Package leaflet: Information for the user

Fingolimod Accord 0.5 mg hard capsules

fingolimod
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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What is Fingolimod Accord
The active substance of Fingolimod Accord is fingolimod.
What Fingolimod Accord is used for
Fingolimod Accord 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 Accord does not cure MS, but helps reduce the number of relapses and slow the progression of physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease affecting the central nervous system (CNS), which includes the brain and spinal cord. In MS, inflammation destroys the protective coating (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 involve difficulty walking, numbness, visual disturbances or problems with balance. Symptoms of a relapse may completely disappear once the relapse ends, although some symptoms may persist.
How Fingolimod Accord works
Fingolimod Accord helps protect the central 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 Accord also reduces some of the body's immune responses.

2. What you need to know before taking Fingolimod Accord

Do not take Fingolimod Accord

if you have a reduced immune response (due to an immunodeficiency syndrome, illness, or medications 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 ischemic attack (TIA) within the last 6 months, or certain types of heart failure;
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 Accord;
if you are currently taking or have recently taken medications 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 Accord.

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

if you have severe breathing problems during sleep (severe sleep apnea);
if you have been told you have an abnormal electrocardiogram (ECG);
if you experience symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations);
if you are currently taking or have recently taken medications that slow the heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase drugs, or pilocarpine);
if you have previously experienced episodes of sudden loss of consciousness or fainting (syncope);
if you plan to get vaccinated;
if you have never had chickenpox;
if you have or have had vision problems 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 inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems);
if you have liver problems;
if you have high blood pressure that cannot be controlled with medication;
if you have severe lung problems or a smoker's cough. If any of these apply to you or you are unsure, talk to your doctor before taking Fingolimod Accord.

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 Accord causes a slowing of the heart rate. As a result, you may experience dizziness, 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 required. Fingolimod Accord may 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 Accord, 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 the first dose 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 Accord after a treatment interruption, depending on how long the interruption was and how long you had been taking Fingolimod Accord 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 disease or heart failure, Fingolimod Accord may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or a reduced heart rate, Fingolimod Accord may not be suitable for you. You will be evaluated by a cardiologist who will advise you on how to start treatment with Fingolimod Accord, including monitoring until the next morning.
If you are taking medications that can reduce heart rate, Fingolimod Accord may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medications that do not reduce heart rate, allowing you to start treatment with Fingolimod Accord. If such a change is not possible, the cardiologist will advise you on how to start treatment with Fingolimod Accord, 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 Accord. If this applies, your doctor will delay the start of treatment with Fingolimod Accord until one month after completing the full vaccination course.

Infections
Fingolimod Accord reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Accord (and up to 2 months after stopping treatment), you may be more susceptible to infections. Any existing infection may worsen. Infections can be severe 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 this could be serious and life-threatening.
Human papillomavirus (HPV) infection, including warts, dysplasia, condyloma, and HPV-related cancers, has been reported in patients treated with Fingolimod Accord. 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 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 difficulty speaking and communicating, 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 Accord will be stopped.
Some people experience an inflammatory reaction when Fingolimod Accord is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can lead to worsening of symptoms, including worsening brain function.

Macular edema
Before starting treatment with Fingolimod Accord, if you have or have had vision problems or 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 Accord.
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 Accord can cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Fingolimod Accord.
The risk of macular edema is higher if you have diabetes or have had an eye inflammation called uveitis. In these cases, your doctor will recommend regular check-ups to detect early signs of macular edema.
If you have had macular edema, talk to your doctor before restarting treatment with Fingolimod Accord.
Macular edema can cause some of the same visual symptoms (optic neuritis) that occur during MS attacks. In the early stages, symptoms may not be noticeable. 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 blurry or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colors or fine details.

Liver function tests
If you have severe liver problems, you must not take Fingolimod Accord. Treatment with Fingolimod Accord can affect your liver function. You may not notice any symptoms, but if you develop yellowing of the skin or whites of the eyes, unusually dark-colored urine (brown), 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 Accord, 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 Accord may need to be stopped.

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

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

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

Posterior reversible encephalopathy syndrome (PRES)
PRES has been rarely reported in patients with multiple sclerosis treated with Fingolimod Accord. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Fingolimod Accord, as it could be serious.

Cancer
Skin tumors have been reported in patients with MS treated with Fingolimod Accord. 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 required before starting treatment with Fingolimod Accord to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may recommend regular follow-up visits.
A type of lymphatic system cancer (lymphoma) has been reported in patients with MS treated with Fingolimod Accord.

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

Switching from other treatments to Fingolimod Accord
Your doctor may switch you directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Accord 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 Accord. When switching from teriflunomide, your doctor may advise waiting for a certain period or performing an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine if Fingolimod Accord is suitable for you.

Women of childbearing potential
Fingolimod Accord may harm the unborn child if used during pregnancy. Before starting treatment, 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 must not become pregnant while taking Fingolimod Accord. It also explains what you need to do to avoid pregnancy while taking Fingolimod Accord. 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 Accord treatment
Do not stop taking Fingolimod Accord 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 Accord. This can be serious (see “If you stop taking Fingolimod Accord” in section 3 and also section 4 “Possible side effects”).

Use in the elderly
Experience with Fingolimod Accord is limited in patients over 65 years of age. If you have any concerns, consult your doctor.

Children and adolescents
Fingolimod Accord is not intended for use in children under 10 years of age, 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 Accord, your doctor will check your vaccination status. If certain vaccinations have not been given, they may need to be administered before starting treatment with Fingolimod Accord;
the first time you take Fingolimod Accord 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 rhythm (see above “slow heart rate (bradycardia) and irregular heartbeat”);
if you experience seizures or epileptic fits before or while taking Fingolimod Accord, inform your doctor;
if you have depression or anxiety or become depressed or anxious during treatment with Fingolimod Accord, inform your doctor. You may need closer monitoring.

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

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

Pregnancy
Do not use Fingolimod Accord during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If Fingolimod Accord 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 Accord 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 malformations.
Therefore, if you are a woman of childbearing potential:

before starting treatment with Fingolimod Accord, your doctor will inform you of the risks 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 Accord 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 must not become pregnant while taking Fingolimod Accord.
If you become pregnant while taking Fingolimod Accord, inform your doctor immediately. Your doctor will decide to stop treatment (see “If you stop taking Fingolimod Accord” in section 3 and also section 4 “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed while taking Fingolimod Accord. Fingolimod Accord is excreted in breast milk and may cause serious adverse effects in the newborn.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive (including bicycles) and use machinery safely. Fingolimod Accord 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 Accord. Your ability to drive and use machinery may be impaired during this time and potentially afterward.

3. How to take Fingolimod Accord

Treatment with Fingolimod Accord will be supervised by a doctor 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.

Recommended dose:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and above):
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 reach a stable body weight above 40 kg will be instructed by the doctor to switch to one 0.5 mg capsule daily. In this case, repeating the first-dose observation period is recommended.

Fingolimod Accord is available only in 0.5 mg hard capsules, which are not suitable for children and adolescents with body weight less than or equal to 40 kg.
Other medicines containing fingolimod are available in a 0.25 mg dose.
Please consult your doctor or pharmacist.
Do not exceed the recommended dose.
Fingolimod Accord is for oral use.
Take Fingolimod Accord once daily with a glass of water. The capsules must always be swallowed whole, without opening them. Fingolimod Accord may be taken with or without food.
Taking Fingolimod Accord at the same time each day will help you remember to take it.
If you have any doubts about how long to continue treatment with Fingolimod Accord, consult your doctor or pharmacist.

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

If you forget to take Fingolimod Accord
If you have been taking Fingolimod Accord for less than 1 month and miss a 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 Accord for at least 1 month and 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 Accord
Do not stop taking Fingolimod Accord or change the dose without first consulting your doctor.
Fingolimod Accord 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 Accord, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.
If you need to restart taking Fingolimod Accord after an interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may reoccur: therefore, restarting treatment will require observation in an outpatient clinic or hospital setting. Do not restart treatment with Fingolimod Accord 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 Accord. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping Fingolimod Accord. This could be serious.

If you have any doubts about how to use 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 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 people with MS and have been reported in pediatric patients treated with Fingolimod Accord
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
Reduced platelet count 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 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 hard, red nodule, a crusted ulcer, 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 rash or hives, swelling of the lips, tongue, or face, which are more likely to occur on the first day of treatment with Fingolimod Accord
Signs of liver disease (including liver failure), such as yellowing of the skin or the whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach area (abdomen), dark (brown-colored) urine, unusual loss of appetite, fatigue, and abnormal liver function tests. In a very small number of cases, liver failure may lead to liver transplantation
Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out 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 to contact your doctor as soon as possible
Inflammatory disease after stopping treatment with Fingolimod Accord (known as immune reconstitution inflammatory syndrome or IRIS)
Infections caused by Cryptococcus (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include painless flesh-colored or bluish-red nodules, often on the face, head, or neck. Merkel cell carcinoma may also present 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 Accord, 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 you experience any of these side effects, contact your doctor immediately.

Other side effects

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

Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Blood tests showing higher levels of liver enzymes
Cough.

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

Tinea versicolor, a fungal skin infection
Dizziness
Severe headache often accompanied by nausea, vomiting, and sensitivity to light (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 Accord 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, contact 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fingolimod Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp."/"EXP". The expiry date refers to the last day of that month.
Store below 25ºC.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of 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 Accord contains

The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are: Capsule contents: pregelatinized starch, magnesium stearate; Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172); Ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

Description of the appearance of Fingolimod Accord and package contents
Gelatin capsule with an opaque bright yellow cap and an opaque white body, size “3”, printed with
“FO 0.5 mg” in black ink, containing white to almost white powder.
Each capsule is approximately 15.8 mm in length.
Fingolimod Accord is available in packages containing 7, 28 or 98 hard capsules in PVC/PVDC/aluminum blisters.
Packages containing 7 x 1, 28 x 1 or 98 x 1 hard capsules in divided unit-dose blisters made of PVC/PVDC/aluminum.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
08039 Barcelona,
Spain

Manufacturer
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL /
NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu