Fingolimod Fresenius Kabi

Leaflet accompanying the packaging: information for the user

Fingolimod Fresenius Kabi, 0.5 mg, hard capsules
Fingolimodum

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

1. What is Fingolimod Fresenius Kabi and what is it used for

What is Fingolimod Fresenius Kabi

Fingolimod Fresenius Kabi contains the active substance fingolimod.

What is Fingolimod Fresenius Kabi used for

Fingolimod Fresenius Kabi 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 Fresenius Kabi 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.

How Fingolimod Fresenius Kabi works

Fingolimod Fresenius Kabi 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.

2. Important information before taking Fingolimod Fresenius Kabi

When not to take Fingolimod Fresenius Kabi

• 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 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 Fresenius Kabi;
• if the patient is currently taking or has recently taken drugs for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or is of childbearing age and is not using effective contraception;
• if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these situations apply to the patient or they have doubts, they should consult a doctor before taking Fingolimod Fresenius Kabi.

Warnings and precautions

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

• if the patient has severe respiratory disorders 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 drugs that slow down the heart rate (such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if the patient has had sudden losses of consciousness or fainting in the past;
• if the patient plans to be vaccinated;
• if the patient has never had chickenpox;
• if the patient has visual disturbances or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) with posterior uveitis (inflammation of the uvea, the middle layer of the eye) or 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 apply to the patient, they should consult a doctor before taking Fingolimod Fresenius Kabi.

Low 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 Fresenius Kabi 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 Fresenius Kabi 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.

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 Fresenius Kabi 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 side effects occur that happen at the beginning of treatment, appropriate action can be taken.

Before the first dose of Fingolimod Fresenius Kabi and after completing the 6-hour observation, 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, 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.

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 Fresenius Kabi.

Infections

Fingolimod Fresenius Kabi reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Fingolimod Fresenius Kabi (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, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, and (or) confusion or seizures (which may 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.

Macular edema

Before starting treatment with Fingolimod Fresenius Kabi, the doctor may refer patients with existing or past visual disturbances or other symptoms of macular edema with posterior uveitis or diabetes for ophthalmological examinations.

The doctor may also refer the patient for ophthalmological examinations 3 to 4 months after starting treatment with Fingolimod Fresenius Kabi.

Macular edema is a condition where the macula becomes swollen. Fingolimod Fresenius Kabi may cause macular edema. Macular edema usually occurs within the first 4 months of treatment with Fingolimod Fresenius Kabi.

The risk of macular edema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will prescribe regular ophthalmological examinations to detect macular edema.

If the patient develops macular edema, they should inform their doctor before resuming treatment with Fingolimod Fresenius Kabi.

Macular edema can cause certain visual disturbances, such as those that occur during an MS relapse (optic neuritis). In the early stages, symptoms may not appear at all.

The patient should inform their doctor about any changes in vision. The doctor may refer the patient for ophthalmological 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 Fresenius Kabi. Fingolimod Fresenius Kabi 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, abnormal dark (brown) urine, pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should immediately tell their doctor.

If the patient experiences any of the above symptoms after starting treatment with Fingolimod Fresenius Kabi, they should immediately tell their doctor.

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 Fresenius Kabi may be discontinued.

High blood pressure

The doctor may regularly check the patient's blood pressure, as Fingolimod Fresenius Kabi can cause a slight increase in blood pressure.

Lung problems

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

White blood cell count

A expected effect of Fingolimod Fresenius Kabi 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 Fresenius Kabi. Otherwise, the doctor may not be able to interpret the results of the blood test, and in the case of certain tests, the doctor may prescribe a larger amount of blood to be taken than usual.

Before starting treatment with Fingolimod Fresenius Kabi, the doctor will check if the patient has a sufficient number of white blood cells in the blood to start treatment and may prescribe regular repetition of blood tests.

If there are not enough white blood cells, it may be necessary to discontinue treatment with Fingolimod Fresenius Kabi.

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). The symptoms of this condition may include severe headache, confusion, seizures, and changes in vision.

If the patient experiences any of these symptoms while taking Fingolimod Fresenius Kabi, they should immediately tell their doctor, as this condition can be severe.

Cancer

In patients with MS treated with Fingolimod Fresenius Kabi, there have been reports of skin cancer.

If the patient notices any lumps on their skin (e.g., shiny lumps with a pearl-like color), spots, or non-healing open sores, they should immediately 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 Fresenius Kabi, it is necessary to examine the skin for any lumps.

The doctor will also perform regular skin checks during treatment with Fingolimod Fresenius Kabi.

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.

Exposure to the sun and protection against sunlight

Fingolimod weakens the immune system. This increases the risk of developing malignant tumors, especially skin cancer.

Patients should limit their exposure to the sun and UV radiation by:

• wearing protective clothing;
• regularly applying sunscreen with a high degree of UV protection.

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 will consider performing an MRI to assess this condition and decide on the possible need to discontinue Fingolimod Fresenius Kabi.

Changing treatment from other drugs to Fingolimod Fresenius Kabi

The doctor may change treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Fresenius Kabi if there are no symptoms of abnormalities 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 Fresenius Kabi.

When changing treatment 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 Fresenius Kabi is suitable for them.

Women of childbearing age

If Fingolimod Fresenius Kabi is used during pregnancy, it may harm the unborn child.

Before starting treatment with Fingolimod Fresenius Kabi, 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 Fresenius Kabi.

The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Fresenius Kabi.

Patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod Fresenius Kabi

The patient should not stop taking Fingolimod Fresenius Kabi or change the dose without consulting their doctor.

The patient should immediately tell their doctorif they think their MS is worsening after stopping treatment with Fingolimod Fresenius Kabi.

This situation can be serious (see "Stopping treatment with Fingolimod Fresenius Kabi" in section 3, as well as section 4 "Possible side effects").

Elderly patients

Experience with the use of Fingolimod Fresenius Kabi in elderly patients (over 65 years) is limited.

In case of doubts, the patient should consult their doctor.

Fingolimod Fresenius Kabi 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 drugs, including other MS treatments, such as interferon-beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Fresenius Kabi should not be taken with these drugs, as it may increase the effect on the immune system (see also "When not to take Fingolimod Fresenius Kabi").
• Corticosteroids, due to the possibility of additive effects on the immune system.
• Vaccines. If the patient needs to be vaccinated, they should consult their doctor first. During and up to 2 months after treatment with Fingolimod Fresenius Kabi, patients should not receive certain types of vaccines (live attenuated vaccines), as they may cause the infection they are supposed to prevent. Other vaccines may also not be effective if given during this period.
• Drugs that slow down heart rate (e.g., beta-blockers, such as atenolol). Taking Fingolimod Fresenius Kabi with these drugs may increase the effect on heart rate in the first days of treatment with Fingolimod Fresenius Kabi.
• Drugs for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Fresenius Kabi should not be taken by patients taking these drugs, as it may increase the effect on irregular heartbeat (see also "When not to take Fingolimod Fresenius Kabi").

Other drugs:

• protease inhibitors, antiviral drugs, such as ketoconazole, azole antifungals, clarithromycin, or telithromycin;
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort preparations (possible risk of reduced efficacy of Fingolimod Fresenius Kabi).

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 Fresenius Kabi should not be taken during pregnancy if the patient is trying to become pregnant or if the patient can become pregnant and is not using effective contraception.

If Fingolimod Fresenius Kabi is used during pregnancy, it may harm the unborn child.

The risk of birth defects in children exposed to fingolimod during pregnancy is about twice as high as in the general population (where the risk of birth defects is about 2-3%).

The most commonly reported birth defects include heart, kidney, and musculoskeletal defects.

Therefore, if the patient is of childbearing age:

• before starting treatment with Fingolimod Fresenius Kabi, 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 Fresenius Kabi and for 2 months after stopping treatment to avoid becoming pregnant.

The doctor will give the patient a card explaining why they should not become pregnant while taking Fingolimod Fresenius Kabi.

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

The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod Fresenius Kabi" in section 3, as well as section 4 "Possible side effects").

The patient will also need to undergo prenatal check-ups.

Breastfeeding

Fingolimod Fresenius Kabi should not be taken during breastfeeding.

Fingolimod Fresenius Kabi 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 bicycles, and operate machines safely.

The patient should not expect Fingolimod Fresenius Kabi to affect their ability to drive vehicles and operate machines.

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 Fresenius Kabi.

During this time and potentially after it, the patient's ability to drive vehicles and operate machines may be impaired.

3. How to take Fingolimod Fresenius Kabi

Treatment with Fingolimod Fresenius Kabi will be supervised by a doctor with experience in treating MS.

This medicine should always be taken exactly as prescribed by the doctor.

In case of doubts, the patient should consult their doctor.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

The patient should not exceed the recommended dose.

Fingolimod Fresenius Kabi is intended for oral administration.

Fingolimod Fresenius Kabi should be taken once a day, with a glass of water.

The capsules should always be swallowed whole, without opening.

Fingolimod Fresenius Kabi can be taken with or without food.

Taking Fingolimod Fresenius Kabi 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 Fresenius Kabi, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Fresenius Kabi than recommended

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

Missing a dose of Fingolimod Fresenius Kabi

If the patient takes Fingolimod Fresenius Kabi for less than 1 month and forgets to take a 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 Fresenius Kabi 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.

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Fresenius Kabi

The patient should not stop taking Fingolimod Fresenius Kabi or change the dose without consulting their doctor.

Fingolimod Fresenius Kabi 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 Fresenius Kabi, the patient should wait 6-8 weeks before starting new MS treatment.

Patients resuming treatment with Fingolimod Fresenius Kabi after more than 2 weeks of stopping the medicine may experience the effect on heart rate again, which is usually observed after starting treatment for the first time, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment.

The patient should not resume treatment with Fingolimod Fresenius Kabi after a break of more than two weeks without consulting their doctor.

The doctor will decide how to monitor the patient after stopping treatment with Fingolimod Fresenius Kabi.

The patient should immediately tell their doctorif they think their MS is worsening after stopping treatment with Fingolimod Fresenius Kabi.

This situation can be serious.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fingolimod Fresenius Kabi 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, unpleasant feeling in the chest, fever (symptoms of respiratory disorders).
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on 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 appears as a shiny lump with a pearl-like color, although it can also have a different appearance.
• Depression and anxiety, which occur more frequently in the population of patients with MS 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, difficulties with color vision and fine details.
• Decreased 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 whose size, shape, elevation, or color changes over time or new moles that appear. Moles can be itchy, bleeding, or ulcerated.
• Seizures, epileptic fits.

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 changes in vision.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a hard, red lump, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar.

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

• Abnormalities in the ECG recording (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 Fresenius Kabi.
• Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right upper abdomen, dark (brown) urine, decreased appetite, fatigue, and abnormal liver function test results. 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 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 immediately tell their doctor.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and (or) disorientation.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include the presence of a painless lump with a raw meat or bluish-red color, often on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass. Prolonged sun exposure and weakened immune system can affect the risk of Merkel cell carcinoma.
• After stopping treatment with Fingolimod Fresenius Kabi, 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 immediately tell 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):

• Fungal skin infections (dermatophytosis) (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 serious or become serious").
• Hypertension (Fingolimod Fresenius Kabi may cause a mild increase in blood pressure).
• Muscle pain.
• Joint pain.

Uncommon (may affect up to 1 in 100 people):

• Low neutrophil count.
• Depressive 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 significant severity, the patient should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse.

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

Jerozolimskie Avenue 181C

02-222 Warsaw

phone: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Fingolimod Fresenius Kabi

The medicine should be stored out of the 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 store above 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine if the packaging is damaged or shows signs of opening.

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. Contents of the pack and other information

What Fingolimod Fresenius Kabi contains

• The active substance of the medicine is fingolimod.

Each capsule contains 0.5 mg of fingolimod (as hydrochloride).

• The other ingredients are: Capsule filling: potassium citrate monohydrate, colloidal silicon dioxide, magnesium stearate. Capsule body: gelatin, titanium dioxide (E171). Capsule cap: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

What Fingolimod Fresenius Kabi looks like and contents of the pack

Fingolimod Fresenius Kabi, 0.5 mg, hard capsules (16 mm, size 3) have a white body and yellow cap.

Each carton contains 7, 28, or 98 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

Taśmowa 7

02-677 Warsaw

Manufacturer/Importer

Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last update of the leaflet: