Package leaflet: Information for the user

Fingolimod MSN, 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

What Fingolimod MSN is
Fingolimod MSN contains the active substance fingolimod.
What Fingolimod MSN is used for
Fingolimod MSN is used in adults for the treatment of relapsing-remitting multiple sclerosis (MS, Sclerosis multiplex), particularly in:

patients who have not responded to prior MS therapy, or
patients with rapidly evolving, severe relapsing-remitting MS.

Fingolimod MSN does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.
Fingolimod is also approved for use in children aged 10 years and older. A medicinal product containing fingolimod from another manufacturer is authorised in the European Union. Ask your doctor or pharmacist if you have any further questions.
What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and spinal cord. In MS, an inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
Relapsing-remitting MS is characterised by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity in the CNS. Symptoms vary among patients but usually include walking difficulties, numbness, vision or balance problems. Symptoms of relapses may completely resolve, although some deficits may persist.
How Fingolimod MSN works
Fingolimod MSN helps protect the CNS from immune system attack by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from crossing into the brain and spinal cord.
In this way, the medicine reduces nerve damage caused by MS. Fingolimod MSN also modulates certain immune responses in the body.

2. Information before taking Fingolimod MSN

When not to take Fingolimod MSN

if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or use of immunosuppressive drugs);
if the patient has severe active infection or active chronic infection, such as hepatitis or tuberculosis;
if the patient has active cancer;
if the patient has severe liver disease;
if the patient has had a heart attack, angina pectoris, stroke, or warning signs of stroke within the last 6 months, or certain types of heart failure;
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) showed QT interval prolongation before starting Fingolimod MSN;
if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or of childbearing age and not using effective contraception;
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of these situations apply or the patient has any doubts, consult a doctor before taking Fingolimod MSN.

Warnings and precautions

Before starting treatment with Fingolimod MSN, discuss the following with your doctor:

if the patient has severe breathing problems during sleep (severe sleep apnoea);
if the patient has been informed that their ECG is abnormal;
if the patient experiences symptoms of slowed heart rate (e.g. dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medications that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting (syncope);
if the patient plans to be vaccinated;
if the patient has never had chickenpox;
if the patient has or has had vision problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye (a condition called macular edema, see below), inflammation or infection of the eye (uveitis), or if the patient has diabetes, which may cause vision problems;
if the patient has liver problems;
if the patient has high blood pressure that cannot be controlled with medication;
if the patient has severe lung disease or smoker's cough.

If any of these situations apply or the patient has any doubts, consult a doctor before taking Fingolimod MSN.

Slow heart rate (bradycardia) and irregular heartbeat

At the beginning of treatment or after taking the first 0.5 mg dose in patients previously taking a 0.25 mg daily dose, Fingolimod MSN slows heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be required. Fingolimod MSN may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is generally expected.

The doctor will ask the patient to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod MSN or the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be administered if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod MSN and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiographic monitoring. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, prolonged monitoring of the patient (for at least 2 additional hours or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod MSN after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod MSN before the interruption.

If the patient is at risk of irregular or abnormal heartbeat or has an abnormal ECG, heart disease, or heart failure, Fingolimod MSN may not be suitable. If the patient has a history of sudden loss of consciousness or slowed heart function, Fingolimod MSN may not be appropriate. A cardiology consultation (with a heart specialist) may be needed to advise on how to start treatment with Fingolimod MSN, including how to monitor the patient overnight.

If the patient is taking medications that may reduce heart rate, Fingolimod MSN may not be suitable. A cardiology consultation may be required to determine whether the patient can switch to other medications that do not reduce heart rate, to allow treatment with Fingolimod MSN. If such a change is not possible, the cardiologist will advise on how to start treatment with Fingolimod MSN, including monitoring until the next day.

Patients who have never had chickenpox

If the patient has never had chickenpox, the doctor will check the patient's immunity to the virus that causes it (varicella-zoster virus). If the patient is not protected against the virus, vaccination may be required before starting treatment with Fingolimod MSN. If this is the case, the doctor will delay the start of treatment with Fingolimod MSN by one month after completing the full vaccination course.

Infections

Fingolimod MSN reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod MSN (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects an infection, has a fever, flu-like symptoms, shingles, or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal infection or herpes virus infection), they should contact the doctor immediately, as this condition may be severe and life-threatening. If the patient feels that multiple sclerosis is worsening (e.g. weakness or vision problems) or notices any new symptoms, they should speak to the doctor immediately, as these may be symptoms of a rare brain disease caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor may consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether treatment with Fingolimod MSN should be discontinued.

In patients treated with Fingolimod MSN, human papillomavirus (HPV) infection has been reported, including cases of warts, dysplasia, and HPV-related malignant tumors. The doctor may consider the need for HPV vaccination before starting treatment. In women, the doctor may also recommend HPV screening tests.

Macular edema

Before starting treatment with Fingolimod MSN, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes for ophthalmological examination.

The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Fingolimod MSN.

The macula is a small area of the retina at the back of the eye that enables clear and sharp vision of shapes, colors, and other details. Fingolimod MSN may cause swelling, known as macular edema. This swelling usually occurs within the first 4 months of treatment with Fingolimod MSN.

The risk of macular edema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular edema.

If the patient develops macular edema, they should inform the doctor before resuming treatment with Fingolimod MSN.

Macular edema may cause certain vision problems, similar to those in MS attacks (optic neuritis). In the early stages, symptoms may not occur at all. Any changes in vision should be reported to the doctor. The doctor may refer the patient for ophthalmological examination, especially if:

the center of the visual field becomes blurry or shadowed;
a blind spot appears in the center of the visual field;
there are difficulties seeing colors or fine details.

Liver function tests

Patients with severe liver disease should not take Fingolimod MSN. Fingolimod MSN may affect liver function test results. The patient may not notice any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark (brown) urine, pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting occur, inform the doctor immediately.

If any of the above symptoms occur after starting treatment with Fingolimod MSN, inform the doctor immediately.

Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver function abnormalities, treatment with Fingolimod MSN may be discontinued.

High blood pressure

The doctor may regularly check blood pressure, as Fingolimod MSN causes a slight increase in blood pressure.

Lung problems

Fingolimod MSN has a minor effect on lung function. Patients with severe lung disease or smoker's cough may have a higher risk of adverse effects.

Blood cell count

A known effect of Fingolimod MSN is a reduction in the number of white blood cells in the blood. Their count usually returns to normal within 2 months after stopping treatment. If blood tests are needed, inform the doctor about taking Fingolimod MSN. Otherwise, the doctor may not be able to interpret blood test results, and for certain tests, the doctor may order a larger blood sample than usual.

Before starting treatment with Fingolimod MSN, the doctor will confirm that the number of white blood cells in the blood is adequate to start treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Fingolimod MSN may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)

In patients with MS treated with fingolimod, cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been rarely reported. Symptoms of this condition may include sudden severe headache, confusion, seizures, and vision problems. If any of these symptoms occur during treatment with Fingolimod MSN, inform the doctor immediately, as this condition may be serious.

Cancer

In patients with MS treated with fingolimod, skin cancers have been reported. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within a few weeks are noticed on the skin, inform the doctor immediately. Symptoms of skin cancer may include unusual growths or changes in skin tissue (e.g. new moles) that change in color, shape, or size over time. Before starting treatment with Fingolimod MSN, a skin examination should be performed to check for any skin lumps. The doctor will also perform regular skin checks during treatment with Fingolimod MSN. If skin problems occur, the doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.

In patients with MS treated with Fingolimod MSN, cases of a certain type of lymphatic system cancer (lymphoma) have been reported.

Sun exposure and sun protection

Fingolimod weakens the immune system. This condition increases the risk of malignant tumors, especially skin cancers. The patient should limit sun and UV radiation exposure by:

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

Unusual brain changes associated with MS relapse

In patients treated with fingolimod, rare cases of unusually large brain changes associated with MS relapse have been reported. In case of a severe MS relapse, the doctor may consider performing an MRI scan to assess this condition and decide on the need to discontinue Fingolimod MSN.

Switching from other medications to Fingolimod MSN

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod MSN if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab treatment, a 2- to 3-month waiting period may be required before starting Fingolimod MSN. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated drug elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion of their situation with the doctor before deciding whether Fingolimod MSN is suitable.

Women of childbearing age

If Fingolimod MSN is used during pregnancy, it may have harmful effects on the unborn child. Before starting treatment with Fingolimod MSN, the doctor will explain the risks to the patient and request a pregnancy test to rule out pregnancy.

The doctor will provide the patient with a card explaining why pregnancy should be avoided during treatment with Fingolimod MSN. The card also contains information on how to avoid pregnancy during treatment with Fingolimod MSN.

Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping Fingolimod MSN treatment

Do not stop taking Fingolimod MSN or change the dose without first consulting a doctor.

Inform the doctor immediately if the patient feels that their MS is worsening after stopping Fingolimod MSN treatment. This situation may be serious (see "Discontinuation of Fingolimod MSN" in section 3 and section 4 "Possible side effects").

Elderly patients

Experience with the use of Fingolimod MSN in elderly patients (over 65 years) is limited. If in doubt, consult a doctor.

Children and adolescents

Fingolimod MSN is not intended for use in children under 10 years of age.

For use in children aged 10 years and older, a medicinal product containing fingolimod from another manufacturer is authorized in the European Union.

Fingolimod MSN and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod MSN must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fingolimod MSN").
Corticosteroids, due to the possibility of additive effects on the immune system.
Vaccines. If the patient requires vaccination, they should first consult the doctor. During and for 2 months after treatment with Fingolimod MSN, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are intended to prevent. Other vaccines may also be ineffective if administered during this period.
Medicines that slow heart function (e.g. beta-blockers such as atenolol). Using Fingolimod MSN together with these medicines could intensify the effect on heart function in the first days of treatment with Fingolimod MSN.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod MSN must not be used in patients taking these medicines, as its use could intensify the effect on irregular heartbeat (see also "When not to take Fingolimod MSN").
Other medicines: protease inhibitors, antiviral drugs such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort products (possible risk of reduced effectiveness of Fingolimod MSN).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult the doctor before using this medicine.

Pregnancy

Fingolimod MSN should not be used during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If Fingolimod MSN is used during pregnancy, there is a risk of harmful effects on the unborn child. The rate of congenital malformations observed in children exposed to Fingolimod MSN during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is about 2-3%). The most frequently reported congenital malformations include developmental abnormalities of the heart, kidneys, and musculoskeletal system.

Therefore, if the patient is of childbearing age:

before starting treatment with Fingolimod MSN, the doctor will inform the patient about the risk to the unborn child and request a pregnancy test to confirm that the patient is not pregnant;
effective contraception must be used during treatment with Fingolimod MSN and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with the doctor.

The doctor will provide the patient with a card explaining why pregnancy should be avoided during treatment with Fingolimod MSN.

If the patient becomes pregnant while taking Fingolimod MSN, inform the doctor immediately. The doctor will decide whether to discontinue treatment (see "Discontinuation of Fingolimod MSN" in section 3 and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.

Breastfeeding

Breastfeeding should not be used during treatment with Fingolimod MSN. Fingolimod MSN may pass into breast milk, posing a risk of serious adverse effects in the child.

Driving and operating machinery

The doctor will inform the patient whether their condition allows them to safely drive vehicles, including bicycles, and operate machinery. Fingolimod MSN is not expected to affect the ability to drive vehicles and operate machinery.

However, at the beginning of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod MSN. During this time and potentially afterwards, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod MSN

Treatment with Fingolimod MSN will be supervised by a doctor experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Recommended dose:
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 once daily.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily. Children and adolescents who initially received one 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will receive instructions from their doctor to change the dose to one 0.5 mg capsule once daily. In such cases, it is recommended to repeat the monitoring period as after administration of the first dose.

Other pharmaceutical companies offer capsules for children and adolescents with body weight less than or equal to 40 kg containing 0.25 mg of fingolimod.
The recommended dose should not be exceeded.
Fingolimod MSN is intended for oral use.
Fingolimod MSN should be taken once daily, with a glass of water. Fingolimod MSN capsules must always be swallowed whole, without opening. Fingolimod MSN may be taken with or without food.
Taking Fingolimod MSN at the same time each day will help you remember to take your dose.
For any questions regarding the duration of treatment with Fingolimod MSN, consult your doctor or pharmacist.
Taking more Fingolimod MSN than recommended
If a patient has taken too much medicine, they should contact their doctor immediately.
Missing a dose of Fingolimod MSN
If a patient has been taking Fingolimod MSN for less than 1 month and has missed one dose for a full day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
If a patient has been taking Fingolimod MSN for at least 1 month and has missed taking the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose. However, if a patient has missed taking the medicine for up to 2 weeks, they may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.
Stopping Fingolimod MSN treatment
Do not stop treatment with Fingolimod MSN or change the dose without first consulting your doctor.
Fingolimod MSN may remain in the body for up to 2 months after stopping treatment. During this time, the white blood cell count (lymphocyte count) may still be reduced, and adverse reactions described in this leaflet may continue to occur. After stopping treatment with Fingolimod MSN, wait 6–8 weeks before starting a new treatment for multiple sclerosis.
For patients restarting treatment with Fingolimod MSN after a break of more than 2 weeks, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring of the patient in a doctor's office or clinic will be necessary upon resuming treatment. Do not restart treatment with Fingolimod MSN after a break of more than two weeks without consulting your doctor.
Your doctor will decide whether and how to monitor you after stopping treatment with Fingolimod MSN. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping treatment with Fingolimod MSN. This situation may be serious.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be or may become serious.
Common (may affect less than 1 in 10 people):

Productive cough, feeling of discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infections (shingles or herpes simplex) with symptoms such as blisters, burning, itching or pain of the skin, usually above the upper part of the body or face. Other symptoms may include fever and malaise in the early stage of infection, followed by numbness, itching or red spots with severe pain
Slow heartbeat (bradycardia), irregular heartbeat
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly lump, although it may also look different
Depression and anxiety are known to occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with fingolimod
Weight loss

Uncommon (may affect less than 1 in 100 people):

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the center of the visual field in the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details
Decreased number of blood platelets, which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible symptoms of melanoma include moles that change in size, shape, elevation or color over time, or new moles appearing. Moles may itch, bleed or ulcerate
Seizures, epileptic fits (more common in children and adolescents than in adults)

Rare (may affect less than 1 in 1,000 people):

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual disturbances
Lymphoma (a type of cancer involving the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red lump, an ulcer covered with a scab or a new ulcer developing in an area of existing scar

Very rare (may affect less than 1 in 10,000 people):

Abnormalities in the ECG test result (T-wave inversion)
Tumor associated with human herpesvirus type 8 infection (Kaposi's sarcoma)

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

Allergic reactions, including rash or itchy hives, swelling of the lips, tongue or face, which are more likely to occur on the day treatment with Fingolimod MSN is started
Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function test results. In very rare cases, liver failure may lead to liver transplantation
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble a relapse of MS. There may also be symptoms that the patient is not aware of, such as changes in mood or behavior, memory decline, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their close contacts notice any new or unusual symptoms, it is very important to inform the doctor as soon as possible
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, light sensitivity, nausea and (or) confusion
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of Merkel cell carcinoma
After discontinuation of Fingolimod MSN treatment, MS symptoms may recur and worsen compared to the period before and during treatment
Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia)

If the patient experiences any of these reactions, it is essential to inform the doctor immediately.
Other adverse reactions
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
Increased liver enzyme activity in blood tests
Cough

Common (may affect less than 1 in 10 people):

Fungal skin infections, dermatophyte-induced fungal infection (tinea versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine)
Low number of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy, red, burning rash (rash)
Itching
Increased level of fats (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema under "Some adverse reactions may be or may become serious")
Hypertension (Fingolimod MSN may cause a mild increase in blood pressure)
Muscle pain
Joint pain

Uncommon (may affect less than 1 in 100 people):

Low number of white blood cells (neutrophils)
Depressed mood
Nausea

Rare (may affect less than 1 in 1,000 people):

Lymphatic system cancer (lymphoma)

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

Peripheral edema

If any of these symptoms are severe, the patient should inform the doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the responsible entity.

5. How to store Fingolimod MSN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after: EXP. The expiry date refers to the last day of the stated month.
Do not use medicines from packaging that is damaged or shows signs of prior opening.
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Fingolimod MSN contains

The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
Other ingredients are:
Capsule contents: pregelatinized starch, maize starch, fumaric acid, stearic acid
Capsule cap: gelatin, titanium dioxide (E 171), purified water
Capsule body: gelatin, titanium dioxide (E 171), purified water
Printing ink: black iron oxide (E 172), shellac (E 904), propylene glycol, potassium hydroxide

What Fingolimod MSN looks like and contents of the pack
Fingolimod MSN 0.5 mg hard capsules consist of a white cap printed with "0.5 mg" and a white body printed with "MF". The capsules contain a white or almost white powder.
Fingolimod MSN hard capsules are available in blisters or unit dose blisters made of PVC/PCTFE/PVC/Aluminium, packed in cardboard boxes containing 7, 10, 14, 28, 30, 98, 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1 or 98 x 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147

Manufacturer/Importer:
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Ltd.
KW20A, Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Fingolimod Tiefenbacher
Czech Republic Fingolimod Tiefenbacher
Ireland Fingolimod Tiefenbacher 0.5 mg hard capsules
Netherlands Fingolimod Tiefenbacher 0.5 mg harde capsules
Germany Fingolimod Tiefenbacher 0.5 mg Hartkapseln
Poland Fingolimod MSN
Romania Fingolimod Tiefenbacher 0.5 mg capsule
Slovakia Fingolimod Tiefenbacher 0.5 mg tvrdé kapsuly
Hungary Fingolimod Tiefenbacher 0.5 mg kapszula

Fingolimod msn