Fingolimod aristo: detailed information

Package leaflet: Information for the user

Fingolimod Aristo, 0.5 mg hard capsules
Fingolimodum
Read the entire 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, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Fingolimod Aristo is and what it is used for
Important information before taking Fingolimod Aristo
How to take Fingolimod Aristo
Possible side effects
How to store Fingolimod Aristo
Contents of the pack and other information

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

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

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

patients who have not responded to previous MS treatment, or
patients with rapidly evolving, severe form of MS.

Fingolimod Aristo 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, the inflammatory process damages the protective covering of nerves (called myelin) in the CNS,
preventing them from functioning properly. This phenomenon is known as demyelination.
Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms
reflecting inflammatory activity within the CNS. Symptoms vary among patients but usually include
walking difficulties, numbness, vision problems, or balance disturbances. Symptoms of relapses may completely resolve,
but some impairments may persist.

How Fingolimod Aristo works
Fingolimod Aristo helps protect the CNS from attack by the immune system 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 causing MS.
Fingolimod Aristo also reduces certain immune responses in the body.

2. Important information before taking Fingolimod Aristo

When not to take Fingolimod Aristo

if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or use of medicines that suppress the immune system);
if the patient has severe active infection or active chronic 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 stroke warning signs, 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 (ECG) showed QT interval prolongation before starting treatment with Fingolimod Aristo;
if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or 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, they must inform their doctor before taking Fingolimod Aristo.

Warnings and precautions

Before starting Fingolimod Aristo, discuss the following with your doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been informed that their ECG tracing is abnormal;
if the patient experiences symptoms of a slow heart rate (e.g. dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medicines 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 receive vaccination;
if the patient has never had chickenpox;
if the patient has or has had vision problems or other symptoms of swelling in the centre of the visual field (macula) at the back of the eye (a condition called macular oedema, 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 disease;
if the patient has high blood pressure that cannot be controlled with medication;
if the patient has severe lung disease or a cough typical of smokers.

If any of these situations apply or the patient has any doubts, they must inform their doctor before taking Fingolimod Aristo.

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 took a daily dose of 0.25 mg using other fingolimod-containing medicines of lower strength, Fingolimod Aristo slows the heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, the patient must inform their doctor immediately, as they may require immediate treatment. Fingolimod Aristo 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 generally 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 Aristo or after the first 0.5 mg dose when switching from a daily dose of 0.25 mg using other fingolimod-containing medicines of lower strength, with hourly monitoring of pulse and blood pressure so that appropriate treatment can be given if any adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod Aristo and 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 ECG shows abnormalities, longer monitoring may be required (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 Aristo after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod Aristo before stopping.

If the patient has irregular or abnormal heartbeat, risk factors for such events, an abnormal ECG, heart disease, or heart failure, Fingolimod Aristo may not be suitable. If the patient has previously experienced sudden loss of consciousness or slowed heart function, Fingolimod Aristo may not be appropriate. Consultation with a cardiologist (a heart specialist) may be necessary to advise on how to start treatment with Fingolimod Aristo, including overnight monitoring.

If the patient is taking medicines that may slow heart rate, Fingolimod Aristo may not be suitable. A cardiologist consultation may be needed to determine whether the patient can switch to other medicines that do not slow heart rate, to allow treatment with Fingolimod Aristo. If such a change is not possible, the cardiologist will advise on how to start treatment with Fingolimod Aristo, including monitoring 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, they may need to receive a vaccination before starting treatment with Fingolimod Aristo. If this is the case, the doctor will delay the start of treatment with Fingolimod Aristo by one month after completing the full vaccination course.

Infections

Fingolimod Aristo reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Aristo (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 a fever, flu-like symptoms, shingles, or a 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 herpesvirus infection), they must contact their doctor immediately, as this condition may be serious and life-threatening.

If the patient feels their disease is worsening (e.g. weakness or vision problems) or notices any new symptoms, they must speak to their doctor immediately, as these may be symptoms of a rare brain disease 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 Fingolimod Aristo should be stopped.

In patients treated with Fingolimod Aristo, human papillomavirus (HPV) infection has been reported, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor may consider vaccinating the patient against HPV before starting treatment. In women, the doctor will also recommend HPV screening tests.

Macular oedema

Before starting treatment with Fingolimod Aristo, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the centre 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 Fingolimod Aristo.

The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colours, and fine details. Fingolimod Aristo may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Aristo.

The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will arrange regular ophthalmological examinations to detect macular oedema.

If the patient develops macular oedema, they must inform their doctor before resuming treatment with Fingolimod Aristo.

Macular oedema may cause vision disturbances similar to those seen in MS attacks (optic neuritis). In early stages, symptoms may be absent. The patient must inform their doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurry or shaded;
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 Aristo.

Fingolimod Aristo may affect liver function test results. The patient may not experience any symptoms, but if they develop yellowing of the skin or whites of the eyes, abnormally dark-coloured urine (brown), pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting, they must inform their doctor immediately.

If any of these symptoms occur after starting treatment with Fingolimod Aristo, the patient must inform their doctor immediately.

Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, treatment with Fingolimod Aristo may be discontinued.

High blood pressure

The doctor may regularly check blood pressure, as Fingolimod Aristo causes a slight increase in blood pressure.

Lung diseases

Fingolimod Aristo has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of adverse effects.

Blood cell count

A known effect of Fingolimod Aristo is a reduction in the number of white blood cells in the blood. Their count usually returns to normal within 2 months after stopping treatment.

If blood tests are needed, the patient must inform their doctor that they are taking Fingolimod Aristo. Otherwise, the doctor may not be able to interpret the blood test results correctly, and for certain tests, the doctor may require a larger blood sample than usual.

Before starting Fingolimod Aristo, the doctor will confirm that the white blood cell count is adequate to begin treatment and may recommend regular repeat testing. If there are not enough white blood cells, treatment with Fingolimod Aristo may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Skin cancers have been reported in patients with MS treated with Fingolimod Aristo. If any lumps (e.g. shiny, pearly-coloured lumps), spots, or open sores that do not heal within a few weeks are noticed on the skin, the patient must 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. A skin examination must be performed before starting treatment with Fingolimod Aristo to detect any skin lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod Aristo. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.

Lymphoma, a type of lymphatic system cancer, has been reported in patients with MS treated with Fingolimod Aristo.

Sun exposure and sun protection

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

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

Unusual brain changes related to MS relapses

Rare cases of unusually large brain lesions related to MS relapses have been reported in patients treated with Fingolimod Aristo. In case of a severe MS relapse, the treating doctor may consider performing an MRI scan to assess this condition and decide whether treatment with Fingolimod Aristo should be discontinued.

Switching from other medicines to Fingolimod Aristo

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Aristo 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 waiting period of 2 to 3 months may be required before starting Fingolimod Aristo. 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 their doctor before deciding whether Fingolimod Aristo is appropriate.

Women of childbearing age

If Fingolimod Aristo is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Aristo, the doctor will explain the risks to the patient and request a pregnancy test to exclude pregnancy. The doctor will provide the patient with an information card explaining why they should not become pregnant while taking Fingolimod Aristo. The card also contains information on how to avoid pregnancy while taking Fingolimod Aristo. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Fingolimod Aristo must 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 Aristo is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in children exposed to Fingolimod Aristo during pregnancy is about twice that 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 Aristo, 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 Fingolimod Aristo and for 2 months after stopping treatment to avoid pregnancy. The patient should discuss effective contraceptive methods with their doctor.

The doctor will provide the patient with an information card explaining why they should not become pregnant while taking Fingolimod Aristo.

If the patient becomes pregnant while taking Fingolimod Aristo, they must inform their doctor immediately. The doctor will decide whether to discontinue treatment (see "Discontinuation of Fingolimod Aristo" in section 3 and section 4 "Possible side effects"). The patient will also need to attend follow-up prenatal examinations.

Breastfeeding

Breastfeeding must not be used while taking Fingolimod Aristo. Fingolimod Aristo 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 drive safely, including cycling, and operate machinery. Fingolimod Aristo is not expected to affect the ability to drive or 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 Fingolimod Aristo. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

Fingolimod Aristo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning this medicine is considered "sodium-free".

3. How to take Fingolimod Aristo

Treatment with Fingolimod Aristo will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Recommended dose:
Adults:
The dose is one 0.5 mg capsule per day.
Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents with body weight of 40 kg or less: one 0.25 mg capsule per day. Fingolimod Aristo 0.5 mg capsules are not suitable for children and adolescents with body weight of 40 kg or less. Other fingolimod-containing medicines with lower strengths (in the form of 0.25 mg capsules) are available.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day.

Children and adolescents who start treatment with one 0.25 mg capsule per day using other fingolimod-containing medicines available in lower strengths, and who later achieve a stable body weight above 40 kg, will receive instructions from their doctor to change the dose to one 0.5 mg capsule once daily. In this case, repeat monitoring as after the first dose is recommended.
Do not exceed the recommended dose.
Fingolimod Aristo is intended for oral use.
Fingolimod Aristo should be taken once daily, with a glass of water. Fingolimod Aristo capsules must always be swallowed whole, without opening. Fingolimod Aristo may be taken with food or independently of meals.
Taking Fingolimod Aristo at the same time each day will help you remember to take your medicine.
If you have any questions about the duration of treatment with Fingolimod Aristo, consult your doctor or pharmacist.
Taking more Fingolimod Aristo than prescribed
If you have taken too much medicine, contact your doctor immediately.
Missing a dose of Fingolimod Aristo
If you have been taking Fingolimod Aristo for less than 1 month and have missed one dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when taking the next dose.
If you have been taking Fingolimod Aristo 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 keep you under observation when taking the next dose. However, if you have missed taking the medicine 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 treatment with Fingolimod Aristo
Do not stop treatment with Fingolimod Aristo or change the dose without first consulting your doctor.
Fingolimod Aristo remains in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may still be reduced and adverse effects described in this leaflet may still occur. After stopping treatment with Fingolimod Aristo, wait 6–8 weeks before starting a new treatment for MS.
In patients restarting treatment with Fingolimod Aristo after more than 2 weeks since discontinuation, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring of the patient in a doctor's office or clinic will be necessary upon resumption of treatment.
Do not restart treatment with Fingolimod Aristo after a break of more than two weeks without consulting your treating physician.
Your treating physician will decide whether and how to monitor you after stopping treatment with Fingolimod Aristo. Inform your doctor immediately if you feel that your MS is worsening after stopping treatment with Fingolimod Aristo. This situation may be serious.
If you have any further questions about using 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 adverse reactions may be or may become serious.

Common (may affect up to 1 in 10 patients)

Cough with sputum, unspecified discomfort in the chest, fever (symptoms of lung disorders).
Herpesvirus infection (shingles or herpes simplex) with symptoms such as: blisters, burning sensation, 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 or red rash with severe pain.
Slow heart rate (bradycardia), irregular heartbeat.
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other appearances.
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 Aristo.
Weight loss.

Uncommon (may affect up to 1 in 100 patients)

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 vision, 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 signs of melanoma include moles that change in size, shape, elevation or color over time, or new moles appearing. Moles may itch, bleed or ulcerate.
Seizures, epileptic seizures (more frequent in children and adolescents than in adults).

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

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual disturbances.
Lymphoma (a type of tumor involving 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 up to 1 in 10,000 patients)

Abnormalities in the ECG recording (T-wave inversion).
Tumor associated with human herpesvirus type 8 infection (Kaposi's sarcoma).

Frequency not known (frequency 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 Aristo 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 liver transplantation.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble a relapse of MS. Other symptoms may also occur that the patient may not be aware of, such as: changes in mood or behavior, temporary memory lapses, difficulties with speech and communication, which should be evaluated by a doctor to rule out PML. Therefore, if a 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 doctor as soon as possible.
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as: headache accompanied by neck stiffness, photophobia, nausea and (or) confusion.
Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include: 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 sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma.
After discontinuation of Fingolimod Aristo treatment, 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 reactions occur, you should immediately inform your doctor.

Other adverse reactions

Very common (may affect 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 affect up to 1 in 10 patients)

Fungal skin infections (dermatophyte-induced fungal infection) (tinea versicolor).
Dizziness.
Severe headache, often accompanied by nausea, vomiting and sensitivity to light (migraine symptoms).
Low number of white blood cells (lymphocytes, leukocytes).
Weakness.
Itchy, red, burning rash (rash).
Itching.
Increased levels of fats (triglycerides) in the blood.
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 (Fingolimod Aristo may cause a mild increase in blood pressure).
Muscle pain.
Joint pain.

Uncommon (may affect up to 1 in 100 patients)

Low number of white blood cells (neutropenia).
Depressed mood.
Nausea.

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

Lymphatic system tumor (lymphoma).

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

Peripheral edema.

If any of these symptoms are severe, you should inform your 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 be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 this medicine can be collected.

5. How to store Fingolimod Aristo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after "EXP". The expiry date refers to the last day of the specified month.
Store below 30°C.
Do not use this medicine if you notice that the packaging is damaged or if there are signs
of prior opening.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the package and other information

What Fingolimod Aristo contains

The active substance is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (in the form of fingolimod hydrochloride).
Other ingredients are: Capsule filling: cellulose, powdered (E460), titanium dioxide (E171), magnesium stearate (E470b). Capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate. Ink for black printing: shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide. Ink for blue printing: shellac (E904), propylene glycol (E1520), indigo carmine (E132).

What Fingolimod Aristo looks like and contents of the pack
Fingolimod Aristo, 0.5 mg, hard gelatin capsule consisting of a light yellow cap and an opaque white body, printed with "H" in black ink on the cap and "F7" in blue ink on the body.
Fingolimod Aristo 0.5 mg hard capsules are available in packs of 7 or 28 capsules in blisters, or in packaging containing a single-dose blister of 7 x 1 capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Poland
Manufacturer/Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Fingolimod Aristo 0,5 mg Hartkapseln
Czech Republic Fingolimod Aristo
Denmark Fingolimod Aristo
Spain Fingolimod Aristo 0,5 mg cápsulas duras, EFG
Netherlands Fingolimod Aristo 0,5 mg harde capsules
Germany Fingolimod Aristo 0,5 mg Hartkapseln
Poland Fingolimod Aristo
Sweden Fingolimod Aristo 0,5 mg hårda kapslar
Italy Fingolimod Aristo