Package leaflet: Information for the patient

Fimodigo, 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 Fimodigo is and what it is used for
Before you take Fimodigo
How to take Fimodigo
Possible side effects
How to store Fimodigo
Contents of the pack and other information

1. What Fimodigo is and what it is used for

What Fimodigo is
The active substance in Fimodigo is fingolimod.
What Fimodigo is used for
Fimodigo is used in adults and children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS, Latin: Sclerosis multiplex), particularly in:

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

Fimodigo does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.
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, the inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
The relapsing-remitting form of MS is characterized by repeated relapses (recurrences) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary among patients but usually include walking difficulties, numbness, vision or balance problems. Symptoms of relapses may completely resolve, but some impairments may persist.
How Fimodigo works
Fimodigo helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage causing MS. Fimodigo also reduces certain immune responses in the body.

2. Before you take Fimodigo
When not to take Fimodigo

if you have a weakened immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system);
if you have a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
if you have active cancer;
if you have severe liver disease;
if you have had a heart attack, angina, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months;
if you have a certain type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) showed QT interval prolongation before starting Fimodigo treatment;
if you are currently taking or have recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol;
if you are pregnant or are of childbearing potential and not using effective contraception.
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If this applies, tell your doctor and do not take Fimodigo.

Warnings and precautions
Before starting Fimodigo, discuss with your doctor:

if you have severe breathing problems during sleep (sleep apnoea);
if you have been told that your ECG recording is abnormal;
if you have symptoms of a slow heart rate (e.g. dizziness, nausea or palpitations);
if you are taking or have recently taken medicines that slow heart rate (such as beta-blockers, verapamil, diltiazem or ivabradine, digoxin, cholinesterase inhibitors or pilocarpine);
if you have previously experienced sudden loss of consciousness or fainting;
if you plan to be vaccinated;
if you have never had chickenpox;
if you have or have had vision problems or other symptoms of swelling in the center of your visual field (macula) at the back of the eye (a condition called macular oedema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes, which may cause vision problems;
if you have liver problems;
if you have high blood pressure that cannot be controlled with medication;
if you have severe lung disease or a cough typical of smokers. If any of these apply, tell your doctor before taking Fimodigo.

Slow heart rate (bradycardia) and irregular heartbeat
At the start of treatment or after taking the first dose of 0.5 mg in patients previously taking a 0.25 mg daily dose, fingolimod slows the heart rate. As a result, you may feel dizzy, tired, have a strong heartbeat, or experience low blood pressure. If these symptoms are severe, inform your doctor immediately, as immediate treatment may be required. Fingolimod may also cause an 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 expected.
Your doctor will ask you to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Fimodigo or after 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 given if side effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fimodigo and again after the 6-hour observation period. During this time, your doctor may continuously monitor your heart function using electrocardiography. If, after 6 hours of observation, you have a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring (for at least 2 additional hours or possibly until the next day) may be required until symptoms resolve. The same procedure may be recommended if you restart Fimodigo treatment after a treatment interruption, depending on the duration of the break and how long you had been taking Fimodigo before the interruption.
If you have an irregular or abnormal heartbeat, risk factors for such events, an abnormal ECG, or heart disease or heart failure, Fimodigo may not be suitable for you.
If you have a history of sudden loss of consciousness or slowed heart function, Fimodigo may not be suitable. You may need to consult a cardiologist (a heart specialist) who will advise on how to start Fimodigo treatment, including overnight monitoring.
If you are taking medicines that may slow your heart rate, Fimodigo may not be suitable. You may need to consult a cardiologist, who will check whether you can switch to other medicines that do not slow the heart rate, to allow Fimodigo treatment. If such a switch is not possible, the cardiologist will advise you on how to start Fimodigo treatment, including monitoring until the day after the first dose of Fimodigo.

Patients who have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity to the varicella-zoster virus. If you are not protected against the virus, you may need to be vaccinated before starting Fimodigo treatment. If so, your doctor will delay starting Fimodigo treatment by one month after completing the full vaccination course.

Infections
Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fimodigo (and for up to 2 months after stopping treatment), you may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If you think you have an infection, have a fever, flu-like symptoms, shingles, or a headache with neck stiffness, light sensitivity, nausea, rash and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infections), contact your doctor immediately, as this condition may be serious and life-threatening. If you think your condition is worsening (e.g. weakness or vision problems) or if you notice any new symptoms, speak to your doctor immediately, as these may be signs 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. Your doctor may consider performing a magnetic resonance imaging (MRI) scan to assess your condition and decide whether Fimodigo treatment should be stopped.
Infections with human papillomavirus (HPV) have been reported in patients treated with fingolimod, including cases of warts, dysplasia, papillomas and HPV-related malignancies.
Your doctor may consider the need for HPV vaccination before starting treatment.
For women, your doctor will also recommend HPV screening tests.

Macular oedema
Before starting Fimodigo treatment, your doctor may refer you for ophthalmological examination if you currently have or have had vision problems, other symptoms of swelling in the center of your visual field (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.
Your doctor may refer you for ophthalmological examination 3 to 4 months after starting Fimodigo treatment.
The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colors and fine details. Fimodigo may cause swelling of the macula, a condition called macular oedema. This usually occurs within the first 4 months of Fimodigo treatment.
The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such cases, your doctor will arrange regular ophthalmological examinations to detect macular oedema.
If you develop macular oedema, inform your doctor before restarting Fimodigo treatment.
Macular oedema may cause visual disturbances similar to those in an MS attack (optic neuritis). In early stages, symptoms may be absent. Report any changes in vision to your doctor. Your doctor may refer you for ophthalmological examination, especially if:

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

Liver function tests
Patients with severe liver disease should not take Fimodigo. Fimodigo may affect liver function test results. You may not experience any symptoms, but if you develop 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, tell your doctor immediately.
If any of these symptoms occur after starting Fimodigo treatment, tell your doctor immediately.
Before, during and after treatment, your doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, Fimodigo treatment may be discontinued.

High blood pressure
Your doctor may regularly check your blood pressure, as Fimodigo causes a slight increase in blood pressure.

Lung diseases
Fimodigo has a minor effect on lung function. Patients with severe lung disease or a smoker's cough are at higher risk of side effects.

Blood cell count
A known effect of fingolimod is a reduction in white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. When blood tests are needed, inform your doctor that you are taking Fimodigo. Otherwise, your doctor may be unable to interpret blood test results, and for certain tests, your doctor may require a larger blood sample than usual.
Before starting Fimodigo, your doctor will confirm that your white blood cell count is adequate to begin treatment and may recommend regular repeat testing. If there are insufficient white blood cells, Fimodigo treatment may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in MS patients treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures and vision changes. If you experience any of these symptoms during Fimodigo treatment, tell your doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in MS patients treated with fingolimod. If you notice any lumps on your skin (e.g. shiny, pearly lumps), spots or open sores that do not heal within a few weeks, tell your treating doctor immediately. Skin cancer symptoms may include abnormal growths or changes in skin tissue (e.g. unusual moles) that change in color, shape or size over time.
Before starting Fimodigo treatment, a skin examination must be performed to detect any skin lumps. Your treating doctor will also perform regular skin checks during Fimodigo treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may recommend regular visits after consultation.
Cases of a certain type of lymphatic system cancer (lymphoma) have been reported in MS patients treated with fingolimod.

Sun exposure and protection from solar radiation
Fingolimod weakens the immune system. This increases the risk of malignancies, especially skin cancers. You 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
Rare cases of unusually large brain lesions associated with MS relapse have been reported in patients treated with fingolimod. In case of a severe MS relapse, your treating doctor may consider performing an MRI scan to assess this condition and decide whether Fimodigo treatment should be discontinued.

Switching from other treatments to Fimodigo
Your doctor may switch treatment directly from interferon-beta, glatiramer acetate or dimethyl fumarate to Fimodigo if there are no signs of abnormalities from previous treatment. Your 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 Fimodigo. When switching from teriflunomide, your doctor may advise waiting a certain time or undergoing an accelerated drug elimination procedure. Patients previously treated with alemtuzumab require careful assessment and discussion with their doctor to determine if Fimodigo is suitable.

Women of childbearing potential
If Fimodigo is used during pregnancy, it may harm the unborn child. Before starting Fimodigo treatment, your doctor will explain the risks and request a pregnancy test to exclude pregnancy. Your doctor will provide you with an information card explaining why you should not become pregnant while taking Fimodigo. The card also contains information on how to avoid pregnancy while taking Fimodigo.
You must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping Fimodigo treatment
Do not stop taking Fimodigo or change the dose without first consulting your doctor.
Inform your doctor immediately if you think your MS is worsening after stopping Fimodigo treatment. This situation may be serious (see "Stopping Fimodigo" in section 3 and section 4 "Possible side effects").

Elderly patients
Experience with fingolimod in elderly patients (over 65 years) is limited. If in doubt, consult your doctor.

Children and adolescents
Fimodigo is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
The warnings and precautions listed above also apply to children and adolescents.
Particularly important information for children, adolescents and their caregivers includes:

before starting Fimodigo treatment, your doctor will check your vaccination status. If you have not received certain vaccinations, vaccination may be required before starting Fimodigo treatment.
during the first dose of Fimodigo or when switching from a 0.25 mg to a 0.5 mg daily dose, your doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
if you experience seizures or epileptic fits before or during Fimodigo treatment, inform your doctor.
if you develop depression or anxiety or feel low mood or anxiety while taking Fimodigo, inform your doctor. You may require closer monitoring.

Fimodigo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, and any medicines you plan 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. Do not take Fimodigo with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fimodigo").
Corticosteroids, due to the potential for additive effects on the immune system.
Vaccines. If you need a vaccine, consult your doctor first. During and for 2 months after Fimodigo treatment, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if given during this period.
Medicines that slow heart rate (e.g. beta-blockers such as atenolol). Taking Fimodigo with these medicines could intensify the effect on heart function in the first days of Fimodigo treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. Do not take Fimodigo if you are taking these medicines, as their use could intensify the effect on irregular heartbeat (see also "When not to take Fimodigo").
Other medicines: protease inhibitors, medicines used in infections, such as ketoconazole, azole antifungals, clarithromycin or telithromycin. o carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz or St John's wort preparations (possible risk of reduced effectiveness of Fimodigo).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, consult your doctor before using this medicine.

Pregnancy
Fimodigo should not be used during pregnancy, if you are trying to become pregnant, or if you could become pregnant and are not using effective contraception. If Fimodigo is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in children exposed to fingolimod during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is about 2-3%).
The most commonly reported congenital malformations include developmental defects of the heart, kidneys and musculoskeletal system.
Therefore, if you are of childbearing potential:

before starting Fimodigo treatment, your doctor will inform you of the risks to the unborn child and request a pregnancy test to confirm you are not pregnant, and
you must use effective contraception during Fimodigo treatment and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with your doctor.

Your doctor will provide you with an information card explaining why you should not become pregnant while taking Fimodigo.
If you become pregnant while taking Fimodigo, tell your doctor immediately. Your doctor will decide whether to discontinue treatment (see "Stopping Fimodigo" in section 3 and section 4 "Possible side effects").
You will also need to attend follow-up prenatal examinations.

Breastfeeding
Do not breastfeed while taking Fimodigo. Fingolimod may pass into breast milk, posing a risk of serious side effects in the infant.

Driving and using machines
Your doctor will inform you whether your condition allows you to drive safely, including cycling, and operate machinery. Fimodigo is not expected to affect your ability to drive or operate machinery.
However, at the start of treatment, you must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fimodigo. During this time and potentially afterwards, your ability to drive and operate machinery may be impaired.

3. How to take Fimodigo

Treatment with Fimodigo will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your physician.
The recommended dose is:
Adults:
Dose: one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
Dose based on body weight:

Children and adolescents with body weight of 40 kg or less: one 0.25 mg capsule once daily. Other fingolimod-containing medicinal products are available in a lower dose (as 0.25 mg capsules).
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily.

Children and adolescents who start treatment with one 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will receive instructions from their physician to change the dose to one 0.5 mg capsule once daily. In such cases, repeat monitoring as after the first dose administration is recommended.
Do not exceed the recommended dose.
Fimodigo is intended for oral use.
Fimodigo should be taken once daily with a glass of water. Fimodigo capsules should always be swallowed whole, without opening. Fimodigo may be taken with food or between meals.
Taking Fimodigo at the same time each day will help you remember to take your dose.
For any questions regarding the duration of treatment with Fimodigo, consult your physician or pharmacist.
Accidental overdose of Fimodigo
If a patient has taken more than the recommended dose, they should contact their physician immediately.
Missed dose of Fimodigo
If a patient has been taking Fimodigo for less than 1 month and misses one full day's dose, they should contact their physician before taking the next dose. The physician may decide to observe the patient when administering the next dose.
If a patient has been taking Fimodigo for at least 1 month and has missed treatment for more than 2 weeks, they should contact their physician before taking the next dose. The physician may decide to observe the patient when administering the next dose.
However, if a patient has missed treatment for up to 2 weeks, they may take the next dose according to schedule.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Fimodigo
Do not discontinue treatment with Fimodigo or change the dosing regimen without first consulting your physician.
Fimodigo may remain in the body for up to 2 months after treatment is stopped.
During this time, 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 Fimodigo, a waiting period of 6–8 weeks is required before starting a new multiple sclerosis treatment.
In patients restarting Fimodigo after a treatment interruption of more than 2 weeks, the effect on heart rate observed typically after initial treatment initiation may reoccur, necessitating patient monitoring in a physician's office or outpatient clinic upon treatment reinitiation. Do not restart Fimodigo after a treatment break exceeding two weeks without consulting the treating physician.
The treating physician will decide whether and how the patient should be monitored after stopping treatment with Fimodigo. Inform your physician immediately if you believe your multiple sclerosis is worsening after stopping Fimodigo. This situation may be serious.
If you have any further questions about using this medicine, consult your physician 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):

Cough with sputum, unspecified discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning sensation, itching or pain in 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 patches with severe pain
Slow heart rate (bradycardia), irregular heartbeat
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have a different appearance
Depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with Fimodigo
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 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 platelet count, which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible signs of melanoma include moles that change in size, shape, elevation or color over time, or new moles. Moles may itch, bleed or ulcerate
Seizures, epileptic seizures (more frequent 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 tumor involving the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab or a new ulcer developing at the site of an existing scar

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

Abnormalities in the ECG test (T-wave inversion)
Tumor associated with human herpesvirus 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 of starting treatment with Fimodigo
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 tests. 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 MS relapse. There may also be symptoms that the patient may not be aware of, such as changes in mood or behavior, transient memory lapses, difficulty speaking and communicating, which should be evaluated by a physician to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their family members notice any new or unusual symptoms, it is very important to inform the treating physician as soon as possible
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache associated with 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 developing Merkel cell carcinoma
After discontinuation of treatment with Fimodigo, 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 any of these reactions occur in the patient, the patient should immediately inform the physician.

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 (dermatophytosis) (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine symptoms)
Low number of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy, red, burning rash (rash)
Itching
Increased levels of blood fats (triglycerides)
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 (Fimodigo 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)
Depressive mood
Nausea

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

Lymphatic system tumor (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 physician.

Reporting of adverse reactions

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

5. How to store Fimodigo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after "Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use medicines from packaging that is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Fimodigo contains

The active substance is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (in the form of fingolimod hydrochloride).
Other components are:
Capsule filling: monopotassium citrate monohydrate, colloidal anhydrous silica, magnesium stearate.
Capsule shell: titanium dioxide (E 171), gelatin.
Capsule cap: titanium dioxide (E 172), iron oxide yellow (E 171), gelatin.

What Fimodigo looks like and contents of the pack
Fimodigo 0.5 mg hard capsules (16 mm, size 3) have a white body and a yellow cap.
Blisters OPA/Aluminum/PVC/Aluminum containing 7, 28 or 98 hard capsules in a cardboard box.
Single-dose blisters OPA/Aluminum/PVC/Aluminum containing 7, 28 or 98 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Vipharm S.A
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturer/Importer:
Synthon Hispania S.L.
C/ Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain

Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Fimodigo
Netherlands: Fimodigo 0.5 mg harde capsules
Poland: Fimodigo
Slovakia: Fimodigo 0.5 mg
Hungary: Fimodigo 0.5 mg kemény kapszula

Date of the latest review of the leaflet: 24.07.2024