Package leaflet: Information for the user

FINGOLIMOD EG 0.5 mg hard capsules

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FINGOLIMOD EG and what is it used for

What is FINGOLIMOD EG
The active substance of FINGOLIMOD EG is fingolimod.
What FINGOLIMOD EG is used for
FINGOLIMOD EG is used in adults, adolescents, and children aged 10 years and older and with a body weight > 40 kg for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

patients who have not responded to therapy with a treatment for MS, or
patients with highly active rapidly evolving MS.

FINGOLIMOD EG does not cure MS, but helps reduce the number of relapses and slows the progression of physical disability caused by MS.
What is multiple sclerosis?
MS is a chronic disease that affects the central nervous system (CNS), which includes the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds nerves in the CNS, impairing normal nerve function. This process is known as demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms reflecting inflammatory activity in the central nervous system. Symptoms vary from patient to patient but usually include difficulty walking, numbness, visual disturbances, or balance problems. Symptoms of a relapse may completely disappear once the relapse ends, although some impairments may persist.
How FINGOLIMOD EG works
FINGOLIMOD EG helps protect the nervous system from attacks by the immune system by reducing the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body, thereby preventing them from reaching the brain and spinal cord. This limits nerve damage caused by MS. FINGOLIMOD EG also reduces some of the body's immune responses.

2. What you should know before taking FINGOLIMOD EG

Do not take FINGOLIMOD EG

if you have a reduced immune response (due to immunodeficiency syndrome, a disease, or medicines that suppress the immune system);
if your doctor suspects you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed;
if you currently have a severe infection or a chronic ongoing infection, such as hepatitis or tuberculosis;
if you have active cancer;
if you suffer from severe liver problems;
if you have had a heart attack, angina, stroke, or a transient ischaemic attack (TIA), or certain types of heart failure in the last 6 months;
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with FINGOLIMOD EG;
if you are taking or have recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if you are pregnant or are a woman of childbearing potential who is not using effective contraception;
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).
If any of these apply to you or you are unsure, talk to your doctor before taking FINGOLIMOD EG.

Warnings and precautions
Talk to your doctor before taking FINGOLIMOD EG:

if you have severe breathing problems during sleep (severe sleep apnoea);
if you have been told that you have an abnormal electrocardiogram (ECG);
if you experience symptoms of slow heart rate (e.g. dizziness, nausea, or awareness of your heartbeat);
if you are taking or have recently taken medicines that slow down the heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine);
if you have previously had episodes of sudden loss of consciousness or fainting (syncope);
if you intend to be vaccinated;
if you have never had chickenpox;
if you have or have had vision disorders or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular oedema, see below), if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems);
if you suffer from liver problems;
if you have high blood pressure that cannot be controlled by medication;
if you suffer from severe lung problems or have a smoker’s cough.
If any of these apply to you or you are unsure, talk to your doctor before taking FINGOLIMOD EG.

Slow heart rate (bradycardia) and irregular heartbeat
At the start of treatment, or when switching from the 0.25 mg daily dose to the first 0.5 mg dose, fingolimod causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, contact your doctor, as immediate treatment may be necessary. Fingolimod may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate usually returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.
Your doctor will ask you to remain in the clinic or hospital for at least 6 hours after taking the first dose of FINGOLIMOD EG, or when switching from the 0.25 mg daily dose to the first 0.5 mg dose. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if any adverse effects occur at the beginning of treatment. You must have an electrocardiogram (ECG) performed before taking the first dose of FINGOLIMOD EG and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time.
If, after 6 hours, your heart rate is very low or continues to decrease, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, and possibly until the next morning), until these issues resolve. The same may apply if you restart FINGOLIMOD EG after a treatment interruption, depending on the length of the interruption and how long you had been taking FINGOLIMOD EG before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your ECG is abnormal, or if you have heart disorders or heart failure, FINGOLIMOD EG may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, FINGOLIMOD EG may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with FINGOLIMOD EG, including monitoring until the next morning.
If you are taking medicines that can reduce heart rate, FINGOLIMOD EG may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medicines that do not reduce heart rate, allowing you to start treatment with FINGOLIMOD EG. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with FINGOLIMOD EG, including monitoring until the next morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be required before starting treatment with FINGOLIMOD EG. If this applies, your doctor will delay the start of FINGOLIMOD EG treatment until one month after completing the full vaccination course.

Infections
Fingolimod reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking FINGOLIMOD EG (and up to 2 months after stopping treatment), you may be more likely to develop infections. Any existing infection may worsen. Infections can be serious and life-threatening. If you think you have an infection, have a fever, flu-like symptoms, shingles, or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (these may be symptoms of meningitis and/or encephalitis caused by fungal or viral herpes infection), contact your doctor immediately, as this could be serious and life-threatening.
Human papillomavirus (HPV) infection, including warts, dysplasia, condylomas, 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 HPV screening.

PML
PML is a rare brain disease caused by an infection that can lead to severe disability or death. Your doctor will schedule magnetic resonance imaging (MRI) scans before starting treatment and during treatment to monitor the risk of PML.
If you think your multiple sclerosis (MS) is worsening or if you notice any new symptoms, such as changes in mood or behaviour, new or worsening weakness on one side of the body, changes in vision, confusion, memory lapses, or difficulty with language and communication, speak to your doctor as soon as possible.
These may be symptoms of PML. Also talk to your partner or caregiver and inform them about your treatment. They may notice symptoms you are not aware of.
If you develop PML, it can be treated and treatment with FINGOLIMOD EG will be stopped. Some people experience an inflammatory reaction when FINGOLIMOD EG is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may lead to worsening of the condition, including worsening brain function.

Macular oedema
Before starting treatment with FINGOLIMOD EG, if you have or have had vision disorders or other signs of swelling in the central area of vision (macula) at the back of the eye, if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes, your doctor may ask you to have an eye examination.
Your doctor may also ask you to have an eye examination 3–4 months after starting treatment with FINGOLIMOD EG.
The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colours, and fine details clearly. Fingolimod can cause swelling of the macula, a condition known as macular oedema. Swelling usually occurs within the first 4 months of treatment with FINGOLIMOD EG.
The risk of macular oedema is higher if you have diabetes or have had eye inflammation called uveitis. In these cases, your doctor may recommend regular monitoring to detect early signs of macular oedema.
If you have previously had macular oedema, talk to your doctor before restarting treatment with FINGOLIMOD EG.
Macular oedema can cause visual symptoms (optic neuritis) that may also occur during MS relapses. In the early stages, there may be no symptoms. Make sure to inform your doctor of any changes in vision. Your doctor may ask you to have an eye examination, especially if:

the central area of vision is blurred or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colours or fine details.

Liver function tests
If you have severe liver problems, you must not take FINGOLIMOD EG. Treatment with fingolimod may affect your liver function. You may not notice any symptoms, but if you notice yellowing of the skin or whites of the eyes, unusually dark-coloured urine (brown), pain on the right side of the stomach area (abdomen), fatigue, unusual loss of appetite, or unexplained nausea and vomiting, contact your doctor immediately.
If you experience any of these symptoms after starting treatment with FINGOLIMOD EG, contact your doctor immediately.
Before, during, and after treatment, your doctor will ask you to have blood tests to monitor liver function. If results indicate a liver problem, treatment with FINGOLIMOD EG may need to be stopped.

High blood pressure
Since fingolimod causes a slight increase in blood pressure, your doctor may monitor your blood pressure regularly.

Lung problems
Fingolimod has a mild effect on lung function. Undesirable effects may occur more easily in patients with severe lung problems or smoker’s cough.

Blood count
The intended effect of treatment with FINGOLIMOD EG is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking FINGOLIMOD EG. Otherwise, your doctor may not be able to correctly interpret the test results, and for certain types of tests, your doctor may need to collect more blood than usual.
Before starting treatment with FINGOLIMOD EG, your doctor will confirm that your white blood cell count is sufficient and may ask you to have regular blood counts. If your white blood cell count is too low, treatment with FINGOLIMOD EG may need to be stopped.

Reversible posterior encephalopathy syndrome (PRES)
A rare condition called reversible posterior encephalopathy syndrome (PRES) has been reported in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with FINGOLIMOD EG, as it could be serious.

Cancer
Skin tumours have been reported in patients with MS treated with fingolimod. Contact your doctor immediately if you notice the appearance of any skin nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin (e.g. unusual moles) with changes in colour, shape, or size over time. A skin examination is necessary before starting treatment with FINGOLIMOD EG to check for possible skin nodules. Your doctor will also perform regular skin checks during treatment with FINGOLIMOD EG. If skin problems occur, your doctor may refer you to a dermatologist who, after examination, may decide that regular monitoring is important for you.
A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with fingolimod.

Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing tumours, particularly skin tumours. You should limit exposure to sunlight and UV radiation:

by wearing appropriate protective clothing;
by regularly applying sunscreen with high UV protection.

Unusual brain lesions associated with MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with fingolimod. In case of a severe relapse, your doctor will assess whether an MRI should be performed to evaluate this condition and decide whether you need to stop taking FINGOLIMOD EG.

Switching from other treatments to FINGOLIMOD EG
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to FINGOLIMOD EG if there are no signs of abnormalities caused by the previous treatment. Your doctor may perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with FINGOLIMOD EG. For switching from teriflunomide, your doctor may advise you to wait for a certain period or proceed with an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether FINGOLIMOD EG is suitable for you.

Women of childbearing potential
Fingolimod may harm the unborn child if used during pregnancy. Before starting treatment with FINGOLIMOD EG, 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 an educational reminder explaining why you should not become pregnant while taking FINGOLIMOD EG. It will also explain what you need to do to avoid pregnancy while taking FINGOLIMOD EG. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping fingolimod treatment
Do not stop taking FINGOLIMOD EG or change your dose without first consulting your doctor.
Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with FINGOLIMOD EG. This may be serious (see “If you stop taking FINGOLIMOD EG” in section 3 and also section 4 “Possible side effects”).

Elderly
Experience with fingolimod in elderly patients (over 65 years of age) is limited. If you have any doubts, consult your doctor.

Children and adolescents
FINGOLIMOD EG is not intended for use in children under 10 years of age and weighing less than 40 kg, as it has not been studied in this age group of patients with MS.
The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children, adolescents, and their caregivers:

Before starting treatment with FINGOLIMOD EG, your doctor will check your vaccination status. If you have not received certain vaccinations, they may need to be administered before starting treatment with FINGOLIMOD EG.
The first time you take FINGOLIMOD EG or when switching from the 0.25 mg daily dose to the 0.5 mg daily dose, your doctor will monitor your heart rate and heartbeat (see above “Slow heart rate (bradycardia) and irregular heartbeat”).
If you experience seizures or epileptic fits before or while taking FINGOLIMOD EG, inform your doctor.
If you suffer from depression or anxiety, or become depressed or anxious during treatment with FINGOLIMOD EG, inform your doctor. You may need closer monitoring.

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

Medicines that suppress or modify 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 EG with these medicines, as this may intensify the effect on the immune system (see also “Do not take FINGOLIMOD EG”).
Corticosteroids, due to possible additive effects on the immune system.
Vaccines. If you need to be vaccinated, ask your doctor for advice first. During and up to 2 months after treatment with FINGOLIMOD EG, you must not receive certain types of vaccines (live attenuated vaccines), as they may trigger the infection they are meant to prevent. Other vaccines may not work as well if administered during this period.
Medicines that slow down the heart rate (such as beta-blockers, e.g. atenolol). Concomitant use of FINGOLIMOD EG with these medicines may intensify the effect on heart rate during the first days of treatment with FINGOLIMOD EG.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use FINGOLIMOD EG if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take FINGOLIMOD EG”).
Other medicines or protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of fingolimod).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not use FINGOLIMOD EG during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential not using effective contraception. If FINGOLIMOD EG is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in newborns exposed to fingolimod during pregnancy is about twice the rate observed in the general population (in which the rate of congenital malformations is approximately 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal malformations.
Therefore, if you are a woman of childbearing potential:

before starting treatment with FINGOLIMOD EG, your doctor will inform you of the risk to the unborn child and ask you to have a pregnancy test to ensure you are not pregnant, and
you must use effective contraception during treatment with FINGOLIMOD EG and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you additional educational material explaining why you should not become pregnant while taking FINGOLIMOD EG.
If you become pregnant while taking FINGOLIMOD EG, inform your doctor immediately. Your doctor will decide to stop treatment (see “If you stop taking FINGOLIMOD EG” in section 3 and also section 4 “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed during treatment with FINGOLIMOD EG. Fingolimod is excreted in breast milk, with a risk of serious adverse effects for the infant.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive (including bicycles) and use machinery safely. FINGOLIMOD EG should not affect your ability to drive or use machinery.
However, at the start of treatment, you must remain at your doctor’s office or in hospital for 6 hours after taking the first dose of FINGOLIMOD EG. Your ability to drive and use machinery may be impaired during this time and potentially afterwards.

3. How to take FINGOLIMOD EG

Treatment with FINGOLIMOD EG will be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as your doctor has instructed you. If you have any doubts, contact your doctor.

Recommended dose:
Adults
The dose is one 0.5 mg capsule once daily.

Children and adolescents (from 10 years of age and weighing more than 40 kg)
One 0.5 mg capsule daily. Children and adolescents who start treatment with a 0.25 mg capsule daily and subsequently reach a stable body weight above 40 kg will be instructed by the doctor to switch to treatment with one 0.5 mg capsule daily. In this case, repeating the first-dose observation period is recommended.

Children and adolescents (from 10 years of age and weighing less than or equal to 40 kg)
FINGOLIMOD EG 0.5 mg hard capsules are not suitable for use in pediatric patients with body weight ≤ 40 kg. Other medicinal products containing fingolimod at a lower dosage (such as 0.25 mg capsules) are available.

Do not exceed the recommended dose.

Method of administration
FINGOLIMOD EG is for oral use.
Take FINGOLIMOD EG once daily with a glass of water. FINGOLIMOD EG capsules must always be swallowed whole, without opening them. FINGOLIMOD EG may be taken regardless of meals.
Taking FINGOLIMOD EG at the same time each day will help you remember when to take your medicine.

Duration of treatment
If you have any doubts about the duration of treatment with FINGOLIMOD EG, speak with your doctor or pharmacist.

If you take more FINGOLIMOD EG than you should
If you have taken too many FINGOLIMOD EG capsules, inform your doctor immediately.

If you forget to take FINGOLIMOD EG
If you have been taking FINGOLIMOD EG for less than 1 month and forget to take one dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.

If you have been taking FINGOLIMOD EG for at least 1 month and have missed taking the medicine for more than 2 weeks, consult your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as scheduled.

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

If you stop taking FINGOLIMOD EG
Do not stop taking FINGOLIMOD EG or change the dose without first consulting your doctor.
Fingolimod will remain in your body for up to 2 months after stopping treatment. The number of white blood cells (lymphocytes) may remain low during this period, and the side effects described in this leaflet may still occur. After stopping treatment with FINGOLIMOD EG, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.

If it becomes necessary to restart FINGOLIMOD EG after an interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may reappear: therefore, restarting treatment will require observation in an outpatient clinic or hospital setting. Do not restart treatment with FINGOLIMOD EG after an interruption of more than two weeks without consulting your doctor.

Your doctor will decide whether and how monitoring is needed after stopping treatment with FINGOLIMOD EG. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with FINGOLIMOD EG. This could be serious.

If you have any doubts about using this medicine, consult 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 could be or become serious
Common (may affect up to 1 in 10 people)

Cough with phlegm, chest discomfort, fever (signs of lung disorders);
Herpes virus infection (cold sores or shingles), with symptoms such as blisters, burning, itching or pain of the skin, usually on the upper part of the body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching or red spots with severe pain;
Slow heartbeat (bradycardia), irregular heart rhythm;
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other appearances;
Depression and anxiety are known to occur more frequently in the MS population and have 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 blind spots in the center of vision, blurred vision, problems distinguishing colors or details;
Reduction in platelets in the blood, leading to increased 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 may change in size, shape, thickness or color over time, or new moles. Moles may itch, bleed or ulcerate;
Seizures, epileptic fits (more frequent in children and adolescents than in adults).

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

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures and/or vision 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, an ulcerated crusted lesion, or a new ulceration on a pre-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).

Not known (frequency cannot be estimated from the available data)

Allergic reactions, including symptoms such as skin rash or hives, swelling of the lips, tongue or face, which are more likely to occur on the first day of treatment with FINGOLIMOD EG;
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 stomach area (abdomen), dark urine (brown-colored), unusual lack of appetite, tiredness, and abnormal liver function tests. In a very limited number of cases, liver failure may lead to liver transplantation;
Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may resemble an MS relapse. Other symptoms may occur that you may not personally notice, such as changes in mood or behavior, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important that you contact your doctor as soon as possible;
Inflammatory disease after stopping treatment with FINGOLIMOD EG (known as immune reconstitution inflammatory syndrome or IRIS);
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, light sensitivity, nausea and/or confusion;
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include painless flesh-colored or bluish-red nodules, often 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 influence the risk of developing Merkel cell carcinoma;
After stopping treatment with FINGOLIMOD EG, MS symptoms may reappear and possibly worsen compared to before or during treatment;
Autoimmune form of anemia (reduction in red blood cells) where red blood cells are destroyed (autoimmune hemolytic anemia).

If any of these symptoms affect you, contact your doctor immediately.
Other side effects
Very common (may affect more than 1 in 10 people)

Influenza virus infection with symptoms such as tiredness, 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 higher levels of liver enzymes;
Cough.

Common (may affect up to 1 in 10 people)

Ringworm, a fungal skin infection (pityriasis versicolor);
Dizziness;
Severe headache often accompanied by nausea, vomiting and light sensitivity (migraine);
Low levels of white blood cells in the blood (lymphocytes, leukocytes);
Weakness;
Itchy rash with redness and burning (eczema);
Itching;
Increased blood levels of fats (triglycerides);
Hair loss;
Shortness of breath;
Depression;
Blurred vision (see also the section on macular edema “Some side effects may be or become serious”);
Hypertension (FINGOLIMOD EG 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 in the blood (neutrophils);
Depressed mood;
Nausea.

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

Cancer of the lymphatic system (lymphoma).

Not known (frequency cannot be estimated from the available data)

Peripheral swelling.

If any of these side effects become severe, inform your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FINGOLIMOD EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after the word "EXP.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FINGOLIMOD EG contains
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.

Description of the appearance of FINGOLIMOD EG and package contents
FINGOLIMOD EG 0.5 mg hard capsules are size 3 hard gelatin capsules with an opaque yellow cap and an opaque white body.
FINGOLIMOD EG 0.5 mg hard capsules are available in blisters in pack sizes of 7, 28, 30, 56, 84, 98, 100 hard capsules and in unit dose divisible blisters in pack sizes of 7x1, 28x1, 30x1, 56x1, 84x1, 98x1, 100x1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturers
Haupt Pharma Amareg GmbH, Donaustaufr Str. 378, 93055 Regensburg, Germany
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria
Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland
Centrafarm Services B.V., Van de Reijtstraat 31-E, 4814 NE Breda, The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria: Fingolimod STADA 0.5 mg Hartkapseln
Belgium: Fingolimod EG 0.5 mg harde capsules
Cyprus: FINGOLIMOD/STADA
Croatia: Fingolimod STADA 0.5 mg tvrde capsule
Denmark: Fingolimod STADA
Estonia: Fingolimod STADA
Finland: Fingolimod STADA 0.5 mg kapseli kova
France: FINGOLIMOD EG 0.5 mg, gélule
Germany: Fingolimod STADA 0.5 mg Hartkapseln
Greece: FINGOLIMOD/STADA
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 cietās kapsulas
Lithuania: Fingolimod STADA 0.5 mg kietosios kapsulės
Luxembourg: Fingolimod EG 0.5 mg gélules
Norway: Fingolimod STADA
Netherlands: Fingolimod CF 0.5 mg, harde capsules
Poland: Fingolimod Stada
Portugal: Fingolimod Stada
Czech Republic: Fingolimod STADA
Slovakia: Fingolimod STADA 0.5 mg tvrdé kapsuly
Slovenia: Fingolimod STADA 0.5 mg trde kapsule
Spain: Fingolimod STADA 0.5 mg cápsulas duras EFG
Sweden: Fingolimod STADA 0.5 mg hårda kapslar
Hungary: Fingolimod Stada 0.5 mg kemény kapszula