Fingolimod Pharmascience

Package Leaflet: Information for the User

Fingolimod Pharmascience, 0.5 mg, hard capsules

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Fingolimod Pharmascience is and what it is used for
• 2. Important information before taking Fingolimod Pharmascience
• 3. How to take Fingolimod Pharmascience
• 4. Possible side effects
• 5. How to store Fingolimod Pharmascience
• 6. Contents of the pack and other information

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

What Fingolimod Pharmascience is

The active substance in Fingolimod Pharmascience is fingolimod.

What Fingolimod Pharmascience is used for

Fingolimod Pharmascience is used to treat adults and children and adolescents (10 years of age and older) with relapsing-remitting multiple sclerosis (MS), particularly those who:

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

Fingolimod Pharmascience does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS.

What multiple sclerosis is

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.

How Fingolimod Pharmascience works

Fingolimod Pharmascience helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely in the patient's body and preventing them from entering the brain and spinal cord. In this way, the medicine reduces nerve damage caused by MS. Fingolimod Pharmascience also weakens some immune responses of the body.

2. Important information before taking Fingolimod Pharmascience

When not to take Fingolimod Pharmascience

• if the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking immunosuppressive medicines),
• if the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis,
• if the patient has an active malignant disease,
• if the patient has severe liver disease,
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke in the last 6 months,
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Pharmascience,
• if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol,
• if the patient is pregnant or breastfeeding or planning to become pregnant,
• if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If this is the case or if there are any doubts, the patient should inform their doctor before taking Fingolimod Pharmascience.

Warnings and precautions

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

• if the patient has severe respiratory problems during sleep (sleep apnea),
• if the patient has been informed that their ECG is abnormal,
• if the patient experiences symptoms of slow heart rate (such as dizziness, nausea, or palpitations),
• if the patient is taking or has recently taken medicines that slow down the heart rate (such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine),
• if the patient has a history of sudden loss of consciousness or fainting,
• if the patient plans to receive a vaccination,
• if the patient has never had chickenpox,
• if the patient has or has had vision problems or other symptoms of macular edema (such as blurred vision or blind spots),
• if the patient has liver disease,
• if the patient has high blood pressure that cannot be controlled with medicines,
• if the patient has severe lung disease or a cough typical of smokers. If any of these situations occur or if there are any doubts, the patient should inform their doctor before taking Fingolimod Pharmascience.

Low heart rate (bradycardia) and irregular heartbeat

At the start of treatment or after taking the first dose of 0.5 mg, Fingolimod Pharmascience slows down the heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are very severe, the patient should inform their doctor immediately, as they may need urgent treatment.

Infections

Fingolimod Pharmascience reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Fingolimod Pharmascience (and up to 2 months after stopping treatment), the patient may be more susceptible to infections. Any existing infections may worsen and become life-threatening. If the patient thinks they have an infection, have a fever, experience flu-like symptoms, have shingles, or have a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion (which may be caused by a fungal infection and may be symptoms of meningitis), they should contact their doctor immediately, as this condition may be severe and life-threatening.

Macular edema

Before starting treatment with Fingolimod Pharmascience, the doctor may refer patients with existing or previous vision problems or other symptoms of macular edema for ophthalmological examinations.

Liver function tests

Patient with severe liver function disorders should not take Fingolimod Pharmascience. Fingolimod Pharmascience may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or whites of the eyes, abnormal dark urine (brown color), or unexplained nausea and vomiting, they should inform their doctor immediately.

High blood pressure

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

Lung diseases

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

Blood cell count

The expected effect of Fingolimod Pharmascience 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.

Posterior reversible encephalopathy syndrome (PRES)

In patients with MS treated with Fingolimod Pharmascience, there have been rare reports of a condition called posterior reversible encephalopathy syndrome (PRES). The symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If the patient experiences any of these symptoms during treatment with Fingolimod Pharmascience, they should inform their doctor immediately, as this condition may be severe.

Cancer

In patients with MS treated with Fingolimod Pharmascience, there have been reports of skin cancer. If the patient notices any lumps (such as shiny lumps with a pearl-like color), spots, or open sores that do not heal within a few weeks, they should inform their doctor immediately.

Sun exposure and protection from sunlight

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

• wearing protective clothing;
• applying sunscreen with a high sun protection factor regularly.

Unusual changes in the brain related to MS relapse

In patients treated with Fingolimod Pharmascience, there have been rare reports of unusually large changes in the brain related to MS relapse. In case of a severe MS relapse, the doctor may consider performing an MRI scan to assess the condition and decide whether to discontinue Fingolimod Pharmascience.

Switching from other medicines to Fingolimod Pharmascience

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Pharmascience if there are no symptoms of abnormality caused by previous treatment. The doctor may order a blood test to rule out these abnormalities.

Pregnancy and breastfeeding

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

Pregnancy

Fingolimod Pharmascience should not be taken during pregnancy if the patient is trying to become pregnant or if the patient may become pregnant and is not using effective contraception. If Fingolimod Pharmascience is taken during pregnancy, there is a risk of harm to the unborn baby.

The doctor will inform the patient about the risk to the unborn baby and ask them to perform a pregnancy test to ensure they are not pregnant before starting treatment with Fingolimod Pharmascience.

The doctor will give the patient a card explaining why they should not become pregnant while taking Fingolimod Pharmascience.

If the patient becomes pregnant while taking Fingolimod Pharmascience, they should

inform their doctor immediately. The doctor will decide whether to discontinue treatment (see "Discontinuing Fingolimod Pharmascience" in section 3 and also section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.

Breastfeeding

Fingolimod Pharmascience should not be taken while breastfeeding. Fingolimod may pass into breast milk, posing a risk of severe side effects to the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including riding a bicycle and operating machines. The patient should not expect Fingolimod Pharmascience to affect their ability to drive vehicles and operate machines.

However, at the start of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Pharmascience. During this time and potentially after it, the patient's ability to drive vehicles and operate machines may be impaired.

3. How to take Fingolimod Pharmascience

Treatment with Fingolimod Pharmascience will be supervised by a doctor with experience in treating multiple sclerosis.

This medicine should always be taken exactly as the doctor has instructed. If the patient has any doubts, they should consult their doctor.

The recommended dose is:

Adults: one 0.5 mg capsule per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children and adolescents with a body weight of 40 kg or less: one 0.25 mg capsule per day.
• children and adolescents with a body weight over 40 kg: one 0.5 mg capsule per day.

Fingolimod Pharmascience, 0.5 mg, hard capsules are not suitable for children with a body weight of ≤ 40 kg. Other medicines containing fingolimod are available in a lower dose (0.25 mg capsules).

Children and adolescents starting treatment with one 0.25 mg capsule per day and later reaching a stable body weight over 40 kg will be advised by their doctor to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period as after the first dose of Fingolimod Pharmascience.

The patient should not exceed the recommended dose.

Fingolimod Pharmascience is intended for oral use.

The patient should take Fingolimod Pharmascience once a day, with a glass of water. The capsules should always be swallowed whole, without opening. Fingolimod Pharmascience can be taken with or without food.

Taking Fingolimod Pharmascience at the same time every day will help the patient remember to take their medicine.

If the patient has any questions about the duration of treatment with Fingolimod Pharmascience, they should consult their doctor or pharmacist.

Taking a higher dose of Fingolimod Pharmascience than recommended

If the patient takes too much of the medicine, they should contact their doctor immediately.

Missing a dose of Fingolimod Pharmascience

If the patient has been taking Fingolimod Pharmascience for less than 1 month and forgets to take a dose for the whole day, they should contact their doctor before taking the next dose.

The doctor may decide to keep the patient under observation when taking the next dose.

If the patient has been taking Fingolimod Pharmascience for at least 1 month and forgets to take the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when taking the next dose. However, if the patient forgets to take the medicine for up to 2 weeks, they can take the next dose as planned.

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be or may become severe
Frequently(may affect less than 1 in 10 people):

• cough with expectoration, unspecified unpleasant feeling in the chest, fever (symptoms of pulmonary disorders),
• herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning sensation, itching, or skin pain, usually above the upper body or face. Other symptoms may include fever and weakness at an early stage of infection, followed by numbness, itching, or red spots with severe pain,
• slow heart rate (bradycardia), irregular heartbeat,
• a type of skin cancer called basal cell carcinoma (BCC), which often occurs as a pearly nodule, although it may also have a different appearance,
• it is known that depression and anxiety occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with Fingolimod Pharmascience,
• weight loss.

Infrequently(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 defects 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 the appearance of moles whose size, shape, elevation, or color may change over time or new moles may appear. Moles may itch, bleed, or ulcerate,
• seizures, epileptic seizures (more common in children and adolescents than in adults).

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

• a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms that may occur include sudden, severe headache, confusion, seizures, and/or vision disturbances,
• lymphoma (a type of cancer that affects the lymphatic system),
• squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab, or a fresh ulcer at the site of an existing scar.

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

• abnormalities in the ECG recording (T-wave inversion),
• a tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma).

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

• allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fingolimod Pharmascience,
• symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the abdomen (stomach), dark urine (brown color), decreased appetite, fatigue, and abnormal liver function test results. In a very small number of cases, liver failure may lead to liver transplantation,
• the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to an MS relapse. Other symptoms that the patient may not be aware of may also occur, such as changes in mood or behavior, transient memory lapses, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient thinks their MS is getting worse or if

the patient or their relatives notice any new or unusual symptoms, it is very important to tell the doctor as soon as possible,

• cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion,
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include the presence of a painless nodule, flesh-colored or blue-red, often located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system may affect the risk of Merkel cell carcinoma,
• after stopping Fingolimod Pharmascience, MS symptoms may return and worsen compared to the period before treatment and during its duration,
• autoimmune hemolytic anemia (a condition in which red blood cells are destroyed),

If any of these side effects occur, tell your doctor immediately.
Other side effects
Very frequently(may affect more than 1 in 10 people):

• 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.

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

• fungal skin infections (ringworm),
• dizziness,
• severe headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine),
• low white blood cell count (lymphocytes, leukocytes),
• weakness,
• itchy, red, burning rash (rash),
• itching,
• increased triglyceride levels in the blood,
• hair loss,
• shortness of breath,
• depression,
• blurred vision (see also the section on macular edema under "Some side effects may be or may become severe"),
• high blood pressure (Fingolimod Pharmascience may cause a mild increase in blood pressure),
• muscle pain,
• joint pain.

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

• low white blood cell count (neutrophils),
• depressive mood,
• nausea.

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

• lymphoma (a type of cancer that affects the lymphatic system).

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

• peripheral edema.

If any of these symptoms occur with great intensity, tell your doctor.
Reporting of side effects

Reporting of side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. +48 22 49 21 301, Fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fingolimod Pharmascience

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original package to protect from moisture.
Do not use medicines from damaged or opened packages.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fingolimod Pharmascience contains

• The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
• Other ingredients Capsule core: calcium hydrogen phosphate, magnesium stearate. Capsule shell: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin. Printing ink: shellac (E 904), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171).

What Fingolimod Pharmascience looks like and contents of the pack

Opaque, hard gelatin capsule, 16 mm in diameter, with a black print "FIN" above "0.5 mg" on a light yellow cap and two radial bands printed with yellow ink on a white body.
Fingolimod Pharmascience is available in packs of 7, 7x1, 28, or 98 capsules or in multipacks containing 84 capsules (3 packs of 28 capsules). Not all pack sizes may be marketed.

Marketing authorization holder

Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer/Importer

Pharmascience International Limited
1st floor Iacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country Name of the medicinal product

Cyprus

Fingolimod Pharmascience 0.5 mg σκληρά καψάκια

Bulgaria

Финголимод Фармасайънс 0,5 mg твърди капсули
Fingolimod Pharmascience 0.5 mg hard capsule

Croatia

Fingolimod Pharmascience 0.5 mg tvrde kapsule

Poland

Fingolimod Pharmascience

Slovenia

Fingolimod Pharmascience 0,5 mg trde kapsule

Hungary

Fingolimod Pharmascience 0,5 mg kemény kapszula

Date of last revision of the leaflet: