Package leaflet: Information for the patient

INZOLFI, 0.25 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, pharmacist or nurse.
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 side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What INZOLFI is and what it is used for
What you need to know before taking INZOLFI
How to take INZOLFI
Possible side effects
How to store INZOLFI
Contents of the pack and other information

1. What INZOLFI is and what it is used for

What INZOLFI is
INZOLFI contains the active substance fingolimod.

What INZOLFI is used for
INZOLFI is used in adults, 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 with rapidly evolving, severe form of MS.

INZOLFI 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, inflammatory processes destroy 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 between patients but
typically include walking difficulties, numbness, vision problems or balance disturbances.
Symptoms of relapses may completely resolve, although some deficits may persist.

How INZOLFI works
INZOLFI 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 body and by preventing them from
entering the brain and spinal cord. In this way, the medicine reduces nerve damage caused by MS.
INZOLFI also reduces certain immune responses in the body.

2. Important information before using Inzolfi

When not to use Inzolfi

if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system);
if the patient has severe active infection or active chronic 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 whose electrocardiogram (ECG) showed QT interval prolongation before starting treatment with Inzolfi;
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 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 this is the case or the patient has any doubts, consult a doctor before using Inzolfi.

Warnings and precautions
Before starting Inzolfi, discuss with your doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been informed that their ECG tracing 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 eye problems;
if the patient has liver disease;
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 or the patient has any doubts, consult a doctor before taking Inzolfi.

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, Inzolfi 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 required. Inzolfi 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 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 Inzolfi 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 effects occur at the beginning of treatment. An ECG will be performed before the first dose of Inzolfi and again after the 6-hour observation period. During this time, the doctor may perform continuous monitoring of 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, prolonged monitoring of the patient (for at least 2 additional hours or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Inzolfi after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Inzolfi.

If the patient has irregular or abnormal heartbeat, risk factors for such events, abnormal ECG findings, or heart disease or heart failure, Inzolfi may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Inzolfi may not be suitable. Consultation with a cardiologist (a heart specialist) may be required to advise on how to start treatment with Inzolfi, including overnight monitoring.
If the patient is taking medicines that may slow heart rate, Inzolfi may not be suitable. Consultation with a cardiologist may be required to determine whether the patient can switch to other medicines that do not slow heart rate, to allow treatment with Inzolfi. If such a change is not possible, the cardiologist will advise the patient on how to start treatment with Inzolfi, including monitoring until the day after the first dose of Inzolfi.

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 Inzolfi. If this is the case, the doctor will delay the start of Inzolfi treatment by one month after completing the full vaccination course.

Infections
Inzolfi reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Inzolfi (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 fever, flu-like symptoms, shingles, or headache with neck stiffness, sensitivity to light, 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 a doctor immediately, as this condition may be serious 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 a 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 may consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether Inzolfi treatment should be discontinued.

In patients treated with Inzolfi, human papillomavirus (HPV) infection has been reported, including cases of warts, dysplasia, and HPV-related cancers. The doctor may consider HPV vaccination before starting treatment. In women, the doctor will also recommend HPV screening tests.

Macular oedema
Before starting treatment with Inzolfi, the doctor may refer patients with current or past 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 Inzolfi.

The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colours, and fine details. Inzolfi may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Inzolfi.

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 the doctor before resuming treatment with Inzolfi.

Macular oedema may cause vision disturbances similar to those during a multiple sclerosis (MS) attack (optic neuritis). In early stages, symptoms may be absent. Any changes in vision should be reported to the doctor. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurry or shaded;
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 Inzolfi. Inzolfi 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 Inzolfi, 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 Inzolfi may be discontinued.

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

Lung diseases
Inzolfi 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 known effect of Inzolfi is a reduction in the number of white blood cells in the blood. Their count usually returns to normal within 2 months after stopping treatment. If blood tests are needed, inform the doctor that the patient is taking Inzolfi. Otherwise, the doctor may not be able to interpret blood test results correctly, and for certain tests, the doctor may order a larger blood sample than usual.

Before starting Inzolfi, the doctor will confirm that the white blood cell count is appropriate to begin treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Inzolfi may need to be discontinued.

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

Cancer
In patients with MS treated with Inzolfi, skin cancers have been reported. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within several weeks appear on the skin, inform the 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. Skin examination for any lumps should be performed before starting treatment with Inzolfi. The doctor will also perform regular skin checks during treatment with Inzolfi. If skin problems occur, the doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.

In patients with MS treated with fingolimod, a 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 malignant tumours, especially skin cancers. The patient should limit sun and UV radiation exposure by:

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

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

Switching from other medicines to Inzolfi
The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Inzolfi, 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 2- to 3-month waiting period may be required before starting Inzolfi. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with the doctor before deciding whether Inzolfi is suitable.

Women of childbearing potential
If Inzolfi is used during pregnancy, it may harm the unborn child. Before starting treatment with Inzolfi, the doctor will explain the risks to the patient and request a pregnancy test to exclude pregnancy. The doctor will provide the patient with a card explaining why pregnancy should be avoided during Inzolfi treatment. The card also contains information on how to avoid pregnancy during Inzolfi treatment. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

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

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

Children and adolescents
Inzolfi 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 Inzolfi, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be required before starting Inzolfi treatment.
During the first dose of Inzolfi 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 Inzolfi treatment, inform the doctor.
If the patient develops depression or anxiety or feels low mood or anxiety during Inzolfi treatment, inform the doctor. The patient may require closer monitoring.

Inzolfi and other medicines
Inform the 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. Inzolfi must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to use Inzolfi").
Corticosteroids, due to the potential for additive effects on the immune system.
Vaccines. If the patient requires vaccination, they should consult the doctor first. During and for 2 months after Inzolfi treatment, 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 Inzolfi together with these medicines could intensify the effect on heart function in the first days of Inzolfi treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Inzolfi must not be used in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to use Inzolfi").
Other medicines: protease inhibitors, medicines used for infections 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 Inzolfi).

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

Pregnancy
Inzolfi must 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 Inzolfi 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 Inzolfi 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 defects of the heart, kidneys, and musculoskeletal system. Therefore, if the patient is of childbearing age:

before starting Inzolfi treatment, the doctor will inform the patient of the risk to the unborn child and request a pregnancy test to confirm the patient is not pregnant;
effective contraception must be used during Inzolfi treatment and for two 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 pregnancy should be avoided during Inzolfi treatment.
If the patient becomes pregnant while taking Inzolfi, inform the doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping Inzolfi" in section 3 and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.

Breastfeeding
Do not breastfeed while taking Inzolfi. Inzolfi 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 safe driving, including cycling, and operating machinery. Inzolfi 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 Inzolfi. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

3. How to take Inzolfi

Treatment with Inzolfi will be supervised by a physician experienced in managing multiple sclerosis.
This medicine should always be taken exactly as prescribed by the physician. In case of doubt, consult your doctor.

Recommended dose:
Adults:
The recommended dose is two 0.25 mg capsules per day.

Children and adolescents (aged 10 years and above):
The dose depends on body weight:

Children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day.
Children and adolescents weighing more than 40 kg: two 0.25 mg capsules per day.

Children and adolescents who start treatment with one 0.25 mg capsule per day and later achieve a stable body weight above 40 kg will receive instructions from their doctor to increase the dose to two 0.25 mg capsules per day. In such cases, it is recommended to repeat the observation period as after the first dose of the medicine.

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

Taking more Inzolfi than recommended
If a patient has taken more than the prescribed dose, they should contact their doctor immediately.

Missed dose of Inzolfi
If a patient has been taking Inzolfi for less than 1 month and misses a 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 Inzolfi for at least 1 month and has missed taking the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to observe the patient when administering the next dose. However, if the patient has missed taking the medicine 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 Inzolfi
Do not stop taking Inzolfi or change the dose without first consulting your doctor. Inzolfi may remain in the body for up to 2 months after stopping treatment. During this time, white blood cell counts (lymphocyte counts) may still be reduced, and adverse reactions described in this leaflet may continue to occur. After stopping treatment with Inzolfi, a waiting period of 6–8 weeks is required before starting a new treatment for multiple sclerosis.

For patients restarting treatment with Inzolfi after a break of more than 2 weeks, the effect on heart rate observed typically after starting treatment for the first time may reoccur, and monitoring of the patient in a doctor's office or clinic will be necessary upon resuming treatment. Do not restart treatment with Inzolfi after a break of more than two weeks without consulting your treating physician. The treating physician will decide whether and how the patient should be monitored after interruption of Inzolfi treatment. Inform your doctor immediately if you feel that your multiple sclerosis is worsening after stopping Inzolfi. This situation may be serious.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be or may become serious.

Common (may occur in fewer than 1 in 10 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 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 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 are known to occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with Inzolfi
Weight loss

Uncommon (may occur in fewer than 1 in 100 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 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 symptoms of melanoma include moles that change in size, shape, elevation or color over time, or new moles appearing. Moles may itch, bleed or ulcerate
Seizures, epileptic seizures (more common in children and adolescents than in adults)

Rare (may occur in fewer than 1 in 1000 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 tumor involving 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 fewer than 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 not known (frequency cannot be estimated from available data):

Allergic reactions, including rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day treatment with Inzolfi 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 an MS relapse. There may also be symptoms the patient is not aware of, such as changes in mood or behavior, temporary memory lapses, difficulty speaking and communicating, 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, photophobia, nausea and (or) confusion
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 Inzolfi treatment, 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 side effects occur in a patient, you should tell your doctor immediately.

Other possible side 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 cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Increased liver enzyme activity in blood tests
Cough

Common (may occur in fewer than 1 in 10 patients):

Fungal skin infections (dermatophyte-induced fungal infection) (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and sensitivity to light (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 "Some side effects may be or may become serious")
Hypertension (Inzolfi may cause a mild increase in blood pressure)
Muscle pain
Joint pain

Uncommon (may occur in fewer than 1 in 100 patients):

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

Rare (may occur in fewer than 1 in 1000 patients):

Lymphatic system tumor (lymphoma)

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

Peripheral edema

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

Reporting of side effects

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Side effects 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
Tel.: 22 49 21 301, Fax: 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of side effects helps to provide more information on the safety of the medicine.

5. How to store INZOLFI

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister
after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Inzolfi contains

The active substance is fingolimod.
Each hard capsule contains 0.25 mg of fingolimod in the form of fingolimod hydrochloride.
Other components are: Capsule contents: mannitol, hydroxypropylcellulose (E 463), hydroxypropylbetadex, magnesium stearate (E 470b). Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172). Printing ink: shellac (E 904), black iron oxide (E 172), propylene glycol (E 1520).

What Inzolfi looks like and contents of the pack
A 16 mm capsule with an opaque ivory-colored cap and body,
with radial black printing “FTY 0.25 mg” on the cap and a black band printed
on the body.
Inzolfi capsules are available in:

transparent PVC/PVDC/Aluminum blister packs containing 28 hard capsules, packed in a cardboard carton.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg, Bavaria
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Inzolfi 0.25 mg, hard capsules
Denmark Inzolfi
Finland Inzolfi 0.25 mg, hard capsules
Iceland Inzolfi 0.25 mg hörð hylki
Norway Inzolfi
Poland INZOLFI
Sweden Inzolfi 0.25 mg hårda kapslar
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00