Fingolimod Sun

Leaflet accompanying the packaging: information for the user

Fingolimod SUN, 0.5 mg, hard capsules
fingolimod

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fingolimod and what is it used for
• 2. Important information before taking Fingolimod
• 3. How to take Fingolimod
• 4. Possible side effects
• 5. How to store Fingolimod
• 6. Contents of the pack and other information

1. What is Fingolimod and what is it used for

What is Fingolimod

The active substance of Fingolimod is fingolimod.

What is Fingolimod used for

Fingolimod is used in adults and children and adolescents (aged 10 years and older, weighing over 40 kg) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• patients who have not responded to MS treatment or
• patients with rapidly evolving, severe MS. Fingolimod does not cure MS, but helps reduce the number of relapses and slows down the progression of disability caused by MS.

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.

Relapsing-remitting MS is characterized by recurring relapses (exacerbations) of neurological symptoms, reflecting the inflammatory process in the CNS. Symptoms vary among patients, but usually include walking difficulties, numbness, vision problems, or balance problems. Relapse symptoms may completely resolve, but some disturbances may persist.

How Fingolimod works

Fingolimod helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely in the patient's body and preventing them from entering the brain and spinal cord. In this way, the medicine reduces nerve damage caused by MS. This medicine also weakens some immune system reactions.

2. Important information before taking Fingolimod

When not to take Fingolimod

• if the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive medications)
• if the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has an active malignant disease
• if the patient has severe liver disease
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with this medicine
• 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 is 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 occur, you must tell your doctor, without taking Fingolimod
.

Warnings and precautions

Before starting treatment with Fingolimod, discuss with your doctor:

• -if the patient has severe breathing difficulties during sleep (sleep apnea)
• -if the patient has been informed that their ECG is abnormal
• -if the patient has symptoms of slow 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, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine)
• if the patient has had sudden loss of consciousness or fainting in the past
• if the patient plans to undergo vaccination
• if the patient has never had chickenpox
• if the patient has vision problems or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) with posterior uveitis (inflammation of the uvea, the middle layer of the eye), or if the patient has diabetes, which can cause vision problems
• if the patient has liver disease
• if the patient has high blood pressure that cannot be controlled with medication
• if the patient has severe lung disease or a cough typical of smokers.

If any of these situations occur, you must tell your doctor before taking Fingolimod
.
V002
Low heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of Fingolimod 0.5 mg in patients who have previously taken another medicine containing fingolimod at a lower dose (daily dose of 0.25 mg), fingolimod slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure. If these symptoms are severe, you must inform your doctor, as they may require immediate treatment.
Fingolimodmay also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day.
Low 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 stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod or after the first dose of Fingolimod 0.5 mg when changing treatment from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any adverse reactions occur that happen at the beginning of treatment, appropriate treatment can be administered. Before the first dose of Fingolimod and after completing the 6-hour observation, an ECG will be performed on the patient. During this time, the doctor may continuously monitor the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, it may be necessary to extend the monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day), until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with this medicine after a break in treatment, depending on how long the break lasted and how long the patient took this medicine before the break.
If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, fingolimod may not be suitable for them.
If the patient has had sudden loss of consciousness or slow heart rate in the past, Fingolimod may not be suitable for them. It may be necessary to consult a cardiologist (a specialist who deals with the heart), who will advise on how to start treatment with this medicine, including how to monitor the patient at night.
If the patient is taking medications that can slow down the heart rate, Fingolimod may not be suitable. It may be necessary to consult a cardiologist, who will check if the patient can switch to other medications that do not slow down the heart rate, to allow treatment with Fingolimod. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with this medicine, taking into account nighttime monitoring.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella-zoster virus. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fingolimod. If this is the case, the doctor will delay the start of treatment with this medicine by one month after completing the full vaccination cycle.
Infections
Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking this medicine (and for 2 months after stopping treatment), the patient may be more prone to infections. Any existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or viral infections), they should contact their doctor immediately, as this condition can be severe.
If the patient experiences any of the above symptoms after starting treatment with Fingolimod, they must tell their doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with this medicine may be discontinued.
High blood pressure
The doctor may regularly check the patient's blood pressure, as fingolimod can cause a slight increase in blood pressure.
Lung diseases
Fingolimod has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at greater risk of adverse reactions.
Blood cell count
The expected effect of fingolimod is a decrease in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests need to be performed, the patient should inform their doctor that they are taking this medicine. Otherwise, the doctor may not be able to interpret the results of the blood test, and in the case of certain tests, the doctor may order more blood to be drawn than usual.
Before starting treatment with Fingolimod, the doctor will confirm that the patient has a suitable number of white blood cells in the blood to start treatment and may order regular blood tests to be repeated.
If the patient does not have a sufficient number of white blood cells, it may be necessary to discontinue treatment with this medicine.
Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with fingolimod, there have been rare reports of a condition called posterior reversible encephalopathy syndrome (PRES). The symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with this medicine, the patient should contact their doctor immediately, as this condition can be severe.
Cancer
There have been reports of skin cancers in patients with MS treated with fingolimod. If the patient notices any lumps on their skin (e.g., shiny lumps with a pearly color), spots, or open sores that do not heal within a few weeks, they should contact their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., unusual moles), which change in color, shape, or size over time.
Before starting treatment with this medicine, it is necessary to examine the patient's skin to detect any lumps. The treating doctor will also perform regular skin checks during treatment with fingolimod. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with them.
There have been reports of a type of lymphoma (a type of cancer of the lymphatic system) in patients with MS treated with fingolimod.
Exposure to the sun and protection from sunlight

• wearing protective clothing.
• regularly applying sunscreen with a high level of protection against UV radiation.

Unusual changes in the brain associated with MS relapse
There have been reports of rare cases of unusually large changes in the brain associated with MS relapse in patients treated with Fingolimod. In the case of a severe MS relapse, the treating doctor may consider performing an MRI to assess this condition and decide on the possible need to discontinue treatment with this medicine.
Switching from other medicines to Fingolimod SUN
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod, if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out these abnormalities. After stopping treatment with natalizumab, it may be necessary to wait 2 to 3 months before starting treatment with Fingolimod. When switching from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fingolimod is suitable for them.
Women of childbearing age
If Fingolimod is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod SUN, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to ensure they are not pregnant. The doctor will provide the patient with a card explaining why they should not become pregnant while taking this medicine.
The patient must use effective contraception during treatment with Fingolimod and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").
If the patient becomes pregnant while taking this medicine, they must tell their doctor immediately.The doctor will decide on discontinuing treatment (see "Discontinuing Fingolimod" in section 3, and also section 4 "Possible side effects"). The patient will also need to undergo prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod.This medicine may pass into breast milk, posing a risk of severe side effects to the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including cycling and operating machinery. It is not expected that this medicine will affect the ability to drive vehicles and operate machinery.
However, at the beginning of treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of this medicine. During this time and potentially after it, the ability to drive vehicles and operate machinery may be impaired.

Fingolimod contains potassium

This medicine contains 0.013 mmol (or 0.515 mg) of potassium per capsule/maximum daily dose.
This should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

Fingolimod contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Fingolimod

Treatment with Fingolimod will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken as directed by the doctor. If you have any doubts, ask your doctor.
The recommended dose is:

Adults:

One hard capsule of Fingolimod 0.5 mg per day.

Children and adolescents (aged 10 years and older):

The dose depends on body weight:

• children and adolescents weighing 40 kg or less:one 0.25 mg capsule per day. Fingolimod, 0.5 mg, hard capsules are not suitable for children and adolescents weighing 40 kg or less. Other medicines containing fingolimod are available in a lower dose (0.25 mg capsules).
• children and adolescents weighing over 40 kg:one hard capsule of Fingolimod 0.5 mg per day.

Children and adolescents starting treatment with one 0.25 mg capsule of another medicine containing fingolimod per day and later reaching a stable weight over 40 kg will be advised by their doctor to switch to one 0.5 mg capsule of Fingolimod per day. In this case, it is recommended to repeat the observation period as after the first dose of Fingolimod.
Do not exceed the recommended dose.
Fingolimod is intended for oral use.
Fingolimod should be taken once a day, with a glass of water. Fingolimod capsules should always be swallowed whole, without opening them. Fingolimod can be taken with or without food.
Taking Fingolimod at the same time every day will help you remember to take your medicine.
If you have any questions about the duration of treatment with Fingolimod, ask your doctor or pharmacist.

Taking a higher dose of Fingolimod than recommended

If you have taken too much of this medicine, contact your doctor immediately.

Missing a dose of Fingolimod

If you have been taking Fingolimod for less than 1 month and you miss a dose for the entire day, contact your doctor before taking the next dose. The doctor may decide to keep you under observation during the next dose.
If you have been taking Fingolimod for at least 1 month and you miss taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. The doctor may decide to keep you under observation during the next dose. However, if you miss taking the medicine for up to 2 weeks, you can take the next dose as planned.
Do not take a double dose to make up for a missed dose.

Discontinuing Fingolimod

Do not stop taking Fingolimod or change the dose without first consulting your doctor.
Fingolimod stays in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod, wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Fingolimod after more than 2 weeks of stopping the medicine, the effect on heart rate may occur again, which is usually observed after starting treatment for the first time, and monitoring of the patient's condition will be necessary in the doctor's office or clinic due to the resumption of treatment. Do not resume treatment with this medicine after a break of more than two weeks without consulting your doctor.
The treating doctor will decide whether and how to monitor the patient after stopping treatment with this medicine. If you think your MS is getting worse after stopping treatment with Fingolimod, tell your doctor immediately. This situation can be serious.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fingolimod can cause side effects, although not everybody gets them.
Some side effects may be serious or become serious.

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

• cough with expectoration, unspecified unpleasant chest sensation, fever (symptoms of respiratory disorders)
• herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots 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 lump, although it can have other appearances
• it is known that depression and anxiety occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with fingolimod
• weight loss.

Common (may affect up to 1 in 10 people)

• pneumonia with symptoms such as fever, cough, difficulty breathing
• macular edema (swelling in the center of the field of vision in the retina, at the back of the eye) with symptoms such as shadows or gaps in the center of the field of vision, blurred vision, difficulty seeing colors and details
• reduced platelet count, which increases the risk of bleeding or bruising
• malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible symptoms of melanoma include moles that change in size, shape, elevation, or color over time or new moles that appear. Moles can be itchy, bleeding, or ulcerated
• seizures, convulsions (more common in children and adolescents than in adults)

Uncommon (may affect up to 1 in 100 people)

• posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures, and/or vision changes
• lymphoma (a type of cancer affecting the lymphatic system)
• squamous cell carcinoma: a type of skin cancer that can appear as a hard, red lump, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar

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

• abnormalities in the ECG recording (T-wave inversion)
• a tumor associated with human herpesvirus 8 (Kaposi's sarcoma)

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

• allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with fingolimod
• 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 upper abdomen, dark (brown) urine, decreased appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure can lead to liver transplantation
• risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to an MS relapse. They may also include symptoms that the patient is not aware of, such as mood or behavior changes, transient memory lapses, difficulty speaking or communicating, which should be evaluated by the doctor to rule out PML. Therefore, if the patient thinks their MS is getting worse or if the patient or their relatives notice any new or unusual symptoms, it is very important to tell their doctor as soon as possible
• fungal infections (e.g., cryptococcal infections), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless lump with a fleshy color or bluish-red, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass. Prolonged sun exposure and weakened immune system may affect the risk of Merkel cell carcinoma
• after stopping treatment with fingolimod, MS symptoms may recur and worsen compared to the period before treatment and during treatment
• autoimmune hemolytic anemia (a condition where red blood cells are destroyed)

If you experience any of the above symptoms, you must consult 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
• increased liver enzyme activity in blood tests
• cough

Common (may affect up to 1 in 10 people)

• fungal infections of the skin (e.g., ringworm)
• dizziness
• severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• low white blood cell count (lymphocytes, leukocytes)
• weakness
• itchy, red, burning rash (rash)
• itching
• increased triglyceride levels in the blood
• hair loss
• shortness of breath
• depression
• blurred vision (see also the section on macular edema under "Some side effects may be or become serious")
• high blood pressure (this medicine may cause a mild increase in blood pressure)
• muscle pain
• joint pain.

Uncommon (may affect up to 1 in 100 people)

• low white blood cell count (neutrophils)
• depressed mood
• nausea.

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

• lymphoma (a type of cancer affecting the lymphatic system).

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

• peripheral edema.

If any of these symptoms occur with a high intensity, you must tell your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fingolimod

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 "Expiry date (EXP)".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should 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 pack and other information

What does Fingolimod SUN contain

• The active substance of the medicinal product is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (in the form of fingolimod hydrochloride).
• Other ingredients are:
• Capsule filling: magnesium stearate, potassium polacrilin (see section 2), crospovidone type A, colloidal silicon dioxide, anhydrous
• Capsule shell:Capsule cap:iron oxide, yellow (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate Capsule body:titanium dioxide (E 171), gelatin, sodium lauryl sulfate Ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide, iron oxide, black (E 172).

What Fingolimod SUN looks like and what the pack contains

The hard gelatin capsules of Fingolimod SUN, 0.5 mg, consist of a yellow opaque cap and a white opaque body with a black ink print axially "064" on the cap and on the body.
Fingolimod SUN is available in packs containing perforated divisible blisters for single doses.
Pack sizes: cardboard box containing 7 x 1, 28 x 1, 56 x 1 or 98 x 1 hard capsules.
Not all pack sizes may be marketed in a given country.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
Strada Fabricii nr 124
400632 Cluj-Napoca, Cluj
Romania

This medicinal product is authorised in the Member States of the European

Economic Area under the following names:

Germany:
Fingolimod Basics
Spain:
Fingolimod SUN
France:
Fingolimod SUN
Italy:
Fingolimod SUN
Netherlands:
Fingolimod SUN
United Kingdom (Northern Ireland): Fingolimod SUN
Date of last revision of the leaflet:27.08.2021

Other sources of information

The latest approved information on this medicinal product is available at the following URL address:
https://sunpharma.com/poland-educational-materials/