Fingolimod symphar: detailed information

Package leaflet: Information for the user

Fingolimod Symphar, 0.5 mg, hard capsules
Fingolimodum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

What Fingolimod Symphar is and what it is used for
Important information before taking Fingolimod Symphar
How to take Fingolimod Symphar
Possible side effects
How to store Fingolimod Symphar
Contents of the pack and other information

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

What Fingolimod Symphar is
The active substance in Fingolimod Symphar is fingolimod.

What Fingolimod Symphar is used for
Fingolimod Symphar is used in adults, 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 prior MS treatment, or
patients with rapidly evolving, severe form of MS.

Fingolimod Symphar 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 recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary among patients but typically include walking difficulties, numbness, vision disturbances, or balance problems. Symptoms of relapses may completely resolve, although some neurological deficits may persist.

How Fingolimod Symphar works
Fingolimod Symphar helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body and by preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage caused by MS. Fingolimod Symphar also reduces certain immune responses in the body.

2. Important information before taking Fingolimod Symphar

When not to take Fingolimod Symphar

if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or medications that suppress the immune system);
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 experienced a heart attack, angina, stroke, transient ischaemic attack (TIA), or certain types of heart failure within the past 6 months;
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) showed QT interval prolongation before starting treatment with Fingolimod Symphar;
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 potential 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 this is the case, the patient should inform the doctor and must not take Fingolimod Symphar.

Warnings and precautions
Before starting treatment with Fingolimod Symphar, discuss the following with the doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been informed that their ECG is abnormal;
if the patient experiences symptoms of a 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, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting;
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 centre of the 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 the patient has diabetes, which may 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 smoker's cough.

If any of these situations apply, the patient should inform the doctor before taking Fingolimod Symphar.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients previously on a 0.25 mg daily dose, Fingolimod Symphar slows heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, the patient should inform the doctor immediately, as medical treatment may be required. Fingolimod Symphar 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.

The doctor will ask the patient to remain at the medical office or clinic for at least 6 hours after taking the first dose of Fingolimod Symphar or the first 0.5 mg dose when switching from a 0.25 mg daily dose. During this time, heart rate and blood pressure will be monitored hourly so that appropriate treatment can be given if adverse effects occur, which are most common at the start of treatment. An ECG will be performed before the first dose and again after the 6-hour observation period. The doctor may perform continuous cardiac monitoring using ECG during this time. If, after 6 hours of observation, the patient has a very slow heart rate or decreasing heart rate, or if the ECG shows abnormalities, the patient may require longer monitoring (at least 2 additional hours or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient restarts Fingolimod Symphar after a treatment interruption, depending on the duration of the break and how long the patient had previously taken Fingolimod Symphar.

Fingolimod Symphar may not be suitable for patients with irregular or abnormal heartbeat, risk factors for such events, abnormal ECG, heart disease, or heart failure. If the patient has previously experienced sudden loss of consciousness or slowed heart function, Fingolimod Symphar may not be appropriate. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start treatment with Fingolimod Symphar, including overnight monitoring.

If the patient is taking medications that may reduce heart rate, Fingolimod Symphar may not be appropriate. A cardiologist consultation may be necessary to determine whether the patient can switch to other medications that do not reduce heart rate, to allow treatment with Fingolimod Symphar. If such a switch is not possible, the cardiologist will advise on how to initiate treatment with Fingolimod Symphar, including monitoring the day after the first dose.

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, vaccination may be required before starting treatment with Fingolimod Symphar. If this is the case, the doctor will delay starting Fingolimod Symphar by one month after completing the full vaccination series.

Infections
Fingolimod Symphar reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Symphar (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 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 or herpes virus infection), the patient should contact the doctor immediately, as this condition may be serious and life-threatening.

If the patient feels their condition is worsening (e.g. weakness or vision problems) or notices any new symptoms, they should contact 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 Symphar should be stopped.

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

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

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

The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colours, and fine details. Fingolimod Symphar may cause swelling of the macula, a condition called macular oedema. This usually occurs within the first 4 months of treatment with Fingolimod Symphar.

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

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

Macular oedema may cause vision disturbances similar to those seen in MS relapses (optic neuritis). In early stages, symptoms may be absent. The patient should inform the doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurry or shaded;
a blind spot appears in the centre of the visual field;
there are difficulties seeing colours or fine details.

Liver function tests
Patients with severe liver disease should not take Fingolimod Symphar. Fingolimod Symphar may affect liver function test results. The patient may not experience 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, the patient should inform the doctor immediately.

If any of these symptoms occur after starting treatment with Fingolimod Symphar, the patient should inform the doctor immediately.

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

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

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

Blood cell count
A known effect of Fingolimod Symphar is a reduction in white blood cells. The count usually returns to normal within 2 months after stopping treatment.

If blood tests are needed, the patient should inform the doctor about taking Fingolimod Symphar. Otherwise, the doctor may misinterpret test results, and for certain tests, a larger blood sample than usual may be required.

Before starting Fingolimod Symphar, the doctor will confirm that the white blood cell count is adequate to begin treatment and may recommend regular repeat testing. If white blood cell count is too low, treatment with Fingolimod Symphar may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported in MS patients treated with Fingolimod Symphar. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod Symphar, the patient should inform the doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in MS patients treated with Fingolimod Symphar. If any skin nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within several weeks are noticed, the patient should inform the doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. new moles) that change in colour, shape, or size over time.

Before starting treatment with Fingolimod Symphar, a skin examination should be performed to check for any skin nodules. The treating doctor will also perform regular skin checks during treatment with Fingolimod Symphar. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.

Lymphoma, a type of lymphatic system cancer, has been reported in MS patients treated with Fingolimod Symphar.

Sun exposure and sun protection
Fingolimod weakens the immune system. This increases the risk of malignant tumours, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

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

Unusual brain changes associated with MS relapses
Rare cases of unusually large brain lesions associated with MS relapses have been reported in patients treated with Fingolimod Symphar. In case of a severe MS relapse, the treating doctor may consider performing an MRI scan to assess this condition and decide whether treatment with Fingolimod Symphar should be discontinued.

Switching from other medications to Fingolimod Symphar
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Symphar 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, a waiting period of 2 to 3 months may be required before starting Fingolimod Symphar. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with the doctor before deciding whether Fingolimod Symphar is appropriate.

Women of childbearing potential
If Fingolimod Symphar is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Symphar, 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 an information card explaining why pregnancy should be avoided during treatment with Fingolimod Symphar. The card also contains information on how to avoid pregnancy while taking Fingolimod Symphar.

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 Symphar
Do not stop taking Fingolimod Symphar or change the dose without first consulting the doctor.
The patient should inform the doctor immediately if they feel their MS is worsening after stopping Fingolimod Symphar. This situation may be serious (see "Discontinuation of Fingolimod Symphar" in section 3 and section 4 "Possible side effects").

Elderly patients
Experience with Fingolimod Symphar in elderly patients (over 65 years) is limited. If in doubt, consult the doctor.

Children and adolescents
Fingolimod Symphar is not intended for use in children under 10 years of age, as it has not been studied in paediatric MS patients in this age group.

The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children, adolescents, and their caregivers:

Before starting treatment with Fingolimod Symphar, the doctor will check the patient's vaccination status. If certain vaccinations have not been received, vaccination may be required before starting treatment.
During the first dose of Fingolimod Symphar or when switching from a 0.25 mg to a 0.5 mg daily dose, the doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
If the patient experiences seizures or epileptic fits before or during treatment with Fingolimod Symphar, they should inform the doctor.
If the patient develops depression or anxiety, or feels low mood or anxiety during treatment with Fingolimod Symphar, they should inform the doctor. Closer monitoring may be required.

Fingolimod Symphar and other medicines
The patient should inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take:

Immunosuppressive or immunomodulatory medicines, including other MS treatments such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Symphar 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 Symphar").
Corticosteroids, due to possible additive effects on the immune system.
Vaccines. If the patient requires vaccination, they should consult the doctor first. During and for 2 months after treatment with Fingolimod Symphar, 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). Using Fingolimod Symphar with these medicines could intensify the effect on heart function in the first days of treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Symphar must not be used in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Fingolimod Symphar").
Other medicines: protease inhibitors, antiviral agents such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort preparations (possible risk of reduced effectiveness of Fingolimod Symphar).

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 Symphar must 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 Symphar 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 Symphar 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 heart, kidney, and musculoskeletal system developmental defects. Therefore, if the patient is of childbearing potential:

before starting treatment with Fingolimod Symphar, the doctor will inform the patient of the risk to the unborn child and request a pregnancy test to confirm the patient is not pregnant;
effective contraception must be used during treatment with Fingolimod Symphar and for 2 months after stopping treatment to avoid pregnancy. The patient should discuss effective contraceptive methods with the doctor.

The doctor will provide the patient with an information card explaining why pregnancy should be avoided during treatment with Fingolimod Symphar.

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

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

Driving and operating machinery
The doctor will inform the patient whether their condition allows safe driving, including cycling, and operating machinery. Fingolimod Symphar is not expected to affect the ability to drive or operate machinery.

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

3. How to take Fingolimod Symphar

Treatment with Fingolimod Symphar 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 doctor.

Recommended dose:
Adults:
The recommended 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 of 40 kg or less: one 0.25 mg capsule once daily. Medicinal products from other pharmaceutical companies containing fingolimod are available in lower strengths (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 started treatment with one 0.25 mg capsule of fingolimod per day 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 observation period as after the first dose of the medicine.

Do not exceed the recommended dose. Fingolimod Symphar is intended for oral use. Fingolimod Symphar should be taken once daily with a glass of water. Fingolimod Symphar capsules should always be swallowed whole, without opening. Fingolimod Symphar may be taken with or without food. Taking Fingolimod Symphar at the same time each day will help you remember to take it. If you have any doubts regarding the duration of treatment with Fingolimod Symphar, consult your doctor or pharmacist.

Taking more Fingolimod Symphar than prescribed
If you have taken more than the prescribed dose, contact your doctor immediately.

Missed dose of Fingolimod Symphar
If you have been taking Fingolimod Symphar for less than 1 month and have missed one dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Fingolimod Symphar for at least 1 month and have missed taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have missed taking the medicine for up to 2 weeks, you may take the next dose as scheduled.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Symphar
Do not stop treatment with Fingolimod Symphar or change the dose without first consulting your doctor.

Fingolimod Symphar remains in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocyte count) may still be reduced and adverse effects described in this leaflet may continue to occur. After stopping treatment with Fingolimod Symphar, wait 6–8 weeks before starting a new treatment for multiple sclerosis.

In patients restarting treatment with Fingolimod Symphar 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 when treatment is resumed. Do not restart treatment with Fingolimod Symphar after a break lasting more than two weeks without consulting your treating physician.

Your treating physician will decide whether and how monitoring should be carried out after stopping treatment with Fingolimod Symphar. Inform your doctor immediately if you feel that your multiple sclerosis is worsening after stopping treatment with Fingolimod Symphar. This situation may be serious.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be or may become serious.

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

Cough with sputum production, unspecified discomfort in the chest, fever (symptoms of lung disorders),
Herpesvirus infection (shingles or cold sores) 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 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 may also have a different appearance,
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 Symphar,
Weight loss.

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

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 vision, 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 seizures (more frequent in children and adolescents than in adults).

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

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 patients):

Abnormalities in the ECG test (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 of starting treatment with Fingolimod Symphar,
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, temporary memory lapses, difficulties in speaking and communicating, which should be evaluated by a doctor to exclude PML. Therefore, if the patient feels that their MS is worsening or if the patient or their relatives notice any new or unusual symptoms, it is very important to inform the treating doctor as soon as possible,
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and (or) confusion,
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include the presence of 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 exposure to sunlight and weakened immune system may influence the risk of developing Merkel cell carcinoma,
After discontinuation of treatment with Fingolimod Symphar, MS symptoms may return 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 effects occur, the patient should immediately inform their doctor.

Other adverse effects

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

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 patients):

Fungal skin infections (dermatophyte-induced fungal infection) (tinea versicolor),
Dizziness,
Severe headache, often accompanied by nausea, vomiting and sensitivity to light (migraine symptoms),
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 effects may be or may become serious"),
Hypertension (Fingolimod Symphar may cause a mild increase in blood pressure),
Muscle pain,
Joint pain.

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

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

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

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 their doctor.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the responsible entity.

Reporting adverse effects helps to collect more information on the safety of using the medicine.

5. How to store Fingolimod Symphar

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 store above 30°C.
Keep in the original packaging to protect from moisture.
Do not use medicines from containers that are damaged or show 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. These measures will help
protect the environment.

6. Contents of the pack and other information

What Fingolimod Symphar contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (in the form of fingolimod hydrochloride).
The other components are:
Capsule contents: monohydrate potassium citrate, colloidal anhydrous silica, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171).
Capsule cap: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

What Fingolimod Symphar looks like and contents of the pack
Fingolimod Symphar 0.5 mg hard capsules (16 mm, size 3) consist of a white, opaque body and a yellow, opaque cap.

Blister pack:
Fingolimod Symphar 0.5 mg is available in packs containing 7, 28 or 98 hard capsules.
Single-dose blister pack:
Fingolimod Symphar 0.5 mg is available in packs containing 7, 28, 98 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland

Manufacturer/Importer
Synthon Hispania S.L.
C/ Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Fingolimod Synthon 0.5 mg, hard capsules
Germany Fingolimod Holsten 0.5 mg Hartkapseln
Estonia Fingolimod Norameda
Finland Fingolimod Avansor
France Fingolimod Synthon 0.5 mg, gélule
Hungary Fingolimod-Q Pharma 0.5 mg kemény kapszula
Iceland Fingolimod WH
Croatia Fingolimod Alpha-Medical 0.5 mg tvrde capsule
Latvia Fingolimod Norameda 0.5 mg kietos kapsulės
Lithuania Fingolimod Norameda 0.5 mg cietās kapsulas
Poland Fingolimod Symphar
Portugal Fingolimod Reig Jofre
Spain Fingolimod Sala 0.5 mg cápsulas duras EFG
United Kingdom Fingolimod 0.5 mg, hard capsules
Sweden Fingolimod Avansor