Package leaflet: Information for the user

Areleptan, 0.5 mg, hard capsules
fingolimod
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Leaflet contents

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

1. What Areleptan is and what it is used for

What Areleptan is
Areleptan contains the active substance fingolimod.

What Areleptan is used for
Areleptan is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (Latin: Sclerosis multiplex, MS), particularly in:

Patients who have not responded to previous MS treatments, or
Patients with rapidly evolving, severe forms of MS.

Areleptan does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.

What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammatory processes damage the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon 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 among patients but typically include walking difficulties, numbness, visual disturbances, or balance problems. Symptoms of relapses may completely resolve, although some deficits may persist.

How Areleptan works
Areleptan 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. In this way, the medicine limits nerve damage associated with MS. Areleptan also modulates certain immune responses in the body.

2. Important Information Before Using Areleptan

When not to take Areleptan

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, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months.
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (EKG) showed QT interval prolongation before starting treatment with Areleptan.
if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol.
if the patient is pregnant or is of childbearing age and not using effective contraception.
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of these situations apply or the patient has any doubts, consult a doctor before taking Areleptan.
Warnings and precautions
Before starting Areleptan, discuss the following with your doctor:

if the patient has severe breathing problems during sleep (severe sleep apnea).
if the patient has been informed that their EKG tracing 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, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine).
if the patient has previously experienced sudden loss of consciousness or fainting.
if the patient plans to be vaccinated.
if the patient has never had chickenpox.
if the patient has or has had vision problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye (a condition called macular edema, see below), inflammation or infection of the eye (uveitis), or if the patient has diabetes, which may cause vision problems.
if the patient has liver problems.
if the patient has high blood pressure that cannot be controlled with medication.
if the patient has severe lung disease or a smoker's cough.

If any of these situations apply or the patient has any doubts, consult a doctor before taking Areleptan.
Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after the first dose of 0.5 mg in patients previously on a 0.25 mg daily dose, Areleptan slows the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary. Areleptan 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 Areleptan or the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be administered if adverse effects occur at the beginning of treatment. An EKG will be performed before the first dose of Areleptan and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiography. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the EKG shows abnormalities, longer monitoring (at least 2 additional hours or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Areleptan after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Areleptan before the interruption.
If the patient has irregular or abnormal heartbeat, risk factors for such events, an abnormal EKG, heart disease, or heart failure, Areleptan may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Areleptan may not be suitable. Consultation with a cardiologist (a heart specialist) may be necessary to advise on how to start treatment with Areleptan, including overnight monitoring.
If the patient is taking medications that may slow heart rate, Areleptan may not be suitable. Consultation with a cardiologist may be necessary to determine whether the patient can switch to other medications that do not slow heart rate to allow treatment with Areleptan. If such a switch is not possible, the cardiologist will advise on how to start treatment with Areleptan, including monitoring until the day after the first dose.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella zoster virus. If the patient is not protected against the virus, vaccination may be required before starting treatment with Areleptan. If this is the case, the doctor will delay starting treatment with Areleptan by one month after completing the full vaccination course.
Infections
Areleptan reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Areleptan (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects an infection, has fever, flu-like symptoms, shingles, or headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), the patient should contact the doctor immediately, as this condition may be severe and life-threatening.
If the patient feels their condition is worsening (e.g. weakness or vision problems) or notices any new symptoms, they should contact the doctor immediately, as these may be symptoms of a rare brain disease caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor may consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether treatment with Areleptan should be discontinued.
Infections with human papillomavirus (HPV) have been reported in patients treated with Areleptan, including cases of warts, dysplasia, condylomas, and HPV-related malignant tumors. The doctor may consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV.
Macular edema
Before starting treatment with Areleptan, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the center of the visual field (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Areleptan.
The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colors, and other details. Areleptan may cause swelling of the macula, a condition called macular edema. This swelling usually occurs within the first 4 months of treatment with Areleptan.
The risk of macular edema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular edema.
If the patient develops macular edema, they should inform the doctor before resuming treatment with Areleptan.
Macular edema may cause certain vision disturbances, similar to those in MS attacks (optic neuritis). In the early stages, symptoms may be absent. Any changes in vision should be reported to the doctor. The doctor may refer the patient for ophthalmological examination, especially if:

the center of the visual field becomes blurry or shadowed;
a blind spot appears in the center of the visual field;
there are difficulties with color vision or seeing fine details.

Liver function tests
Patients with severe liver disease should not take Areleptan. Areleptan 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 doctor should be informed immediately.
If any of the above symptoms occur after starting treatment with Areleptan, the doctor should be informed immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, treatment with Areleptan may be discontinued.
High blood pressure
The doctor may regularly check blood pressure, as Areleptan causes a slight increase in blood pressure.
Lung problems
Areleptan has a minor effect on lung function. Patients with severe lung disease or a smoker's cough are at higher risk of adverse effects.
Blood cell count
A known effect of Areleptan 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. When blood tests are needed, inform the doctor about taking Areleptan. Otherwise, the doctor may not be able to interpret blood test results, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting Areleptan, the doctor will confirm that the white blood cell count is appropriate to start treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Areleptan may need to be discontinued.
Posterior reversible encephalopathy syndrome (PRES)
Rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported in MS patients treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Areleptan, inform the doctor immediately, as this condition may be severe.
Cancer
Skin cancers have been reported in MS patients treated with Areleptan. If any skin nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within a few weeks are noticed, inform the treating doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. atypical moles) that change color, shape, or size over time. Before starting treatment with Areleptan, a skin examination should be performed to check for any skin nodules. The treating doctor will also perform regular skin checks during treatment with Areleptan. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consultation.
Lymphoma, a type of cancer of the lymphatic system, has been reported in MS patients treated with Areleptan.
Sun exposure and sun protection
Fingolimod weakens the immune system.
This condition increases the risk of malignant tumors, especially skin cancers.
The patient should limit sun and UV radiation exposure by:

wearing protective clothing.
regularly applying sunscreen with high UV protection.

Unusual brain lesions 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 a severe MS relapse, the treating doctor may consider performing an MRI to assess this condition and decide on the need to discontinue Areleptan.
Switching from other medications to Areleptan
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Areleptan if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab treatment, a 2-3 month waiting period may be necessary before starting Areleptan. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with the doctor before deciding if Areleptan is suitable.
Women of childbearing age
If Areleptan is used during pregnancy, it may harm the unborn child. Before starting treatment with Areleptan, the doctor will explain the risks to the patient and request a pregnancy test to rule out pregnancy. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during treatment with Areleptan. The card also contains information on how to avoid pregnancy while taking Areleptan. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").
Worsening of MS after stopping Areleptan
Do not stop taking Areleptan or change the dose without first consulting a doctor.
Inform the doctor immediately if the patient feels their MS is worsening after stopping treatment with Areleptan. This situation may be serious (see "Stopping treatment with Areleptan" in section 3 and section 4 "Possible side effects").
Elderly patients
Experience with the use of Areleptan in elderly patients (over 65 years) is limited. If in doubt, consult a doctor.
Children and adolescents
Areleptan is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
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 Areleptan, 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 Areleptan.
During the first dose of Areleptan or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
If the patient experiences seizures or epileptic fits before or during treatment with Areleptan, inform the doctor.
If the patient develops depression or anxiety or feels low mood or anxiety during treatment with Areleptan, inform the doctor. The patient may require closer monitoring.

Areleptan and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Areleptan must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Areleptan").
Corticosteroids, due to the possibility of additive effects on the immune system.
Vaccines. If the patient needs vaccination, they should first consult the doctor. During and up to 2 months after treatment with Areleptan, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if administered during this period.
Medicines that slow heart function (e.g. beta-blockers such as atenolol). Using Areleptan together with these medicines could intensify the effect on heart function in the first days of treatment with Areleptan.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Areleptan must not be used in patients taking these medicines, as its use could intensify the effect on irregular heartbeat (see also "When not to take Areleptan").
Other medicines: protease inhibitors, antifungal agents such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort preparations (possible risk of reduced effectiveness of Areleptan).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Pregnancy
Areleptan 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 Areleptan 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 Areleptan during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is approximately 2-3%).
The most commonly reported congenital malformations include heart, kidney, and musculoskeletal system developmental defects.
Therefore, if the patient is of childbearing age:

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

The doctor will provide the patient with an information card explaining why pregnancy should be avoided during treatment with Areleptan.
If the patient becomes pregnant while taking Areleptan, inform the doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping treatment with Areleptan" in section 3 and section 4 "Possible side effects").
The patient will also need to attend prenatal check-ups.
Breastfeeding
Breastfeeding is not recommended during treatment with Areleptan. Areleptan may pass into breast milk, posing 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. Areleptan is not expected to affect the ability to drive and operate machinery.
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 Areleptan. During this time and potentially afterward, the ability to drive and operate machinery may be impaired.

3. How to take Areleptan

Treatment with Areleptan will be supervised by a doctor experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor.

Use in adults
The recommended dose is one hard capsule per day.

Use in children and adolescents (aged 10 years and older)
The dose depends on body weight:
The recommended dose is one 0.5 mg hard capsule per day for children and adolescents with body weight above 40 kg.
Other strengths of this medicine are suitable for children and adolescents aged 10 years and older with body weight equal to or less than 40 kg; please consult the doctor or pharmacist about the availability of hard capsules containing fingolimod in other strengths.
Do not exceed the recommended dose.

Areleptan is intended for oral administration.
Areleptan should be taken once daily with a glass of water. Areleptan capsules should always be swallowed whole, without opening. Areleptan may be taken with or without food.
Taking Areleptan at the same time each day will help remember to take the medicine.
For any questions regarding the duration of treatment with Areleptan, consult the doctor or pharmacist.

If more Areleptan has been taken than recommended
If a patient has taken an excessive dose of the medicine, they should contact the doctor immediately.

If a dose of Areleptan has been missed
If a patient has been taking Areleptan for less than 1 month and has missed one daily dose, they should contact the doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
If a patient has been taking Areleptan for at least 1 month and has missed taking the medicine for more than 2 weeks, they should contact the doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
However, if a patient has missed taking the medicine for up to 2 weeks, they may take the next dose according to the schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Areleptan
Do not stop treatment with Areleptan or change the dose without first consulting the doctor.
Areleptan remains in the body for up to 2 months after stopping treatment. During this time, the white blood cell count (lymphocyte count) may still be reduced, and adverse reactions described in this leaflet may continue to occur. After stopping treatment with Areleptan, wait 6–8 weeks before starting a new treatment for MS.

In patients restarting treatment with Areleptan after a break of more than 2 weeks, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring of the patient’s condition will be necessary in a doctor’s office or clinic due to resumption of treatment. Do not restart treatment with Areleptan after a break lasting more than two weeks without consulting the treating physician.

The treating physician will decide whether and how the patient should be monitored after stopping treatment with Areleptan. Inform the doctor immediately if the patient feels that their MS is worsening after stopping treatment with Areleptan. This situation may be serious.

If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

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

Common (may affect less than 1 in 10 people):

Productive cough, unspecified discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning, itching, or pain in the skin, usually above the upper part of the body or face. Other symptoms may include fever and malaise in the early stage of infection, followed by numbness, itching, red patches, and severe pain
Slow heart rate (bradycardia), irregular heartbeat
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have a different appearance
Depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with fingolimod
Weight loss

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

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the center of the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details
Decreased platelet count, which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible symptoms of melanoma include moles that change in size, shape, elevation, or color over time, or the appearance of new moles. Moles may itch, bleed, or ulcerate
Seizures, epileptic seizures (more frequent in children and adolescents than in adults)

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

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

Very rare (may affect less than 1 in 10,000 people):

Abnormalities in the ECG test (T-wave inversion)
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 rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day treatment with Areleptan is started
Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure may lead to the need for liver transplantation
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble a relapse of MS. Other symptoms, which the patient may not be aware of, may also occur, such as changes in mood or behavior, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a physician to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their family notice any new or unusual symptoms, it is very important to inform the treating physician as soon as possible
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, light sensitivity, nausea, and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include 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 Areleptan, MS symptoms may recur 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 reactions occur, the patient should immediately inform their doctor.

Other adverse reactions

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

Viral 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 less than 1 in 10 people):

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

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

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

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

Cancer of the lymphatic system (lymphoma)

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

Peripheral edema

If any of these symptoms are severe, the patient should inform their doctor.

Reporting of adverse reactions

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

5. How to store the medicine Areleptan

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister pack after "Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Areleptan contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
Other components are:
Capsule filling: calcium phosphate tribasic, stearic acid
Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172)
Printing ink: shellac, iron oxide black (E 172)

What Areleptan looks like and contents of the pack
Areleptan 0.5 mg hard capsules contain a white to almost white powder and are presented as size 3 hard gelatin capsules approximately 16 mm long, composed of a yellow opaque cap and a white opaque body, with the imprint "0.5 mg" printed in black ink on the cap.

Areleptan 0.5 mg hard capsules are packed in cardboard boxes containing a specified number of blisters made of PVC/PE/PVDC/Aluminum, the corresponding number of capsules, and the package leaflet.

Pack sizes:
Cardboard boxes containing 7, 14, 28, 84 or 98 hard capsules.
Not all pack sizes may be marketed in a given country.

Marketing Authorisation Holder and Manufacturer
Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna, Austria
Tel. No.: +43 (0) 1 786 03 86-00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark: Areleptan
Austria: Areleptan 0.5 mg Hartkapseln
Bulgaria: Aрелептaн 0.5 mg Твърди капсули
Croatia: Areleptan 0.5 mg tvrde kapsule
Czech Republic: Areleptan 0.5 mg tvrdé tobolky
Finland: Areleptan 0.5 mg kovat kapselit
Hungary: Areleptan 0.5 mg kemény kapszula
Norway: Areleptan
Poland: Areleptan
Slovakia: Areleptan 0.5 mg tvrdé kapsuly
Slovenia: Areleptan 0.5 mg trde kapsule
Sweden: Areleptan 0.5 mg hårda kapslar