Package leaflet: Information for the user

Fingolimod Stada, 0.5 mg, hard capsules
Fingolimod
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

What Fingolimod Stada is
The active substance in Fingolimod Stada is fingolimod.

What Fingolimod Stada is used for
Fingolimod Stada is used in adults, and in children and adolescents (aged 10 years and older with body weight > 40 kg) for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

patients who have not responded to previous MS treatments, or
patients with rapidly evolving, severe relapsing-remitting MS.

Fingolimod Stada does not cure MS, but 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), which consists of the brain and spinal cord. In MS, an inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This is known as demyelination. The relapsing-remitting form of MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary between patients but typically include walking difficulties, numbness, vision problems, or balance disturbances. Symptoms of relapses may completely resolve, although some deficits may persist.

How Fingolimod Stada works
Fingolimod Stada helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from entering the brain and spinal cord. This limits nerve damage caused by MS. Fingolimod Stada also suppresses certain immune responses in the body.

2. Important information before taking Fingolimod Stada

When not to use Fingolimod Stada

if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6)
if the patient's immune response is reduced (due to immunodeficiency syndrome, disease or medicines that suppress the immune system)
if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis
if the patient has active malignant tumour (cancer)
if the patient has serious liver problems
if the patient has had a heart attack, angina, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months
if the patient has certain types of irregular or abnormal heartbeats (arrhythmias); this also includes patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Stada
if the patient is taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol
if the patient is pregnant or is of childbearing potential and is not using effective contraception
The patient concerned, or who has any doubts, should consult a doctor before taking Fingolimod Stada.

Warnings and precautions
Before taking Fingolimod Stada, consult a doctor if:

the patient has serious breathing problems during sleep (severe sleep apnoea)
the patient has been informed of an abnormal electrocardiogram (ECG)
the patient has symptoms of slow heartbeat (e.g. dizziness, nausea or palpitations)
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)
the patient has a history of episodes of sudden loss of consciousness or fainting
the patient plans to receive a vaccine
the patient has never had chickenpox
the patient has or has had vision disorders or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular oedema, see below), inflammatory or infectious eye disease (uveitis) or diabetes (which may cause eye problems)
the patient has liver problems
the patient has high blood pressure that cannot be controlled with medication
the patient has serious lung problems or smoker's cough
The patient concerned, or who has any doubts, should consult a doctor before taking Fingolimod Stada.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients who previously
received a daily dose of 0.25 mg, Fingolimod Stada slows the heart rate. As a result, the patient may
experience dizziness, fatigue, palpitations or a drop in blood pressure. If these symptoms are severe, inform the doctor,
as immediate treatment may be necessary. Fingolimod may also cause irregular heartbeat, especially after the first dose.
Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.
The doctor will ask the patient to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Stada or after the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring of pulse and blood pressure, so that appropriate actions can be taken if adverse effects occur at the beginning of treatment. An ECG should be performed before the first dose of Fingolimod Stada and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's electrocardiogram. If, after this 6-hour period, the patient has a very slow or decreasing heart rate, or if the ECG shows abnormalities, prolonged monitoring of the patient may be required (for at least 2 additional hours, or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Stada after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod Stada.
If the patient has irregular or abnormal heartbeat, risk factors for such events, an abnormal ECG, or heart disease or heart failure, Fingolimod Stada may not be suitable.
If the patient has experienced an episode of sudden loss of consciousness or slowed heart function, Fingolimod Stada may not be suitable. A consultation with a cardiologist (a heart specialist) may be necessary to advise on how to initiate treatment with Fingolimod Stada, including monitoring the patient until the next day.
If the patient is taking medicines that may reduce heart rate, Fingolimod Stada may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow treatment with Fingolimod Stada. If such a change is not possible, the cardiologist will advise the patient on how to initiate treatment with Fingolimod Stada, including monitoring until the next day.

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

Infections
Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Stada (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects they have an infection, has fever, flu-like symptoms, shingles, or headache with neck stiffness, light sensitivity, nausea, rash and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), they should contact a doctor immediately, as this condition may be severe and life-threatening. If the patient feels their disease (MS) is worsening (e.g. weakness or vision problems) or notices any new symptoms, they should speak to a doctor immediately, as these may be symptoms of a rare brain disease caused by infection, known as progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor will consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether treatment with Fingolimod Stada should be discontinued.
Infections with human papillomavirus (HPV) have been reported in patients treated with fingolimod, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor will consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV infection.

Macular oedema
Before starting treatment with Fingolimod Stada, the doctor may refer patients with current or past vision disorders or other signs of swelling in the central area of vision (macula) at the back of the eye, inflammatory or infectious eye disease (uveitis) or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3–4 months after starting treatment with Fingolimod Stada.
The macula is a small area of the retina located at the back of the eye that enables clear, sharp vision of shapes, colours and details. Fingolimod may cause swelling of the macula, a condition known as macular oedema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Stada.
The likelihood of macular oedema is higher in patients with diabetes and in patients who have had uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular oedema.
If the patient develops macular oedema, they should inform the doctor before resuming treatment with Fingolimod Stada.
Macular oedema may cause symptoms of vision disturbances similar to those of an MS attack (optic neuritis). In the early stages, symptoms may be absent. If any changes in vision occur, the patient should inform the doctor immediately.
The doctor may ask the patient to undergo an ophthalmological examination, especially in the following cases:

the centre of the visual field becomes blurry or shadowed
a blind spot appears in the centre of the visual field
difficulty seeing colours or fine details occurs

Liver function tests
Patients with severe liver disease should not take Fingolimod Stada. Fingolimod may affect liver function test results. The patient may not experience any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark (brown) urine, pain in the right side of the abdomen, fatigue, reduced appetite or unexplained nausea and vomiting occur, the patient should inform the doctor immediately.
If any of these symptoms occur after starting treatment with Fingolimod Stada, the patient should inform the doctor immediately.
Before, during and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver problems, treatment with Fingolimod Stada may need to be discontinued.

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

Lung problems
Fingolimod has a minor effect on lung function. Patients with severe lung disease or smoker's cough are at increased risk of adverse effects.

Blood counts
A desired effect of treatment with Fingolimod Stada is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, inform the doctor about taking Fingolimod Stada. Otherwise, the doctor may not be able to interpret the blood test results, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting treatment with Fingolimod Stada, the doctor will confirm that the white blood cell count is appropriate to start treatment and may order regular repeat tests.
If the white blood cell count is insufficient, treatment with Fingolimod Stada may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
In rare cases, patients with MS treated with fingolimod have reported a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms of this condition may include sudden severe headache, confusion, seizures and vision changes. If the patient experiences any of these symptoms during treatment with Fingolimod Stada, they should inform the doctor immediately, as this condition may be serious.

Malignant tumours
Skin cancer has been reported in patients with MS treated with fingolimod. If any nodules (e.g. pearly nodules), spots or open sores that do not heal within a few weeks are noticed on the skin, the patient should inform their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. new moles) that change in colour, shape or size over time. Before starting treatment with Fingolimod Stada, a skin examination should be performed to check for any nodules on the skin. The doctor will also perform regular skin checks during treatment with Fingolimod Stada. If skin problems occur, the doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
Cases of certain types of lymphatic system tumours (lymphomas) have been reported in patients with MS treated with Fingolimod Stada.

Sun exposure and sun protection
Fingolimod weakens the immune system. This condition increases the risk of malignant tumours, especially skin cancer. The patient should limit sun and UV radiation exposure by:

wearing protective clothing
regularly applying sunscreen with high UV protection factor

Unusual brain changes associated with MS relapse
Rare cases of unusually large brain lesions associated with MS relapse have been reported in patients treated with fingolimod. In case of severe MS relapse, the treating doctor will consider performing an MRI scan to assess this condition and decide whether treatment with Fingolimod Stada should be discontinued.

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

Women of childbearing potential
If fingolimod were used during pregnancy, it could have harmful effects on the unborn child. Before starting treatment with Fingolimod Stada, the doctor will explain the risks to the patient and request a pregnancy test to rule out pregnancy. The doctor will provide the patient with an information card explaining why she should not become pregnant while taking Fingolimod Stada. The card also contains information on how to avoid pregnancy while taking Fingolimod Stada. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

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

Elderly patients
Experience with the use of Fingolimod Stada in elderly patients (over 65 years of age) is limited. Consult a doctor if you have any concerns.

Children and adolescents
Fingolimod Stada is not intended for use in children under 10 years of age and weighing less than 40 kg, as it has not been studied in MS patients in this age group.
The warnings and precautions listed above also apply to children and adolescents.
The following information is particularly important for children, adolescents and their caregivers:

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

Other medicines and Fingolimod Stada
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. If the patient is taking any of the following medicines, inform the doctor:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate or alemtuzumab. Fingolimod Stada must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to use Fingolimod Stada").
Corticosteroids, due to possible additional effects on the immune system.
Vaccines. If vaccination is necessary, consult the doctor first. During treatment and for 2 months after treatment with Fingolimod Stada, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are intended to prevent. Other vaccines may be less effective than usual if administered during this period.
Medicines that slow heart rate (e.g. beta-blockers such as atenolol). Using Fingolimod Stada together with these medicines could intensify the effect on heart function in the first days of treatment with Fingolimod Stada.
Medicines used to treat irregular heart rhythm, such as quinidine, disopyramide, amiodarone or sotalol. Fingolimod Stada must not be used in patients taking these medicines, as its use could intensify the effect on irregular heart rhythm (see also "When not to use Fingolimod Stada").
Other medicines: protease inhibitors, antiviral medicines such as ketoconazole, azole antifungal medicines, clarithromycin or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz or St John's wort products (potential risk of reduced efficacy of fingolimod).

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using the medicine.
Pregnancy
Fingolimod Stada should not be used during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If Fingolimod Stada is used during pregnancy, there is a risk of harmful effects on the unborn child.
The rate of congenital malformations observed in children exposed to fingolimod during pregnancy is about twice as high as the rate observed in the general population (where the rate of congenital malformations is about 2–3%). The most commonly reported congenital malformations include developmental abnormalities of the heart, kidneys and musculoskeletal system.
Therefore, if the patient is of childbearing age:

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

The doctor will provide the patient with additional educational materials explaining why she should not become pregnant while taking Fingolimod Stada.
If pregnancy occurs during treatment with Fingolimod Stada, contact the doctor immediately.
The doctor will decide whether to discontinue treatment (see "Stopping treatment with Fingolimod Stada" in section 3 and section 4 "Possible side effects"). Specialised prenatal monitoring will be carried out.
Breastfeeding
Patients should not breastfeed while taking Fingolimod Stada. Fingolimod may pass into breast milk, so there is a risk of serious adverse effects in the infant.

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

3. How to take Fingolimod Stada

Treatment with Fingolimod Stada will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.

Recommended dose:
Adults
The dose is one tablet (0.5 mg) daily.

Children and adolescents (aged 10 years and older, with body weight above 40 kg)
One 0.5 mg capsule daily. Children and adolescents initiating treatment with one 0.25 mg capsule per day, who subsequently achieve a stable body weight above 40 kg, will receive instructions from their physician to change the dose to one 0.5 mg capsule once daily. In this case, a repeat observation period, similar to that after the first dose, is recommended.

Children and adolescents (aged at least 10 years, with body weight ≤ 40 kg)
Fingolimod Stada 0.5 mg hard capsules are not suitable for children with body weight ≤ 40 kg. Alternative fingolimod-containing medicines with lower dosage strengths (0.25 mg capsules) are available.

Do not take more than the recommended dose.

Method of administration
Fingolimod Stada is intended for oral use.
Fingolimod Stada should be taken once daily, with a glass of water. Fingolimod Stada capsules must always be swallowed whole, without opening. Fingolimod Stada may be taken with or without food.
Taking Fingolimod Stada at the same time each day will help you remember to take your dose.

Duration of treatment
If you have any questions about how long treatment with Fingolimod Stada should continue, consult your doctor or pharmacist.

Taking more Fingolimod Stada than prescribed
If you take too much medicine, contact your doctor immediately.

If you miss a dose of Fingolimod Stada
If you have been taking Fingolimod Stada for less than 1 month and have missed one full day's dose, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.
If you have been taking Fingolimod Stada for at least 1 month and have missed doses for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed doses for up to 2 weeks, you may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping Fingolimod Stada
Do not stop taking Fingolimod Stada or change the dose without first consulting your doctor.
Fingolimod remains in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may remain low and adverse effects described in this leaflet may still occur. After stopping treatment with Fingolimod Stada, wait 6–8 weeks before starting a new multiple sclerosis treatment.

In patients restarting Fingolimod Stada after a treatment interruption of more than 2 weeks, the effect on heart rate observed usually after first initiation of treatment may reoccur, and monitoring in a doctor's office or clinic will be necessary upon resuming treatment. Do not restart Fingolimod Stada after a treatment break lasting more than two weeks without consulting your treating physician.

Your treating physician will decide whether and how monitoring should be performed after stopping treatment with Fingolimod Stada. Inform your doctor immediately if you feel that your multiple sclerosis is worsening after stopping Fingolimod Stada. This situation may be serious.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some side effects may be serious or may become serious.

Common (may occur in up to 1 in 10 patients)

Cough with sputum, feeling of discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infection (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on the upper part of the body or face. Other symptoms may include: fever and weakness in the early stage of infection, followed by numbness, itching or red spots with severe pain
Slow heartbeat (bradycardia), irregular heartbeat
A certain type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly lump, although it may also look different
Depression and anxiety 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
Weight loss

Uncommon (may occur in up to 1 in 100 patients)

Pneumonia, with symptoms such as fever, cough and difficulty breathing
Macular edema (swelling of the central area of the retina at the back of the eye), presenting as shadows or a blind spot in the center of the visual field, blurred vision, and problems with color and detail vision
Decreased platelet count, increasing the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer which usually arises from an atypical mole). Possible signs of melanoma include moles that may change in size, shape, elevation above the skin or color over time, or the development of new moles. These moles may itch, bleed or ulcerate
Seizures, epileptic seizures (more frequently in children and adolescents than in adults)

Rare (may occur in up to 1 in 1,000 patients)

A condition called "posterior reversible encephalopathy syndrome" (PRES). Symptoms of this disease may include sudden, severe headache, confusion, seizures and (or) visual disturbances
Lymphomas (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 new ulcer developing at the site of an existing scar

Very rare (may occur in up to 1 in 10,000 patients)

Abnormalities in electrocardiogram (ECG) (T-wave inversion)
Tumour associated with human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency not known (cannot be estimated from 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 treatment with Fingolimod Stada is started
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function test results. In very rare cases, liver failure may lead to liver transplantation
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble a relapse of MS. There may also be symptoms that the patient may not be aware of, such as changes in mood or behavior, temporary memory lapses, difficulties in speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their family members notice any new or unusual symptoms, it is very important to inform the treating doctor as soon as possible
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and (or) confusion
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include the presence of a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term exposure to sunlight and weakened immune system may influence the risk of developing Merkel cell carcinoma
After discontinuation of treatment with Fingolimod Stada, MS symptoms may return and worsen compared to the period before and during treatment
Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia)

If any of these conditions occur, you should inform your doctor immediately.

Other adverse reactions

Very common (may occur in more than 1 in 10 patients)

Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Increased liver enzyme activity in blood tests
Cough

Common (may occur in up to 1 in 10 patients)

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

Uncommon (may occur in up to 1 in 100 patients)

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

Rare (may occur in up to 1 in 1,000 patients)

Lymphatic system tumour (lymphoma)

Frequency not known (cannot be estimated from available data)

Peripheral edema

If any of these symptoms occur severely, you should inform your treating doctor.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fingolimod Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister foil after the words
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Do not use the carton if there are visible signs of damage or tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Fingolimod Stada contains
The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
The other ingredients are:

Capsule contents: microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin

What Fingolimod Stada looks like and contents of the pack
Fingolimod Stada 0.5 mg hard capsules are hard gelatin capsules of size 3 with a yellow opaque cap and a white opaque body.
Fingolimod Stada 0.5 mg hard capsules are available in blister packs contained in cardboard boxes of 7, 28, 30, 56, 84, 98 or 100 capsules, and in unit dose blister packs contained in cartons containing 7 x 1, 28 x 1, 30 x 1, 56 x 1, 84 x 1, 98 x 1 or 100 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Wien
Austria
Centrafarm Services B.V.
Van de Reijstraat 31-E
4814 NE Breda
The Netherlands
Clonmel Healthcare Limited
Waterford Road
Clonmel, E91 D768
Ireland
Haupt Pharma Amareg GmbH
Donaustaufer Str. 378
93055 Regensburg
Germany

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Fingolimod STADA 0.5 mg Hartkapseln
Belgium: Fingolimod EG 0.5 mg harde capsules
Czech Republic: Fingolimod STADA
Denmark: Fingolimod STADA
Germany: Fingolimod STADA 0.5 mg Hartkapseln
Spain: Fingolimod STADA 0.5 mg cápsulas duras EFG
Finland: Fingolimod STADA 0.5 mg kapseli kova
France: FINGOLIMOD EG 0.5 mg, gélule
Croatia: Fingolimod STADA 0.5 mg tvrde capsule
Hungary: Fingolimod Stada 0.5mg kemény kapszula
Ireland: Fingolimod Clonmel 0.5 mg hard capsules
Iceland: Fingolimod STADA 0.5 mg hörð hylki
Italy: FINGOLIMOD EG
Luxembourg: Fingolimod EG 0.5 mg gélules
The Netherlands: Fingolimod CF 0.5 mg, harde capsules
Poland: Fingolimod Stada
Portugal: Fingolimod Stada
Sweden: Fingolimod STADA 0.5 mg hårda kapslar
Slovenia: Fingolimod STADA 0.5 mg trde kapsule
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