Hantico

Leaflet accompanying the packaging: information for the user

Chantico, 0.5 mg, hard capsules
Fingolimod

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Chantico and what is it used for
• 2. Important information before taking Chantico
• 3. How to take Chantico
• 4. Possible side effects
• 5. How to store Chantico
• 6. Package contents and other information

1. What is Chantico and what is it used for

What is Chantico

Chantico contains the active substance fingolimod.

What is Chantico used for

Chantico is used in adults and children and adolescents (aged 10 and over) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

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

Chantico does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS.

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.
The relapsing-remitting form of MS is characterized by recurring episodes (relapses) of neurological symptoms, reflecting the inflammatory process in the CNS. Symptoms vary from patient to patient, but usually include walking difficulties, numbness, vision problems, or balance problems. Relapse symptoms may completely disappear, but some disturbances 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 in the patient's body and preventing them from entering the brain and spinal cord. In this way, Chantico limits nerve damage caused by MS. Chantico also weakens some immune system reactions.

2. Important information before taking Chantico

When not to take Chantico

• if the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive drugs);
• if the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has an active malignant disease;
• if the patient has severe liver disease;
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke in the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), which includes patients who have had an electrocardiogram (ECG) showing a prolonged QT interval 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 is of childbearing age and is 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 doubts, they should consult their doctor before taking Chantico.

Warnings and precautions

Before starting treatment with Chantico, the patient should discuss the following with their doctor:

• if the patient has severe respiratory problems during sleep (sleep apnea);
• if the patient has been informed that their ECG is abnormal;
• if the patient has symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations);
• if the patient is taking or has recently taken medications that slow the heart rate (such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if the patient has had sudden loss of consciousness or fainting in the past;
• if the patient plans to be vaccinated;
• if the patient has never had chickenpox;
• if the patient has vision problems or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) or has diabetes, which can 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 cough typical of smokers. If any of these situations occur or the patient has 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 dose of 0.5 mg, Chantico slows down the heart rate. As a result, the patient may feel dizzy, tired, have palpitations, or experience low blood pressure. If these symptoms are severe, the patient should inform their doctor immediately, as they may require immediate treatment. Chantico may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate usually returns to normal within a month. During this period, no clinically significant effect on heart rate is expected.
The doctor will ask the patient to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Chantico or after the first dose of 0.5 mg in case of a change in treatment from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any adverse reactions occur at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Chantico and after completing the 6-hour observation, the patient will undergo an ECG. During this time, the doctor may continuously monitor the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, there may be a need for longer monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day), until these symptoms disappear. The same procedure may be recommended if the patient resumes treatment with Chantico after a break in treatment, depending on how long the break lasted and how long the patient took Chantico before the break.
If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, Chantico may not be suitable for them.
If the patient has had sudden loss of consciousness or slow heart rate in the past, Chantico may not be suitable for them. The patient may need to consult a cardiologist (a heart specialist) who will advise on how to start treatment with Chantico, including how to monitor the patient at night.
If the patient is taking medications that can slow the heart rate, Chantico may not be suitable. The patient may need to consult a cardiologist who will check if the patient can switch to other medications that do not slow the 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, taking into account 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, they may need to be vaccinated before starting treatment with Chantico. If this is the case, the doctor will delay the start of treatment with Chantico for one month after the full vaccination cycle.
Infections
Chantico reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Chantico (and up to 2 months after stopping treatment), the patient may be more prone to infections. Any existing infections may worsen.
Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, and (or) confusion or seizures (which may be symptoms of meningitis and (or) encephalitis caused by fungal or viral infections), they should contact their doctor immediately, as this may be a serious condition.
If the patient thinks their MS is getting worse (e.g., weakness or vision problems) or if the patient notices any new symptoms, they should talk to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection, called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can lead to severe disability or death. The doctor will consider performing an MRI scan to assess the patient's condition and decide whether to stop taking Chantico.
Patients treated with Chantico have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, warts, and HPV-related cancer.
The doctor will consider whether the patient needs to be vaccinated against HPV before starting treatment with Chantico. In the case of women, the doctor will also recommend screening for HPV.
Macular edema
Before starting treatment with Chantico, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) or uveitis (inflammation of the uvea, the middle layer of the eye) or diabetes to an eye examination.
The doctor may refer the patient for an eye examination 3 to 4 months after starting treatment with Chantico.
The macula is a small area of the retina, located at the back of the eye, which enables sharp and clear vision of shapes, colors, and other details. Chantico may cause macular edema, a condition where the macula becomes swollen. Macular edema 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 prescribe regular eye examinations to detect macular edema.
If the patient develops macular edema, they should inform their doctor before resuming treatment with Chantico.
Macular edema can cause vision problems similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not appear at all.
The patient should inform their doctor about any changes in vision. The doctor may refer the patient for an eye examination, especially in the following cases:

• if the center of the visual field becomes blurry or shaded;
• if a defect appears in the center of the visual field;
• if the patient experiences difficulties with color vision or fine details.

Liver function tests
If the patient has severe liver disease, they should not take Chantico. Chantico may affect liver function. The patient is unlikely to experience any symptoms, but if the patient develops yellowing of the skin or whites of the eyes, abnormal dark urine (brown), pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should inform their doctor immediately.
If any of these symptoms occur after starting treatment with Chantico, the patient should inform their doctor immediately.
Before, during, and after treatment, the doctor will prescribe blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with Chantico may be discontinued.
High blood pressure
Since Chantico can cause a slight increase in blood pressure, the doctor may prescribe regular blood pressure checks for the patient.
Lung diseases
Chantico has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at increased risk of adverse reactions.
White blood cell count
The expected effect of Chantico is a decrease 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 necessary, the patient should inform their doctor that they are taking Chantico. Otherwise, the doctor may not be able to interpret the test results, and in the case of certain tests, the doctor may prescribe a larger amount of blood than usual.
Before starting treatment with Chantico, the doctor will confirm whether the patient has a sufficient number of white blood cells to start treatment and may prescribe regular blood tests. If there are not enough white blood cells, treatment with Chantico may need to be discontinued.
Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with Chantico, there have been rare reports of posterior reversible encephalopathy syndrome. Symptoms may include severe headache, confusion, seizures, and vision problems. If the patient experiences any of these symptoms while taking Chantico, they should inform their doctor immediately, as this may be a serious condition.
Cancer
Patients treated with Chantico have reported skin cancer. The patient should inform their doctor immediately if they notice any lumps on the skin (e.g., shiny pearl-like lumps), spots, or open sores that do not heal for several weeks. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Before starting treatment with Chantico, it is necessary to examine the skin to detect any lumps. 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 on the need for regular visits after consulting with the patient.
Patients with MS treated with fingolimod have reported a type of lymphoma (a cancer of the lymphatic system).
Exposure to the sun and protection from sunlight
Fingolimod weakens the immune system. This increases the risk of cancer, especially skin cancer. The patient should limit exposure to the sun and UV radiation by:

• wearing protective clothing.
• applying sunscreen with a high level of UV protection regularly.

Unusual changes in the brain related to MS relapse
Patients treated with Chantico have reported rare cases of unusually large changes in the brain related to MS relapse. In the case of a severe MS relapse, the treating doctor will consider performing an MRI scan to assess the patient's condition and decide whether to stop taking Chantico.
Switching from other medicines to Chantico
The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Chantico, if there are no symptoms of abnormality caused by the previous treatment. The doctor may prescribe a blood test to rule out these abnormalities.
After stopping treatment with natalizumab, it may be necessary to wait 2 to 3 months before starting treatment with Chantico. In the case of switching from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure. If the patient has been treated with alemtuzumab, this requires careful evaluation and discussion with the doctor to decide whether Chantico is suitable for the patient.
Women of childbearing age
If Chantico is used during pregnancy, it may harm the unborn child. Before starting treatment with Chantico, the doctor will explain the risk to the patient and prescribe a pregnancy test to ensure the patient is not pregnant, and

The doctor will give the patient a card explaining why they should not become pregnant while taking Chantico.
If the patient becomes pregnant while taking Chantico, they should inform their doctor immediately. The doctor will decide whether to stop treatment (see "Stopping Chantico" in section 3 and section 4 "Possible side effects"). The patient should undergo specialized prenatal examinations.
Breastfeeding
While taking Chantico, the patient should not breastfeed. Chantico passes into breast milk, which poses a risk of serious side effects in the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles, including bicycles, and operate machinery safely. Chantico should not affect the patient's ability to drive or operate machinery.
However, when starting treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of Chantico. The patient's ability to drive or operate machinery may be impaired during this time and potentially after that.
The patient should not resume treatment with Chantico after a break of more than 2 weeks without consulting their doctor.

3. How to take Chantico

Treatment with Chantico will be supervised by a doctor experienced in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor.
The recommended dose is:

Adults:

The dose is 1 capsule of 0.5 mg per day.

Children and adolescents (aged 10 and over):

The dose depends on body weight:

• Children and adolescents with a body weight of 40 kg or less: 1 capsule of 0.25 mg of fingolimod per day. Other medicinal products containing fingolimod with lower strengths (in the form of a 0.25 mg capsule) are available
• Children and adolescents with a body weight over 40 kg: 1 capsule of 0.5 mg per day. Children and adolescents starting treatment with 1 capsule of 0.25 mg of fingolimod per day and later achieving a stable body weight over 40 kg will be advised by their doctor to switch to 1 capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period as after the first dose of Chantico.

Do not exceed the recommended dose.
Chantico is intended for oral use.
Chantico should be taken once a day, with a glass of water. Chantico should always be swallowed whole, without opening the capsules. Chantico can be taken with or without food.
Taking Chantico at the same time every day will help the patient remember to take their medicine.
If the patient has any doubts about how long to take Chantico, they should consult their doctor or pharmacist.

Taking a higher dose of Chantico than recommended

If the patient takes a higher dose of Chantico than recommended, they should contact their doctor immediately.

Missing a dose of Chantico

If the patient has been taking Chantico for less than 1 month and forgets to take 1 dose for a whole day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose.
If the patient has been taking Chantico for at least 1 month and forgets to take the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose. However, if the patient forgets to take the medicine for up to 2 weeks, they can take the next dose as planned.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Chantico

Do not stop taking Chantico or change the dose without consulting your doctor first.
Chantico stays in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Chantico, the patient should wait 6-8 weeks before starting new MS treatment.
If the patient needs to resume treatment with Chantico more than 2 weeks after stopping treatment, the effect on heart rate observed usually after starting treatment for the first time may recur, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. Do not resume treatment with Chantico after a break of more than 2 weeks without consulting your doctor.
The doctor will decide whether and how the patient requires monitoring after stopping treatment with Chantico. If the patient thinks their MS is getting worse after stopping treatment with Chantico, they should inform their doctor immediately, as this may be a serious condition.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Chantico can cause side effects, although not everybody gets them.
Some side effects may be serious
Common(may affect up to 1 in 10 people):

• Cough with expectoration, feeling of discomfort in the chest, fever (symptoms of respiratory disorders).
• Herpes virus infection (shingles or herpes) with symptoms such as blisters, burning, itching, or skin pain, usually on the upper body or face. Other symptoms may include fever and weakness in the early stages 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 pearl-like lump, although it can take other forms.
• Depression and anxiety, which 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 people):

• Pneumonia with symptoms such as fever, cough, difficulty breathing.
• Macular edema (swelling in the center of the visual field in the retina, at the back of the eye) with symptoms such as shadows or dark spots in the visual field, blurred vision, problems with color vision and fine details.
• Reduced platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible symptoms of melanoma may include moles that change in size, shape, or color over time or the appearance of new moles. Moles may be itchy, bleeding, or ulcerated.
• Seizures, convulsions (more common in children and adolescents than in adults).

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

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures, and vision problems.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red lump, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar.

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

• Abnormalities in the ECG (inversion of the T wave).
• A tumor associated with human herpesvirus 8 (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.
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right upper abdomen, dark (brown) urine, decreased appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure may require a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to those of an MS relapse. They may also include symptoms that the patient is not aware of, such as mood or behavior changes, transient memory lapses, speech or communication difficulties, which the doctor should evaluate to rule out PML. Therefore, if the patient thinks their MS is getting worse or if the patient or their relatives notice any new or unusual symptoms, it is very important to inform their doctor as soon as possible.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and (or) confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless lump or mass, often blue-red in color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass. Prolonged sun exposure and weakened immune system may increase the risk of Merkel cell carcinoma.
• After stopping treatment with Chantico, MS symptoms may recur and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition where red blood cells are destroyed).

If the patient experiences any of these side effects, they should inform their doctor immediately.
Other side effects

• Very common(may affect more than 1 in 10 people):
• Influenza-like infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Feeling of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Increased liver enzyme activity in blood tests
• Cough

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

• Fungal skin infection (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itchy, red, burning rash (rash)
• Itching
• Increased triglyceride levels in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the section on macular edema under "Some side effects may be serious")
• Hypertension (Chantico may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

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

• Low neutrophil count
• Depressed mood
• Nausea

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

• Lymphoma (a type of cancer affecting the lymphatic system)
• Frequency not known(cannot be estimated from the available data):
• Peripheral edema

If any of these symptoms occur with significant severity, the patient should inform their doctor.
Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Chantico

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Chantico contains

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

What Chantico looks like and what the package contains

Chantico 0.5 mg is a hard, white and yellow capsule, size 3 (16 mm in length).
Chantico 0.5 mg, hard capsules are available in OPA/Aluminum/PVC/Aluminum blisters containing 28 capsules, in a cardboard box.

Marketing authorization 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
Netherlands
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

To obtain more detailed information, please contact the representative of the marketing authorization 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
biuro@gl-pharma.pl

Date of the last update of the leaflet: