Fingolimod +pharma

Leaflet accompanying the packaging: information for the user

Fingolimod +pharma, 0.5 mg, hard capsules
Fingolimodum

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

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

Table of contents of the leaflet

1.
What is Fingolimod +pharma and what is it used for

• 2. Important information before taking Fingolimod +pharma
• 3. How to take Fingolimod +pharma
• 4. Possible side effects
• 5. How to store Fingolimod +pharma
• 6. Package contents and other information

1. What is Fingolimod +pharma and what is it used for

What is Fingolimod +pharma

Fingolimod +pharma contains the active substance fingolimod.

What is Fingolimod +pharma used for

Fingolimod +pharma 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 +pharma 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 from patient to patient, but usually include walking difficulties, numbness, vision problems, or balance problems. Relapse symptoms may completely resolve, but some disturbances may persist.

How Fingolimod +pharma works

Fingolimod +pharma 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 +pharma also weakens some immune responses of the body.

2. Important information before taking Fingolimod +pharma

When not to take Fingolimod +pharma

• if the patient has reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive drugs)
• if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis
• if the patient has active cancer
• if the patient has severe liver disease
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within 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 +pharma
• 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 pregnantor of childbearing age and not using effective contraception
• if the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6) If such a situation applies to the patient or the patient has doubts, they should consult their doctor before taking Fingolimod +pharma.

Warnings and precautions

Before starting treatment with Fingolimod +pharma, 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 experiences symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations)
• if the patient is taking or has recently taken medications that slow heart rate(such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine)
• if the patient has a history of sudden loss of consciousness or fainting
• if the patient plans to receive a vaccination
• - if the patient has never had chickenpox
• if the patient has or has had vision problemsor other symptoms of macular edema (macular edema) or inflammation or infection of the eye (uveitis) or if the patient has 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 diseaseor a cough typical of smokers

If any of these situations apply to the patient or the patient has doubts, they should consult their doctor before taking Fingolimod +pharma.
The patient should also consult their doctor if they experience any of the following:
Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg, Fingolimod +pharma slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or a decrease in blood pressure. If these symptoms are severe, the patient should inform their doctor, as they may require immediate treatment. Fingolimod +pharma may also cause irregular heartbeat, especially after taking 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 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 +pharma or after the first dose of 0.5 mg when changing from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any adverse reactions occur that are common at the beginning of treatment, appropriate treatment can be administered. Before the first dose of Fingolimod +pharma and after the 6-hour observation period, the patient will undergo an ECG.
During this time, the doctor may perform continuous monitoring of the patient's heart function 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 +pharma after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod +pharma 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 +pharma may not be suitable for them.
If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod +pharma may not be suitable for them. It may be necessary to consult a cardiologist (a heart specialist) who will advise on how to start treatment with Fingolimod +pharma, including how to monitor the patient at night.
If the patient is taking medications that can slow down the heart rate, Fingolimod +pharma may not be suitable. It may be necessary to consult a cardiologist to check if the patient can switch to other medications that do not slow down the heart rate, to allow treatment with Fingolimod +pharma. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod +pharma, taking into account monitoring until the next day after administration of the first dose of Fingolimod +pharma.

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 +pharma. If this is the case, the doctor will delay the start of treatment with Fingolimod +pharma for one month after the full vaccination course.

Infections

Fingolimod +pharma reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod +pharma (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, and (or) disorientation 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's condition worsens (e.g., weakness or vision problems) or if the patient notices any new symptoms, they should talk to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection, called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can lead to severe disability or death. The doctor will consider performing an MRI scan to assess the patient's condition and decide whether to discontinue Fingolimod +pharma.

Macular edema

Before starting treatment with Fingolimod +pharma, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema or inflammation or infection of the eye (uveitis) or diabetes for ophthalmological examinations.
The doctor may also refer the patient for ophthalmological examinations 3-4 months after starting treatment with Fingolimod +pharma.
The macula is a small area of the retina, located at the back of the eye, which enables clear and sharp vision of shapes, colors, and other details. Fingolimod +pharma may cause macular edema, a condition called macular edema. Macular edema usually occurs within the first 4 months of treatment with Fingolimod +pharma.
The risk of macular edema is higher in patients with diabetesor a history of uveitis. In such cases, the doctor will prescribe regular ophthalmological examinations to detect macular edema.
If the patient develops macular edema, they should inform their doctor before resuming treatment with Fingolimod +pharma.
Macular edema can cause certain vision problems, 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 ophthalmological examinations, especially if:

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

Liver function tests

Patients with severe liver disease should not take Fingolimod +pharma.
Fingolimod +pharma may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or eyes, dark (brown) urine, pain in the right side of the abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should tell their doctor immediately.
If the patient experiences any of the above symptoms after starting treatment with Fingolimod +pharma, 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 +pharma may be discontinued.

High blood pressure

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

Lung problems

Fingolimod +pharma 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.

Blood cell count

The expected effect of Fingolimod +pharma 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 necessary, the patient should inform their doctor that they are taking Fingolimod +pharma. Otherwise, the doctor may not be able to interpret the blood test results, and in the case of certain tests, the doctor may prescribe a larger amount of blood to be drawn than usual.
Before starting treatment with Fingolimod +pharma, the doctor will confirm that the patient has a suitable number of white blood cells in their blood to start treatment and may prescribe regular repeat tests.
If the patient has an insufficient number of white blood cells, it may be necessary to discontinue treatment with Fingolimod +pharma.

Posterior reversible encephalopathy syndrome (PRES)

In patients with MS treated with Fingolimod +pharma, posterior reversible encephalopathy syndrome (PRES) has been rarely reported. Symptoms of this disease may include severe headache, disorientation, seizures, and vision changes. If the patient experiences any of these symptoms while taking Fingolimod +pharma, they should tell their doctor immediately, as this condition can be severe.

Cancer

In patients with MS treated with Fingolimod +pharma, skin cancers have been reported. If the patient notices any lumps (e.g., shiny lumps with a pearl-like color), spots, or open sores that do not heal within a few weeks, they should tell their doctor immediately. 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 +pharma, it is necessary to examine the skin for any lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod +pharma. 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.
In patients with MS treated with Fingolimod +pharma, a certain type of lymphoma (a type of cancer of the lymphatic system) has been reported.

Exposure to the sun and protection from sunlight

Fingolimod +pharma weakens the immune system. This condition increases the risk of developing cancers, especially skin cancers. The patient should limit their exposure to the sun 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

In patients treated with fingolimod, rare cases of unusually large changes in the brain associated with MS relapse have been reported. 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 discontinue Fingolimod +pharma.

Switching from other medicines to Fingolimod +pharma

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod +pharma 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 +pharma. 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 +pharma is suitable for them.

Women of childbearing age

If Fingolimod +pharma is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod +pharma, 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 +pharma. The card also contains information on what to do to avoid becoming pregnant while taking Fingolimod +pharma. Female patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

Worsening of MS after stopping Fingolimod +pharma

The patient should not stop taking Fingolimod +pharma or change the dose without consulting their doctor.
The patient should tell their doctor immediately if they think their MS is worsening after stopping treatment with Fingolimod +pharma. This situation can be serious (see "Stopping Fingolimod +pharma" in section 3, as well as section 4 "Possible side effects").

Elderly patients

Experience with Fingolimod +pharma in elderly patients (over 65 years) is limited. If in doubt, the patient should consult their doctor.

Children and adolescents

Fingolimod +pharma is not intended for use in children under 10 years of age, as it has not been tested in this age group with MS.
The warnings and precautions mentioned above also apply to children and adolescents. The following information is particularly important for children and adolescents and their caregivers:

• before starting treatment with Fingolimod +pharma, 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 +pharma.
• when taking Fingolimod +pharma 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 "Slow heart rate (bradycardia) and irregular heartbeat" above)
• if the patient experiences seizures or convulsions before or during treatment with Fingolimod +pharma, they should tell their doctor
• if the patient experiences depression or anxiety, or if they feel low or anxious while taking Fingolimod +pharma, they should tell their doctor. The patient may require closer monitoring.

Fingolimod +pharma 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. The patient should tell their doctor if they are taking any of the following medicines:

• immunosuppressive or immunomodulatory medicines, including other MS treatments, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fingolimod +pharma should not be taken with these medicines, as it may increase the effect on the immune system (see also "When not to take Fingolimod +pharma").
• corticosteroidsdue to the potential for additive effects on the immune system
• vaccines- if the patient requires vaccination, they should consult their doctor first. During treatment and for 2 months after stopping treatment with Fingolimod +pharma, patients should not receive certain types of live attenuated vaccines, as they may cause infection. Other vaccines may also not be effective if administered during this period.
• medicines that slow down heart rate(e.g., beta blockers, such as atenolol) Taking Fingolimod +pharma with these medicines may increase the effect on heart rate in the first few days of treatment.
• medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod +pharma 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 +pharma").
• other medicines:
• protease inhibitors, antiviral medicines, 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 +pharma)

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 or pharmacist before taking this medicine.
Pregnancy
Fingolimod +pharma should not be taken 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 +pharma is taken during pregnancy, it may harm the unborn child. The incidence of birth defects observed in children exposed to Fingolimod +pharma during pregnancy is about twice as high as that observed in the general population (in which the incidence of birth defects is about 2-3%). The most commonly reported birth defects include heart, kidney, and musculoskeletal developmental abnormalities.
Therefore, if the patient is of childbearing age:

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

The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod +pharma.

If the patient becomes pregnant while taking Fingolimod +pharma, they should

tell their doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping Fingolimod +pharma" in section 3, as well as section 4 "Possible side effects"). The patient will also need to undergo prenatal check-ups.
Breastfeeding
The patient should not breastfeed while taking Fingolimod +pharma. Fingolimod +pharma may pass into breast milk, posing a risk of serious side effects in the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including riding a bicycle and operating machinery. It is not expected that Fingolimod +pharma will affect the ability to drive vehicles or 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 +pharma. During this time or potentially after this period, the ability to drive vehicles or operate machinery may be impaired.

3. How to take Fingolimod +pharma

Treatment with Fingolimod +pharma will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor.

Recommended dose Adults

The dose is one 0.5 mg capsule per day.
Children and adolescents (aged 10 and over)

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 +pharma.
The patient should not exceed the recommended dose.
Fingolimod +pharma is only available in a 0.5 mg dose, capsules. Therefore, if smaller doses are required, another medicine should be used.
Fingolimod +pharma is for oral use.
The patient should take Fingolimod +pharma once a day, with a glass of water. Fingolimod +pharma capsules should always be swallowed whole, without opening them.
Fingolimod +pharma can be taken with or without food. Taking Fingolimod +pharma at the same time every day will help the patient remember to take their medicine.
If the patient has questions about the duration of treatment with Fingolimod +pharma, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod +pharma than recommended

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

Missing a dose of Fingolimod +pharma

If the patient has been taking Fingolimod +pharma for less than a month and forgets to take the first 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 has been taking Fingolimod +pharma for at least a 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 the missed dose.

Stopping Fingolimod +pharma

The patient should not stop taking Fingolimod +pharma or change the dose without consulting their doctor.
Fingolimod +pharma 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 the patient may still experience side effects described in this leaflet. After stopping treatment with Fingolimod +pharma, the patient should wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Fingolimod +pharma after a break of more than 2 weeks, 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. The patient should not resume treatment with Fingolimod +pharma 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 +pharma. The patient should tell their doctor immediately if they think their MS is worsening after stopping treatment with Fingolimod +pharma. 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 +pharma 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, unpleasant feeling in the chest, fever (respiratory disorders)
• herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on 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 occurs as a pearl-like nodule, although it may have a different appearance
• it is known that depression and anxiety occur more frequently in the MS population and have also been reported in children and adolescents treated with fingolimod
• weight loss

Uncommon(may affect up to 1 in 100 people)

• pneumonia with symptoms such as fever, cough, difficulty breathing
• macular edema with symptoms such as shadows or defects in the center of the visual field, blurred vision, difficulty perceiving colors and details
• reduced platelet count, which increases the risk of bleeding or bruising
• malignant melanoma (a type of skin cancer) with possible symptoms including moles whose size, shape, elevation, or color changes over time or new moles. Moles can be itchy, bleeding, or ulcerating.
• seizures, convulsions (more common in children and adolescents than in adults)

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

• posterior reversible encephalopathy syndrome (PRES) with symptoms such as severe headache, disorientation, 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 area 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 type 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 +pharma
• symptoms of liver disease (including liver failure) such as yellowing of the skin or eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting. In very rare cases, liver failure may require a liver transplant.
• risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. They may also include symptoms that the patient is not aware of, such as changes in mood or behavior, transient memory loss, difficulty speaking or communicating, 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 immediately.
• cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and (or) disorientation
• cancer of Merkel cells (a type of skin cancer). Possible symptoms of Merkel cell cancer include a painless nodule with a raw meat or blue-red color, usually located on the face, head, or neck. Merkel cell cancer can also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system may affect the risk of Merkel cell cancer.
• after stopping treatment with Fingolimod +pharma, MS symptoms may recur and worsen compared to the period before treatment and during treatment
• autoimmune hemolytic anemia (a condition in which 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 - dermatophyte infections (ringworm)
• dizziness
• severe headache, often 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 "Some side effects may be or may become serious")
• high blood pressure (Fingolimod +pharma 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 +pharma

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 packaging after "EXP". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fingolimod +pharma contains

• The active substance of the medicinal product is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule content:calcium hydrogen phosphate, hydroxypropylcellulose, magnesium stearate Body of the capsule:gelatin, titanium dioxide (E 171) Capsule cap:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) Printing ink:shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527)

What Fingolimod +pharma looks like and what the pack contains

Fingolimod +pharma, 0.5 mg, hard capsules, consists of a white or almost white body and a yellow cap with "C886 0.5 mg" printed on the cap. Fingolimod +pharma is available in packs containing 7, 7x1, 10, 14, 28, 30, 84, 98, and 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Coripharma ehf.
Reykjavikurvegur 78-80
220 Hafnarfjörður
Iceland
Genericon Pharma Gesellschaft m.b.H.
Hafnerstraße 211
8054 Graz
Austria

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland
Fingolimod +pharma
Czech Republic
Fingolimod +pharma
Austria
Fingolimod Genericon 0.5 mg Hartkapseln
In order to obtain more detailed information on this medicinal product, you should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last update of the leaflet:May 2022