Package leaflet: Information for the user

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

Contents of the leaflet

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

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

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

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

Fingolimod Richter does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.
What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and spinal cord. In MS, the inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary among patients but usually include walking difficulties, numbness, vision problems, or balance disturbances. Symptoms of relapses may completely resolve, although some deficits may persist.
How Fingolimod Richter works
Fingolimod Richter 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. Fingolimod Richter also suppresses certain immune responses in the body.

2. Information before using Fingolimod Richter

When not to use Fingolimod Richter

if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system);
if the doctor suspects that the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been diagnosed in the patient;
if the patient has a severe active infection or an 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 in whom an electrocardiogram (ECG) showed QT interval prolongation before starting treatment with Fingolimod Richter;
if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or is of childbearing age and not using effective contraception;
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If this is the case or the patient has any doubts, consult the doctor before using Fingolimod Richter.

Warnings and precautions
Before starting treatment with Fingolimod Richter, discuss with the doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been informed that their ECG recording is abnormal;
if the patient experiences symptoms of slow heart rate (e.g. dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medicines that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting;
if the patient plans to be vaccinated;
if the patient has never had chickenpox;
if the patient has or has had vision problems or other symptoms of swelling in the 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 lowered with medication;
if the patient has severe lung disease or a smoker's cough. If any of these situations apply or the patient has any doubts, consult the doctor before taking Fingolimod Richter.

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 took a 0.25 mg daily dose, Fingolimod Richter slows heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary. Fingolimod Richter may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is generally expected.
The doctor will ask the patient to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Richter 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 administered if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod Richter and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiography. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring of the patient's condition may be required (at least 2 additional hours or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Richter after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod Richter before stopping treatment.
If the patient has irregular or abnormal heartbeat, risk factors for these events, an abnormal ECG, heart disease, or heart failure, Fingolimod Richter may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Fingolimod Richter may not be suitable. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start treatment with Fingolimod Richter, including overnight monitoring.
If the patient is taking medicines that may reduce heart rate, Fingolimod Richter may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not reduce heart rate, allowing treatment with Fingolimod Richter. If such a change is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Richter, including monitoring until the day after the first dose of Fingolimod Richter.

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

Infections
Fingolimod Richter reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Richter (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects an infection, has a fever, flu-like symptoms, shingles, or headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infections), contact the doctor immediately, as this condition may be severe and life-threatening.
Infections with human papillomavirus (HPV), including cases of warts, dysplasia, papillomas, and HPV-related malignant tumors, have been reported in patients treated with Fingolimod Richter. The doctor will consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV.

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

Macular edema
Before starting treatment with Fingolimod Richter, 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 Fingolimod Richter.
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. Fingolimod Richter may cause swelling of the macula, a condition called macular edema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Richter.
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, inform the doctor before resuming treatment with Fingolimod Richter.
Macular edema may cause certain vision problems, similar to those in an MS attack (optic neuritis). In the early stages, symptoms may not occur at all. Inform the doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

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

Liver function tests
Patients with severe liver disease should not take Fingolimod Richter. Fingolimod Richter 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 the above symptoms occur after starting treatment with Fingolimod Richter, inform the doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, treatment with Fingolimod Richter may be discontinued.

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

Lung diseases
Fingolimod Richter 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 Fingolimod Richter 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, inform the doctor about taking Fingolimod Richter. Otherwise, the doctor may not be able to interpret blood test results, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting treatment with Fingolimod Richter, the doctor will confirm that the number of white blood cells in the blood is appropriate to start treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Fingolimod Richter may need to be discontinued.

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

Cancer
Skin cancers have been reported in patients with MS treated with Fingolimod Richter. If any skin nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within a few weeks are noticed, inform the treating doctor immediately. 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. Before starting treatment with Fingolimod Richter, a skin examination is necessary to detect any skin nodules. The treating doctor will also perform regular skin checks during treatment with Fingolimod Richter. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
Cases of a certain type of lymphatic system cancer (lymphoma) have been reported in patients with MS treated with Fingolimod Richter.

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

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

Unusual brain changes associated with MS relapse
Rare cases of unusually large brain changes associated with MS relapse have been reported in patients treated with Fingolimod Richter. In the case of a severe MS relapse, the treating doctor will consider performing an MRI scan to assess this condition and decide whether discontinuation of Fingolimod Richter is necessary.

Switching from other medicines to Fingolimod Richter
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Richter if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out these abnormalities. After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting treatment with Fingolimod Richter. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion of their situation with the doctor before deciding whether Fingolimod Richter is suitable for them.

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

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

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

Children and adolescents
Fingolimod Richter 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.
Warnings and precautions listed above also apply to children and adolescents.
The following information is particularly important for children, adolescents, and their caregivers:

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

Fingolimod Richter and other medicines
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:

medicines that suppress or modulate the immune system, including other medicines used in the treatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Richter must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to use Fingolimod Richter").
corticosteroids, due to the possibility of additive effects on the immune system.
vaccines. If the patient requires vaccination, they should first consult the doctor. During and for 2 months after treatment with Fingolimod Richter, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if administered during this period.
medicines that slow heart function (e.g. beta-blockers such as atenolol). Using Fingolimod Richter together with these medicines could intensify the effect on heart function in the first days of treatment with Fingolimod Richter.
medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Richter must not be used in patients taking these medicines, as its use could intensify the effect on irregular heartbeat (see also "When not to use Fingolimod Richter").
other medicines: protease inhibitors, medicines 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 efficacy of Fingolimod Richter).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult the doctor before using this medicine.
Pregnancy
Fingolimod Richter should not be used during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If Fingolimod Richter is used during pregnancy, there is a risk of harmful effects on the unborn child. The rate of congenital malformations observed in children exposed to Fingolimod Richter during pregnancy is about 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 developmental defects of the heart, kidneys, and musculoskeletal system.
Therefore, if the patient is of childbearing age:

before starting treatment with Fingolimod Richter, the doctor will inform the patient about the risk to the unborn child and request a pregnancy test to confirm that the patient is not pregnant, and
effective contraception must be used during treatment with Fingolimod Richter and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with the doctor.

The doctor will provide the patient with an information card explaining why pregnancy should be avoided while using Fingolimod Richter.
If the patient becomes pregnant while using Fingolimod Richter, inform the doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod Richter" in section 3, and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.
Breastfeeding
Breastfeeding should not be used during treatment with Fingolimod Richter. Fingolimod Richter may pass into breast milk, posing a risk of severe adverse effects in the child.

Driving and operating machinery
The doctor will inform the patient whether their condition allows them to safely drive vehicles, including bicycles, and operate machinery. No effect of Fingolimod Richter on the ability to drive vehicles and operate machinery is expected.
However, at the beginning of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Richter. During this time and potentially afterward, the ability to drive vehicles and operate machinery may be impaired.

3. How to use Fingolimod Richter

Treatment with Fingolimod Richter will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
The recommended dose is:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents weighing 40 kg or less: one 0.25 mg capsule once daily. Other medicinal products containing fingolimod are available at a lower dose (as 0.25 mg capsules).
Children and adolescents weighing more than 40 kg: one 0.5 mg capsule once daily. Children and adolescents who started treatment with one 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will receive instructions from their doctor to change the dose to one 0.5 mg capsule once daily. In this case, repeat observation period as after the first dose is recommended.

Do not exceed the recommended dose.
Fingolimod Richter is intended for oral use.
Fingolimod Richter should be taken once daily, with a glass of water. Fingolimod Richter capsules must always be swallowed whole, without opening. Fingolimod Richter may be taken with or without food.
Taking Fingolimod Richter at the same time each day will help you remember to take your dose.
If you have any questions about the duration of treatment with Fingolimod Richter, consult your doctor or pharmacist.
Taking more Fingolimod Richter than prescribed
If you have taken too much of this medicine, contact your doctor immediately.
Missing a dose of Fingolimod Richter
If you have been taking Fingolimod Richter for less than 1 month and have missed one 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 Fingolimod Richter for at least 1 month and have missed 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 have missed taking the medicine 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 Fingolimod Richter
Do not stop taking Fingolimod Richter or change the dose without first consulting your doctor.
Fingolimod Richter remains in the body for up to 2 months after stopping treatment. During this time, the white blood cell count (lymphocyte count) may still be reduced and adverse reactions described in this leaflet may continue to occur. After stopping treatment with Fingolimod Richter, wait 6–8 weeks before starting a new multiple sclerosis treatment.
In patients restarting Fingolimod Richter after a break of more than 2 weeks, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring of the patient’s condition will be required in a doctor’s office or clinic due to resumption of treatment. Do not restart treatment with Fingolimod Richter after a break lasting more than two weeks without consulting your treating physician.
Your treating physician will decide whether and how you should be monitored after stopping treatment with Fingolimod Richter. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping Fingolimod Richter. This situation may be serious.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be or may become serious.
Common (may affect less than 1 in 10 patients):

Productive cough, unspecified discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning sensation, itching or pain in the skin, usually above the upper part of the body or face. Other symptoms may include fever and malaise in the early stage of infection, followed by numbness, itching or red spots with severe pain
Slow heartbeat (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 patients with MS and have also been reported in children and adolescents treated with Fingolimod Richter.
Weight loss

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

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the center of the visual field in the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details
Decreased platelet count, which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible symptoms of melanoma include moles whose size, shape, elevation or color may change 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 affect less than 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 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 affect less 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 unknown (frequency cannot be estimated from available data):

Allergic reactions, including symptoms such as rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day of starting treatment with Fingolimod Richter
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 that the patient may not be 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 family members notice any new or unusual symptoms, it is very important to inform the treating physician as soon as possible
Inflammatory disorders after discontinuation of Fingolimod Richter treatment (known as immune reconstitution inflammatory syndrome or IRIS)
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and (or) confusion
Merkel cell carcinoma (a type of skin cancer). Possible 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 impaired immune system may influence the risk of Merkel cell carcinoma
After stopping treatment with Fingolimod Richter, MS symptoms may return and worsen compared to the period before treatment 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 reactions occur in the patient, they should be reported to the doctor immediately.
Other adverse reactions
Very common (may affect 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 affect less than 1 in 10 patients):

Fungal skin infections (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and sensitivity to light (migraine)
Low number of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy, red, stinging rash (rash)
Itching
Increased levels of blood fats (triglycerides)
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema under "Some adverse reactions may be or may become serious")
Hypertension (Fingolimod Richter may cause a mild increase in blood pressure)
Muscle pain
Joint pain

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

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

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

Lymphatic system tumor (lymphoma)

Frequency unknown (frequency cannot be estimated from available data):

Peripheral edema

If any of these symptoms occur severely, the doctor should be informed.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, they should be reported to the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel. +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine's use can be collected.

5. How to store Fingolimod Richter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following “Expiry date (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 you notice that the packaging is damaged or shows signs of prior opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fingolimod Richter contains

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

What Fingolimod Richter looks like and contents of the pack
Fingolimod Richter 0.5 mg hard capsules (16 mm, size 3) have a white body and a yellow cap.
Fingolimod Richter 0.5 mg hard capsules are available in blisters or unit dose blisters containing 28 or 98 capsules, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
Tel. +48 22 75 59 648
E-mail: [email protected]

Manufacturer/Importer
Synthon Hispania S.L.
C/Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands Fingolimod Richter
Poland Fingolimod Richter
Bulgaria Fingolimod Richter 0.5 mg hard capsules
Czech Republic Fingolimod Richter
Estonia Fingolimod Richter
Hungary Fingolimod Richter 0.5 mg hard capsules
Lithuania Fingolimod Richter 0.5 mg hard capsules
Romania Fingolimod Richter 0.5 mg capsules
Slovakia Fingolimod Richter 0.5 mg hard capsules

Fingolimod richter