Fingolimod +pharma: detailed information

Package leaflet: Information for the user

Fingolimod +pharma, 0.5 mg, hard capsules
Fingolimodum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Fingolimod +pharma is and what it is used for
Important information before taking Fingolimod +pharma
How to take Fingolimod +pharma
Possible side effects
How to store Fingolimod +pharma
Contents of the pack and other information

1. What Fingolimod +pharma is and what it is used for
What Fingolimod +pharma is
Fingolimod +pharma contains the active substance fingolimod.
What Fingolimod +pharma is used for
Fingolimod +pharma is used in adults and in children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS, sclerosis multiplex), particularly in:

patients who have not responded to MS treatment, or
patients who have a rapidly progressing, severe form of MS

Fingolimod +pharma 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, an inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
Relapsing-remitting MS is characterised by recurrent 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 impairments may persist.
How Fingolimod +pharma works
Fingolimod +pharma helps protect the CNS from attack by the immune system by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the patient's body and by preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage causing MS. Fingolimod +pharma also reduces certain immune responses in the body.

2. Important information before taking Fingolimod +pharma

When not to take Fingolimod +pharma

if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6)
if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or use of immunosuppressive medicines)
if the doctor suspects the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed
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 stroke warning signs, 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 whose electrocardiogram (ECG) showed a prolonged QT interval before starting treatment with Fingolimod +pharma
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 this applies to the patient or if the patient has any doubts, please consult the doctor before taking Fingolimod +pharma.

Warnings and precautions
Before starting Fingolimod +pharma, discuss with the doctor:

if the patient has severe breathing problems during sleep (sleep apnoea)
if the patient has been told that their ECG recording is abnormal
if the patient experiences symptoms of a slow heart rate (e.g. dizziness, nausea, or palpitations)
if the patient is taking or has recently taken medicines that slow the 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 cough typical of smokers If any of these situations apply to the patient or if the patient has any doubts, please consult the doctor before taking Fingolimod +pharma.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients previously taking a 0.25 mg daily dose of fingolimod, Fingolimod +pharma slows the heart rate. As a result, the patient may feel dizzy, tired, have a strong heartbeat, or experience low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary. Fingolimod +pharma may also cause an irregular heartbeat, especially after taking the first dose.
Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is 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 +pharma or after the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly measurement of pulse and blood pressure, so that appropriate treatment can be administered if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod +pharma and 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, the patient may need longer monitoring (for at least 2 additional hours or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod +pharma after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod +pharma before the interruption.
If the patient has an irregular or abnormal heartbeat or risk factors for these events, has an abnormal ECG, or has heart disease or heart failure, Fingolimod +pharma may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Fingolimod +pharma may not be appropriate. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start treatment with Fingolimod +pharma, including how to monitor the patient overnight.
If the patient is taking medicines that may reduce heart rate, Fingolimod +pharma 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 +pharma. If such a change is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod +pharma, including monitoring until the day after the first dose of Fingolimod +pharma.

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 +pharma. In such cases, the doctor will delay the start of treatment with Fingolimod +pharma by one month after completing the full vaccination course.

Infections
Fingolimod +pharma reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod +pharma (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 an infection, has a fever, flu-like symptoms, shingles, or a 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 infections), the patient should contact the doctor immediately, as this condition may be serious and life-threatening.
Infections with human papillomavirus (HPV) have been reported in patients treated with Fingolimod +pharma, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor will consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV.

PML
PML (progressive multifocal leukoencephalopathy) is a rare brain disorder caused by infection that may lead to severe disability or death. The treating doctor will order magnetic resonance imaging (MRI) scans before and during treatment to monitor the risk of PML.
If the patient feels that their multiple sclerosis is worsening or if they notice new symptoms, such as changes in mood or behaviour, new weakness or worsening of existing weakness on one side of the body, vision changes, confusion, memory loss, or difficulties with speech and communication, they should speak to the doctor as soon as possible. These may be symptoms of PML. The patient should also talk to their partner or caregivers and inform them about the treatment. Symptoms may occur that the patient is not aware of.
If PML occurs, treatment may be required, and treatment with Fingolimod +pharma will be stopped. In some patients, after removing Fingolimod +pharma from the body, an inflammatory reaction may occur. This reaction (called immune reconstitution inflammatory syndrome or IRIS) may lead to worsening of the patient's condition, including worsening of brain function.

Macular oedema
Before starting treatment with Fingolimod +pharma, 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 3-4 months after starting treatment with Fingolimod +pharma.
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 other details. Fingolimod +pharma may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Fingolimod +pharma.
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, inform the doctor before resuming treatment with Fingolimod +pharma.
Macular oedema may cause certain vision disturbances, similar to those in an MS attack (optic neuritis). In the early stages, symptoms may be absent. Report any changes in vision to the doctor. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurred or shaded
a blind spot appears in the centre of the visual field
there are difficulties seeing colours or fine details

Liver function tests
Patients with severe liver disease should not take Fingolimod +pharma.
Fingolimod +pharma may affect liver function test results. The patient may 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, inform the doctor immediately.
If any of these symptoms occur after starting treatment with Fingolimod +pharma, inform the 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 +pharma may be stopped.

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

Lung problems
Fingolimod +pharma has a minor effect on lung function. Patients with severe lung disease or a smoker's cough are at higher risk of adverse effects.

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

Posterior reversible encephalopathy syndrome (PRES)
Rarely, patients with MS treated with Fingolimod +pharma have reported a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod +pharma, inform the doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in patients with MS treated with Fingolimod +pharma. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within several weeks are noticed on the skin, inform the treating 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. Before starting treatment with Fingolimod +pharma, a skin examination must be performed to check for any lumps on the skin. The treating doctor will also perform regular skin checks during treatment with Fingolimod +pharma. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
Lymphoma, a type of lymphatic system cancer, has been reported in patients with MS treated with Fingolimod +pharma.

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

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

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

Switching from other medicines to Fingolimod +pharma
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod +pharma 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, it may be necessary to wait 2 to 3 months before starting Fingolimod +pharma. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated drug elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion of their situation with the doctor before deciding whether Fingolimod +pharma is suitable.

Women of childbearing age
If Fingolimod +pharma is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod +pharma, 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 +pharma. The card also contains information on how to avoid pregnancy while taking Fingolimod +pharma. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod +pharma
Do not stop taking Fingolimod +pharma or change the dose without first consulting the doctor.
Inform the doctor immediately if the patient feels that their MS is worsening after stopping treatment with Fingolimod +pharma. This situation may be serious (see "Stopping treatment with Fingolimod +pharma" in section 3 and section 4 "Possible side effects").

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

Children and adolescents
Fingolimod +pharma 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 +pharma, 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 +pharma.
during the first dose of Fingolimod +pharma 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 seizures or epileptic fits occur before or during treatment with Fingolimod +pharma, inform the doctor
if depression or anxiety occurs, or if the patient feels low mood or anxiety while taking Fingolimod +pharma, inform the doctor. The patient may require closer monitoring.

Fingolimod +pharma and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Inform the doctor if the patient is taking any of the following medicines:

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 +pharma with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fingolimod +pharma")
corticosteroids - due to the possibility of additive effects on the immune system
vaccines - if the patient requires vaccination, they should consult the doctor first. During treatment and for 2 months after stopping Fingolimod +pharma, 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 +pharma with these medicines could intensify the effect on heart function in the first days of treatment with Fingolimod +pharma
medicines for irregular heartbeat, such as: quinidine, disopyramide, amiodarone, or sotalol. Do not use Fingolimod +pharma in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Fingolimod +pharma")
other medicines:
- protease inhibitors, antiviral medicines, such as ketoconazole, azole antifungals, clarithromycin, or telithromycin
- carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort preparations (possible risk of reduced effectiveness of Fingolimod +pharma)

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult the doctor or pharmacist before taking this medicine.
Pregnancy
Fingolimod +pharma 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 +pharma 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 +pharma during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most commonly reported congenital malformations include heart, kidney, and musculoskeletal system developmental defects.
For this reason, if the patient is of childbearing age:

before starting treatment with Fingolimod +pharma, 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 +pharma and for 2 months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with the doctor.

The doctor will provide the patient with a card explaining why she should not become pregnant while taking Fingolimod +pharma.
If the patient becomes pregnant while taking Fingolimod +pharma, inform the doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod +pharma" in section 3 and section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod +pharma. Fingolimod +pharma 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 safely drive vehicles, including bicycles, and operate machinery. Fingolimod +pharma is not expected to affect the ability to drive vehicles and 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 +pharma. During this time or potentially after this period, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod +pharma
Treatment with Fingolimod +pharma will be supervised by a doctor experienced in treating multiple sclerosis.
This medicine should always be taken as prescribed by the doctor. If in doubt, consult the doctor.
Recommended dose
Adults
The dose is one 0.5 mg capsule per day.
Children and adolescents (aged 10 years and older)
The dose depends on body weight

children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule per day
children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day

Children and adolescents starting treatment with one 0.25 mg capsule per day who later achieve a stable body weight above 40 kg will receive instructions from the doctor to change the dose to one 0.5 mg capsule once daily. In this case, repeating the observation period as after the first dose is recommended.
Do not exceed the recommended dose.
Fingolimod +pharma is available only as 0.5 mg capsules. Therefore, if lower doses are required, another medicine should be used.
Fingolimod +pharma is intended for oral administration.
Fingolimod +pharma should be taken once daily with a glass of water. Fingolimod +pharma capsules should always be swallowed whole, without opening them.
Fingolimod +pharma can be taken with or without food. Taking Fingolimod +pharma at the same time each day will help remember to take the medicine.
For questions about the duration of treatment with Fingolimod +pharma, consult the doctor or pharmacist.
Taking more Fingolimod +pharma than recommended
If the patient takes too much Fingolimod +pharma, they should contact the doctor immediately.
Missing a dose of Fingolimod +pharma
If the patient has been taking Fingolimod +pharma for less than one month and forgets to take the first dose for a whole day, they should contact the doctor before taking the next dose. The doctor may decide to keep the patient under observation when taking the next dose.
If the patient has been taking Fingolimod +pharma for at least one month and forgets to take it for more than 2 weeks, they should contact the doctor before taking the next dose. The doctor may decide to keep the patient under observation when taking the next dose. However, if the patient forgets to take the medicine for up to 2 weeks, they may take the next dose as planned.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Fingolimod +pharma
Do not stop treatment with Fingolimod +pharma or change the dosage without first consulting the doctor.
Fingolimod +pharma remains in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocyte count) may also be reduced, and adverse effects described in this leaflet may still occur. After stopping treatment with Fingolimod +pharma, wait 6-8 weeks before starting a new MS treatment.
In patients resuming treatment with Fingolimod +pharma after more than 2 weeks since stopping the medicine, the effect on heart rate, usually observed after starting treatment for the first time, may reoccur, and monitoring of the patient in the doctor's office or clinic will be necessary due to resuming treatment. Do not resume treatment with Fingolimod +pharma after a break lasting more than 2 weeks without consulting the treating doctor.
The treating doctor will decide whether and how to monitor the patient after stopping treatment with Fingolimod +pharma. Inform the doctor immediately if the patient feels that their MS is worsening after stopping treatment with Fingolimod +pharma. This situation may be serious.
If you have any further questions about using this medicine, please 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 1 to 10 out of 100 patients)

productive cough, unspecified discomfort in the chest, fever (symptoms of lung disorders)
herpesvirus infection (shingles or herpes simplex) with symptoms such as: blisters, burning sensation, itching or pain in 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, ang. basal cell carcinoma), which often appears as a pearly nodule, although it may also have a different appearance
depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with fingolimod
weight loss

Uncommon (may occur in 1 to 10 out of 1,000 patients)

pneumonia with symptoms such as fever, cough, difficulty breathing
macular edema (swelling in the center of the retina at the back of the eye) with symptoms such as: shadows or blind spots in the center of vision, 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 that change in size, shape, elevation or pigmentation over time, or the appearance of new moles. Moles may itch, bleed or ulcerate.
seizures, epileptic seizures (more frequently in children and adolescents than in adults)

Rare (may occur in 1 to 10 out of 10,000 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 crust or a new ulcer developing at the site of an existing scar

Very rare (may occur in less than 1 out of 10,000 patients)

abnormalities in ECG findings (T-wave inversion)
tumor associated with human herpesvirus 8 infection (Kaposi’s sarcoma)

Frequency not known (frequency cannot be estimated from 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 of starting treatment with Fingolimod +pharma
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 tests. 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 MS relapse. There may also be symptoms not noticed by the patient, such as changes in mood or behavior, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a doctor to exclude 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 doctor as soon as possible.
inflammatory disorders after discontinuation of Fingolimod +pharma treatment (known as immune reconstitution inflammatory syndrome or IRIS)
cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as: headache accompanied by neck stiffness, sensitivity to light, nausea and (or) confusion
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 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 stopping treatment with Fingolimod +pharma, 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, you should immediately inform the
doctor.
Other adverse effects
Very common (may occur in more than 1 out of 100 patients)

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 occur in 1 to 10 out of 100 patients)

fungal skin infections – dermatophyte-induced fungal infection (tinea versicolor)
dizziness
severe headache, often accompanied by nausea, vomiting and sensitivity to light (migraine)
low number of white blood cells (lymphocytes, leukocytes)
weakness
itchy, red, burning rash (rash)
itching
increased blood fat levels (triglycerides)
hair loss
shortness of breath
depression
blurred vision (see also the section on macular edema “Some adverse effects may be or may become serious”)
hypertension (Fingolimod +pharma may cause a mild increase in blood pressure)
muscle pain
joint pain

Uncommon (may occur in 1 to 10 out of 1,000 patients)

low number of white blood cells (neutrophils)
depressive mood
nausea

Rare (may occur in 1 to 10 out of 10,000 patients)

cancer of the lymphatic system (lymphoma)

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

peripheral edema

If any of these symptoms are severe, you should inform the
doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring of 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 effects can also be reported to the marketing authorization holder or its representative
in Poland. Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Fingolimod +pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This helps protect the environment.

6. Contents of the pack and other information

What Fingolimod +pharma contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other ingredients are:
Capsule contents: calcium hydrogen phosphate, hydroxypropyl cellulose, magnesium stearate
Capsule shell: gelatin, titanium dioxide (E 171)
Capsule cap: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172)
Printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527)

What Fingolimod +pharma looks like and contents of the pack
Fingolimod +pharma, 0.5 mg, hard capsules, consists of a white or almost white body and a yellow cap marked with "C886 0.5 mg" printed on the cap.
Fingolimod +pharma is available in packs containing 7, 7x1, 10, 14, 28, 30, 84, 98, and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Coripharma ehf.
Reykjavikurvegur 78-80
220 Hafnarfjörður
Iceland
Genericon Pharma Gesellschaft m.b.H.
Hafnerstraße 211
8054 Graz
Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Fingolimod +pharma
Czech Republic Fingolimod +pharma
Austria Fingolimod Genericon 0.5 mg Hartkapseln

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]