Fingolimod Stada

Leaflet accompanying the packaging: Information for the user

Fingolimod Stada, 0.5 mg, hard capsules
Fingolimod

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

What is Fingolimod Stada

The active substance of Fingolimod Stada is fingolimod.

What is Fingolimod Stada used for

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

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

Fingolimod Stada 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 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 from patient to patient but usually include gait disturbances, numbness, vision problems, or balance disorders. Relapse symptoms may completely resolve, but some disorders may persist.

How does Fingolimod Stada work

Fingolimod Stada helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely in the body and preventing them from entering the brain and spinal cord. This limits nerve damage caused by MS. Fingolimod Stada also weakens some immune responses of the body.

2. Important information before taking Fingolimod Stada

When not to take Fingolimod Stada

• if the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6)
• if the patient's immune system is weakened(due to immunodeficiency syndrome, disease, or drugs that suppress the immune system)
• if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis
• if the patient has active malignant tumors
• if the patient has severe liver problems
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within the last 6 months
• if the patient has certain types of irregular or abnormal heartbeats(arrhythmias); this also applies to patients who have an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Stada
• if the patient is taking or has recently taken medications for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol
• if the patient is pregnantor is able to become pregnant and is not using effective contraception. The patient should consult a doctor before taking Fingolimod Stada.

Warnings and precautions

Before taking Fingolimod Stada, consult a doctor if:

• the patient has severe breathing problems during sleep(severe sleep apnea)
• the patient has been informed of an abnormal electrocardiogram
• the patient experiences symptoms of slow heart rate(e.g., dizziness, nausea, or palpitations)
• the patient is taking or has recently taken medications that slow heart rate(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine)
• the patient has a history of sudden loss of consciousness or fainting
• the patient is planning to receive a vaccination
• the patient has never had chickenpox
• the patient has vision problemsor other signs of macular edema (swelling in the central part of the retina) in the back of the eye, inflammation, or infection of the eye (uveitis), or diabetes (which can cause eye problems)
• the patient has liver problems
• the patient has uncontrolled high blood pressure
• the patient has severe lung problemsor smoker's cough. The patient should consult a doctor before taking Fingolimod Stada.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg in patients who previously took a daily dose of 0.25 mg, Fingolimod Stada slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or a decrease in blood pressure. If these symptoms are severe, the patient should inform their doctor, as they may require immediate treatment. Fingolimod may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within a day. Slow heart rate usually returns to normal within a 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 Stada or after the first dose of 0.5 mg when changing treatment from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any adverse reactions occur at the beginning of treatment, appropriate actions can be taken. Before the first dose of Fingolimod Stada and after the 6-hour observation period, the patient should undergo an ECG examination. During this time, the doctor may continuously monitor the patient's electrocardiogram. If after this 6-hour period the patient has a very slow or decreasing heart rate or if the ECG examination 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 Stada after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Stada before the break.
If the patient has irregular or abnormal heartbeat or risk factors for these events, if there are ECG abnormalities or heart disease or heart failure, Fingolimod Stada may not be suitable for them.
If the patient has had an episode of sudden loss of consciousness or slow heart rate, Fingolimod Stada 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 Stada, including how to monitor the patient until the next day.
If the patient is taking medications that can slow heart rate, Fingolimod Stada may not be suitable. It may be necessary to consult a cardiologist to check if the patient can switch to other medications that do not slow heart rate, to allow treatment with Fingolimod Stada. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Stada, taking into account monitoring until the next day.
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 Stada. If this is the case, the doctor will postpone the start of treatment with Fingolimod Stada until one month after the full vaccination course.
Infections
Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Stada (and for 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, they should immediately contact their doctor, as this condition can be severe and life-threatening. If the patient has a fever, flu-like symptoms, shingles, or headache with stiff neck, sensitivity to light, nausea, vomiting, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or viral infections), they should immediately contact their doctor.
Patients treated with fingolimod have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, warts, and HPV-related cancer. The doctor will consider the need for HPV vaccination before starting treatment with Fingolimod Stada. In women, the doctor will also recommend screening for HPV infection.
Macular edema
Before starting treatment with Fingolimod Stada, the doctor may refer patients with existing or past vision problems or other signs of macular edema (swelling in the central part of the retina) in the back of the eye, inflammation, or infection of the eye (uveitis), or diabetes for ophthalmological examinations.
The doctor may also refer the patient for ophthalmological examinations 3-4 months after starting treatment with Fingolimod Stada.
Macular edema is a condition that affects the macula, a small area of the retina responsible for sharp, clear vision. Fingolimod may cause macular edema, usually within the first 4 months of treatment.
The risk of macular edema is higher in patients with diabetesand in patients who have had uveitis. In such cases, the doctor will recommend regular ophthalmological examinations to detect macular edema.
If the patient experiences macular edema, they should inform their doctor before resuming treatment with Fingolimod Stada.
Macular edema can cause vision problems similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not appear at all. If any changes in vision occur, the patient should immediately inform their doctor.
The doctor may ask the patient to undergo an ophthalmological examination, especially in the following cases:

• the center of the visual field becomes blurry or shaded
• a defect appears in the center of the visual field
• there are difficulties with color vision or fine details

Liver function tests
Patients with severe liver disease should not take Fingolimod Stada. Fingolimod 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 (brown) urine, pain in the right side of the abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should immediately inform their doctor.
If any of these symptoms occur after starting treatment with Fingolimod Stada, the patient should immediately inform their doctor.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver problems, it may be necessary to stop treatment with Fingolimod Stada.
High blood pressure
The doctor may regularly check blood pressure, as Fingolimod Stada can cause a slight increase in blood pressure.
Lung problems
Fingolimod has a minor effect on lung function. Patients with severe lung disease or smoker's cough are at higher risk of adverse reactions.
Blood morphology
The desired effect of treatment with Fingolimod Stada is a decrease in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are necessary, the patient should inform their doctor that they are taking Fingolimod Stada. Otherwise, the doctor may not be able to interpret the blood test results, and in the case of certain tests, the doctor may order more blood to be drawn than usual.
Before starting treatment with Fingolimod Stada, the doctor will check if the patient has a suitable number of white blood cells in the blood to start treatment and may order regular blood tests.
If the number of white blood cells is insufficient, it may be necessary to stop treatment with Fingolimod Stada.
Posterior reversible encephalopathy syndrome (PRES)
In rare cases, patients with MS treated with fingolimod have reported a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod Stada, the patient should immediately inform their doctor, as this condition can be severe.
Malignant tumors
Patients with MS treated with fingolimod have reported malignant tumors. If the patient notices any lumps on the skin (e.g., shiny lumps with a pearl-like color), spots, or open sores that do not heal within a few weeks, they should immediately inform their doctor. 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 Stada, it is necessary to examine the skin for any lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod Stada. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with the patient.
Patients with MS treated with Fingolimod Stada have also reported a type of lymphoma (a type of cancer of the lymphatic system).
Exposure to sunlight and protection from ultraviolet radiation
Fingolimod weakens the immune system. This increases the risk of malignant tumors, especially skin cancer. The patient should limit exposure to sunlight and ultraviolet radiation by:

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

Unusual changes in the brain associated with MS relapse
Patients treated with fingolimod have reported rare cases of unusually large changes in the brain associated with MS relapse. In the case of a severe MS relapse, the treating doctor will consider performing an MRI examination to assess this condition and decide on the possible need to stop taking Fingolimod Stada.
Switching from other medicines to Fingolimod Stada
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Stada if there are no symptoms of disorders caused by previous treatment. The doctor may order a blood test to rule out such disorders. After stopping treatment with natalizumab, it may be necessary to wait 2 to 3 months before starting treatment with Fingolimod Stada. 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 Stada is suitable for them.
Women of childbearing age
If fingolimod were used during pregnancy, it could harm the unborn child. Before starting treatment with Fingolimod Stada, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod Stada. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Stada. Female patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

In case of pregnancy during treatment with Fingolimod Stada, the patient should immediately

contact their doctor. The doctor will decide on stopping treatment (see "Stopping Fingolimod Stada" in section 3, as well as section 4 "Possible side effects"). Specialized prenatal care will be provided.

Breastfeeding

Female patients should not breastfeed while taking Fingolimod Stada. Fingolimod may pass into breast milk, so there is a risk of serious side effects in the baby.

Driving and operating machinery

The doctor will inform the patient whether their condition allows them to drive vehicles, including bicycles, and operate machinery safely. It has not been found that Fingolimod Stada affects 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 Stada. During this time and potentially later, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod Stada

Treatment with Fingolimod Stada will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.

Recommended dose:

Adults
The dose is one tablet (0.5 mg) per day.
Children and adolescents (aged 10 and older, weighing over 40 kg)
One capsule of 0.5 mg per day. Children and adolescents starting treatment with one capsule of 0.25 mg per day and later reaching a stable weight over 40 kg will be advised by their doctor to switch to one capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period as after the first dose of Fingolimod Stada.
Children and adolescents (aged 10 and older, weighing up to 40 kg)
Fingolimod Stada, hard capsules of 0.5 mg are not suitable for children weighing ≤ 40 kg. Other fingolimod medicines with lower doses (in the form of capsules of 0.25 mg) are available.
Do not exceed the recommended dose.

Method of administration

Fingolimod Stada is intended for oral use.
Fingolimod Stada should be taken once a day, with a glass of water. Fingolimod Stada capsules should always be swallowed whole, without opening. Fingolimod Stada can be taken with or without food.
Taking Fingolimod Stada at the same time every day will help the patient remember to take their medicine.

Duration of treatment

In case of questions about the duration of treatment with Fingolimod Stada, the patient should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Stada than recommended

In case of taking too much of the medicine, the patient should immediately contact their doctor.

Missing a dose of Fingolimod Stada

If the patient has been taking Fingolimod Stada for less than 1 month and misses a dose for the entire day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the administration of the next dose.
If the patient has been taking Fingolimod Stada for at least 1 month and misses a dose 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 administration of the next dose. However, if the patient misses a dose 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 Fingolimod Stada

Do not stop taking Fingolimod Stada or change the dosage without consulting a doctor first.
Fingolimod remains in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be low, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Stada, the patient should wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Fingolimod Stada after a break of more than 2 weeks, the effect on heart rate observed usually after the first dose may recur, and monitoring of the patient's condition in a doctor's office or clinic will be necessary due to the resumption of treatment. Do not resume treatment with Fingolimod Stada after a break of more than 2 weeks without consulting the treating doctor.
The treating doctor will decide whether and how to monitor the patient after stopping treatment with Fingolimod Stada. The patient should immediately inform their doctor if they think their MS has worsened after stopping treatment with Fingolimod Stada. This situation can be serious.
In case of further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• cough with expectoration, feeling of discomfort in the chest, fever (respiratory symptoms)
• herpesvirus infections (shingles) with symptoms such as blisters, burning, itching, or pain on the skin, typically on the upper body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots with severe pain
• slow heart rate (bradycardia), irregular heartbeat
• a certain type of skin cancer, called basal cell carcinoma (BCC), which often appears as a pearl-like nodule, although it can have other forms
• it is known that depression and anxiety occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with fingolimod
• weight loss

Common(may affect up to 1 in 100 people)

• pneumonia, with symptoms such as fever, cough, and difficulty breathing
• macular edema (swelling in the central part of the retina) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, and problems with color vision and fine details
• low platelet count, which increases the risk of bleeding or bruising
• malignant melanoma (a type of skin cancer). Possible signs of melanoma include moles that change size, shape, elevation above the skin, or color over time, or new moles. These moles can be itchy, bleed, or ulcerate
• seizures, convulsions (more common in children and adolescents than in adults)

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

• posterior reversible encephalopathy syndrome (PRES). Symptoms of this condition may include severe headache, confusion, seizures, and vision changes
• lymphoma (a type of cancer of 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, open sore

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

• electrocardiogram abnormalities (T-wave inversion)
• malignant tumor associated with human herpesvirus 8 (Kaposi's sarcoma)

Frequency not known(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 Stada
• liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes, nausea or vomiting, dark (brown) urine, pain in the right side of the 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 lapses, difficulties with speech and communication, which the doctor should assess to rule out PML. Therefore, if the patient thinks their MS is worsening or if the patient or their relatives notice any new or unusual symptoms, it is very important to inform their doctor as soon as possible
• fungal infections (cryptococcal infections), including symptoms such as headache with stiff neck, sensitivity to light, nausea, and/or confusion or seizures
• merkel cell carcinoma (a type of skin cancer). Possible symptoms of merkel cell carcinoma include a painless nodule with a raw meat or bluish-red color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system can affect the risk of merkel cell carcinoma
• after stopping treatment with Fingolimod Stada, MS symptoms may recur and worsen compared to the period before treatment and during treatment
• autoimmune hemolytic anemia (a condition in which red blood cells are destroyed)

In case of any of these conditions, the patient should immediately inform their doctor.
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)

• pityriasis versicolor (a type of fungal skin infection)
• dizziness
• severe headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine)
• low white blood cell count (lymphocytes, leukocytes)
• weakness
• itchy, red, burning rash (eczema)
• itching
• high triglyceride levels in the blood
• hair loss
• shortness of breath
• depression
• blurred vision (see also the section on macular edema under "Some side effects may be or become serious")
• high blood pressure (Fingolimod Stada may cause a mild increase in blood pressure)
• muscle pain
• joint pain

Uncommon(may affect up to 1 in 100 people)

• low neutrophil count
• low mood
• nausea

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

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

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

• peripheral edema

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

5. How to store Fingolimod Stada

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 the words "Expiry Date" (EXP). The expiry date refers to the last day of the month stated. Do not store above 25 °C. Do not use the carton if signs of damage or attempted opening are visible. 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. Package contents and other information

What Fingolimod Stada contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride). The other ingredients are:

• Capsule content: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate
• Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin

What Fingolimod Stada looks like and pack contents

Fingolimod Stada, 0.5 mg, hard capsules, are hard gelatin capsules, size 3, with a yellow opaque cap and a white opaque body. Fingolimod Stada, 0.5 mg, hard capsules, are available in blisters packaged in cardboard boxes of 7, 28, 30, 56, 84, 98, or 100 capsules, and in single-dose blisters packaged in cartons containing 7 x 1, 28 x 1, 30 x 1, 56 x 1, 84 x 1, 98 x 1, or 100 x 1 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm Services B.V.
Van de Reijstraat 31-E
4814 NE Breda
Netherlands
Clonmel Healthcare Limited
Waterford Road
Clonmel, E91 D768
Ireland
Haupt Pharma Amareg GmbH
Donaustaufer Str. 378
93055 Regensburg
Germany

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

Economic Area under the following names:

Austria: Fingolimod STADA 0.5 mg Hartkapseln
Belgium: Fingolimod EG 0.5 mg hard capsules
Czech Republic: Fingolimod STADA
Denmark: Fingolimod STADA
Germany: Fingolimod STADA 0.5 mg Hartkapseln
Spain: Fingolimod STADA 0.5 mg cápsulas duras EFG
Finland: Fingolimod STADA 0.5 mg kapseli kova
France: FINGOLIMOD EG 0.5 mg, gélule
Croatia: Fingolimod STADA 0.5 mg tvrde capsule
Hungary: Fingolimod Stada 0.5mg kemény kapszula
Ireland: Fingolimod Clonmel 0.5 mg hard capsules
Iceland: Fingolimod STADA 0.5 mg hörð hylki
Italy: FINGOLIMOD EG
Luxembourg: Fingolimod EG 0.5 mg gélules
Netherlands: Fingolimod CF 0.5 mg, harde capsules
Poland: Fingolimod Stada
Portugal: Fingolimod Stada
Sweden: Fingolimod STADA 0.5 mg hårda kapslar
Slovenia: Fingolimod STADA 0.5 mg trde kapsule
Slovakia: Fingolimod STADA 0.5mg tvrdé kapsuly

Date of last revision of the leaflet: