Fingolimod Rihter

Leaflet accompanying the packaging: information for the user

Fingolimod Richter, 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 possible 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 Fingolimod Richter and what is it used for
• 2. Important information before taking Fingolimod Richter
• 3. How to take Fingolimod Richter
• 4. Possible side effects
• 5. How to store Fingolimod Richter
• 6. Package contents and other information

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

What is Fingolimod Richter

The active substance in Fingolimod Richter is fingolimod.

What is Fingolimod Richter used for

Fingolimod Richter 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.

Fingolimod Richter 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.

How Fingolimod Richter works

Fingolimod Richter 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, the medicine reduces nerve damage caused by MS. Fingolimod Richter also weakens some immune system reactions.

2. Important information before taking Fingolimod Richter

When not to take Fingolimod Richter

• if the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive medications);
• 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, stroke, or symptoms of stroke in the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Richter;
• 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, the patient should tell their doctor and not take Fingolimod Richter.

Warnings and precautions

Before starting treatment with Fingolimod Richter, 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 (such as 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 (such as blurred vision or blind spots) 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, the patient should tell their doctor before taking Fingolimod Richter.

Low heart rate (bradycardia) and irregular heartbeat

At the beginning of treatment or after taking the first dose of 0.5 mg, Fingolimod Richter 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 tell their doctor, as they may need immediate treatment. Fingolimod Richter may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Low heart rate usually returns to normal within one month.

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 Fingolimod Richter 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 measurement of pulse and blood pressure, so that if any side effects occur that happen at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Fingolimod Richter and after the 6-hour observation period, 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, the patient may need longer monitoring (for at least 2 hours longer 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 break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Richter before the break.

If the patient has an irregular or abnormal heartbeat, or risk factors for these events, or an abnormal ECG or heart disease, or heart failure, Fingolimod Richter may not be suitable for them.

If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod Richter may not be suitable for them. The patient may need to consult a cardiologist who will advise on how to start treatment with Fingolimod Richter, including how to monitor the patient at night.

If the patient is taking medications that can slow the heart rate, Fingolimod Richter may not be suitable. The patient may need to consult a cardiologist to check if they can switch to other medications that do not slow the heart rate, to allow treatment with Fingolimod Richter. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Richter, taking into account monitoring until the next day after administration of 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, they may need to be vaccinated before starting treatment with Fingolimod Richter. If this is the case, the doctor will delay the start of treatment with Fingolimod Richter by one month after the full vaccination cycle.

Infections

Fingolimod Richter reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Fingolimod Richter (and up to 2 months after stopping treatment), the patient may be more susceptible to infections. 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, rash, and/or confusion, they should contact their doctor immediately, as this condition can be severe.

Macular edema

Before starting treatment with Fingolimod Richter, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (such as blurred vision or blind spots) or with diabetes for eye exams.

The doctor may refer the patient for eye exams 3 to 4 months after starting treatment with Fingolimod Richter.

Macular edema is a condition where the macula (a small area of the retina at the back of the eye) becomes swollen. Fingolimod Richter can cause macular edema. Macular edema 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 prescribe regular eye exams to detect macular edema.

If the patient has had macular edema, they should tell their doctor before resuming treatment with Fingolimod Richter.

Macular edema can cause vision problems similar to those experienced during an MS relapse (such as optic neuritis). In the early stages, symptoms may not appear at all.

The patient should tell their doctor about any changes in vision. The doctor may refer the patient for eye exams, especially if:

• the center of the visual field becomes blurred or shaded;
• a defect appears in the center of the visual field;
• the patient has difficulty seeing colors or fine details.

Liver function tests

Patients with severe liver disease should not take Fingolimod Richter. Fingolimod Richter may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or whites of the eyes, dark (brown) urine, pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should tell their doctor immediately.

If the patient experiences any of these symptoms after starting treatment with Fingolimod Richter, they should tell 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 Fingolimod Richter may be discontinued.

High blood pressure

The doctor may regularly check the patient's blood pressure, as Fingolimod Richter can cause a slight increase in blood pressure.

Lung disease

Fingolimod Richter has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at greater risk of side effects.

Blood cell count

A expected 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, the patient should tell their doctor that they are taking Fingolimod Richter. 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 Fingolimod Richter, the doctor will check if the patient has a sufficient number of white blood cells to start treatment and may prescribe regular repeat tests.

If there are not enough white blood cells, it may be necessary to discontinue treatment with Fingolimod Richter.

Posterior reversible encephalopathy syndrome (PRES)

In patients with MS treated with Fingolimod Richter, there have been rare reports of a condition called posterior reversible encephalopathy syndrome (PRES). The symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If the patient experiences any of these symptoms during treatment with Fingolimod Richter, they should tell their doctor immediately, as this condition can be severe.

Cancer

In patients with MS treated with Fingolimod Richter, there have been reports of skin cancers. If the patient notices any lumps on their skin (such as shiny lumps with a pearly color), spots, or open sores that do not heal within a few weeks, they should tell their doctor immediately. The symptoms of skin cancer may include abnormal growths or changes in skin tissue (such as unusual moles) that change color, shape, or size over time.

Before starting treatment with Fingolimod Richter, it is necessary to examine the skin to detect any lumps. The doctor will also perform regular skin checks during treatment with Fingolimod Richter. If skin problems occur, the doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with them.

In patients with MS treated with Fingolimod Richter, there have been reports of a type of lymphoma (a type of cancer of the lymphatic system).

Sun exposure and protection from sunlight

Fingolimod weakens the immune system. This increases the risk of developing malignant tumors, especially skin cancers. The patient should limit sun exposure and UV radiation by:

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

Unusual changes in the brain associated with MS relapse

In patients treated with Fingolimod Richter, there have been rare reports of unusually large changes in the brain associated with MS relapse. In the case of a severe MS relapse, the doctor may consider performing an MRI to assess this condition and decide on the possible need to discontinue Fingolimod Richter.

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 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 Fingolimod Richter. When switching from teriflunomide, the doctor may advise the patient to wait for some time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fingolimod Richter is suitable for them.

Women of childbearing age

If Fingolimod Richter is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Richter, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will give the patient a card explaining why they should not become pregnant while taking Fingolimod Richter. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Richter. Female patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

If the patient becomes pregnant while taking Fingolimod Richter, they should tell their doctor immediately. The doctor will decide on the possible need to discontinue treatment (see "Discontinuing Fingolimod Richter" in section 3, as well as section 4 "Possible side effects"). The patient will also need to undergo regular prenatal check-ups.

Breastfeeding

Fingolimod Richter should not be used during breastfeeding. Fingolimod Richter may pass into breast milk, posing a risk of severe side effects in the child.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including cycling and operating machinery. It is not expected that Fingolimod Richter will affect the ability to drive vehicles and operate machinery.

However, at the beginning of treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Richter. During this time and potentially after it, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod Richter

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

Do not exceed the recommended dose.

Fingolimod Richter is intended for oral use.

Fingolimod Richter should be taken once a day, with a glass of water. Fingolimod Richter capsules should always be swallowed whole, without opening. Fingolimod Richter can be taken with or without food.

Taking Fingolimod Richter at the same time every day will help the patient remember to take their medicine.

If the patient has any questions about the duration of treatment with Fingolimod Richter, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Richter than recommended

If the patient has taken too much of the medicine, they should contact their doctor immediately.

Missing a dose of Fingolimod Richter

If the patient has been taking Fingolimod Richter for less than 1 month and has forgotten to take 1 dose for the whole day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the administration of the next dose.

If the patient has been taking Fingolimod Richter for at least 1 month and has forgotten 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 administration of the next dose. However, if the patient has forgotten 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.

Discontinuing Fingolimod Richter

Do not stop taking Fingolimod Richter or change the dose without consulting the doctor first.

Fingolimod Richter 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 Fingolimod Richter, the patient should wait 6-8 weeks before starting new MS treatment.

In patients resuming treatment with Fingolimod Richter after more than 2 weeks of stopping the medicine, the effect on heart rate observed 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 Fingolimod Richter after a break of more than 2 weeks without consulting the treating doctor.

The treating doctor will decide how to monitor the patient after stopping treatment with Fingolimod Richter. If the patient thinks their MS is getting worse after stopping treatment with Fingolimod Richter, they should tell their doctor immediately. This situation can be serious.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fingolimod Richter can cause side effects, although not everybody gets them.

Some side effects may be or may become serious

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

• Cough with expectoration, unspecified unpleasant chest sensation, fever (respiratory symptoms)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning sensation, itching, or pain of the skin, usually above the upper body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots with severe pain
• Slow heart rate (bradycardia), irregular heartbeat
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it can have other appearances
• Depression and anxiety are more common in the MS population and have also been reported in children and adolescents treated with Fingolimod Richter.
• 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 blind spots in the center of the visual field, blurred vision, difficulty seeing colors 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 include moles that change in size, shape, or color over time or new moles that appear. Moles can 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 severe headache, confusion, seizures, and vision changes
• Lymphoma (a type of cancer affecting the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that can appear as a hard, red nodule, 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(frequency 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 treatment with Fingolimod Richter.
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes, nausea or vomiting, pain in the right upper abdomen, fatigue, decreased appetite, and abnormal liver function test results. In very rare cases, liver failure can lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to 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 tell their doctor immediately
• 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 nodule with a raw meat color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Long-term sun exposure and weakened immune system can increase 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 hemolytic anemia (a condition where red blood cells are destroyed).

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

Other side effects

Very common(may affect more than 1 in 10 people):

• Flu-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 infections (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• 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 or may become serious")
• High blood pressure (Fingolimod Richter 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 of the lymphatic system)

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

• Peripheral edema

If any of these symptoms occur with significant severity, the patient should tell their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fingolimod Richter

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not use medicines from damaged or opened packages.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What does Fingolimod Richter contain

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

What Fingolimod Richter looks like and what the pack contains

Hard capsules (16 mm, size 3) of Fingolimod Richter 0.5 mg, have a white body and a yellow
cap.
Fingolimod Richter, 0.5 mg, hard capsules are available in blisters or single-dose blisters
containing 28 or 98 capsules, 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: lekalert@grodzisk.rgnet.org

Manufacturer/Importer

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

This medicinal product is authorised in the Member States of the European Economic Area

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 capsule
Lithuania
Fingolimod Richter 0.5 mg hard capsules
Romania
Fingolimod Richter 0.5 mg capsules
Slovakia
Fingolimod Richter 0.5 mg hard capsules

Date of last revision of the leaflet: