Fingolimod Aristo

Leaflet accompanying the packaging: information for the user

Fingolimod Aristo, 0.5 mg hard capsules

Fingolimod

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

What is Fingolimod Aristo

The active substance in Fingolimod Aristo is fingolimod.

What is Fingolimod Aristo used for

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

• patients who have not responded to MS treatment or
• patients with rapidly evolving severe MS.

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

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination. 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 usually include walking difficulties, numbness, vision problems, or balance problems. Relapse symptoms may completely resolve, but some disturbances may persist.

How Fingolimod Aristo works

Fingolimod Aristo 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 limits nerve damage caused by MS. Fingolimod Aristo also weakens some immune system reactions.

2. Important information before taking Fingolimod Aristo

When not to take Fingolimod Aristo

• if the patient has a reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive medicines);
• if the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has an active malignant disease;
• if the patient has severe liver disease;
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat(arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Aristo;
• if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or breastfeedingor is of childbearing age and not using effective contraception;
• if the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of these situations apply or the patient has doubts, they should tell their doctor before taking Fingolimod Aristo.

Warnings and precautions

Before starting treatment with Fingolimod Aristo, the patient should discuss the following with their doctor:

• if the patient has severe respiratory problems during sleep (sleep apnea);
• if the patient has been informed that their ECG is abnormal;
• if the patient experiences symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations);
• if the patient is taking or has recently taken medicines that slow down the heart rate(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterases, or pilocarpine);
• if the patient has had sudden loss of consciousness or fainting in the past;
• if the patient plans to get vaccinated;
• if the patient has never had chickenpox;
• if the patient has or has had vision problemsor other symptoms of macular edema (a condition where the macula, the part of the retina responsible for central vision, becomes swollen) or uveitis (inflammation of the uvea, the middle layer of the eye), or if the patient has diabetes, which can cause vision problems;
• if the patient has liver disease;
• if the patient has high blood pressure that cannot be controlled with medication;
• if the patient has severe lung disease or a cough typical of smokers.

If any of these situations apply or the patient has doubts, they should tell their doctor before taking Fingolimod Aristo.

Low heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg, Fingolimod Aristo slows down 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 their doctor, as they may need immediate treatment.Fingolimod Aristo may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Low heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.
The doctor will ask the patient to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Aristo or after taking the first dose of 0.5 mg when switching from a daily dose of 0.25 mg using another fingolimod medicine with lower strength, with hourly measurements of heart rate and blood pressure, so that if any adverse reactions occur at the beginning of treatment, appropriate treatment can be administered. Before the first dose of Fingolimod Aristo and after the 6-hour observation period, an ECG will be performed on the patient. During this time, the doctor may continuously monitor the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, it may be necessary to extend the monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Aristo after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Aristo before the break.
If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, Fingolimod Aristo may not be suitable for them.
If the patient has had sudden loss of consciousness or slow heart rate in the past, Fingolimod Aristo may not be suitable for them. It may be necessary to consult a cardiologist (a heart specialist) who will advise on how to start treatment with Fingolimod Aristo, including how to monitor the patient at night.
If the patient is taking medicines that can slow down the heart rate, Fingolimod Aristo may not be suitable. It may be necessary to consult a cardiologist, who will check if the patient can switch to other medicines that do not slow down the heart rate, to allow treatment with Fingolimod Aristo. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Aristo, taking into account monitoring until the next day after administration of the first dose of Fingolimod Aristo.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella-zoster virus. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fingolimod Aristo.
If this is the case, the doctor will delay the start of treatment with Fingolimod Aristo for one month after the full vaccination cycle.
Infections
Fingolimod Aristo reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Aristo (and for 2 months after stopping treatment), the patient may be more susceptible to infections. Any existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, and (or) vomiting, or confusion or seizures (which may be symptoms of meningitis or encephalitis caused by fungal or herpesvirus infections), they should contact their doctor immediately, as this condition can be severe and life-threatening.
If the patient thinks their disease is getting worse (e.g., weakness or vision problems) or if the patient notices any new symptoms, they should talk to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection, called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can lead to severe disability or death. The doctor will consider performing an MRI scan to assess the patient's condition and decide whether to stop taking Fingolimod Aristo.
Patients treated with Fingolimod Aristo have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, warts, and HPV-related cancer. The doctor will consider vaccinating the patient against HPV before starting treatment with Fingolimod Aristo. In women, the doctor will also recommend screening for HPV.
Macular edema
Before starting treatment with Fingolimod Aristo, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (a condition where the macula, the part of the retina responsible for central vision, becomes swollen) or uveitis (inflammation of the uvea, the middle layer of the eye) or diabetes for eye examinations.
The doctor may refer the patient for eye examinations 3 to 4 months after starting treatment with Fingolimod Aristo.
The macula is a small area of the retina, located at the back of the eye, that allows for sharp and detailed vision. Fingolimod Aristo can cause macular edema, a condition where the macula becomes swollen. Macular edema usually occurs within the first 4 months of treatment with Fingolimod Aristo.
The risk of macular edema is higher in patients with diabetesor a history of uveitis. In such cases, the doctor will prescribe regular eye examinations to detect macular edema.
If the patient develops macular edema, they should inform their doctor before resuming treatment with Fingolimod Aristo.
Macular edema can cause vision problems similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not be noticeable. The patient should inform their doctor about any changes in vision. The doctor may refer the patient for eye examinations, especially if:

• the center of the visual field becomes blurry or shaded;
• a defect appears in the center of the visual field;
• the patient experiences difficulties with color vision or fine details.

Liver function tests
Patients with severe liver disease should not take Fingolimod Aristo.
Fingolimod Aristo may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or whites of the eyes, dark urine, pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should tell their doctor immediately.
If any of these symptoms occur in the patient after starting treatment with Fingolimod Aristo, they should tell their doctor immediately.
Before, during, and after treatment, the doctor will prescribe blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with Fingolimod Aristo may be stopped.
High blood pressure
The doctor may regularly check the patient's blood pressure, as Fingolimod Aristo can cause a slight increase in blood pressure.
Lung disease
Fingolimod Aristo has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of adverse reactions.
Blood cell count
The expected effect of Fingolimod Aristo 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 blood tests are necessary, the patient should inform their doctor that they are taking Fingolimod Aristo. Otherwise, the doctor may not be able to interpret the test results, and in the case of certain tests, the doctor may prescribe a larger amount of blood than usual.
Before starting treatment with Fingolimod Aristo, the doctor will check if the patient has a suitable number of white blood cells in the blood to start treatment and may prescribe regular blood tests.
If the patient has an insufficient number of white blood cells, it may be necessary to stop treatment with Fingolimod Aristo.
Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with Fingolimod Aristo, there have been rare reports of a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If the patient experiences any of these symptoms while taking Fingolimod Aristo, they should tell their doctor immediately, as this condition can be severe.
Cancer
Patients with MS treated with Fingolimod Aristo have reported skin cancers.
If the patient notices any lumps (e.g., shiny lumps with a pearly color), spots, or open sores that do not heal within a few weeks, they should tell their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., new moles) that change color, shape, or size over time. Before starting treatment with Fingolimod Aristo, it is necessary to examine the skin for any lumps. The doctor will also perform regular skin checks during treatment with Fingolimod Aristo. If skin problems occur, the doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with them.
Patients with MS treated with Fingolimod Aristo have also reported a type of cancer of the lymphatic system (lymphoma).
Exposure to sunlight and protection from ultraviolet radiation
Fingolimod Aristo weakens the immune system. This increases the risk of developing cancers, especially skin cancers. The patient should limit their exposure to sunlight and UV radiation by:

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

Unusual changes in the brain related to MS relapse
Patients treated with Fingolimod Aristo have reported rare cases of unusually large changes in the brain related to MS relapse. In the case of a severe MS relapse, the doctor will consider performing an MRI scan to assess the patient's condition and decide whether to stop taking Fingolimod Aristo.
Switching from other medicines to Fingolimod Aristo
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Aristo if there are no symptoms of abnormality caused by previous treatment. The doctor may prescribe 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 Aristo. When switching from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fingolimod Aristo is suitable for them.
Women of childbearing age
If Fingolimod Aristo is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Aristo, the doctor will explain the risk to the patient and ask them to take a pregnancy test to rule out pregnancy. The doctor will give the patient a card explaining why they should not become pregnant while taking Fingolimod Aristo. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Aristo. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

If the patient becomes pregnant while taking Fingolimod Aristo, they should tell their doctor immediately.

The doctor will decide whether to stop treatment(see "Stopping treatment with Fingolimod Aristo" in section 3, as well as section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod Aristo. Fingolimod Aristo may pass into breast milk, posing a risk of severe side effects in the baby.

Driving and using machines

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

Fingolimod Aristo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Fingolimod Aristo

Treatment with Fingolimod Aristo will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor.
The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and older):

The dose depends on body weight:

• Children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day. Fingolimod Aristo 0.5 mg capsules are not suitable for children and adolescents weighing 40 kg or less. Other fingolimod medicines with lower strengths (0.25 mg capsules) are available.
• Children and adolescents weighing more than 40 kg: one 0.5 mg capsule per day.

Children and adolescents starting treatment with one 0.25 mg capsule per day using other fingolimod medicines with lower strengths and later reaching a stable 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.
Do not exceed the recommended dose.
Fingolimod Aristo is for oral use.
Fingolimod Aristo should be taken once a day, with a glass of water. Fingolimod Aristo capsules should always be swallowed whole, without opening. Fingolimod Aristo can be taken with or without food.
Taking Fingolimod Aristo at the same time every day will help the patient remember to take their medicine.
If the patient has questions about the duration of treatment with Fingolimod Aristo, they should consult their doctor or pharmacist.

Taking more than the recommended dose of Fingolimod Aristo

If the patient takes too much of the medicine, they should contact their doctor immediately.

Missing a dose of Fingolimod Aristo

If the patient takes Fingolimod Aristo for less than 1 month and forgets to take 1 dose for a whole day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose.
If the patient takes Fingolimod Aristo for at least 1 month and forgets to take the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose. However, if the patient forgets to take the medicine for up to 2 weeks, they can take the next dose as planned.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Aristo

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

4. Possible side effects

Like all medicines, Fingolimod Aristo can cause side effects, although not everybody gets them.
Some side effects may be or may become severe
Very common(may affect up to 1 in 10 people)

• Cough with expectoration, unpleasant feeling in the chest, fever (respiratory symptoms).
• Infection with herpesviruses (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots.
• Slow heart rate (bradycardia), irregular heartbeat.
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it can have other appearances.
• Depression and anxiety, which are more common in the MS population and have also been reported in children and adolescents treated with Fingolimod Aristo.
• 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 defects in the center of the visual field, blurred vision, difficulty seeing colors and fine details.
• Reduced platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an abnormal mole). Possible symptoms of melanoma include moles that change in size, shape, or color over time or new moles. Moles can be itchy, bleed, or ulcerate.
• Seizures, convulsions (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 severe headache, confusion, seizures, and vision changes.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a hard, red nodule, an ulcer with a scab, or a new, fresh ulcer in the place of an existing scar.

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

• Abnormalities in the ECG (inversion of the T wave).
• A tumor associated with human herpesvirus 8 (Kaposi's sarcoma).

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

• Allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fingolimod Aristo.
• Symptoms of liver disease (including liver failure) such as yellowing of the skin or whites of the eyes, nausea or vomiting, pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting. In very rare cases, liver failure can lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. They may also include symptoms that the patient is not aware of, such as mood or behavior changes, transient memory loss, speech or communication difficulties, which the doctor should assess to rule out PML. Therefore, if the patient thinks their MS is getting worse or if the patient or their relatives notice any new or unusual symptoms, it is very important to tell their doctor as soon as possible.
• Cryptococcal infections (a type of fungal infection), including symptoms such as headache, stiff neck, sensitivity to light, nausea, and (or) confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless nodule with a fleshy or bluish-red color, often located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass.
• Relapse of MS symptoms after stopping treatment with Fingolimod Aristo.
• Autoimmune hemolytic anemia (a condition where red blood cells are destroyed).

If the patient experiences any of these side effects, they should tell their doctor immediately.
Other side effects
Very common(may affect more than 1 in 10 people)

• Influenza 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 infections (e.g., ringworm).
• Dizziness.
• Severe headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms).
• Low white blood cell count (lymphocytes, leukocytes).
• Weakness.
• Itchy, red, burning rash (rash).
• Itching.
• Increased triglyceride levels in the blood.
• Hair loss.
• Shortness of breath.
• Depression.
• Blurred vision (see also the section on macular edema under "Some side effects may be or may become severe").
• Hypertension (Fingolimod Aristo may cause a mild increase in blood pressure).
• Muscle pain.
• Joint pain.

Uncommon(may affect up to 1 in 100 people)

• Low neutrophil count.
• Depressed mood.
• Nausea.

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

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

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

• Peripheral edema.

If any of these symptoms occur with significant severity, the patient should tell their doctor.

5. How to store Fingolimod Aristo

The medicinal product should be stored out of sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month stated. Store in a temperature below 30°C. Do not use this medicinal product if you notice that the packaging is damaged or there are signs of previous attempts to open it. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Fingolimod Aristo contains

• The active substance is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
• The other ingredients are: Capsule filling: cellulose powder (E460), titanium dioxide (E171), magnesium stearate (E470b). Capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate. Black ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide. Blue ink: shellac (E904), propylene glycol (E1520), indigo carmine (E132).

What Fingolimod Aristo looks like and package contents

Fingolimod Aristo, 0.5 mg, hard capsule, gelatin capsule composed of a light yellow cap and an opaque white body with "H" printed in black ink on the cap and "F7" printed in blue ink on the body. Fingolimod Aristo, 0.5 mg, hard capsules are available in packs of 7 or 28 capsules in blisters, or in packs containing a single-dose blister of 7 x 1 capsule. Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw

Manufacturer/Importer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Fingolimod Aristo 0.5 mg Hartkapseln
Czech Republic
Fingolimod Aristo
Denmark
Fingolimod Aristo
Spain
Fingolimod Aristo 0.5 mg cápsulas duras, EFG
Netherlands
Fingolimod Aristo 0.5 mg harde capsules
Germany
Fingolimod Aristo 0.5 mg Hartkapseln
Poland
Fingolimod Aristo
Sweden
Fingolimod Aristo 0.5 mg hårda kapslar
Italy
Fingolimod Aristo

Date of last update of the leaflet: