Fingolimod bluefish

Package leaflet: Information for the patient

Fingolimod Bluefish, 0.5 mg, hard capsules
Fingolimodum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Fingolimod Bluefish contains the active substance fingolimod.
Fingolimod Bluefish is used in adults, children, and adolescents (aged 10 years and older)
for the treatment of relapsing-remitting multiple sclerosis (MS, Latin: Sclerosis multiplex),
particularly in:

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

Fingolimod Bluefish 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,
preventing them from functioning properly. This phenomenon is known as demyelination.
The relapsing-remitting form of MS is characterized by recurrent episodes (relapses) of neurological symptoms,
reflecting inflammatory activity within the CNS. Symptoms vary among patients, but usually include walking difficulties, numbness, visual disturbances, or balance problems. Symptoms of relapses may completely resolve, although some deficits may persist.
How Fingolimod Bluefish works
Fingolimod Bluefish helps protect the CNS from attacks by the immune system 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 Bluefish also suppresses certain immune responses in the body.

2. Important information before taking Fingolimod Bluefish

When not to take Fingolimod Bluefish

• if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or use of immunosuppressive medicines);
• 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 an electrocardiogram (ECG) has shown QT interval prolongation before starting treatment with Fingolimod Bluefish;
• if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or is of childbearing age 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 or the patient has any doubts, they should consult their doctor before taking Fingolimod Bluefish.

Warnings and precautions
Before starting Fingolimod Bluefish, discuss the following with your 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 medicines 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 centre 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 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 smoker-type cough. If any of these situations apply or the patient has any doubts, they should consult their doctor before taking Fingolimod Bluefish.

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 Bluefish slows heart rate.
As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary. Fingolimod Bluefish 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. During this period, no clinically significant effect on heart rate is generally expected.
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 Bluefish 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 treatment can be given if any adverse reactions occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod Bluefish and again after the 6-hour observation period.
During this time, the doctor may continuously monitor the patient's heart function using electrocardiography. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring may be required (at least 2 additional hours or possibly overnight) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Bluefish after a treatment interruption, depending on how long the interruption lasted and how long the patient had previously taken Fingolimod Bluefish.
If the patient has irregular or abnormal heartbeat, risk factors for such events, an abnormal ECG, heart disease, or heart failure, Fingolimod Bluefish may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Fingolimod Bluefish may not be suitable. A consultation with a cardiologist may be needed to advise on how to start treatment with Fingolimod Bluefish, including overnight monitoring.
If the patient is taking medicines that may reduce heart rate, Fingolimod Bluefish may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow treatment with Fingolimod Bluefish. If such a change is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Bluefish, including monitoring into the next day after the first dose.

Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the chickenpox virus (varicella zoster virus). If the patient is not protected against the virus, vaccination may be required before starting treatment with Fingolimod Bluefish. If this is the case, the doctor will delay the start of treatment with Fingolimod Bluefish by one month after completion of the full vaccination course.

Infections
Fingolimod Bluefish reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Bluefish (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. 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, 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 infection or herpes virus infection), they should contact their doctor immediately, as this condition may be severe and life-threatening.
If the patient feels their condition is worsening (e.g. weakness or vision problems) or notices 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 a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether treatment with Fingolimod Bluefish should be discontinued.
Cases of human papillomavirus (HPV) infection, including warts, dysplasia, papillomas, and HPV-related malignancies, have been reported in patients treated with Fingolimod Bluefish. The doctor may consider the need for HPV vaccination before starting treatment. In women, the doctor may also recommend routine HPV screening.

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

• the centre of the visual field becomes blurry or shadowed;
• a blind spot appears in the centre of the visual field;
• difficulty seeing colours or fine details occurs.

Liver function tests
Patients with severe liver disease should not take Fingolimod Bluefish. Fingolimod Bluefish may affect liver function. The patient may not experience any symptoms, but if they develop 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, they should inform their doctor immediately.
If any of these symptoms occur after starting treatment with Fingolimod Bluefish, they should inform their doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, treatment with Fingolimod Bluefish may be discontinued.

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

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

Blood cell count
A decrease in white blood cells (especially lymphocytes) is an expected effect of Fingolimod Bluefish. Their number usually returns to normal within 2 months after stopping treatment.
If blood tests are needed, inform the doctor that the patient is taking Fingolimod Bluefish. Otherwise, the doctor may not be able to interpret the blood test results correctly, and for certain tests, the doctor may require a larger blood sample than usual.
Before starting Fingolimod Bluefish, the doctor will confirm that the white blood cell count is appropriate to begin treatment and may recommend regular repeat testing. If there are insufficient white blood cells, treatment with Fingolimod Bluefish may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported in patients with MS treated with Fingolimod Bluefish. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If the patient experiences any of these symptoms while being treated with Fingolimod Bluefish, they should inform their doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in patients with MS treated with Fingolimod Bluefish. If the patient notices any lumps (e.g. shiny, pearly lumps), spots, or open sores on the skin that do not heal within several weeks, they should inform their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. new moles) that change in colour, shape, or size over time. A skin examination should be performed before starting treatment with Fingolimod Bluefish to check for any skin lumps. The doctor will also perform regular skin checks during treatment with Fingolimod Bluefish. If skin problems occur, the doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.
Cases of a certain type of lymphatic system cancer (lymphoma) have been reported in patients with MS treated with Fingolimod Bluefish.

Sun exposure and sun protection
Fingolimod weakens the immune system. This condition increases the risk of malignancies, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

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

Unusual brain changes associated with MS relapses
Rare cases of unusually large brain lesions associated with MS relapses have been reported in patients treated with Fingolimod Bluefish. In the case of a severe MS relapse, the treating doctor may consider performing an MRI scan to assess this condition and decide whether treatment with Fingolimod Bluefish should be discontinued.

Switching from other medicines to Fingolimod Bluefish
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Bluefish 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, a waiting period of 2 to 3 months may be required before starting Fingolimod Bluefish. 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 with their doctor before deciding whether Fingolimod Bluefish is suitable.

Women of childbearing age
If Fingolimod Bluefish is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Bluefish, 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 they should not become pregnant while taking Fingolimod Bluefish. The card also contains information on how to avoid pregnancy while taking Fingolimod Bluefish. 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 Bluefish
Do not stop taking Fingolimod Bluefish or change the dose without first consulting the doctor.
Inform the doctor immediately if the patient feels their MS is worsening after stopping treatment with Fingolimod Bluefish. This situation may be serious (see "Stopping treatment with Fingolimod Bluefish" in section 3 and section 4 "Possible side effects").

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

Children and adolescents
Fingolimod Bluefish is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
The warnings and precautions listed above also apply to children and adolescents.
The following information is particularly important for children, adolescents, and their caregivers:

• Before starting treatment with Fingolimod Bluefish, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be necessary before starting treatment with Fingolimod Bluefish.
• When first taking Fingolimod Bluefish or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
• If the patient experiences seizures or epileptic fits before or during treatment with Fingolimod Bluefish, inform the doctor.
• If the patient develops depression or anxiety or feels low mood or anxiety while taking Fingolimod Bluefish, inform the doctor. The patient may require closer monitoring.

Fingolimod Bluefish and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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. Do not use Fingolimod Bluefish together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fingolimod Bluefish").
• Corticosteroids, due to the potential for additive effects on the immune system.
• Vaccines. If the patient requires vaccination, they should consult their doctor first. During and for 2 months after treatment with Fingolimod Bluefish, 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 given during this period.
• Medicines that slow heart rate (e.g. beta-blockers such as atenolol). Using Fingolimod Bluefish together with these medicines could intensify the effect on heart rate in the first days of treatment with Fingolimod Bluefish.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Do not use Fingolimod Bluefish in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Fingolimod Bluefish").
• Other medicines: protease inhibitors, antiviral medicines such as ketoconazole, azole antifungals, clarithromycin or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort (potential risk of reduced effectiveness of Fingolimod Bluefish).

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

Pregnancy
Fingolimod Bluefish 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 Bluefish is used during pregnancy, there is a risk of harmful effects on the unborn child. The rate of congenital malformations observed in children exposed to Fingolimod Bluefish 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 Bluefish, the doctor will inform the patient of the risks to the unborn child and request a pregnancy test to confirm that the patient is not pregnant;
• effective contraception must be used during treatment with Fingolimod Bluefish 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 Bluefish. If the patient becomes pregnant while taking Fingolimod Bluefish, she must inform her doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod Bluefish" in section 3 and section 4 "Possible side effects"). The patient will also need to attend follow-up prenatal examinations.

Breastfeeding
Do not breastfeed while taking Fingolimod Bluefish. Fingolimod Bluefish may pass into breast 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 drive safely, including cycling, and operate machinery. Fingolimod Bluefish 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 Bluefish. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

Fingolimod Bluefish contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. the medicine is considered "sodium-free".

3. How to take Fingolimod Bluefish

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

Recommended dose:
Adults:
One 0.5 mg capsule once daily.

Use in children and adolescents (aged 10 years and above):
Dose depends on body weight:

• Children and adolescents with body weight less than or equal to 40 kg: one 0.25 mg capsule once daily.
• Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily.
  Children and adolescents who started treatment with one 0.25 mg capsule once daily and later achieve a stable body weight above 40 kg will receive instructions from their doctor to switch to one 0.5 mg capsule once daily. In this case, repeat observation period as after the first dose is recommended.

Do not exceed the recommended dose.
Fingolimod Bluefish is intended for oral administration.
Fingolimod Bluefish should be taken once daily, with a glass of water. Fingolimod Bluefish capsules should always be swallowed whole, without opening. Fingolimod Bluefish may be taken with or without food.
Taking Fingolimod Bluefish at the same time each day will help you remember to take your dose.
If you have any questions about the duration of treatment with Fingolimod Bluefish, consult your doctor or pharmacist.

Taking more than the recommended dose of Fingolimod Bluefish
If a patient takes more than the recommended dose, they should contact their doctor immediately.

Missing a dose of Fingolimod Bluefish
If a patient has been taking Fingolimod Bluefish for less than 1 month and forgets to take one dose for a full day, they should contact their doctor before taking the next dose.
The doctor may decide to observe the patient when administering the next dose.

If a patient has been taking Fingolimod Bluefish 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 observe the patient when administering the next dose. However, if the patient has missed doses for up to 2 weeks, they may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Bluefish
Do not stop taking Fingolimod Bluefish or change the dosing regimen without first consulting your doctor.
Fingolimod Bluefish remains in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may remain low, and adverse reactions described in this leaflet may still occur.
After stopping Fingolimod Bluefish, wait 6–8 weeks before starting a new treatment for multiple sclerosis.

In patients restarting Fingolimod Bluefish 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 required when resuming treatment.
Do not restart treatment with Fingolimod Bluefish after a break of more than two weeks without consulting your treating physician.

Your treating physician will decide whether and how monitoring should be performed after stopping treatment with Fingolimod Bluefish. Inform your doctor immediately if you feel that your multiple sclerosis is worsening after stopping Fingolimod Bluefish. This situation may be serious.

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

4. Possible adverse reactions

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

Common (may affect less than 1 in 10 people):

• Productive cough, unspecified chest discomfort, fever (signs of lung disorders).
• Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning, itching or pain of the skin, usually above the upper part of the body or face. Other symptoms may include fever and malaise in the early stage of infection, followed by numbness, itching or red patches 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 are known to occur with increased frequency in the population of patients with MS and have also been reported in children and adolescents treated with Fingolimod Bluefish.
• Weight loss.

Uncommon (may affect less than 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 blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details.
• Decreased platelet count, 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 whose size, shape, elevation or color may change over time, or the appearance of new moles. Moles may itch, bleed or ulcerate.
• Seizures, epileptic seizures (more frequent in children and adolescents than in adults).

Rare (may affect less than 1 in 1,000 people):

• 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 firm, red nodule, an ulcer covered with a scab or a new ulcer developing at the site of an existing scar.

Very rare (may affect less than 1 in 10,000 people):

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

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

• Allergic reactions, including rash or itchy hives, swelling of the lips, tongue or face, which are more likely to occur on the day treatment with Fingolimod Bluefish is started.
• 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 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 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 the patient is not aware of, such as changes in mood or behavior, transient memory lapses, difficulties in speaking and communicating, which should be evaluated by a physician 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 physician 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 symptoms of Merkel cell carcinoma include the presence of a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma.
• After discontinuation of treatment with Fingolimod Bluefish, MS symptoms may recur 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 adverse reactions occur, you should immediately inform your doctor.

Other adverse reactions

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

• Viral influenza infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Feeling of pressure or pain in cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Increased liver enzyme activity in blood tests
• Cough

Common (may affect less than 1 in 10 people):

• Fungal skin infections (dermatophytosis) (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 blood levels of fats (triglycerides)
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also section on macular edema under "Some adverse reactions may be or may become serious")
• Hypertension (Fingolimod Bluefish may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon (may affect less than 1 in 100 people):

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

Rare (may affect less than 1 in 1,000 people):

• Lymphatic system cancer (lymphoma)

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

• Peripheral edema

If any of these symptoms occur severely, you should inform your doctor.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fingolimod Bluefish

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after: Expiry date (EXP). The expiry date refers to the last day of the stated month.

PVC/PVDC/Aluminum blisters: Store below 30°C.
PVC/PE/PVDC/Aluminum blisters: No special storage conditions apply.

Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fingolimod Bluefish contains

• The active substance is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
• The other ingredients are: calcium hydrogen phosphate dihydrate (E 341), sodium croscarmellose (E 468), hydroxypropyl cellulose (E 463) and magnesium stearate. Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172). Printing ink: shellac, propylene glycol (E 1520), concentrated ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

What Fingolimod Bluefish looks like and contents of the pack
Fingolimod Bluefish is a hard capsule with a yellow cap and a white, opaque body, printed with black ink “FD 0.5 mg” on the cap.
Fingolimod Bluefish is available in blisters of 28 or 98 hard capsules.
The blisters are packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer
Genepharm S.A.
18 km Marathonos Avenue
153 51 Pallini Attiki
Greece

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