Fingolimod fresenius kabi

Package leaflet: Information for the user

Fingolimod Fresenius Kabi, 0.5 mg, hard capsules
Fingolimodum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Fingolimod Fresenius Kabi is and what it is used for
2. What you need to know 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 Fingolimod Fresenius Kabi is and what it is used for

What Fingolimod Fresenius Kabi is
Fingolimod Fresenius Kabi contains the active substance fingolimod.

What Fingolimod Fresenius Kabi is used for
Fingolimod Fresenius Kabi is used in adult patients for the treatment of relapsing-remitting
multiple sclerosis (MS), particularly in:

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

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

What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain
and spinal cord. In MS, the inflammatory process destroys the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
The relapsing-remitting form of MS is characterized by repeated episodes (relapses) of neurological symptoms, reflecting inflammatory activity within the CNS. Symptoms vary among patients, but usually include walking difficulties, numbness, vision or balance problems. Symptoms of relapses may completely resolve, although some deficits may persist.

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 throughout the body and by preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage caused by MS. Fingolimod Fresenius Kabi also dampens certain immune responses in the body.

2. Important information before taking Fingolimod Fresenius Kabi

When not to take Fingolimod Fresenius Kabi

• if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or medications that suppress the immune system);
• if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has active cancer;
• if the patient has severe liver disease;
• if the patient has had a heart attack, angina, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom electrocardiographic examination (ECG) has shown QT interval prolongation before starting treatment with Fingolimod Fresenius Kabi;
• 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 pregnant or of childbearing potential and 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 if the patient has any doubts, they should consult their doctor before taking Fingolimod Fresenius Kabi.

Warnings and precautions
Before starting treatment with Fingolimod Fresenius Kabi, discuss with the doctor:

• if the patient has severe breathing problems during sleep (sleep apnoea);
• if the patient has been informed that their ECG recording 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 medications that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if the patient has previously experienced 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 problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye (a condition called macular oedema, see below), inflammation or infection of the eye (uveitis), or if the patient has diabetes (which may cause eye 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 smoker-type cough. If any of these situations apply to the patient, they should consult their doctor before taking Fingolimod Fresenius Kabi.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients who previously
received a 0.25 mg daily dose, Fingolimod Fresenius Kabi slows the heart rate.
As a result, the patient may feel dizzy, tired, have palpitations, or experience low blood pressure.
If these symptoms are severe, the doctor should be informed immediately, as immediate treatment may be necessary. Fingolimod Fresenius Kabi may also
cause irregular heartbeat, especially after the first dose. Irregular heartbeat
usually returns to normal within less than one day. Slow heart rate usually
returns to normal within one month.
The doctor will ask the patient to remain 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 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring
of pulse and blood pressure, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod
Fresenius Kabi and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using
electrocardiographic monitoring. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate, or if the ECG shows
abnormalities, longer monitoring of the patient's condition may be required (at least
2 hours longer or possibly until the next day), until these symptoms resolve. The same
approach may be recommended if the patient resumes treatment with Fingolimod Fresenius Kabi
after a treatment interruption, depending on how long the interruption lasted and how long the patient
had been taking Fingolimod Fresenius Kabi before the interruption.
If the patient has irregular or abnormal heartbeat, risk factors for these
events, abnormal ECG findings, heart disease, or heart failure,
Fingolimod Fresenius Kabi may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function,
Fingolimod Fresenius Kabi may not be suitable in these cases. A consultation with a cardiologist (a heart specialist) may be needed, who will advise on how to start
treatment with Fingolimod Fresenius Kabi, including how to monitor the patient overnight.
If the patient is taking medications that may slow heart rate, Fingolimod Fresenius Kabi
may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medications that do not slow heart rate, to allow treatment with Fingolimod Fresenius Kabi. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Fresenius Kabi, including monitoring until the day after administration of the first dose of Fingolimod Fresenius Kabi.

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, vaccination may be required before starting treatment with Fingolimod Fresenius Kabi. If this is the case, the doctor will delay the start of treatment with Fingolimod Fresenius Kabi by one month after completion of the full vaccination course.

Infections
Fingolimod Fresenius Kabi reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Fresenius Kabi (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Any existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects they have an infection, has a fever, flu-like symptoms, shingles, or headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), they should contact their doctor immediately, as this condition may be severe and life-threatening.
If the patient feels their disease is worsening (e.g. weakness or vision problems) or if they notice any new symptoms, they should speak to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor will consider performing an MRI scan to assess the patient's condition and decide whether stopping Fingolimod Fresenius Kabi is necessary.
In patients treated with fingolimod, human papillomavirus (HPV) infection has been reported, including cases of warts, cervical dysplasia, and HPV-related cancers.
The doctor may consider the need for HPV vaccination before starting treatment.
For women, the doctor will also recommend regular HPV screening tests.

Macular oedema
Before starting treatment with Fingolimod Fresenius Kabi, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye, inflammation or infection of the eye (uveitis), or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Fingolimod Fresenius Kabi.
The macula is a small area of the retina at the back of the eye that enables clear and sharp vision of shapes, colors, and other details. Fingolimod Fresenius Kabi may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Fresenius Kabi.
The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular oedema.
If the patient develops macular oedema, they should inform their doctor before resuming treatment with Fingolimod Fresenius Kabi.
Macular oedema may cause certain vision problems, similar to those in MS relapses (optic neuritis). In the early stages, symptoms may be absent.
The patient should inform their doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

• the center of the visual field becomes blurry or shadowed;
• a blind spot appears in the center of the visual field;
• there are difficulties seeing colors or fine details.

Liver function tests
Patients with severe liver disease should not take Fingolimod Fresenius Kabi.
Fingolimod Fresenius Kabi may affect liver function test results. The patient
probably will not experience any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark (brown) urine, pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting occur, the doctor should be informed immediately.
If any of the above symptoms occur after starting treatment with Fingolimod Fresenius Kabi, the doctor should be informed immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function.
If test results indicate liver function abnormalities, treatment with Fingolimod Fresenius Kabi may be discontinued.

High blood pressure
The doctor may regularly check blood pressure, as Fingolimod Fresenius Kabi causes a slight increase in blood pressure.

Lung problems
Fingolimod Fresenius Kabi has a minor effect on lung function. Patients with severe lung disease or smoker-type cough are at higher risk of adverse effects.

Blood cell count
A known effect of Fingolimod Fresenius Kabi is a reduction in the number of white blood cells in the blood. The number usually returns to normal within 2 months after stopping treatment.
If blood tests are needed, the patient should inform the doctor about taking Fingolimod Fresenius Kabi. Otherwise, the doctor may not be able to interpret the blood test results correctly, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting treatment with Fingolimod Fresenius Kabi, the doctor will confirm that the white blood cell count is adequate to start treatment and may order regular repeat tests.
If there are insufficient white blood cells, treatment with Fingolimod Fresenius Kabi may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with fingolimod, a rare condition called posterior reversible encephalopathy syndrome (PRES) has been reported. Symptoms of this condition may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod Fresenius Kabi, the patient should inform their doctor immediately, as this condition may be serious.

Cancer
In patients with MS treated with Fingolimod Fresenius Kabi, skin cancer has been reported.
If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within several weeks are noticed on the skin, the patient should inform their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in the skin tissue (e.g. new moles) that change in color, shape, or size over time. Before starting treatment with Fingolimod Fresenius Kabi, a skin examination should be performed to check for any skin lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod Fresenius Kabi. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
In patients with MS treated with fingolimod, a certain type of lymphatic system cancer (lymphoma) has been reported.

Sun exposure and sun protection
Fingolimod weakens the immune system. This condition increases the risk of developing malignant tumors, especially skin cancer. Patients should limit exposure to sunlight and UV radiation by:

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

Unusual brain lesions associated with MS relapses
In patients treated with fingolimod, rare cases of unusually large brain lesions associated with MS relapses have been reported. In the case of a severe MS relapse, the treating doctor may consider performing an MRI scan to assess this condition and decide whether stopping Fingolimod Fresenius Kabi is necessary.

Switching from other medications to Fingolimod Fresenius Kabi
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Fresenius Kabi, if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting Fingolimod Fresenius Kabi. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion of their situation with the doctor before deciding whether Fingolimod Fresenius Kabi is suitable for them.

Women of childbearing potential
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 request a pregnancy test to rule out pregnancy.
The doctor will provide the patient with a card explaining why she should not become pregnant while taking Fingolimod Fresenius Kabi. The card also contains information on how to avoid pregnancy while taking Fingolimod Fresenius Kabi. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping Fingolimod Fresenius Kabi
Do not stop taking Fingolimod Fresenius Kabi or change the dose without consulting the doctor.
The patient should inform the doctor immediately if they feel their MS is worsening after stopping treatment with Fingolimod Fresenius Kabi. This situation may be serious (see "Stopping treatment with Fingolimod Fresenius Kabi" in section 3 and section 4 "Possible side effects").

Elderly patients
Experience with Fingolimod Fresenius Kabi in elderly patients (over 65 years) is limited. If in doubt, consult a doctor.

Fingolimod Fresenius Kabi and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take:

• Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Fresenius Kabi must not be used together with these medicines, as this could intensify 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 vaccination, they should consult their doctor first. During and for 2 months after treatment with Fingolimod Fresenius Kabi, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if administered during this period.

• Medicines that slow heart rate (e.g. beta-blockers such as atenolol). Using Fingolimod Fresenius Kabi together with these medicines could intensify the effect on heart function in the first days of treatment with Fingolimod Fresenius Kabi.

• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Fresenius Kabi must not be used in patients taking these medicines, as
  its use could intensify the effect on irregular heartbeat (see also "When not
  to take Fingolimod Fresenius Kabi").

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Pregnancy
Fingolimod Fresenius Kabi should not be used 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 Fresenius Kabi is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in children exposed to fingolimod during pregnancy is approximately twice that observed in the general population (where the rate of congenital malformations is about 2-3%). The most commonly reported congenital malformations include developmental abnormalities of the heart, kidneys, and musculoskeletal system.
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 request a pregnancy test to confirm that the patient is not pregnant, and
• effective contraception must be used during treatment with Fingolimod Fresenius Kabi and for two months after stopping treatment to avoid pregnancy. The patient should discuss effective contraceptive methods with their doctor.

The doctor will provide the patient with a card explaining why she should not become pregnant while taking Fingolimod Fresenius Kabi.
If the patient becomes pregnant while taking Fingolimod Fresenius Kabi, she should inform her doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod Fresenius Kabi" in section 3 and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.

Breastfeeding
Breastfeeding should not be done while taking Fingolimod Fresenius Kabi. Fingolimod Fresenius Kabi may pass into human milk, posing a risk of serious adverse effects in the infant.

Driving and operating machinery
The doctor will inform the patient whether their condition allows them to safely drive vehicles, including bicycles, and operate machinery. Fingolimod Fresenius Kabi is not expected to affect the ability to drive or operate machinery.
However, at the beginning of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Fresenius Kabi. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

3. How to take Fingolimod Fresenius Kabi

Treatment with Fingolimod Fresenius Kabi will be supervised by a physician experienced in the treatment of MS.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

The recommended dose is:
Adults:
The recommended dose is one 0.5 mg capsule once daily.
Do not exceed the recommended dose.
Fingolimod Fresenius Kabi is intended for oral administration.
Fingolimod Fresenius Kabi should be taken once daily, with a glass of water. The capsules must always be swallowed whole, without opening. Fingolimod Fresenius Kabi may be taken with or without food.
Taking Fingolimod Fresenius Kabi at the same time each day will help you remember to take the medicine.
If you have any questions about how long treatment with Fingolimod Fresenius Kabi should continue, consult your doctor or pharmacist.

Taking more Fingolimod Fresenius Kabi than prescribed
If you have taken more than the prescribed dose, contact your doctor immediately.

If you forget to take Fingolimod Fresenius Kabi
If you have been taking Fingolimod Fresenius Kabi for less than 1 month and have missed a dose for a full day, you should contact your doctor before taking the next dose.
Your doctor may decide to observe you when you take the next dose.

If you have been taking Fingolimod Fresenius Kabi for at least 1 month and have missed doses for more than 2 weeks, you should contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed doses for up to 2 weeks, you may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Fresenius Kabi
Do not stop taking Fingolimod Fresenius Kabi or change the dose without first consulting your doctor.
Fingolimod Fresenius Kabi may remain in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocyte count) may still be reduced, and adverse effects described in this leaflet may still occur. After stopping treatment with Fingolimod Fresenius Kabi, you should wait 6–8 weeks before starting a new MS treatment.

For patients restarting treatment with Fingolimod Fresenius Kabi after a break of more than 2 weeks, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring in a doctor's office or clinic will be necessary when restarting treatment. Do not restart treatment with Fingolimod Fresenius Kabi after a break of more than two weeks without consulting your treating physician.

Your treating physician will decide whether and how you should be monitored after stopping treatment with Fingolimod Fresenius Kabi. You must inform your doctor immediately if you feel that your MS is worsening after stopping treatment with Fingolimod Fresenius Kabi. This situation may be serious.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be or may become serious.

Common (may occur in up to 1 in 10 patients):

• Productive cough, unspecified discomfort in the chest, fever (symptoms of lung disorders).
• Herpesvirus infection (shingles or cold sores) with symptoms such as blisters, burning, itching or pain in the skin, usually above the upper part of the body or face. Other symptoms may include fever and weakness in the early stage of 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 pearly nodule, although it may also have a different appearance.
• Depression and anxiety, occurring more frequently in the population of MS patients treated with fingolimod.
• Weight loss.

Uncommon (may occur in up to 1 in 100 patients):

• 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 blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details.
• Decreased number of blood platelets, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible signs of melanoma include moles that change in size, shape, elevation or pigmentation over time, or new moles appearing. Moles may itch, bleed or ulcerate.
• Seizures, epileptic fits.

Rare (may occur in up to 1 in 1,000 patients):

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual 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 nodule, an ulcer covered with a scab, or a new ulcer developing at the site of an existing scar.

Very rare (may occur in up to 1 in 10,000 patients):

• Abnormalities in ECG test results (T-wave inversion).
• Tumor associated with human herpesvirus type 8 infection (Kaposi's sarcoma).

Frequency unknown (frequency cannot be estimated from 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.
• Signs 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 side of the abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function test results. In very rare cases, liver failure may lead to the need for liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble a relapse of MS. There may also be symptoms that the patient may not be aware of, such as changes in mood or behavior, temporary memory lapses, difficulties in speaking and communication, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening or if the patient or their family notice any new or unusual symptoms, it is very important to inform the treating doctor as soon as possible.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, light sensitivity, nausea and (or) disorientation.
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the presence of a painless, flesh-colored or bluish-red nodule, often on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term exposure to sunlight and a weakened immune system may influence the risk of developing Merkel cell carcinoma.
• After discontinuation of treatment with Fingolimod Fresenius Kabi, MS symptoms may return and worsen compared to the period before and during treatment.
• Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia).

If any of these effects occur in the patient, inform the doctor immediately.

Other adverse effects

Very common (may occur in more than 1 in 10 patients):

• Influenza virus 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 occur in up to 1 in 10 patients):

• Fungal skin infections (dermatophyte-induced fungal infection) (pityriasis versicolor).
• Dizziness.
• Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine symptoms).
• Low number of white blood cells (lymphocytes, leukocytes).
• Weakness.
• Itchy, red, burning rash (rash).
• Itching.
• Increased levels of fats (triglycerides) in the blood.
• Hair loss.
• Shortness of breath.
• Depression.
• Blurred vision (see also the section on macular edema under the heading "Some adverse effects may be or may become serious").
• Hypertension (Fingolimod Fresenius Kabi may cause a mild increase in blood pressure).
• Muscle pain.
• Joint pain.

Uncommon (may occur in up to 1 in 100 patients):

• Low number of white blood cells (neutrophils).
• Depressed mood.
• Nausea.

Rare (may occur in up to 1 in 1,000 patients):

• Cancer of the lymphatic system (lymphoma).

Frequency unknown (frequency cannot be estimated from available data):

• Peripheral edema.

If any of these symptoms occur severely, inform the doctor.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Fingolimod Fresenius Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Fingolimod Fresenius Kabi contains

• The active substance is fingolimod.

Each capsule contains 0.5 mg of fingolimod (in the form of hydrochloride).

• The other ingredients are: Capsule fill: monohydrate potassium citrate, anhydrous colloidal silicon dioxide, magnesium stearate. Capsule shell: 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 a yellow cap.
Each cardboard box contains 7, 28 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Poland

Manufacturer/Importer
Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicine is authorised for marketing in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: