Fingolimod Aurovitas

Package Leaflet: Information for the User

Fingolimod Aurovitas, 0.5 mg, hard capsules
Fingolimodum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Fingolimod Aurovitas is and what it is used for
• 2. What you need to know before you take Fingolimod Aurovitas
• 3. How to take Fingolimod Aurovitas
• 4. Possible side effects
• 5. How to store Fingolimod Aurovitas
• 6. 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 to treat adults and children and adolescents (10 years of age and older) with a relapsing-remitting form of multiple sclerosis (MS), in particular:

• patients who have not responded to MS treatment or
• patients who have a rapidly evolving, severe form of MS.

Fingolimod Aurovitas does not cure MS, but it helps to reduce the number of relapses and slow down the progression of disability caused by MS.

What multiple sclerosis is

MS is a long-term disease of the central nervous system (CNS), which includes the brain and spinal cord. In MS, the inflammatory process damages the protective covering (myelin) of the nerves in the CNS, preventing them from working properly. This is called demyelination.

The relapsing-remitting form of MS is characterized by recurring relapses (exacerbations) of neurological symptoms, reflecting the inflammatory process in the CNS. Symptoms vary among patients, but often include problems with walking, numbness, vision problems, or balance problems. Symptoms of relapses may completely disappear, but some problems 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 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. Fingolimod Aurovitas also reduces some immune reactions in the body.

2. What you need to know before you take Fingolimod Aurovitas

When not to take Fingolimod Aurovitas

• if you have a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive medicines);
• if your doctor suspects that you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if you have been diagnosed with PML;
• if you have a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if you have an active malignant disease;
• if you have severe liver disease;
• if you have had a heart attack, angina, stroke, or symptoms of stroke in the last 6 months;
• if you have a certain type of irregular or abnormal heartbeat (arrhythmia), including those with a prolonged QT interval on their electrocardiogram (ECG) before starting treatment with Fingolimod Aurovitas;
• if you are taking or have recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if you are pregnant or breastfeeding or plan to become pregnant or are of childbearing potential and not using effective contraception;
• if you are allergic to fingolimod or any of the other ingredients of this medicine.

If any of these conditions apply to you, or if you are in doubt, consult your doctor before taking Fingolimod Aurovitas.

Warnings and precautions

Before starting treatment with Fingolimod Aurovitas, discuss with your doctor:

• if you have severe respiratory problems during sleep (severe sleep apnea);
• if you have been told that your ECG is abnormal;
• if you have symptoms of slow heart rate (such as dizziness, fatigue, or palpitations);
• if you are taking or have recently taken medicines that slow the heart rate (such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if you have had sudden loss of consciousness or fainting (syncope) in the past;
• if you are planning to receive a vaccination;
• if you have never had chickenpox;
• if you have or have had vision problemsor other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) or uveitis (inflammation of the uvea, the middle layer of the eye) or if you have diabetes(which can cause vision problems);
• if you have liver problems;
• if you have uncontrolled high blood pressure;
• if you have severe lung diseaseor a chronic cough typical of smokers.

If any of these conditions apply to you, or if you are in doubt, consult your doctor before taking Fingolimod Aurovitas.

Slow heart rate (bradycardia) and irregular heartbeat

At the start of treatment or after taking the first dose of 0.5 mg, Fingolimod Aurovitas slows down the heart rate. As a result, you may feel dizzy, tired, or have palpitations or a drop in blood pressure. If these symptoms are severe, you should tell your doctor, as you may need immediate treatment.Fingolimod Aurovitas may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.

Your doctor will ask you to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Aurovitas or after the first dose of 0.5 mg when switching from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any side effects occur at the start of treatment, appropriate treatment can be given. Before the first dose of Fingolimod Aurovitas and after the 6-hour observation period, an ECG will be performed. During this time, your doctor may continuously monitor your heart activity using an electrocardiogram. If after 6 hours of observation you have a very slow or decreasing heart rate or if the ECG shows abnormalities, you may need to be monitored for a longer period (for at least 2 hours longer or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if you restart treatment with Fingolimod Aurovitas after a treatment interruption, depending on how long the interruption lasted and how long you took Fingolimod Aurovitas before the interruption.

If you have irregular or abnormal heartbeat or are at risk of having them, or if you have an abnormal ECG, heart disease, or heart failure, Fingolimod Aurovitas may not be suitable for you.

If you have a history of sudden loss of consciousness or slow heart rate, Fingolimod Aurovitas may not be suitable for you. You may need to consult a cardiologist (a doctor specializing in heart conditions) who will advise on how to start treatment with Fingolimod Aurovitas, including how to monitor you at night.

If you are taking medicines that can slow the heart rate, Fingolimod Aurovitas may not be suitable for you. You may need to consult a cardiologist who will check if you can switch to other medicines that do not slow the heart rate, to allow treatment with Fingolimod Aurovitas. If such a switch is not possible, the cardiologist will advise on how to start treatment with Fingolimod Aurovitas, taking into account monitoring until the next day after the first dose of Fingolimod Aurovitas.

Patients who have never had chickenpox

If you have never had chickenpox, your doctor will check if you are immune to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, you may need to be vaccinated before starting treatment with Fingolimod Aurovitas. If this is the case, your doctor will delay the start of treatment with Fingolimod Aurovitas for one month after the full course of vaccination.

Infections

Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Aurovitas (and for 2 months after stopping treatment), you may be more likely to get infections. Any existing infections may get worse. Infections can be severe and life-threatening. If you think you have an infection, have a fever, feel flu-like symptoms, have shingles, or have a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (convulsions) (which can be symptoms of meningitis and/or encephalitis caused by a fungal or viral infection), you should contact your doctor immediately, as this can be severe and life-threatening.

Patients treated with Fingolimod Aurovitas have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, papillomas, and HPV-related malignant tumors. Your doctor will consider the need for vaccination against HPV before starting treatment with Fingolimod Aurovitas. For women, the doctor will also recommend screening for HPV.

PML

PML is a rare brain disorder caused by infection that can lead to severe disability or death. Your doctor will order an MRI scan before starting treatment and during treatment to monitor the risk of PML.

If you think your MS is getting worse or if you notice new symptoms, such as changes in mood or behavior, new weakness, or worsening of existing weakness on one side of the body, changes in vision, confusion, transient memory loss, or difficulties with speech and communication, you should talk to your doctor as soon as possible. These can be symptoms of PML. You should also talk to your partner or caregivers and inform them about your treatment. You may not be aware of symptoms that are apparent to others.

If you develop PML, it can be treated, and treatment with Fingolimod Aurovitas will be stopped. In some patients, after the removal of fingolimod from the body, there can be an inflammatory reaction. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can worsen the patient's condition, including worsening of brain function.

Macular edema

Before starting treatment with Fingolimod Aurovitas, your doctor may refer you for eye exams if you have existing or past vision problems or other symptoms of macular edema or uveitis or if you have diabetes.

Your doctor may refer you for eye exams 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 allows for sharp, clear vision of shapes, colors, and other details. Fingolimod can cause swelling, a condition called macular edema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Aurovitas.

The risk of macular edema is higher in patients with diabetes or a history of uveitis. In such cases, your doctor will recommend regular eye exams to detect macular edema.

If you develop macular edema, you should inform your doctor before resuming treatment with Fingolimod Aurovitas.

Macular edema can cause certain vision problems, similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not appear at all.

You should inform your doctor about any changes in your vision. Your doctor may refer you for eye exams, especially if:

• the center of your vision becomes blurred or shaded;
• a blind spot appears in the center of your vision;
• you have difficulty seeing colors or fine details.

Liver function tests

Patients with severe liver disease should not take Fingolimod Aurovitas, as it may affect liver function tests. You may not notice any symptoms, but if you experience yellowing of the skin or whites of the eyes, dark urine, pain on the right side of the abdomen, fatigue, or loss of appetite or unexplained nausea and vomiting, you should immediately inform your doctor. If you experience any of these symptoms after starting treatment with Fingolimod Aurovitas, you should immediately inform your doctor. Before, during, and after treatment, your doctor will order blood tests to monitor liver function. If the test results indicate liver problems, treatment with Fingolimod Aurovitas may be stopped.

High blood pressure

Your doctor may regularly check your blood pressure, as fingolimod can cause a slight increase in blood pressure.

Lung problems

Fingolimod has a minor effect on lung function. Patients with severe lung disease or a chronic cough typical of smokers are at a higher risk of side effects.

Blood cell count

A expected effect of Fingolimod Aurovitas is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If you need to have blood tests, you should inform your doctor that you are taking Fingolimod Aurovitas. Otherwise, your doctor may not be able to interpret the results of the blood test, and in the case of certain tests, your doctor may order more blood to be taken than usual.

Before starting treatment with Fingolimod Aurovitas, your doctor will check if you have a sufficient number of white blood cells in your blood to start treatment and may order regular repeat tests. If you do not have enough white blood cells, it may be necessary to stop treatment with Fingolimod Aurovitas.

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). Symptoms of this condition may include sudden severe headache, confusion, seizures, and vision problems. If you experience any of these symptoms while taking Fingolimod Aurovitas, you should immediately inform your doctor, as this can be severe.

Cancer

In patients with MS treated with fingolimod, there have been reports of skin cancers. If you notice any lumps on your skin (such as shiny lumps with a pearl-like color), spots, or open sores that do not heal within a few weeks, you should immediately contact your doctor. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (such as unusual moles) that change color, shape, or size over time. Before starting treatment with Fingolimod Aurovitas, it is necessary to examine your skin for any lumps. Your doctor will also perform regular skin checks during treatment with Fingolimod Aurovitas. If you experience skin problems, your doctor may refer you to a dermatologist who, after consulting with you, may decide on the need for regular visits.

In patients with MS treated with fingolimod, there have been reports of a certain type of cancer of the lymphatic system (lymphoma).

Exposure to sunlight and protection against ultraviolet radiation

Fingolimod weakens the immune system. This increases the risk of developing malignant tumors, especially skin cancers. You should limit your exposure to sunlight and ultraviolet radiation by:

• wearing protective clothing.
• regularly applying a sunscreen with a high sun protection factor.

Unusual changes in the brain related to MS relapse

In patients treated with fingolimod, there have been rare reports of unusually large changes in the brain related to MS relapse. In the case of a severe MS relapse, your doctor will consider performing an MRI scan to assess this condition and decide on the possible need to stop taking Fingolimod Aurovitas.

Switching from other medicines to Fingolimod Aurovitas

Your doctor may switch your treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Aurovitas if there are no symptoms of abnormality caused by previous treatment. Your 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 Aurovitas. When switching from teriflunomide, your doctor may advise you to wait for a certain period or undergo an accelerated elimination procedure. If you are treated with alemtuzumab, careful evaluation and discussion with your doctor are necessary before deciding whether Fingolimod Aurovitas is suitable for you.

Women of childbearing potential

If fingolimod is used during pregnancy, it may harm the unborn baby. Before starting treatment with Fingolimod Aurovitas, your doctor will explain the risk to you and ask you to have a pregnancy test to rule out pregnancy. Your doctor will give you a card explaining why you should not become pregnant while taking Fingolimod Aurovitas. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Aurovitas. Female patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

If you become pregnant while taking Fingolimod Aurovitas, you should immediately inform your doctor.Your doctor will decide whether to stop treatment (see "Stopping Fingolimod Aurovitas" in section 3 and section 4 "Possible side effects"). You will also need to have regular prenatal check-ups.

Breastfeeding

You should not breastfeed while taking Fingolimod Aurovitas.Fingolimod Aurovitas may pass into breast milk, posing a risk of severe side effects to the baby.

Driving and using machines

Your doctor will inform you whether your disease allows you to drive or use machines safely. You should not expect Fingolimod Aurovitas to affect your ability to drive or use machines.

However, at the start of treatment, you must stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Aurovitas. During this time and potentially after it, your ability to drive or use machines may be impaired.

Fingolimod Aurovitas contains maltodextrin (glucose)

Maltodextrin is absorbed as glucose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Fingolimod Aurovitas contains sodium

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

3. How to take Fingolimod Aurovitas

Treatment with Fingolimod Aurovitas will be supervised by a doctor with experience in treating multiple sclerosis.

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a body weight of 40 kg or less: one 0.25 mg capsule per day.
• Children and adolescents with a body weight over 40 kg: one 0.5 mg capsule per day. Children and adolescents starting treatment with one 0.25 mg capsule per day and later reaching a stable body weight over 40 kg will be advised by their doctor to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period as after the first dose of Fingolimod Aurovitas.

Do not take more than the recommended dose.

Fingolimod Aurovitas is for oral use.

Take Fingolimod Aurovitas once a day, with a glass of water. Fingolimod Aurovitas capsules should always be swallowed whole, without opening.

Fingolimod Aurovitas can be taken with or without food.

Taking Fingolimod Aurovitas 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 Aurovitas, ask your doctor or pharmacist.

If you take more Fingolimod Aurovitas than you should

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

If you forget to take Fingolimod Aurovitas

If you have been taking Fingolimod Aurovitas for less than 1 month and you miss a dose for the whole day, you should contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when taking the next dose.

If you have been taking Fingolimod Aurovitas for at least 1 month and you miss taking it for more than 2 weeks, you should contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when taking the next dose. However, if you miss taking it for up to 2 weeks, you can take the next dose as planned.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be or may become serious
Common(may affect up to 1 in 10 people):

• Cough with expectoration, feeling of discomfort in the chest, fever (symptoms of lung disorders)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning sensation, itching or skin pain, usually above the upper body or face. Other symptoms may include fever and weakness at an early stage of infection, followed by numbness, itching, or red spots with severe pain
• Slow heart rate (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 have a different appearance
• 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.

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 retina, at the back of the eye) with symptoms such as shadows or defects 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 symptoms of melanoma include the appearance of moles whose size, shape, elevation, or color may change over time or new moles may appear. 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, disorientation, seizures, and (or) vision 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 ulcerated nodule covered with a scab, or a fresh ulcer at the site of an existing scar

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

• Abnormalities in the ECG recording (T-wave inversion)
• Tumors associated with human herpesvirus 8 infection (Kaposi's sarcoma).

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

• Allergic reactions, including symptoms of rash or itching 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 color), decreased 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). PML symptoms may be similar to an MS relapse. There may also be symptoms that the patient is not aware of, such as mood or behavior changes, memory loss, difficulty speaking and communicating, which should be assessed by a doctor to rule out PML. Therefore, if the patient thinks that 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.
• Inflammatory disorders after stopping 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, stiff neck, sensitivity to light, nausea, and (or) disorientation.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include the presence of a painless nodule, flesh-colored or blue-red, often located on the face, head, or neck. Merkel cell carcinoma may also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system may affect the risk of Merkel cell carcinoma.
• After stopping Fingolimod Aurovitas, MS symptoms may return and worsen compared to the period before treatment and during its duration.
• Autoimmune hemolytic anemia (decreased red blood cell count), in which red blood cells are destroyed.

If any of these reactions occur, inform 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 skin infection, fungal skin infection (pityriasis versicolor)
• Dizziness
• Severe headache, often accompanied by nausea, vomiting, and sensitivity to light

(migraine)

• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching, red, burning rash (exanthema)
• 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 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):

• Lymphoma (lymphatic system cancer)

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

• Peripheral edema

If any of these symptoms occur with great intensity, inform your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
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 Aurovitas

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.
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. This 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).
Other ingredients are:
Filler: maltodextrin, talc, sodium stearyl fumarate.
Capsule shell:
Body: titanium dioxide (E 171), iron oxide black (E 172), gelatin.
Cap: titanium dioxide (E 171), iron oxide yellow (E 172), gelatin.
Ink: shellac, iron oxide black (E 172), potassium hydroxide.

What Fingolimod Aurovitas looks like and contents of the pack

Hard gelatin capsule, size "3", with a light yellow cap and a gray body, with a black ink print "FGL 05" on the cap, filled with a 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, single-dose blisters containing 28 x 1 hard capsule, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

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 authorized in the Member States of the European Economic Area 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 0.5mg, harde capsules
Portugal:
Fingolimod Generis
Poland:
Fingolimod Aurovitas
Spain:
Fingolimod Aurovitas 0.5 mg cápsulas duras EFG

Date of last revision of the leaflet: 05/2025