Fingolimod Stada 0.5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fingolimod Stada 0.5 mg hard capsules EFG

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

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

Contents of the leaflet

What Fingolimod Stada is and what it is used for
What you need to know before taking Fingolimod Stada
How to take Fingolimod Stada
Possible side effects
How to store Fingolimod Stada
Contents of the pack and other information

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

What Fingolimod Stada is

The active substance in 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) (characterized by relapses), particularly in:

patients who do not respond to treatment despite receiving therapy for MS.

patients who rapidly develop severe MS.

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

What multiple sclerosis is

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

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

How Fingolimod Stada works

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

2. What you need to know before taking Fingolimod Stada

Do not take Fingolimod Stada if

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

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

Warnings and precautions

Talk to your doctor before starting fingolimod if:

you have severe breathing problems while sleeping (severe sleep apnea).
you have been told you have an abnormal electrocardiogram.
you have symptoms of a slow heartbeat (e.g., dizziness, nausea, or palpitations).
you are currently taking or have recently taken medications that slow your heart rate (such as beta-blockers, verapamil, diltiazem, 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 area of vision (the macula) at the back of the eye, eye inflammation or infection (uveitis), or if you have diabetes (which can cause eye problems).
you have liver problems.
you have uncontrolled high blood pressure despite medication.
you have severe lung problems or "smoker's cough."

If any of the above apply to you or you are unsure, inform 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 cases where your previous dose of 0.25 mg once daily has been changed, fingolimod causes a reduction in heart rate. As a result, you may feel dizzy or fatigued, become aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, inform your doctor immediately, as you may require immediate treatment. Fingolimod may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. Slow heart rate typically normalizes within one month. During this period, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly monitoring of pulse and blood pressure, after taking the first dose of fingolimod or after taking the first 0.5 mg dose if your previous dose was changed from 0.25 mg once daily, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. You will need to have an electrocardiogram (ECG) before the first dose of fingolimod and again after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If after the 6-hour period your heart rate is very slow or decreasing, or if your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours and possibly overnight) until the issue resolves. The same may apply if you are restarting fingolimod after a treatment interruption, depending on the duration of the interruption and how long you had previously taken fingolimod.

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

If you have previously experienced sudden fainting or a slow heart rate, fingolimod may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start fingolimod treatment, including overnight monitoring.

If you are taking other medications that may slow your heart rate, fingolimod may not be suitable for you. A cardiologist must evaluate you and determine whether you can switch to alternative medications that do not reduce heart rate to allow fingolimod treatment. If such a switch is not possible, the cardiologist will advise on how to start fingolimod treatment, 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 fingolimod treatment. If so, your doctor will delay the start of fingolimod treatment by one month after completing the vaccination series.

Infections

Fingolimod reduces the number of white blood cells in the blood (especially lymphocytes). White blood cells fight infections. During treatment with fingolimod (and for up to two months after stopping treatment), you may be more susceptible to infections. An existing infection may even worsen. Infections can be serious and potentially fatal. If you suspect you have an infection, have a fever, flu-like symptoms, herpes (shingles), or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits) (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infections), contact your doctor immediately, as this could be serious and life-threatening. If you think your MS is worsening (e.g., weakness or visual changes) or notice any new symptoms, inform your doctor immediately, as these could be symptoms of a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. Your doctor will assess whether a magnetic resonance imaging (MRI) scan is needed to evaluate your condition and decide whether you need to stop taking fingolimod.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-related cancers, has been reported in patients treated with fingolimod. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screenings.

Macular edema

Before starting fingolimod treatment, 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 (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting fingolimod treatment, 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 fine details clearly and sharply. Fingolimod can cause inflammation of the macula, a condition known as macular edema. This inflammation usually occurs within the first four months of fingolimod treatment.

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

If you have previously had macular edema, discuss this with your doctor before continuing fingolimod treatment.

Macular edema can cause visual symptoms similar to those of an MS attack (optic neuritis). Initially, you may have no symptoms. You must report any changes in your vision to your doctor. Your doctor may want to perform an eye examination, especially if:

the center of your visual field becomes blurry or contains shadows;
a blind spot appears in the center of your visual field;
you have difficulty seeing colors or fine details.

Liver function tests

If you have severe liver problems, you must not take fingolimod. Fingolimod can affect liver function. You may not experience any symptoms, but if you notice yellowing of the skin or the white part of the eye (jaundice), abnormally dark urine (brown-colored), pain in the right side of your abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.

If you experience any of these symptoms after starting fingolimod treatment, inform your doctor immediately.

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

High blood pressure

Since fingolimod causes a slight increase in blood pressure, your doctor will want you to have your blood pressure monitored regularly.

Lung problems

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

Blood count

The expected effect of fingolimod treatment is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you have blood tests, inform your doctor that you are taking fingolimod, as otherwise your doctor may not interpret the results correctly. For certain blood tests, your doctor may need more blood than usual.

Before starting fingolimod treatment, your doctor will confirm that you have sufficient white blood cells in your blood and may want to repeat blood counts regularly. If your white blood cell count is too low, you may need to stop fingolimod treatment.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, a condition called posterior reversible encephalopathy syndrome (PRES) has been reported in multiple sclerosis patients treated with fingolimod. Symptoms may include sudden and severe headache, confusion, seizures, and vision changes.

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

Cancer

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

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

Sun exposure and sun protection

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

wearing appropriate protective clothing.
regularly applying sunscreen with a high UV protection factor.

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 whether an MRI scan is needed to evaluate your condition and decide whether 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 abnormalities caused by the previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting fingolimod. When switching from teriflunomide, your doctor may advise waiting or undergoing an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is required, and you should discuss with your doctor whether fingolimod is suitable for you.

Women of childbearing potential

If fingolimod is used during pregnancy, it may harm the fetus. Before starting fingolimod treatment, your doctor will explain the risks and request a pregnancy test to confirm you are not pregnant. Your doctor will give you an information card explaining why you must not become pregnant while taking fingolimod and what you should do to avoid pregnancy. 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 fingolimod treatment

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

Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment, as this could be serious (see section 3 “If you stop taking fingolimod” and 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 must not be given to children under 10 years of age and weighing less than 40 kg, as it has not been studied in this age group in patients with MS.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children, adolescents, and their caregivers:

Before starting fingolimod treatment, your doctor will check your vaccination status. If you have not received certain vaccines, you may need to be vaccinated before starting fingolimod treatment.
The first time you take fingolimod, or when switching from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the section above “Slow heart rate (bradycardia) and irregular heartbeats”).
If you have seizures or fits before or while taking fingolimod, inform your doctor.
If you have depression or anxiety, or if you feel depressed or anxious during fingolimod treatment, inform your doctor. You may require closer monitoring.

Other medicines and Fingolimod Stada

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

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 must not use fingolimod with these medicines, as this could intensify the effect on the immune system (see also “Do not take fingolimod”).
Corticosteroids, due to an additive effect on the immune system.
Vaccines. If you need a vaccine, inform your doctor first. During treatment with fingolimod and for up to two months after stopping, you must not receive certain vaccines (those made with live attenuated viruses), as they could cause the infections they are meant to prevent. Other vaccines may not work as effectively if given during this period.
Medicines that slow the heart rate (e.g., beta-blockers such as atenolol). Using fingolimod with these medicines may intensify the effect on heart rate during the first few days after starting fingolimod.
Medicines to treat irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you take any of these medicines, you must not use fingolimod, as this could intensify the effect on irregular heartbeats (see also “Do not take fingolimod”).
Other medicines:

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

o carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced fingolimod effectiveness).

Pregnancy and breastfeeding

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

Pregnancy

Do not use fingolimod during pregnancy, if you plan to become pregnant, or if you are a woman of childbearing potential and are not using an effective contraceptive method. If fingolimod is used during pregnancy, there is a risk of harm to the fetus. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately twice that observed in the general population (where the congenital malformation rate is approximately 2–3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing potential:

before starting fingolimod treatment, your doctor will inform you of the risk to the fetus and request a pregnancy test to confirm you are not pregnant,

and,

during treatment with fingolimod and for two months after stopping treatment, you must use an effective contraceptive method to prevent pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will provide you with additional educational materials explaining why you must 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 taking fingolimod” and section 4 “Possible side effects”). You will receive specific prenatal follow-up.

Breastfeeding

You must not breastfeed during treatment with fingolimod. Fingolimod passes into breast milk, and there is a risk that the baby may experience serious adverse effects.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive vehicles, including bicycles, and operate machinery safely. Fingolimod is not expected to affect your ability to drive or use machines.

However, at the start of treatment, you will need to remain at the clinic or hospital for 6 hours after taking the first dose of fingolimod. During this time and possibly afterward, your ability to drive and use machines may be impaired.

3. How to take Fingolimod Stada

Treatment with fingolimod will be supervised by a physician experienced in the treatment of multiple sclerosis.

Always follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Recommended dose:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and older with a body weight above 40 kg):

One 0.5 mg capsule per day. For children and adolescents who initially started on a 0.25 mg capsule per day and subsequently reach a stable body weight above 40 kg, your doctor will instruct you to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Children and adolescents (aged 10 years and older with a body weight equal to or less than 40 kg): Fingolimod 0.5 mg hard capsules are not suitable for pediatric patients with a body weight equal to or less than 40 kg. Other medicinal products 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 administered orally.

Take fingolimod once daily with a glass of water. Fingolimod capsules must always be swallowed whole and must not be opened. Fingolimod may be taken with or without food.

Taking fingolimod at the same time each day will help you remember when to take the medicine.

Duration of treatment

If you have any doubts about how long you should continue 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Fingolimod Stada

If you have been taking fingolimod for less than 1 month and miss a dose for an entire day, speak with 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 have missed taking your treatment for more than 2 weeks, speak with 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 missed taking your treatment for up to 2 weeks, you may take the next dose as originally scheduled.

Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Stada

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

Fingolimod will remain in your body for up to two months after stopping treatment. The number of white blood cells (lymphocyte count) may remain low during this period, and adverse effects described in this leaflet may still occur. After stopping fingolimod treatment, you may need to wait 6–8 weeks before starting a new treatment for MS.

If you restart fingolimod treatment after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and medical monitoring will be necessary when restarting treatment. Do not restart treatment with fingolimod after an interruption of more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up after stopping fingolimod treatment is necessary and how it should be conducted. Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment, as this could be serious.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Some adverse effects may be serious or potentially serious

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

Cough with phlegm, chest discomfort, fever (signs of pulmonary disorders)
Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, stinging, itching, or pain of the skin, especially on the upper body or face. Other symptoms may include fever and weakness in the early phase of infection, followed by numbness, itching, red rashes, or severe pain
Slow heartbeat (bradycardia), irregular heart rhythm
A type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other forms
Depression and anxiety are known to occur more frequently in people with multiple sclerosis, and have 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 (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or a blind spot in the center of the visual field, blurred vision, problems seeing colors or details
Decrease in the number of blood platelets, increasing 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 over time in size, shape, thickness, or color, or the appearance of new moles. Moles may itch, bleed, or ulcerate
Seizures, fits (more frequent in children and adolescents than in adults)

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

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

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

Abnormal electrocardiogram (ECG) finding (T-wave inversion)
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma)

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

Allergic reactions, including rash or urticaria with itching, swelling of the lips, tongue or face, which are more likely to occur on the day treatment with fingolimod is started
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown-colored) urine, loss of appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to the need for a liver transplant.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. Other symptoms may not be noticeable by the patient, such as changes in mood or behavior, memory loss, or difficulties with speech and communication, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening or if you or people close to 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, light sensitivity, nausea and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible signs include the formation of a painless flesh-colored or bluish-red nodule, usually on the face, head, or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure 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 form of anemia (decrease in 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 adverse 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 tests showing abnormal liver enzyme levels
Cough

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

Tinea versicolor (fungal skin infection)
Dizziness
Severe headache, usually accompanied by nausea, vomiting, and light sensitivity (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, redness and burning of the skin (eczema)
Itching
Increased blood levels of certain lipids (triglycerides)
Hair loss
Difficulty breathing
Depression
Blurred vision (see also the section on macular edema under the heading "Some adverse effects may 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)
Depressed mood
Nausea

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

Cancer of the lymphatic system (lymphoma)

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

Peripheral inflammation

If you consider any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

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

5. Storage of Fingolimod Stada

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

Do not use this medicine after the expiry date which is stated on the packaging and on the aluminium blister after EXP. The expiry date refers to 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 tampering.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fingolimod Stada

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

The other components are:

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

Appearance of the product and pack contents

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 unit-dose blister packs containing 7x1, 28x1, 30x1, 56x1, 84x1, 98x1, 100x1 capsules.

Only certain 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
Donaustaufstr. 378
93055 Regensburg
Germany

STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

STADA Arzneimittel GmbH
Muthgasse 36
1190 Wien
Austria

Clonmel Healthcare Ltd.
Waterford Road Clonmel 3
Co. Tipperary
Ireland

Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

This medicinal product is authorised in the European Economic Area member states under 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
The 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 the most recent review of this leaflet: April 2021

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