Package leaflet: Information for the user

Fingolimod HCS 0.5 mg hard capsules

fingolimod
Generic medicine
Please read all of this leaflet carefully before you start 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Fingolimod HCS is
Fingolimod HCS contains the active substance fingolimod.
What Fingolimod HCS is used for
Fingolimod HCS is used in adults and children and adolescents (aged 10 years and older)
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 rapidly evolving severe MS.

Fingolimod HCS 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 damages the protective covering (called myelin)
that surrounds the 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 an inflammatory state of the central nervous system. Symptoms vary
from patient to patient, but usually include difficulty walking, numbness, vision or balance
problems. Symptoms of a relapse may completely disappear once the relapse ends, but some
impairments may persist.
How Fingolimod HCS works
Fingolimod HCS 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 and preventing them from reaching the brain and spinal cord. This limits nerve
damage caused by MS. Fingolimod HCS also reduces some of the body's immune responses.

2. What you should know before taking Fingolimod HCS

Do not take Fingolimod HCS

if you have a reduced immune response (due to immunodeficiency syndrome, an illness, 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 serious liver problems.
if you have had a heart attack, angina, stroke, or a warning sign of stroke, or certain types of heart failure within 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 HCS.
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, speak to your doctor before taking Fingolimod HCS.

Warnings and precautions
Talk to your doctor before taking Fingolimod HCS:

if you have serious breathing problems during sleep (severe sleep apnea).
if you have been told 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 heartbeat (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase drugs, or pilocarpine).
if you have previously had episodes of sudden loss of consciousness or fainting (syncope).
if you intend to get 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 edema, see below), if you have or have had eye inflammation or infection (uveitis), or if you have diabetes (which can cause eye problems).
if you suffer from liver problems.
if you suffer from high blood pressure that cannot be controlled with medication.
if you suffer from serious lung problems or if you have a smoker's cough. If any of these apply to you or you are unsure, speak to your doctor before taking Fingolimod HCS.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or when switching from the 0.25 mg daily dose to the first 0.5 mg dose, Fingolimod HCS 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 immediately, as immediate treatment may be necessary.
Fingolimod HCS can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. The slow heart rate typically 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 HCS 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 side effects occur at the start of treatment. You must have an electrocardiogram (ECG) performed before the first dose of Fingolimod HCS 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 decreasing, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, possibly until the following morning), until these issues resolve. The same may apply if you restart Fingolimod HCS after a treatment interruption, depending on how long the interruption was and how long you had been taking Fingolimod HCS before the interruption.

If you have or are at risk of having an irregular or abnormal heartbeat, if your electrocardiogram is abnormal, or if you have heart disorders or heart failure, Fingolimod HCS may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Fingolimod HCS 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 HCS, including monitoring until the following morning.
If you are taking medicines that can slow your heart rate, Fingolimod HCS 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 slow the heart rate, allowing you to start treatment with Fingolimod HCS. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with Fingolimod HCS, including monitoring until the following 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 HCS. If this applies, your doctor will delay the start of Fingolimod HCS treatment until one month after completing the full vaccination course.

Infections
Fingolimod HCS reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod HCS (and up to 2 months after stopping treatment), you may be more susceptible to 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 (herpes zoster), 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 a fungal or viral herpes infection), contact your doctor immediately, as it could be serious and life-threatening.
Human papillomavirus (HPV) infections, including warts, dysplasia, condylomas, and HPV-related cancers, have been reported in patients treated with Fingolimod HCS. 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 and during treatment to monitor the risk of PML.
If you think your multiple sclerosis (MS) is worsening or if you notice new symptoms, such as changes in mood or behavior, new or worsening weakness on one side of the body, vision changes, confusion, memory lapses, or language and communication difficulties, speak to your doctor as soon as possible. These may be symptoms of PML.
Also speak to your partner or caregiver and inform them about your treatment. They may notice symptoms you might not recognize yourself.
If you develop PML, it can be treated, and treatment with Fingolimod HCS will be stopped. Some people experience an inflammatory reaction when Fingolimod HCS is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can lead to worsening of the condition, including worsening brain function.

Macular edema
Before starting treatment with Fingolimod HCS, 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 eye inflammation or infection (uveitis), or if you have diabetes, your doctor may ask you to undergo an eye examination.
Your doctor may also ask you to have an eye examination 3–4 months after starting treatment with Fingolimod HCS.
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. Fingolimod HCS can cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Fingolimod HCS.
The risk of macular edema is higher if you have diabetes or have had eye inflammation called uveitis. In these cases, your doctor will recommend regular check-ups to detect early signs of macular edema.
If you have previously had macular edema, talk to your doctor before restarting treatment with Fingolimod HCS.
Macular edema can cause some of the visual symptoms (optic neuritis) that also occur during MS attacks. In the early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision. Your doctor may ask you to undergo 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 colors or fine details.

Liver function tests
Do not take Fingolimod HCS if you have serious liver problems. Treatment with Fingolimod HCS 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-colored urine (brown), pain on the right side of the stomach area (abdomen), fatigue, unusual lack of appetite, or unexplained nausea and vomiting, inform your doctor immediately.
If you experience any of these symptoms after starting treatment with Fingolimod HCS, inform your doctor immediately.
Before, during, and after treatment, your doctor will ask you to have blood tests to check your liver function. If results indicate a liver problem, treatment with Fingolimod HCS may need to be stopped.

High blood pressure
Since Fingolimod HCS causes a slight increase in blood pressure, your doctor may perform regular blood pressure checks.

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

Blood count
The intended effect of Fingolimod HCS treatment is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after treatment ends. If you need blood tests, inform your doctor that you are taking Fingolimod HCS. Otherwise, your doctor may not correctly interpret the test results, and for certain types of tests, your doctor may need to draw more blood than usual.
Before starting treatment with Fingolimod HCS, 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 HCS may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported in patients with multiple sclerosis treated with Fingolimod HCS. 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 HCS, as it could be serious.

Cancer
Skin tumors have been reported in patients with MS treated with Fingolimod HCS. Contact your doctor immediately if you notice any new 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 color, thickness, or size over time. A skin examination is necessary before starting treatment with Fingolimod HCS to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Fingolimod HCS. If skin problems occur, your doctor may refer you to a dermatologist who, after evaluation, may recommend regular follow-up visits.
A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with Fingolimod HCS.

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

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

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

Switching from other treatments to Fingolimod HCS
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod HCS if there are no signs of abnormalities from 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 Fingolimod HCS. When 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 HCS is suitable for you.

Women of childbearing potential
Fingolimod HCS may harm the unborn child if used during pregnancy. Before starting treatment with Fingolimod HCS, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a reminder card explaining why you should not become pregnant while taking Fingolimod HCS and what you should do to avoid pregnancy. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Pregnancy worsening after stopping Fingolimod HCS treatment
Do not stop taking Fingolimod HCS or change your dose without first talking to your doctor.
Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Fingolimod HCS. This can be serious (see “If you stop taking Fingolimod HCS” in section 3 and also section 4, “Possible side effects”).

Elderly
Experience with Fingolimod HCS in patients aged over 65 years is limited. If you have any doubts, consult your doctor.

Children and adolescents
Fingolimod HCS is not intended for use in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children and adolescents.
The following information is particularly important for children, adolescents, and those caring for them:

Before starting treatment with Fingolimod HCS, 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 HCS.
The first time you take Fingolimod HCS 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 HCS, inform your doctor.
If you suffer from depression or anxiety or become depressed or anxious during treatment with Fingolimod HCS, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod HCS
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:

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 HCS with these medicines, as this may intensify the effect on the immune system (see also “Do not take Fingolimod HCS”).
Corticosteroids, due to a possible additive effect on the immune system.
Vaccines. If you need a vaccination, consult your doctor first. During and up to 2 months after treatment with Fingolimod HCS, 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 given during this period.
Medicines that slow the heartbeat (such as beta-blockers, e.g., atenolol). Concomitant use of Fingolimod HCS with these medicines may intensify the effect on heart rate in the first days of treatment with Fingolimod HCS.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Fingolimod HCS if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take Fingolimod HCS”).
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 effectiveness of Fingolimod HCS).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.

Pregnancy
Do not use Fingolimod HCS during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If Fingolimod HCS 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 HCS 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 heart, kidney, and musculoskeletal abnormalities.
Therefore, if you are a woman of childbearing potential:

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

Your doctor will give you a reminder card explaining why you should not become pregnant while taking Fingolimod HCS.
If you become pregnant while taking Fingolimod HCS, inform your doctor immediately. Your doctor will decide whether to stop treatment (see “If you stop taking Fingolimod HCS” 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 HCS. Fingolimod HCS is excreted in breast milk, posing a risk of serious adverse effects for the newborn.

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

3. How to take Fingolimod HCS

Treatment with Fingolimod HCS will be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents with body weight less than or equal to 40 kg: one 0.25 mg capsule daily.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule daily. Children and adolescents who start treatment with one 0.25 mg capsule daily and subsequently achieve 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, repeat first-dose observation is recommended.

Fingolimod HCS is not available in the 0.25 mg dosage strength. For this dosage, you should take other fingolimod-containing medicines available on the market. Please ask your doctor or pharmacist.
Do not exceed the recommended dose.
Fingolimod HCS is for oral use.
Take Fingolimod HCS once daily with a glass of water. Fingolimod HCS capsules must always be swallowed whole and must not be opened. Fingolimod HCS may be taken with or without food.
Taking Fingolimod HCS at the same time each day will help you remember when to take the medicine.
If you have any doubts about the duration of treatment with Fingolimod HCS, consult your doctor or pharmacist.
If you take more Fingolimod HCS than you should
If you have taken too many Fingolimod HCS capsules, contact your doctor immediately.
If you forget to take Fingolimod HCS
If you have been taking Fingolimod HCS for less than 1 month and you miss 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 HCS for at least 1 month and you have missed taking the medicine for more than 2 weeks, contact 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 HCS
Do not stop taking Fingolimod HCS or change the dose without first consulting your doctor.
Fingolimod HCS 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 HCS, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.
If it becomes necessary to restart Fingolimod HCS after more than 2 weeks of treatment interruption, the effect on heart rate that normally occurs at the beginning of treatment may occur again: therefore, restarting treatment will require observation in a clinic or hospital setting. Do not restart treatment with Fingolimod HCS 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 HCS. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Fingolimod HCS. This could be serious.
If you have any questions about the use of 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 may 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 (shingles or herpes zoster), with symptoms such as blisters, burning, itching or pain on the skin, usually on the upper 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 with increased frequency in the population affected by MS and have been reported in paediatric patients treated with Fingolimod HCS
Weight loss

Uncommon (may affect up to 1 in 100 people)

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular oedema (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 centre of vision, blurred vision, problems distinguishing colours or details
Reduction in platelets in the blood, 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 may change in size, shape, thickness or colour 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 reversible posterior encephalopathy syndrome (RPES). Symptoms may include sudden onset of 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 crusted ulceration 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)
Tumour 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 HCS
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 (brown-coloured) urine, unusual feeling of loss 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 also occur that you may not personally notice, such as changes in mood or behaviour, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think that 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 HCS (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-coloured or bluish-red nodules, often on the face, head or neck. Merkel cell carcinoma may also present as a painless firm 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 HCS, MS symptoms may reappear and possibly worsen compared to before or during treatment.
Autoimmune form of anaemia (decrease in red blood cells) where red blood cells are destroyed (autoimmune haemolytic anaemia)

If you experience any of these side effects, inform your doctor immediately.

Other side effects

Very common (may affect more than 1 in 10 people)

Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhoea
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, leucocytes)
Weakness
Skin rash with itching, redness and burning (eczema)
Itching
Increased levels of fats (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular oedema “Some side effects may be or become serious”)
Hypertension (Fingolimod HCS 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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after
Exp. The expiry date refers to the last day of that month.
Blister packs:
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture.
Containers:
Do not store above 25°C.
Keep in the sealed container to protect the medicine from moisture.
Do not dispose of any medicines 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 HCS contains

The active substance is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
The other ingredients are: microcrystalline cellulose (E460), povidone, magnesium stearate (E470b) in the capsule content; and titanium dioxide (E171), carrageenan, potassium chloride, hypromellose, yellow iron oxide (E172), and ink (shellac (E904), black iron oxide (E172)) in the capsule shell.

Description of the appearance of Fingolimod HCS and pack sizes
The capsule cap is yellow-brown with a black mark "F 0.5 mg" and the Company's black logo. The capsule body is white. The capsule content is white or almost white powder. Capsule length: 15–17 mm.
Fingolimod HCS is available in packs containing:

7, 14, 28, 30, 98 and 100 hard capsules in non-divisible blisters.
30 x 1 and 100 x 1 hard capsules in unit-dose divisible blisters.
Calendar pack: 7 x 1, 14 x 1, 28 x 1 and 98 x 1 hard capsules in unit-dose divisible blisters.

Fingolimod HCS is also available in containers containing 30 hard capsules, packed in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
Ardena Pamplona S.L., Poligono Mocholi, C/Noain, n°1 de Noain, 31110, Navarra, Spain
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:

Member State Name	Medicinal Product Name
Belgium, Netherlands, Denmark, Norway, Portugal, Spain, Finland, Ireland, United Kingdom, Iceland, Sweden	Fingolimod Krka
Austria, France, Italy	Fingolimod HCS