Package leaflet: Information for the user

Fingolimod Aurovitas, 0.5 mg, hard capsules
Fingolimodum
Please read all of this leaflet carefully before taking this medicine, because 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 ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

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

patients who have not responded to MS treatment, or
patients who have rapidly evolving, severe forms of MS.

Fingolimod Aurovitas does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.
What multiple sclerosis is
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.
Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary between individual patients but typically include walking difficulties, numbness, vision problems or balance disturbances. Symptoms of relapses may completely resolve, although some deficits may persist.
How Fingolimod Aurovitas works
Fingolimod Aurovitas helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the patient's body and by preventing them from entering the brain and spinal cord. In this way, the medicine reduces nerve damage caused by MS. Fingolimod Aurovitas also reduces certain immune responses in the body.

2. Important information before taking Fingolimod Aurovitas

When not to take Fingolimod Aurovitas

if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or use of medicines that suppress the immune system);
if the doctor suspects that the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been diagnosed in the patient;
if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis;
if the patient has active cancer;
if the patient has severe liver disease;
if the patient has had a heart attack, angina, stroke, or warning signs of stroke within the last 6 months;
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom an electrocardiogram (ECG) has shown QT prolongation before starting Fingolimod Aurovitas;
if the patient is taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or is 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 any of these situations apply or the patient has any doubts, the patient should consult a doctor before taking Fingolimod Aurovitas.

Warnings and precautions

Before starting Fingolimod Aurovitas, discuss with the doctor:

if the patient has severe breathing problems during sleep (severe sleep apnoea);
if the patient has been informed that their ECG tracing is abnormal;
if the patient experiences symptoms of slowed heart rate (e.g. dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medicines that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting (syncope);
if the patient plans to receive any vaccination;
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 problems;
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 the above situations apply or the patient has any doubts, the patient should consult a doctor before taking Fingolimod Aurovitas.

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 Aurovitas slows the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure. If these symptoms are severe, the patient should inform the doctor immediately, as immediate treatment may be required. Fingolimod Aurovitas may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. A slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.

The doctor will ask the patient to remain in the clinic or medical facility for at least 6 hours after taking the first dose of Fingolimod Aurovitas 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 administered if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using ECG. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring (at least 2 additional hours or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Aurovitas after a treatment interruption, depending on the duration of the break and how long the patient had previously taken Fingolimod Aurovitas.

If the patient has irregular or abnormal heartbeat or is at risk of developing such conditions, has an abnormal ECG, heart disease, or heart failure, Fingolimod Aurovitas may not be suitable.

If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod Aurovitas may not be appropriate. A consultation with a cardiologist (a heart specialist) may be necessary to advise on how to start treatment with Fingolimod Aurovitas, including overnight monitoring.

If the patient is taking medicines that may reduce heart rate, Fingolimod Aurovitas may not be suitable. A consultation with a cardiologist may be needed to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow treatment with Fingolimod Aurovitas. If such a change is not possible, the cardiologist will advise on how to start treatment with Fingolimod Aurovitas, including monitoring the patient until 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 virus that causes it (varicella-zoster virus). If the patient is not protected against the virus, vaccination may be required before starting Fingolimod Aurovitas. If so, the doctor will delay the start of treatment with Fingolimod Aurovitas 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 Fingolimod Aurovitas (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 fever, flu-like symptoms, shingles, or headache with neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (which may indicate 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.

In patients treated with Fingolimod Aurovitas, infections with human papillomavirus (HPV) have 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 screening tests for HPV.

PML

PML is a rare brain disorder caused by infection that can lead to severe disability or death. The treating doctor will order magnetic resonance imaging (MRI) before starting and during treatment to monitor the risk of PML.

If the patient feels that their multiple sclerosis is worsening or if they notice new symptoms, such as changes in mood or behaviour, new weakness or worsening of existing weakness on one side of the body, vision changes, confusion, memory lapses, or speech and communication difficulties, they should speak to the doctor as soon as possible. These may be symptoms of PML. The patient should also talk to their partner or caregivers and inform them about the treatment. Symptoms may occur that the patient is not aware of.

If PML occurs, treatment with Fingolimod Aurovitas will be stopped. In some patients, after fingolimod is cleared from the body, an inflammatory reaction may occur. This reaction (known as immune reconstitution inflammatory syndrome, IRIS) may lead to worsening of the patient's condition, including worsening of brain function.

Macular oedema

Before starting Fingolimod Aurovitas, 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 refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Fingolimod Aurovitas.

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

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

If macular oedema occurs, the patient should inform the doctor before resuming treatment with Fingolimod Aurovitas.

Macular oedema may cause vision disturbances similar to those during an MS attack (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 shadowed;
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 Aurovitas, as it may affect liver function test results. The patient may not notice any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark urine (brown-coloured), pain on the right side of the abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting occur, the patient should inform the doctor immediately.

If any of the above symptoms occur after starting treatment with Fingolimod Aurovitas, 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 Aurovitas may be discontinued.

High blood pressure

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

Lung problems

Fingolimod 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 Aurovitas is a reduction in white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, the patient should inform the doctor about taking Fingolimod Aurovitas. Otherwise, the doctor may not interpret blood test results correctly, and for certain tests, the doctor may require a larger blood sample than usual.

Before starting Fingolimod Aurovitas, the doctor will confirm that the white blood cell count is appropriate to begin treatment and may recommend regular repeat testing. If white blood cell count is insufficient, treatment with Fingolimod Aurovitas may need to be interrupted.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, patients with MS treated with fingolimod have developed a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden severe headache, confusion, seizures, and vision disturbances. If any of these symptoms occur during treatment with Fingolimod Aurovitas, the patient should inform the doctor immediately, as this condition may be serious.

Cancer

Skin cancers have been reported in patients with MS treated with fingolimod. If any skin nodules (e.g. shiny, pearly nodules), spots, or non-healing open sores appear, the patient should contact the doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. atypical moles) that change in colour, shape, or size over time. A skin examination for any nodules must be performed before starting Fingolimod Aurovitas. The doctor will also perform regular skin checks during treatment with Fingolimod Aurovitas. If skin problems occur, the 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 patients with MS treated with fingolimod.

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 related to MS relapse

Rare cases of unusually large brain lesions related to MS relapse have been reported in patients treated with fingolimod. In case of a severe MS relapse, the doctor may consider performing an MRI to assess this condition and decide whether to discontinue Fingolimod Aurovitas.

Switching from other medicines to Fingolimod Aurovitas

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Aurovitas, 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 2- to 3-month waiting period may be required before starting Fingolimod Aurovitas. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated drug elimination procedure. If the patient is being treated with alemtuzumab, careful evaluation and discussion with the doctor is required before deciding whether Fingolimod Aurovitas is appropriate.

Women of childbearing potential

If fingolimod is used during pregnancy, it may harm the unborn child. Before starting Fingolimod Aurovitas, the doctor will explain the risks to the patient and request a pregnancy test to exclude pregnancy. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during treatment with Fingolimod Aurovitas. The card also contains information on how to avoid pregnancy during treatment. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Deterioration of MS after stopping Fingolimod Aurovitas

Do not stop taking Fingolimod Aurovitas 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 Aurovitas. This situation may be serious (see "Discontinuation of Fingolimod Aurovitas" 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 the doctor.

Children and adolescents

Fingolimod Aurovitas 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. The following information is particularly important for children, adolescents, and their caregivers:

Before starting Fingolimod Aurovitas, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be required before starting Fingolimod Aurovitas.
During the first dose of Fingolimod Aurovitas or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor heart rate and rhythm (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
If the patient experiences seizures or epileptic fits before or during treatment with Fingolimod Aurovitas, inform the doctor.
If the patient develops depression or anxiety or feels low mood or anxiety while taking Fingolimod Aurovitas, inform the doctor. The patient may require closer monitoring.

Fingolimod Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Inform the doctor if the patient is taking any of the following medicines:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Aurovitas 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 Aurovitas").
Corticosteroids, due to the potential for 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 Aurovitas, 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 less effective if given during this period.
Medicines that slow heart rate (e.g. beta-blockers such as atenolol). Using Fingolimod Aurovitas with these medicines could intensify the effect on heart rate in the first days of treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Aurovitas 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 Aurovitas").
Other medicines:
- protease inhibitors, antiviral medicines such as ketoconazole, azole antifungals, clarithromycin, or telithromycin;
- carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort products (possible risk of reduced effectiveness of Fingolimod Aurovitas).

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 Aurovitas should not be used during pregnancy, if the patient is trying to become pregnant, or if the patient could become pregnant and is not using effective contraception. If Fingolimod Aurovitas 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 Aurovitas 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 developmental defects.

Therefore, if the patient is of childbearing age:

before starting Fingolimod Aurovitas, 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, and
effective contraception must be used during treatment with Fingolimod Aurovitas 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 Aurovitas.

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

Breastfeeding

Breastfeeding is not recommended while taking Fingolimod Aurovitas. Fingolimod Aurovitas may pass into breast milk, posing a risk of serious adverse effects in the infant.

Driving and operating machinery

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

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

Fingolimod Aurovitas contains maltodextrin (glucose)

Maltodextrin is absorbed as glucose. If the patient has been diagnosed with intolerance to certain sugars, they should contact the doctor before taking this medicine.

Fingolimod Aurovitas contains sodium

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

3. How to take Fingolimod Aurovitas

Treatment with Fingolimod Aurovitas 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 dosage:
Adults:
Dosage is one 0.5 mg capsule per day.
Children and adolescents (aged 10 years and older):
Dosage depends on body weight:

Children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule per day.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day. Children and adolescents who initially started treatment with one 0.25 mg capsule per day and later 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 this case, repeat monitoring as after the first dose is recommended.

Do not exceed the recommended dose.
Fingolimod Aurovitas is intended for oral administration.
Fingolimod Aurovitas should be taken once daily with a glass of water. Fingolimod Aurovitas capsules should always be swallowed whole, without opening.
Fingolimod Aurovitas may be taken with or without food.
Taking Fingolimod Aurovitas at the same time each day will help you remember to take your dose.
If you have any questions about how long treatment with Fingolimod Aurovitas should continue, consult your doctor or pharmacist.
Taking more Fingolimod Aurovitas than prescribed
If a patient has taken too much medicine, they should contact their doctor immediately.
Missing a dose of Fingolimod Aurovitas
If a patient has been taking Fingolimod Aurovitas for less than 1 month and misses one dose for a full day, they should contact their doctor before taking the next dose.
The doctor may decide to observe the patient when administering the next dose.
If a patient has been taking Fingolimod Aurovitas for at least 1 month and has missed doses for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to observe the patient when administering the next dose. However, if the patient has missed doses for up to 2 weeks, they may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Fingolimod Aurovitas
Do not stop treatment with Fingolimod Aurovitas or change the dosage without first consulting your doctor.
Fingolimod may remain in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may remain reduced and adverse reactions described in this leaflet may still occur. After stopping treatment with Fingolimod Aurovitas, wait 6–8 weeks before starting a new multiple sclerosis treatment.
In patients resuming treatment with Fingolimod Aurovitas after a break of more than 2 weeks, the effect on heart rate observed typically after starting treatment for the first time may reoccur, and monitoring in a doctor's office or clinic will be necessary due to resumption of treatment. Do not restart treatment with Fingolimod Aurovitas after a break lasting more than two weeks without consulting a doctor.
Your doctor will decide whether and how to monitor you after stopping treatment with Fingolimod Aurovitas. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping treatment with Fingolimod Aurovitas. This situation may be serious.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

Productive cough, feeling of 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 heartbeat (bradycardia), irregular heart rhythm
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also look different
Depression and anxiety are known to occur more frequently in the MS patient population and have also been reported in children and adolescents treated with fingolimod
Weight loss

Uncommon (may affect up to 1 in 100 people):

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the center of the visual field in the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details
Decreased 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 common in children and adolescents than in adults)

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

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

Very rare (may affect up to 1 in 10,000 people):

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

Frequency not known (frequency cannot be estimated from 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 Aurovitas
Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach (abdomen), dark urine (brown-colored), loss of 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 may not be aware of, such as changes in mood or behavior, memory decline, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their family notice any new or unusual symptoms, it is very important to inform the doctor as soon as possible
Inflammatory disorders after stopping treatment with Fingolimod Aurovitas (known as immune reconstitution inflammatory syndrome or IRIS)
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, light sensitivity, nausea and (or) confusion
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma
After discontinuation of treatment with Fingolimod Aurovitas, 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 the patient experiences any of these reactions, they should immediately inform their doctor.

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 up to 1 in 10 people):

Fungal skin infection, fungal skin infection (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine)
Low white blood cell count (lymphocytes, leukocytes)
Weakness
Itchy, red, stinging rash (rash)
Itching
Increased levels of fats (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema under "Some adverse reactions may be or may become serious")
Hypertension (Fingolimod Aurovitas 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):

Lymphatic system cancer (lymphoma)

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

Peripheral edema

If any of these symptoms occur severely, the patient should inform their doctor.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fingolimod Aurovitas

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. The expiry date refers to the last day of the month indicated.
Store below 30°C.
Medicines should 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 Aurovitas contains
The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
The other ingredients are:
Capsule fill: maltodextrin, talc, sodium stearyl fumarate.
Capsule shell:
Body: titanium dioxide (E 171), black iron oxide (E 172), gelatin.
Cap: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.
Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.

What Fingolimod Aurovitas looks like and contents of the pack
A hard gelatin capsule, size “3”, with a light yellow cap and grey body, printed in black ink with "FGL 05" on the cap, filled with white or almost white powder.

Fingolimod Aurovitas 0.5 mg is available in blisters containing 7, 28, 56, 84 or 98 hard capsules, and in perforated unit-dose blisters containing 28 x 1 hard capsule, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
email: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Fingolimod AB 0.5 mg hard capsules/gélules/Hartkapseln
France: Fingolimod Arrow 0.5 mg, gélule
Germany: Fingolimod PUREN 0.5 mg Hartkapseln
Italy: Fingolimod Aurobindo
Netherlands: Fingolimod Aurobindo 0.5 mg, hard capsules
Portugal: Fingolimod Generis
Poland: Fingolimod Aurovitas
Spain: Fingolimod Aurovitas 0.5 mg cápsulas duras EFG

Fingolimod aurovitas