Package leaflet: Information for the user

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

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

Contents of the leaflet

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

1. What Chantico is and what it is used for

What Chantico is
Chantico contains the active substance fingolimod.

What Chantico is used for
Chantico is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

patients who have not responded to previous MS treatments, or
patients with rapidly evolving, severe forms of MS.

Chantico 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 damage the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.

Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary between individuals but typically include walking difficulties, numbness, vision disturbances, or balance problems. Symptoms of relapses may completely resolve, although some deficits may persist.

How Chantico works
Chantico helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from entering the brain and spinal cord. In this way, Chantico limits nerve damage caused by MS. Chantico also reduces certain immune responses in the body.

2. Important information before using Chantico

When not to use Chantico

if the patient has reduced immune response (due to immunodeficiency syndrome, illness, or taking medications that suppress the immune system);
if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis;
if the patient has active cancer;
if the patient has severe liver disease;
if the patient has had a heart attack, angina, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months;
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom electrocardiographic examination (ECG) has shown QT interval prolongation before starting treatment with Chantico;
if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or of childbearing potential and not using effective contraception;
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these situations apply or if the patient has any doubts, they should consult their doctor before using Chantico.

Warnings and precautions
Before starting treatment with Chantico, discuss with your doctor:

if the patient has severe breathing disorders during sleep (sleep apnea);
if the patient has been informed that their ECG reading is abnormal;
if the patient experiences symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medications that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting;
if the patient plans to be vaccinated;
if the patient has never had chickenpox;
if the patient has or has had vision disorders or other symptoms of swelling in the center of the visual field (macula) at the back of the eye (a condition called macular edema, 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 disease;
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 if the patient has any doubts, they should consult their doctor before taking Chantico.

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 daily dose of 0.25 mg fingolimod, Chantico slows heart rate. As a
result, the patient may experience dizziness, fatigue, strong heartbeat, or may develop
low blood pressure. If these symptoms are severe, the patient should inform their doctor, as
immediate treatment may be required. Chantico 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 usually 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 Chantico or after the first 0.5 mg dose when
changing treatment from a daily dose of 0.25 mg, with hourly measurement of pulse and blood
pressure, so that appropriate treatment can be administered if adverse reactions occur at the beginning of treatment. An ECG will be performed before the first dose of Chantico and after completion of the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiographic examination. 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 Chantico after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Chantico before the interruption.
If the patient has irregular or abnormal heartbeat, or risk factors for these
events, if there is an abnormal ECG reading or heart disease, or heart failure, Chantico may not be suitable for them.
If the patient has previously experienced sudden loss of consciousness or slowed heart function,
Chantico may not be suitable in these cases. Consultation
with a cardiologist (a heart specialist) may be required, who will advise on how to start treatment with
Chantico, including how to monitor the patient overnight.
If the patient is taking medications that may reduce heart rate, Chantico may not be
appropriate. Consultation with a cardiologist may be necessary to determine whether
the patient can switch to other medications that do not reduce heart rate, to
allow treatment with Chantico. If such a change in treatment is not possible, the cardiologist will advise
the patient on how to start treatment with Chantico, including monitoring until
the next day.
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 Chantico. If this
situation occurs, the doctor will delay the start of treatment with Chantico by one month after completing the full vaccination cycle.
Infections
Chantico reduces the number of white blood cells (particularly lymphocytes). White blood cells
fight infections. While taking Chantico (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, have a fever, flu-like symptoms, shingles, or headache accompanied by
neck stiffness, light sensitivity, nausea, rash, and (or) confusion or seizures
(these may be symptoms of meningitis and (or) encephalitis caused by
fungal or herpes virus infection), they should contact their doctor immediately, as this condition may be severe and life-threatening.
If the patient feels their condition is worsening (e.g., weakness or vision disturbances)
or if the patient notices any new symptoms, they should immediately speak with
their doctor, 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 discontinuation of Chantico is necessary.
Infections with human papillomavirus (HPV) have been reported in patients treated with Chantico,
including cases of warts, dysplasia, warts, and HPV-related malignant tumors.
The doctor will consider the need for HPV vaccination before starting treatment. In
women, the doctor will also recommend screening tests for HPV.
Macular edema
Before starting treatment with Chantico, the doctor may refer patients with current or
past vision disorders or other symptoms of swelling in the center of the visual field (macula) at the back of the eye, inflammation or infection of the eye (uveitis), or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting
treatment with Chantico.
The macula is a small area of the retina at the back of the eye that enables clear and sharp
vision of shapes, colors, and other details. Chantico may cause swelling
of the macula, a condition called macular edema. This swelling usually
occurs within the first 4 months of treatment with Chantico.
The risk of macular edema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular edema.
If the patient develops macular edema, they should inform their doctor before resuming
treatment with Chantico.
Macular edema may cause certain vision disturbance symptoms, similar to those in MS attacks (optic neuritis). In the early stages, symptoms may be absent. The patient should inform their doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially in the following cases:

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

Liver function tests
Chantico should not be used if the patient has severe liver disease. Chantico may affect liver function. The patient may not experience any
symptoms, but if the patient develops yellowing of the skin or whites of the eyes, abnormal dark-colored urine (brown), pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting, they should immediately inform their doctor.
If any of the above symptoms occur after starting treatment with Chantico, the patient should immediately inform their doctor.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function.
If test results indicate liver function disorders, treatment with Chantico may be discontinued.
High blood pressure
Since Chantico causes a slight increase in blood pressure, the doctor may order
regular blood pressure monitoring.
Lung diseases
Chantico has a minor effect on lung function. Patients with severe lung disease or smoker-type cough have an increased risk of adverse reactions.
Blood cell count
A known effect of Chantico is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, the patient should inform their doctor about taking Chantico. Otherwise, the doctor may not be able to interpret the blood test results, and for certain tests, the doctor may order a larger blood sample than usual. Before starting treatment with Chantico, the doctor will confirm that the patient has an adequate number of white blood cells in the blood to start treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Chantico may need to be discontinued.
Posterior reversible encephalopathy syndrome (PRES)
Posterior reversible encephalopathy syndrome (PRES) has been rarely reported in MS patients treated with Chantico. Symptoms may include sudden severe headache, confusion, seizures, and vision disturbances. If the patient experiences any of these symptoms while taking Chantico, they should immediately inform their doctor, as this may be a serious condition.
Cancer
Skin cancer has been reported in patients treated with Chantico. The patient should immediately inform their doctor if they develop any skin nodules (e.g., shiny, pearly nodules), spots, or open wounds that do not heal for several weeks. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., atypical moles) that change color, shape, or size over time. A skin examination is necessary before starting treatment with Chantico to detect any skin nodules. The treating doctor will also perform regular skin checks during treatment with Chantico. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
A certain type of lymphatic system tumor (lymphoma) has been reported in MS patients treated with fingolimod.
Sun exposure and sun protection
Fingolimod weakens the immune system. This increases the risk of malignant tumors, especially skin cancer. The patient should limit sun and UV radiation exposure by:

wearing appropriate protective clothing.
regularly applying sunscreen with high UV protection.

Unusual brain changes associated with MS relapse
Rare cases of unusually large brain changes associated with MS relapse have been reported in patients treated with Chantico. In case of severe MS relapse, the treating doctor will consider performing a magnetic resonance imaging (MRI) scan to assess this condition and decide on the possible need to discontinue Chantico.
Switching from other medications to Chantico
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Chantico, if there are no symptoms of abnormalities caused by previous treatment. The doctor may order blood tests to rule out these abnormalities.
After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting Chantico treatment. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated drug elimination procedure. If the patient was treated with alemtuzumab, careful evaluation and discussion with the doctor are required to decide whether Chantico is suitable for the patient.
Women of childbearing age
If Chantico is used during pregnancy, it may have harmful effects on the unborn child. Before starting treatment with Chantico, the doctor will explain the risks to the patient and order a pregnancy test to rule out pregnancy. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during Chantico treatment. The card also contains information on how to avoid pregnancy during Chantico treatment. The patient must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").
Worsening of MS after stopping Chantico treatment
Do not stop taking Chantico or change the dose without prior consultation with
the doctor.
The patient should immediately inform their doctor if they feel their MS is worsening after stopping Chantico treatment. This situation may be serious (see "Discontinuation of Chantico treatment" in section 3 and section 4 "Possible side effects").
Elderly patients
Experience with the use of Chantico in elderly patients (over 65 years) is limited. If in doubt, consult the doctor.
Children and adolescents
Chantico 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 and adolescents and their caregivers:

Before starting treatment with Chantico, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be necessary before starting Chantico treatment.
During the first dose of Chantico 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 Chantico treatment, they should inform their doctor.
If the patient has depression or anxiety or if the patient feels low mood or anxiety during Chantico treatment, they should inform their doctor. The patient may require closer monitoring.

Other medicines and Chantico
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

Medications that suppress or modulate the immune system, including other medications used in MS treatment, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Chantico must not be used together with these medications, as this could intensify the effect on the immune system (see also "When not to use Chantico").
Corticosteroids, due to the possibility of additive effects on the immune system.
Vaccines. If the patient requires vaccination, they should first consult their doctor. During and for 2 months after Chantico treatment, the patient 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.
Medications that slow heart function (e.g., beta-blockers such as atenolol). Using Chantico together with these medications could intensify the effect on heart function in the first days of Chantico treatment.
Medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Chantico must not be used if the patient is taking these medications, as this could intensify the effect on irregular heartbeat (see also "When not to use Chantico").
Other medications: protease inhibitors, medications used in 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 Chantico).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a
child, they should consult their doctor before using this medicine.
Pregnancy
Chantico 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 Chantico 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 Chantico during pregnancy is approximately twice that observed in the general population (in which the rate of congenital malformations is about 2-3%). The most commonly reported congenital malformations include heart, kidney, and musculoskeletal system defects.
Therefore, if the patient is of childbearing age:

before starting Chantico treatment, the doctor will inform the patient about the risks to the unborn child and order a pregnancy test to confirm that the patient is not pregnant, and
effective contraception must be used during Chantico treatment 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 an information card explaining why pregnancy should be avoided during Chantico treatment.
If the patient becomes pregnant while taking Chantico, they should immediately inform their doctor. The doctor will decide on discontinuing treatment (see "Discontinuation of Chantico treatment" in section 3 and section 4 "Possible side effects"). Specialized prenatal tests should be performed.
Breastfeeding
Breastfeeding should not be used during Chantico treatment. Chantico passes into the breast milk of nursing women, posing a risk of severe adverse effects in the child.
Driving and operating machinery
The doctor will inform the patient whether their condition allows driving vehicles, including bicycles, and safe operation of machinery. Chantico should not affect the patient's 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 Chantico. The patient's ability to drive vehicles and operate machinery may be impaired during this time and potentially afterward.

3. How to take Chantico

Treatment with Chantico will be supervised by a physician experienced in the management 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.

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

Children and adolescents with body weight of 40 kg or less: one 0.25 mg fingolimod capsule once daily. Other medicinal products containing fingolimod at a lower strength (in the form of 0.25 mg capsules) are available.
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 fingolimod capsule daily and subsequently reach a stable body weight above 40 kg will be advised by the physician to switch to one 0.5 mg capsule once daily. In this case, a repeat observation period, similar to that after the first dose, is recommended.

Do not exceed the recommended dose.
Chantico is intended for oral use.
Take Chantico once daily with a glass of water. Swallow the capsule whole without opening it. Chantico may be taken with or without food.
Taking Chantico at the same time each day will help you remember to take your medicine.
If you are unsure how long to continue taking Chantico, consult your doctor or pharmacist.

Overdose of Chantico
If you take more Chantico than prescribed, contact your doctor immediately.

Missed dose of Chantico
If you have been taking Chantico for less than 1 month and miss a dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.
If you have been taking Chantico for at least 1 month and miss doses for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you miss doses for up to 2 weeks, you may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping Chantico
Do not stop taking Chantico or change the dose without first consulting your doctor.
Chantico remains in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may remain reduced, and adverse reactions described in this leaflet may still occur. After stopping Chantico, wait 6–8 weeks before starting a new multiple sclerosis treatment.
If you need to restart Chantico more than 2 weeks after stopping treatment, the effect on heart rate, typically observed when 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 Chantico after a treatment break of more than two weeks without consulting your doctor.
Your doctor will decide whether and how you need to be monitored after stopping Chantico. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping Chantico. This situation may be serious.

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

4. Possible side effects

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

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

Cough with sputum production, feeling of discomfort in the chest, fever (symptoms of lung disorder).
Herpes virus infection (shingles or cold sores), with symptoms such as blisters, burning, itching or pain of the skin, usually on the upper body or face. Other symptoms may include fever and fatigue in the early stage of infection, followed by numbness, tingling, 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 take other forms.
Depression and anxiety are known to occur more frequently in the MS population and have also been reported in children and adolescents treated with fingolimod.
Weight loss.

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

Lung inflammation 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 dark spots in the field of vision, blurred vision, problems distinguishing 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 color over time, or the appearance of new moles. Moles may itch, bleed, or ulcerate.
Seizures, epileptic fits (more frequent in children and adolescents than in adults).

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

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual disturbances.
Lymphoma (a type of tumor affecting the lymphatic system).
Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab, or a new ulcer developing at the site of an existing scar.

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

Abnormalities in the ECG recording (T-wave inversion).
Tumor associated with human herpesvirus type 8 infection (Kaposi’s sarcoma).

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

Allergic reactions including symptoms such as rash or itchy hives, swelling of the lips, tongue or face, which are more likely to occur on the day of starting Chantico treatment.
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, temporary 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 relatives notice any new or unusual symptoms, it is very important to inform the 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 present 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 Chantico 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, the patient should inform their doctor immediately.

Other side effects
Very common (may affect more than 1 in 10 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 affect up to 1 in 10 patients):

Fungal skin 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 become serious”)
Hypertension (Chantico may cause a mild increase in blood pressure)
Muscle pain
Joint pain

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

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

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

Lymphatic system tumor (lymphoma)

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

Peripheral edema

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

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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. Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Chantico medication

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater 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 Chantico contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
Other ingredients are:
Capsule filling: monohydrate potassium citrate, anhydrous colloidal silicon dioxide, magnesium stearate
Capsule shell: titanium dioxide (E 171), gelatin
Capsule cap: iron oxide, yellow (E 172), titanium dioxide (E 171), gelatin

What Chantico looks like and contents of the pack
Chantico 0.5 mg is a hard gelatin capsule, 16 mm in size (size 3), with a white body and a yellow cap.
Chantico 0.5 mg, hard capsules, is available in blisters made of OPA/Aluminium/PVC/Aluminium, containing 28 hard capsules in a cardboard box.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
Synthon Hispania S.L.
C/ Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more detailed information, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]