Fingolimod Msn

Leaflet accompanying the packaging: information for the user

Fingolimod MSN, 0.5 mg, hard capsules
Fingolimod

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 possible side effects 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 MSN and what is it used for
• 2. Important information before taking Fingolimod MSN
• 3. How to take Fingolimod MSN
• 4. Possible side effects
• 5. How to store Fingolimod MSN
• 6. Package contents and other information

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

What is Fingolimod MSN

Fingolimod MSN contains the active substance fingolimod.

What is Fingolimod MSN used for

Fingolimod MSN is used in adults 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 MSN does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS. Fingolimod is also approved for use in children aged 10 and older. A medicinal product containing fingolimod from another company is registered in the European Union. Ask your doctor or pharmacist if you have any further questions.

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 protective sheath of the nerves (called myelin) in the CNS, preventing them 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 disturbances, numbness, vision disturbances, or balance problems. Symptoms of relapses may completely resolve, but some disturbances may persist.

How Fingolimod MSN works

Fingolimod MSN 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 MSN also weakens some immune responses of the body.

2. Important information before taking Fingolimod MSN

When not to take Fingolimod MSN

• if the patient has a reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive drugs);
• 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 MSN;
• if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnantor 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 such a situation occurs or the patient has doubts, they should consult a doctor before taking Fingolimod MSN.

Warnings and precautions

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

• -if the patient has severe respiratory disorders during sleep (severe sleep apnea);
• -if the patient has been informed that their ECG is abnormal;
• -if the patient has symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations);
• if 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);
• if the patient has a history of sudden loss of consciousness or fainting;
• if the patient plans to be 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), uveitis (inflammation of the uvea, the middle layer of the eye), or eye infections, 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 smoker's cough.

If any of these situations occur or the patient has doubts, they should consult a doctor before taking Fingolimod MSN. Bradycardia and irregular heartbeat On initiation of treatment or after the first dose of 0.5 mg in patients who have previously taken a daily dose of 0.25 mg, Fingolimod MSN 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 MSN may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Bradycardia 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 the first dose of Fingolimod MSN 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 adverse reactions occur that happen at the beginning of treatment, appropriate treatment can be administered. Before the first dose of Fingolimod MSN and after the 6-hour observation period, the patient will undergo an ECG. 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, the doctor may decide 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 MSN after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod MSN before the break. If the patient is at risk of irregular or abnormal heartbeat or if there is a risk of their occurrence, if there is an abnormal ECG, heart disease, or heart failure, Fingolimod MSN may not be suitable for them. If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod MSN may not be suitable for them in these cases. Cardiac consultation (with a heart specialist) may be necessary, who will advise on how to start treatment with Fingolimod MSN, including how to monitor the patient at night. If the patient is taking medications that can slow down the heart rate, Fingolimod MSN may not be suitable at that time. A cardiac consultation may be necessary to check if the patient can switch to other medications that do not slow down the heart rate to allow treatment with Fingolimod MSN. If such a change in treatment is not possible, the cardiologist will advise on how to start treatment with Fingolimod MSN, 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 virus that causes it (varicella-zoster virus). If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fingolimod MSN. If this is the case, the doctor will delay the start of treatment with Fingolimod MSN by one month after the full vaccination course. Infections Fingolimod MSN reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Fingolimod MSN (and up to 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, feel flu-like symptoms, have shingles, or have a headache with stiff neck, sensitivity to light, nausea, and/or vomiting, they should immediately contact their doctor, as this condition can be severe and life-threatening. If the patient experiences any of the above symptoms after starting treatment with Fingolimod MSN, they should immediately contact their doctor.Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with Fingolimod MSN may be discontinued. High blood pressure The doctor may regularly check the patient's blood pressure, as Fingolimod MSN can cause a slight increase in blood pressure. Lung problems Fingolimod MSN has a minor effect on lung function. Patients with severe lung disease or smoker's cough may have a higher risk of adverse reactions. Blood cell count The expected effect of Fingolimod MSN 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 MSN. 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 MSN, the doctor will confirm that the patient has a suitable number of white blood cells in the blood to start treatment and may order regular blood tests. If there are not enough white blood cells, it may be necessary to discontinue treatment with Fingolimod MSN. 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/or vision disturbances. If any of these symptoms occur during treatment with Fingolimod MSN, the patient should immediately contact their doctor, as this condition can be severe. Cancer In patients with MS treated with fingolimod, there have been reports of skin cancers. If the patient notices any lumps on their 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 contact 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 MSN, it is necessary to examine the skin for any lumps. The doctor will also perform regular skin checks during treatment with Fingolimod MSN. 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 the patient. Patients with MS treated with Fingolimod MSN have also reported a type of lymphoma (a type of cancer affecting the lymphatic system). Exposure to sunlight and protection against ultraviolet radiation Fingolimod weakens the immune system. This condition increases the risk of developing malignant tumors, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

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

Unusual changes in the brain associated with MS relapse In patients treated with fingolimod, there have been rare reports of unusually large changes in the brain associated with MS relapse. In the case of a severe MS relapse, the doctor may consider performing an MRI to assess this condition and decide on the possible need to discontinue Fingolimod MSN. Switching from other medicines to Fingolimod MSN The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod MSN if there are no symptoms of abnormality caused by previous treatment. The 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 MSN. When switching from teriflunomide, the doctor may advise the patient to wait for some time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fingolimod MSN is suitable for them. Women of childbearing age If Fingolimod MSN is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod MSN, the doctor will explain the risks 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 MSN. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod MSN. Female patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding"). Stopping treatment with Fingolimod MSN Do not stop taking Fingolimod MSN or change the dose without consulting your doctor. If the patient thinks that their MS is getting worse after stopping treatment with Fingolimod MSN, they should immediately contact their doctor, as this situation can be serious (see "Stopping treatment with Fingolimod MSN" in section 3, as well as section 4 "Possible side effects").

Patients over 65 years old

Experience with Fingolimod MSN in patients over 65 years old is limited. In case of doubts, the patient should consult their doctor.

Children and adolescents

Fingolimod MSN is not intended for use in children under 10 years old. For children aged 10 and older, a medicinal product containing fingolimod from another company is registered in the European Union.

Fingolimod MSN and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Immunosuppressive or immunomodulatory medicines, including other MS treatments, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod MSN should not be taken with these medicines, as it may increase the effect on the immune system (see also "When not to take Fingolimod MSN").

Corticosteroids, due to the possibility of additive effects on the immune system. Vaccines If the patient requires vaccination, they should consult their doctor first. During and up to 2 months after treatment with Fingolimod MSN, patients should not receive certain types of vaccines (live attenuated vaccines), as they may cause the infection they are intended to prevent. Other vaccines may also not be effective if administered during this period. Medications that slow down heart rate (e.g., beta blockers, such as atenolol) Taking Fingolimod MSN with these medications may increase the effect on heart rate in the first days of treatment with Fingolimod MSN. Medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol Fingolimod MSN should not be taken by patients taking these medications, as it may increase the effect on irregular heartbeat (see also "When not to take Fingolimod MSN"). Other medications, such as protease inhibitors, antifungal medications (e.g., ketoconazole, azole antifungals, clarithromycin, or telithromycin), carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort products (possible risk of reduced efficacy of Fingolimod MSN).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Pregnancy Fingolimod MSN should not be taken during pregnancy if the patient is trying to become pregnant or if the patient may become pregnant and is not using effective contraception. If Fingolimod MSN is taken during pregnancy, there is a risk of harm to the unborn child. The incidence of birth defects observed in children exposed to Fingolimod MSN during pregnancy is about twice as high as that observed in the general population (where the incidence of birth defects is about 2-3%). The most commonly reported birth defects include developmental heart defects, kidney defects, and musculoskeletal defects. For this reason, if the patient is of childbearing age:

• before starting treatment with Fingolimod MSN, the doctor will inform the patient about the risk to the unborn child and ask them to perform a pregnancy test to ensure that the patient is not pregnant, and
• the patient should use effective contraception during treatment with Fingolimod MSN and for 2 months after stopping treatment to avoid becoming pregnant. The patient should discuss effective contraception methods with their doctor.

The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod MSN. If the patient becomes pregnant while taking Fingolimod MSN, they should immediately contact their doctor. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod MSN" in section 3, as well as section 4 "Possible side effects"). The patient will also need to undergo prenatal check-ups. Breastfeeding Do not breastfeed while taking Fingolimod MSN. Fingolimod MSN may pass into breast milk, posing a risk of severe side effects in the child.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles, including riding a bicycle and operating machines. It is not expected that Fingolimod MSN will affect the ability to drive vehicles and operate machines. However, at the start of treatment, the patient must stay in the doctor's office or clinic for 6 hours after the first dose of Fingolimod MSN. During this time and potentially after it, the ability to drive vehicles and operate machines may be impaired.

3. How to take Fingolimod MSN

Treatment with Fingolimod MSN 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 0.5 mg capsule per day.

Children and adolescents (aged 10 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 MSN.

Other pharmaceutical companies offer capsules for children and adolescents with a body weight of 40 kg or less containing 0.25 mg of fingolimod. Do not exceed the recommended dose. Fingolimod MSN is intended for oral use. Fingolimod MSN should be taken once a day, with a glass of water. The capsules of Fingolimod MSN should always be swallowed whole, without opening. Fingolimod MSN can be taken with or without food. Taking Fingolimod MSN 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 MSN, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod MSN than recommended

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

Missing a dose of Fingolimod MSN

If the patient has been taking Fingolimod MSN for less than 1 month and has missed 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 MSN for at least 1 month and has missed taking 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 administration of the next dose. However, if the patient has missed taking 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 MSN

Do not stop treatment with Fingolimod MSN or change the dose without consulting your doctor. Fingolimod MSN 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 reduced, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod MSN, the patient should wait 6-8 weeks before starting new MS treatment. In patients resuming treatment with Fingolimod MSN after more than 2 weeks of stopping the medicine, the effect on heart rate observed usually after the first dose may occur again, and monitoring of the patient's condition in the doctor's office or clinic may be necessary due to the resumption of treatment. Do not resume treatment with Fingolimod MSN after a break of more than 2 weeks without consulting a doctor. The doctor will decide whether and how to monitor the patient after stopping treatment with Fingolimod MSN. If the patient thinks that their MS is getting worse after stopping treatment with Fingolimod MSN, they should immediately contact their doctor, as this situation can be serious. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• Cough with expectoration, feeling of discomfort in the chest, fever (symptoms of respiratory disorders)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain of the skin, usually above 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 type of skin cancer called basal cell carcinoma (BCC), which often occurs as a pearl-like lump, although it can also have a different appearance
• 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.

Less frequently(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 perceiving colors and details

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

• Posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, 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 lump, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar

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

• Abnormalities in the ECG recording (T-wave inversion)
• 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 itching hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fingolimod MSN
• 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, decreased appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure may require a liver transplant.
• 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 problems, difficulty speaking or communicating, which the doctor should evaluate 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 contact the doctor as soon as possible
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with 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 the presence of a painless lump with a fleshy or blue-red color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass. Long-term sun exposure and weakened immune system may affect the risk of developing Merkel cell carcinoma
• After stopping treatment with Fingolimod MSN, MS symptoms may recur 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 immediately contact their doctor.

Other side effects

Very commonly(may affect more than 1 in 10 people):

• Influenza infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever

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

• Sinusitis with symptoms such as feeling of pressure or pain in the cheeks and forehead
• Headache
• Diarrhea
• Back pain
• Increased liver enzyme activity in blood tests
• Cough

Less frequently(may affect up to 1 in 100 people):

• Fungal skin infections, dermatophyte infections (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching, 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 serious")
• Hypertension (Fingolimod MSN may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

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

• Low neutrophil count
• Depressed mood
• Nausea

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 contact their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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 By reporting side effects, more information can be collected on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Fingolimod MSN

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. Do not use medicines from damaged or opened packages. Store at a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fingolimod MSN contains

• The active substance of Fingolimod MSN is fingolimod.
• Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
• The other ingredients are: capsule filling: maize starch, fumaric acid, stearic acid capsule cap: gelatin, titanium dioxide (E 171), purified water capsule body: gelatin, titanium dioxide (E 171), purified water ink: iron oxide black (E 172), shellac (E 904), propylene glycol, potassium hydroxide.

How the medicinal product Fingolimod MSN looks like and what the pack contains

The hard capsules of Fingolimod MSN 0.5 mg consist of a white cap with the imprint "0.5 mg" and a white body with the imprint "MF". The capsules contain a white or almost white powder.
The hard capsules of Fingolimod MSN are available in blisters or unit dose blisters of PVC/PCTFE/PVC/Aluminium in a cardboard box, containing 7, 10, 14, 28, 30, 98, 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1 or 98 x 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:

Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Ltd.
KW20A, Corradino Park
Paola, PLA 3000
Malta

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

Denmark
Fingolimod Tiefenbacher
Czech Republic
Fingolimod Tiefenbacher
Ireland
Fingolimod Tiefenbacher 0.5 mg hard capsules
Netherlands
Fingolimod Tiefenbacher 0.5 mg hard capsules
Germany
Fingolimod Tiefenbacher 0.5 mg Hartkapseln
Poland
Fingolimod MSN
Romania
Fingolimod Tiefenbacher 0.5 mg capsule
Slovakia
Fingolimod Tiefenbacher 0.5 mg tvrdé kapsuly
Hungary
Fingolimod Tiefenbacher 0.5 mg kapszula

Date of last revision of the leaflet: 10/2024