Fingolimod Teva

Leaflet accompanying the packaging: information for the user

Fingolimod Teva, 0.25 mg, hard capsules

Fingolimod Teva, 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 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

What is Fingolimod Teva

The active substance in Fingolimod Teva is fingolimod.

What is Fingolimod Teva used for

Fingolimod Teva 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 Teva 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 Teva works

Fingolimod Teva 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. This way, the medicine reduces nerve damage caused by MS. Fingolimod Teva also weakens some immune system reactions.

2. Important information before taking Fingolimod Teva

When not to take Fingolimod Teva

• 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, stroke, or symptoms of stroke in 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 Teva;
• 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 breastfeeding;
• if the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6). If this is the case or the patient has doubts, they should tell their doctor before taking Fingolimod Teva.

Warnings and precautions

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

• -if the patient has severe breathing difficulties 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 heart rate(such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if the patient has a history of sudden loss of consciousness or fainting;
• 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 eye 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 problems;
• 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 occur or the patient has doubts, they should tell their doctor before taking Fingolimod Teva.

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 have previously taken a daily dose of 0.25 mg, Fingolimod Teva slows down heart rate. As a result, the patient may experience dizziness, fatigue, or palpitations, or their blood pressure may drop. If these symptoms are severe, the patient should inform their doctor immediately, as they may require immediate treatment. Fingolimod Teva 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.
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 Teva or after the first dose of 0.5 mg in case of a change in treatment from a daily dose of 0.25 mg, with hourly measurements of heart rate and blood pressure, so that if any adverse reactions occur that happen at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Fingolimod Teva and after the 6-hour observation period, an ECG will be performed on the patient. During this time, the doctor may also 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, there may be a need for longer 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 Teva after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Teva 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 Teva may not be suitable for them.
If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod Teva may not be suitable for them. There may be a need for consultation with a cardiologist (a heart specialist) who will advise on how to start treatment with Fingolimod Teva, including how to monitor the patient at night.
If the patient is taking medicines that can slow down heart rate, Fingolimod Teva may not be suitable. There may be a need for consultation with a cardiologist to check if the patient can switch to other medicines that do not slow down heart rate, to allow treatment with Fingolimod Teva. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Teva, taking into account monitoring until the next day after administration of the first dose of Fingolimod Teva.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check if the patient is immune to varicella-zoster virus infection. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fingolimod Teva. If this is the case, the doctor will delay the start of treatment with Fingolimod Teva by one month after the full vaccination course.
Infections
Fingolimod Teva reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Teva (and for 2 months after stopping treatment), the patient may be more prone 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, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by fungal or viral infections), they should contact their doctor immediately, as this condition can be severe and life-threatening.
If the patient thinks their MS 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 can 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 it is necessary to stop taking Fingolimod Teva.
Patients treated with Fingolimod Teva have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, and HPV-related cancer. The doctor will consider whether the patient needs to be vaccinated against HPV before starting treatment with Fingolimod Teva. In women, the doctor will also recommend screening for HPV.
Macular edema
Before starting treatment with Fingolimod Teva, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema or uveitis for eye examinations.
The doctor may also refer the patient for eye examinations after 3 to 4 months of starting treatment with Fingolimod Teva.
The macula is a small area of the retina that allows for sharp, clear vision of shapes, colors, and other details. Fingolimod Teva may cause macular edema, a condition where the macula becomes swollen. Macular edema usually occurs within the first 4 months of treatment with Fingolimod Teva.
The risk of macular edema is higher in patients with diabetesor with a history of uveitis. In such cases, the doctor will prescribe regular eye examinations to detect macular edema.
If the patient has had macular edema, they should inform their doctor before resuming treatment with Fingolimod Teva.
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;
• there is a defect 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 Teva. Fingolimod Teva 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 (jaundice), dark (brown) urine, pain in the right side of the abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should tell their doctor immediately.
If the patient experiences any of these symptoms after starting treatment with Fingolimod Teva, 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 Teva may be discontinued.
High blood pressure
The doctor may regularly check the patient's blood pressure, as Fingolimod Teva can cause a slight increase in blood pressure.
Lung problems
Fingolimod Teva 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.
White blood cell count
The expected effect of Fingolimod Teva is a reduction in white blood cell count in the blood. The count usually returns to normal within 2 months after stopping treatment. If blood tests need to be performed, the patient should inform their doctor that they are taking Fingolimod Teva. Otherwise, the doctor may not be able to interpret the test results correctly, and in the case of certain tests, the doctor may need to take more blood than usual.
Before starting treatment with Fingolimod Teva, the doctor will check if the patient has a suitable white blood cell count to start treatment and may prescribe regular repeat tests. If the patient does not have a sufficient white blood cell count, it may be necessary to discontinue treatment with Fingolimod Teva.
Posterior reversible encephalopathy syndrome (PRES)
Rarely, patients with MS treated with Fingolimod Teva have reported 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 Teva, they should tell their doctor immediately, as this condition can be severe.
Cancer
Patients with MS treated with Fingolimod Teva have reported cases of skin cancer. If the patient notices any lumps on their skin (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. 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 Teva, it is necessary to examine the skin for any lumps. The doctor will also perform regular skin checks during treatment with Fingolimod Teva. 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 have also reported cases of a type of cancer of the lymphatic system (lymphoma).
Exposure to sunlight and protection from ultraviolet radiation
Fingolimod weakens the immune system. This increases the risk of developing cancer, especially skin cancer. The patient should limit their 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 related to MS relapse
Patients treated with fingolimod have reported rare cases of unusually large changes in the brain related to MS relapse. In cases of severe MS relapse, the doctor will consider performing an MRI scan to assess the patient's condition and decide whether to discontinue treatment with Fingolimod Teva.
Switching from other medicines to Fingolimod Teva
The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Teva 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 Teva. In cases of 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 Teva is suitable for them.
Women of childbearing age
If Fingolimod Teva is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Teva, the doctor will explain the risks to the patient and ask them to perform 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 Teva. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Teva. Female 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 Teva, they should tell their doctor immediately.

The doctor will decide whether to stop treatment(see "Stopping treatment with Fingolimod Teva" in section 3 and section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod Teva. Fingolimod Teva 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 condition allows them to drive vehicles safely, including riding a bicycle and operating machinery. It is not expected that Fingolimod Teva 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 Teva. During this time and potentially after it, the patient's ability to drive vehicles or operate machinery may be impaired.

Fingolimod Teva contains sodium

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

3. How to take Fingolimod Teva

Treatment with Fingolimod Teva 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 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 Teva.
Do not exceed the recommended dose.
Fingolimod Teva is for oral use.
Fingolimod Teva should be taken once a day, with a glass of water. The capsules should always be swallowed whole, without opening. Fingolimod Teva can be taken with or without food.
Taking Fingolimod Teva at the same time every day will help the patient remember to take their medicine.
If the patient has any questions about the duration of treatment with Fingolimod Teva, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Teva than recommended

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

Missing a dose of Fingolimod Teva

If the patient takes Fingolimod Teva for less than 1 month and forgets to take 1 dose for the 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 Teva 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 Teva

Do not stop treatment with Fingolimod Teva or change the dose without consulting the doctor first.
Fingolimod Teva stays in the body for up to 2 months after stopping treatment. During this time, the white blood cell count (lymphocyte count) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Teva, the patient should wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Fingolimod Teva after more than 2 weeks off the medicine, the effect on heart rate observed usually after starting treatment for the first time may occur again, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. Do not resume treatment with Fingolimod Teva after a break of more than 2 weeks without consulting the doctor.
The doctor will decide whether and how to monitor the patient after stopping treatment with Fingolimod Teva. If the patient thinks their MS is getting worse after stopping treatment with Fingolimod Teva, 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 Teva can cause side effects, although not everybody gets them.
Some side effects may be or may become severe
Very common(may affect more than 1 in 10 people):

• Cough with expectoration, unpleasant feeling in the chest, fever (respiratory symptoms)
• Infections with herpes viruses (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 are known to occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with fingolimod.
• 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, open sore

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

• Abnormalities in the ECG (inversion of the T wave)
• 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, itching, or hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fingolimod Teva
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, 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 changes in mood or behavior, transient memory loss, difficulty speaking or communicating, which the doctor should evaluate 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
• Fungal infections (cryptococcal infections), including symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion
• Cancer of the Merkel cells (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless nodule with a fleshy color, often located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Long-term sun exposure and weakened immune system may increase the risk of Merkel cell carcinoma
• After stopping treatment with Fingolimod Teva, MS symptoms may relapse and worsen compared to the period before treatment and during treatment.
• 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 (dermatophyte infections) (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 Teva 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 estimated from the available data):

• Peripheral edema

If any of these symptoms occur with a high intensity, the patient should tell their doctor.

5. How to store Fingolimod Teva

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 “Expiry date (EXP)” / “EXP”. The expiry date refers to the last day of the month stated. There are no special precautions for storage. 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 Teva contains

• The active substance is fingolimod. Fingolimod Teva 0.25 mg hard capsules: Each capsule contains 0.25 mg of fingolimod (as hydrochloride). Fingolimod Teva 0.5 mg hard capsules: Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• Other ingredients are: Filler: Corn starch, sodium lauryl sulfate. Fingolimod Teva 0.25 mg hard capsules Capsule shell: Titanium dioxide (E 171), gelatin. Fingolimod Teva 0.5 mg hard capsules Capsule shell: Yellow iron oxide (E 172), titanium dioxide (E 171), gelatin. Printing ink: Shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide

What Fingolimod Teva looks like and package contents

Fingolimod Teva 0.25 mg: A gelatin capsule of approximately 14 mm in size with a black imprint, “TV 3654” on the white opaque capsule cap and “TV 3654” on the white opaque capsule body. Fingolimod Teva 0.5 mg: A gelatin capsule of approximately 14 mm in size with a black imprint, “TV 7820” on the yellow capsule cap and “TV 7820” on the white opaque capsule body. Fingolimod Teva is available in packs containing 7 x 1 hard capsules or 28 x 1 hard capsules in perforated unit dose blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (022) 345 93 00. Manufacturer/Importer: Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria. Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, 31-546 Krakow, Poland. Teva Nederland B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany

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

Germany: Fingolimod-ratiopharm 0.25 mg Hartkapseln; Fingolimod-ratiopharm 0.5 mg Hartkapseln. Belgium: Fingolimod Teva 0.25 mg harde capsules, gélules, Hartkapseln; Fingolimod Teva 0.5 mg harde capsules, gélules, Hartkapseln. Denmark, Estonia, Iceland, Norway, Poland, Portugal, Sweden: Fingolimod Teva. Finland: Fingolimod ratiopharm 0.25 mg kapseli, kova; Fingolimod ratiopharm 0.5 mg kapseli, kova. France: FINGOLIMOD TEVA 0.25 mg, gélule; FINGOLIMOD TEVA 0.5 mg, gélule. Croatia: Fingolimod Teva 0.25 mg tvrde capsule; Fingolimod Teva 0.5 mg tvrde kapsule. Ireland: Fingolimod Teva 0.5 mg Hard Capsules. Lithuania: Fingolimod Teva 0.5 mg kietosios kapsulės. Luxembourg: Fingolimod Teva 0.25mg gélules; Fingolimod Teva 0.5mg gélules. Latvia: Fingolimod Teva 0.5 mg cietās kapsulas. Netherlands: Fingolimod Teva 0.25 mg, harde capsules; Fingolimod Teva 0.5 mg, harde capsules. Slovenia: Fingolimod Teva 0.25 mg trde kapsule; Fingolimod Teva 0.50 mg trde kapsule. United Kingdom (Northern Ireland): Fingolimod Teva 0.25 mg & 0.5 mg Capsule, Hard

Date of last revision of the leaflet: August 2021