Fingolimod Adamed

Leaflet accompanying the packaging: information for the user

Fingolimod Adamed, 0.5 mg, hard capsules
fingolimod

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 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 Adamed and what is it used for
• 2. Important information before taking Fingolimod Adamed
• 3. How to take Fingolimod Adamed
• 4. Possible side effects
• 5. How to store Fingolimod Adamed
• 6. Contents of the pack and other information

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

What is Fingolimod Adamed

Fingolimod Adamed contains the active substance fingolimod.

What is Fingolimod Adamed used for

Fingolimod Adamed is used in adults and children and adolescents (aged 10 years and older) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

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

Fingolimod Adamed 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 relapses (exacerbations) of neurological symptoms, reflecting the inflammatory process in the CNS. Symptoms vary among patients, but usually include walking disturbances, numbness, vision disturbances, or balance problems. Relapse symptoms may completely resolve, but some disturbances may persist.

How Fingolimod Adamed works

Fingolimod Adamed 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 Adamed also weakens some immune responses of the body.

2. Important information before taking Fingolimod Adamed

When not to take Fingolimod Adamed

• if the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive medicines);
• 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 Adamed;
• 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 breastfeeding.
• 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 a doctor before taking Fingolimod Adamed.

Warnings and precautions

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

• -if the patient has severe respiratory disorders 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 medicines 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 visual disturbances or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) with a history of uveitis (inflammation of the uvea, the middle layer of the eye) or diabetes, which may cause vision problems;
• if the patient has liver problems;
• 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 a doctor before taking Fingolimod Adamed.

Low heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg in patients who previously took a daily dose of 0.25 mg, Fingolimod Adamed slows down the heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, the patient should inform their doctor, as they may require immediate treatment. Fingolimod Adamed 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. 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 Fingolimod Adamed or after the first dose of 0.5 mg when changing treatment from a daily dose of 0.25 mg, with hourly measurement of pulse and blood pressure, so that if any adverse reactions occur that happen at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Fingolimod Adamed 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, it may be necessary to extend the monitoring of the patient's condition (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 Adamed after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Adamed 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, Fingolimod Adamed may not be suitable for them.
If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod Adamed 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 Fingolimod Adamed, including how to monitor the patient at night.
If the patient is taking medicines that can slow the heart rate, Fingolimod Adamed may not be suitable. The patient may need to consult a cardiologist who will check if the patient can switch to other medicines that do not slow the heart rate, to allow treatment with Fingolimod Adamed. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Adamed, taking into account monitoring until the next day after administering the first dose of Fingolimod Adamed.
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 Adamed. If this is the case, the doctor will delay the start of treatment with Fingolimod Adamed by one month after completing the full vaccination course.
Infections
Fingolimod Adamed reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Adamed (and for 2 months after stopping treatment), the patient may be more susceptible 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, rash, 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 condition can be severe and life-threatening. If the patient thinks their condition is worsening (e.g., weakness or vision disturbances) or if the patient notices any new symptoms, they should contact 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 Fingolimod Adamed.
Patients treated with Fingolimod Adamed 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 Fingolimod Adamed. In women, the doctor will also recommend screening for HPV.
Macular edema
Before starting treatment with Fingolimod Adamed, the doctor may refer patients with existing or past visual disturbances or other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen) with a history of uveitis (inflammation of the uvea, the middle layer of the eye) or diabetes, which may cause vision problems, for eye examinations.
The doctor may refer the patient for eye examinations 3 to 4 months after starting treatment with Fingolimod Adamed.
The macula is a small area of the retina, located at the back of the eye, which allows for sharp and clear vision of shapes, colors, and other details. Fingolimod Adamed may cause macular edema, a condition called macular edema. This edema usually occurs within the first 4 months of treatment with Fingolimod Adamed.
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 Fingolimod Adamed.
Macular edema may cause certain vision disturbances, similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not occur at all. The patient should inform their doctor about any changes in vision. The doctor may refer the patient for eye examinations, especially if:

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

Liver function tests
Patients with severe liver disease should not take Fingolimod Adamed. Fingolimod Adamed 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 (jaundice), dark (brown) urine, pain in the right upper abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should immediately tell their doctor.
If the patient experiences any of these symptoms after starting treatment with Fingolimod Adamed, they should immediately tell their doctor.
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 Adamed may be discontinued.
High blood pressure
The doctor may regularly check the patient's blood pressure, as Fingolimod Adamed can cause a slight increase in blood pressure.
Lung problems
Fingolimod Adamed has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of adverse reactions.
White blood cell count
A expected effect of Fingolimod Adamed 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 Fingolimod Adamed. Otherwise, the doctor may not be able to interpret the results of the blood test, and in the case of certain tests, the doctor may prescribe a larger amount of blood than usual.
Before starting treatment with Fingolimod Adamed, the doctor will check if the patient has a sufficient number of white blood cells in the blood to start treatment and may prescribe regular repetition of blood tests. If there are not enough white blood cells, it may be necessary to discontinue treatment with Fingolimod Adamed.
Posterior reversible encephalopathy syndrome (PRES)
Rarely, patients with MS treated with Fingolimod Adamed have reported a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms of this condition may include severe headache, confusion, seizures, and/or vision changes. If the patient experiences any of these symptoms while taking Fingolimod Adamed, they should immediately tell their doctor, as this condition can be severe.
Cancer
Patients with MS treated with Fingolimod Adamed have reported skin cancers.
If the patient notices any lumps on their skin (e.g., shiny lumps with a pearl-like color), patches, or open sores that do not heal within a few weeks, they should immediately tell their doctor. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., new moles) that change color, shape, or size over time. Before starting treatment with Fingolimod Adamed, it is necessary to examine the skin for any lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod Adamed. 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 them.
Patients with MS treated with Fingolimod Adamed have also reported a type of lymphoma (a type of cancer of the lymphatic system).
Exposure to sunlight and protection from ultraviolet radiation
Fingolimod Adamed weakens the immune system. This condition increases the risk of developing cancers, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

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

Unusual changes in the brain associated with MS relapse
Patients treated with Fingolimod Adamed have rarely reported rare cases of unusually large changes in the brain associated with MS relapse. In the case of a severe MS relapse, the treating doctor will consider performing an MRI scan to assess the condition and decide whether to stop taking Fingolimod Adamed.
Switching from other medicines to Fingolimod Adamed
The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Adamed 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 Adamed. When switching from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fingolimod Adamed is suitable for them.
Women of childbearing age
If Fingolimod Adamed is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Adamed, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod Adamed. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod Adamed.
Patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").
Worsening of MS after stopping treatment with Fingolimod Adamed
The patient should not stop taking Fingolimod Adamed or change the dose without consulting their doctor first.
The patient should immediately tell their doctor if they think their MS is worsening after stopping treatment with Fingolimod Adamed. This situation can be serious (see "Stopping treatment with Fingolimod Adamed" in section 3, as well as section 4 "Possible side effects").

Elderly patients

Experience with Fingolimod Adamed in elderly patients (over 65 years) is limited. In case of doubts, the patient should consult their doctor.

Children and adolescents

Fingolimod Adamed is not intended for use in children under 10 years of age, as it has not been studied in this age group with MS.
The warnings and precautions mentioned above also apply to children and adolescents.
Particularly important for children and adolescents and their caregivers are the following:

• Before starting treatment with Fingolimod Adamed, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, they may need to be vaccinated before starting treatment with Fingolimod Adamed.
• When taking Fingolimod Adamed for the first time or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor the patient's heart rate and pulse (see "Low heart rate (bradycardia) and irregular heartbeat" above).
• If the patient experiences seizures or convulsions before or while taking Fingolimod Adamed, they should tell their doctor.
• If the patient experiences depression or anxiety or feels low or anxious while taking Fingolimod Adamed, they should tell their doctor. The patient may need closer monitoring.

Fingolimod Adamed and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Immunosuppressive or immunomodulatory medicines, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod Adamed should not be taken with these medicines, as it may increase the effect on the immune system (see also "When not to take Fingolimod Adamed").
• Corticosteroids, due to the potential for additive effects on the immune system.
• Vaccines. If the patient needs to be vaccinated, they should consult their doctor first. During and for 2 months after treatment with Fingolimod Adamed, patients should not receive certain types of live attenuated vaccines, as they may cause the infection they are intended to prevent. Other vaccines may also not be effective if administered during this period.
• Medicines that slow the heart rate (such as beta blockers, e.g., atenolol). Taking Fingolimod Adamed with these medicines may increase the effect on the heart rate in the first days of treatment with Fingolimod Adamed.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod Adamed should not be taken by patients taking these medicines, as it may increase the effect on irregular heartbeat (see also "When not to take Fingolimod Adamed").
• Other medicines: protease inhibitors, antiviral medicines such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort products (possible risk of reduced efficacy of Fingolimod Adamed).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Fingolimod Adamed should not be taken during pregnancy, if the patient is trying to become pregnant, or if the patient can become pregnant and is not using effective contraception. If Fingolimod Adamed is taken during pregnancy, there is a risk of harm to the unborn child. The rate of congenital anomalies observed in children exposed to Fingolimod Adamed during pregnancy is about twice as high as that observed in the general population (where the rate of congenital anomalies is about 2-3%). The most commonly reported congenital anomalies include developmental heart defects, kidney defects, and musculoskeletal defects.
For this reason, if the patient is of childbearing age:

• before starting treatment with Fingolimod Adamed, the doctor will inform the patient about the risk to the unborn child and ask them to perform a pregnancy test to ensure the patient is not pregnant, and
• the patient should use effective contraception during treatment with Fingolimod Adamed and for 2 months after stopping treatment to avoid becoming pregnant. The patient should discuss effective contraceptive methods with their doctor.

The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod Adamed.
If the patient becomes pregnant while taking Fingolimod Adamed, they should immediately tell their doctor. The doctor will decide whether to stop treatment (see "Stopping treatment with Fingolimod Adamed" in section 3, as well as section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.
Breastfeeding
The patient should not breastfeed while taking Fingolimod Adamed. Fingolimod Adamed may pass into breast milk, posing a risk of serious side effects to the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles, including riding a bicycle and operating machinery. The patient should not expect Fingolimod Adamed to affect their 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 Adamed. During this time and potentially after it, the patient's ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod Adamed

Treatment with Fingolimod Adamed 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 years and older):

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.
• 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 change the dose to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period as after the first dose of Fingolimod Adamed.

The patient should not exceed the recommended dose.
Fingolimod Adamed is intended for oral use.
The patient should take Fingolimod Adamed once a day, with a glass of water. Fingolimod Adamed capsules should always be swallowed whole, without opening. Fingolimod Adamed can be taken with or without food.
Taking Fingolimod Adamed 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 Adamed, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Adamed than recommended

If the patient takes too much Fingolimod Adamed, they should immediately contact their doctor.

Missing a dose of Fingolimod Adamed

If the patient takes Fingolimod Adamed for less than 1 month and forgets 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 when taking the next dose.
If the patient takes Fingolimod Adamed 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 when taking 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.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Adamed

The patient should not stop taking Fingolimod Adamed or change the dose without consulting their doctor first.
Fingolimod Adamed 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 Adamed, the patient should wait 6-8 weeks before starting new MS treatment.
Patients resuming treatment with Fingolimod Adamed after more than 2 weeks of stopping the medicine may experience the heart rate effect again, usually observed after starting treatment for the first time, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. The patient should not resume treatment with Fingolimod Adamed after a break of more than 2 weeks without consulting their doctor.
The treating doctor will decide how to monitor the patient after stopping treatment with Fingolimod Adamed. The patient should immediately tell their doctor if they think their MS is worsening after stopping treatment with Fingolimod Adamed. 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 Adamed 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 sensation in the chest, fever (symptoms of respiratory disorders)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning sensation, itching, or skin pain, usually above the upper body or face. Other symptoms may include fever and weakness at the early stage of infection, followed by numbness, itching, or red patches with severe pain
• Slow heart rate (bradycardia), irregular heartbeat
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearl-like nodule, although it may have a different appearance
• Depression and anxiety, which are known to occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with Fingolimod Adamed
• 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 defects in the center of the visual field, blurred vision, difficulty seeing colors and fine details
• Decreased platelet count, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an abnormal mole). Possible symptoms of melanoma include moles whose size, shape, elevation, or color changes over time or new moles that appear. Moles may be itchy, bleed, or ulcerate
• 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/or vision changes
• Lymphoma (a type of cancer affecting the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar

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

• Abnormalities in the ECG recording (T-wave inversion)
• A tumor associated with human herpesvirus 8 infection (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 Adamed
• 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 worsening or if the patient or their caregivers notice any new or unusual symptoms, it is very important to tell 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 nodule with a raw meat color or blue-red, usually located on the face, head, or neck. Merkel cell carcinoma may also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system may affect the risk of Merkel cell carcinoma
• After stopping treatment with Fingolimod Adamed, 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 immediately tell their doctor.
Other side effects
Very common(may affect more than 1 in 10 people):

• Influenza 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 (dermatophyte infections) (ringworm)
• Dizziness
• Severe headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itchy, red, burning rash (erythema)
• Itching
• Increased triglyceride levels in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also "Macular edema" under "Some side effects may be or may become serious")
• Hypertension (Fingolimod Adamed 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(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.

5. How to store Fingolimod Adamed

The medicinal product should be stored out of sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton and blister after "Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the specified month. Do not store above 30°C. Store in the original package to protect from moisture. Do not use this medicinal product if you notice that the packaging is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fingolimod Adamed contains

• The active substance is fingolimod.
• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule filling: potassium citrate monohydrate, colloidal anhydrous silica, magnesium stearate.

Capsule body: gelatin, titanium dioxide (E171).
Capsule cap: gelatin, titanium dioxide (E171), iron oxide yellow (E172).

What Fingolimod Adamed looks like and what the pack contains

Fingolimod Adamed 0.5 mg hard capsules (16 mm, size 3) have an opaque white body and an opaque yellow cap.
Fingolimod Adamed 0.5 mg capsules are available in perforated single-dose blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box containing 28 x 1 hard capsules and/or blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box containing 28 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Manufacturer/Importer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Synthon Hispania S.L.
C/ Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Date of last update of the leaflet:13.01.2025