable body weight of more than 40 kg, the doctor will instruct them to change to a capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period of the first dose.

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 is not suitable for pediatric patients with a body weight of 40 kg or less. There are available other medications that contain a lower dose of fingolimod (such as capsules of 0.25 mg).

Do not exceed the recommended dose.

Administration form

Fingolimod is used orally.

Take fingolimod once a day with a glass of water. Fingolimod capsules must 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.

Treatment duration

If you have doubts about the duration of treatment with fingolimod, consult with 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeFingolimod Stada

If you have been taking fingolimod for less than 1 month and forget to take 1 dose for an entire day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

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

Never take a double dose to compensate for the missed doses.

If you interrupt the treatment with Fingolimod Stada

Do not stop taking fingolimod or change the dose that should be taken without consulting your doctor first.

Fingolimod will remain in your body for up to 2 months after treatment interruption. The number of white blood cells in the blood (lymphocyte count) may remain low during this period and it is possible that the adverse effects described in this prospectus may still occur. After interrupting treatment with fingolimod, you may have to wait 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 rhythm that may occur at the beginning of treatment may repeat and you will need to be monitored in the medical consultation 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 you need to be followed up after interrupting treatment with fingolimod and how. Inform your doctor immediately if you think your MS is worsening after interrupting treatment with fingolimod, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Some side effects can be serious or potentially serious

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

-Cough with mucus (phlegm), chest discomfort, fever (signs of lung changes)

-Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, prickling, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain

-Slow heart rate (bradycardia), irregular heart rhythm

-A type of skin cancer known as basal cell carcinoma (BCC) that often presents as a pearl-like nodule, although it can also 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

Less frequent(may affect up to 1 in 100 people):

-Pneumonia, with symptoms such as fever, cough, difficulty breathing

-Macular edema (inflammation in the central vision area of the retina in the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the center of the visual field, blurry vision, problems seeing colors or details

-Decreased platelet count, which increases the risk of bleeding or bruising

-Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can cause itching, bleeding, or ulceration

-Seizures, attacks (more common in children and adolescents than in adults)

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

-A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden and intense headache, confusion, seizures, and/or visual disturbances

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

-Squamous cell carcinoma: a type of skin cancer that can present as a firm, red nodule, a sore with a scab, or a new sore over an existing scar

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

-Electrocardiogram anomaly (T wave inversion)

-Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency unknown(cannot be estimated from available data):

-Allergic reactions, including symptoms such as rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day the treatment with fingolimod begins

- Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.

-Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those around you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible

-Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion.

-Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless, red or pinkish-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a nodule or firm mass. Long-term exposure to sunlight and a weakened immune system may affect the risk of developing Merkel cell carcinoma

-After stopping treatment with fingolimod, MS symptoms may reappear and may be worse than before or during treatment

-Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed

If you have any of these symptoms,inform your doctor immediately.

Other side effects

Very frequent(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 alterations in liver enzyme levels

- Cough

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

- Tinea versicolor (fungal infection of the skin)

- Dizziness

- Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)

- Low white blood cell count (lymphocytes, leukocytes)

- Weakness

- Itching rash, skin redness, and burning (eczema)

- Itching

- Increased levels of certain lipids in the blood (triglycerides)

- Hair loss

- Difficulty breathing

- Depression

-Blurry vision (see also the section on macular edema under the title "Some side effects can be serious or potentially serious")

- Hypertension (fingolimod may cause a slight increase in blood pressure)

- Muscle pain

- Joint pain

Less frequent(may affect up to 1 in 100 people):

- Low neutrophil count

- Depressive mood

- Nausea

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

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

Frequency unknown(cannot be estimated from available data):

- Peripheral inflammation

If you consider that any of the side effects you are experiencing are severe,inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help to protect the environment.

Composition of Fingolimod Stada

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

The other components are:

-Capule content: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

-Capule coating: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Appearance of the product and contents of the package

Fingolimod 0.5 mg are hard capsules, size No. 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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 medicinal product 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 harde 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 cápsulas duras EFG

Finland:Fingolimod STADA 0.5 mg kapseli kova

France:FINGOLIMOD EG 0.5 mg, gélule

Croatia:Fingolimod STADA 0.5 mg tvrde capsule

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 kapsules

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

Last review date of this leaflet:April 2021

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