Fingolimod Pharmaselect

PATIENT INFORMATION LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fingolimod Pharmaselect, 0.5 mg, hard capsules, fingolimod
Fingolimod should be carefully reviewed before taking the medication, as it contains important information for the patient.

You should carefully read the contents of this leaflet before taking the medication, as it contains important information for the patient.

• You should keep this leaflet to be able to read it again if needed.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

What is Fingolimod Pharmaselect

Fingolimod Pharmaselect contains the active substance fingolimod.

What is Fingolimod Pharmaselect used for

Fingolimod Pharmaselect is used in adults and children and adolescents (aged 10 years and older) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• Patient who have not responded to MS treatment.
• Patient who have rapidly evolving severe MS.

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

What is multiple sclerosis

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

How Fingolimod Pharmaselect works

Fingolimod Pharmaselect 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 medication reduces nerve damage caused by MS. Fingolimod Pharmaselect also weakens some immune responses in the body.

2. Important information before taking Fingolimod Pharmaselect

When not to take Fingolimod Pharmaselect

• If the patient has a reduced immune response (due to immunodeficiency syndrome, disease, or taking medications that suppress the immune system).
• 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), which includes patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Pharmaselect.
• 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 breastfeeding.
• If the patient has an allergy to fingolimod or any of the other ingredients of this medication (listed in section 6).

If any of these situations occur or the patient has doubts, they should consult a doctor before taking Fingolimod Pharmaselect.

Warnings and precautions

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

• If the patient has severe respiratory disorders during sleep (severe 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 medications that slow down the heart rate (such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine).
• If the patient has had sudden loss of consciousness or fainting in the past.
• If the patient plans to get vaccinated.
• If the patient has never had chickenpox.
• If the patient has or has had vision problems or other symptoms of macular edema (such as macular edema, uveitis, or 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 cough typical of smokers.

If any of these situations occur or the patient has doubts, they should consult a doctor before taking Fingolimod Pharmaselect.

Low heart rate and irregular heartbeat

At the beginning of treatment or after taking the first dose of 0.5 mg, Fingolimod Pharmaselect slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or a decrease in blood pressure. If these symptoms are severe, the patient should inform their doctor immediately, as they may require immediate treatment.

Infections

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

Macular edema

Before starting treatment with Fingolimod Pharmaselect, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (such as macular edema, uveitis, or diabetes) for eye exams.

Liver function tests

Patient with severe liver disease should not take Fingolimod Pharmaselect. Fingolimod Pharmaselect may affect liver function tests. The patient is unlikely to experience any symptoms, but if they experience yellowing of the skin or whites of the eyes, abnormal dark (brown) urine, pain in the right upper abdomen, fatigue, decreased appetite, 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 Pharmaselect may cause a slight increase in blood pressure.

Lung problems

Fingolimod Pharmaselect 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 Pharmaselect is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are necessary, the patient should inform their doctor that they are taking Fingolimod Pharmaselect. Otherwise, the doctor may not be able to interpret the results of the blood test, and in the case of certain tests, the doctor may order more blood to be drawn than usual.

Posterior reversible encephalopathy syndrome (PRES)

Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients with MS treated with fingolimod. Symptoms of this condition may include severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod Pharmaselect, the patient should inform their doctor immediately, as this condition can be severe.

Cancer

Cases of skin cancer have been reported in patients with MS treated with Fingolimod Pharmaselect. 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. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (such as unusual moles) that change color, shape, or size over time.

Exposure to sunlight and protection from ultraviolet radiation

Fingolimod weakens the immune system.

This condition increases the risk of developing cancers, especially skin cancers. The patient should limit their exposure to sunlight and ultraviolet radiation by:

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

Unusual changes in the brain associated with MS relapse

Rare cases of unusually large brain lesions associated with MS relapse have been reported in patients treated with fingolimod. If the patient experiences a severe relapse, their doctor may consider performing an MRI to assess this condition and decide whether to stop taking Fingolimod Pharmaselect.

Switching from other medications to Fingolimod Pharmaselect

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Pharmaselect if there are no symptoms of abnormality caused by previous treatment. The doctor may order a blood test to rule out these abnormalities. After stopping treatment with natalizumab, it may be necessary to wait 2-3 months before starting treatment with Fingolimod Pharmaselect.

Women of childbearing age

If Fingolimod Pharmaselect is used during pregnancy, it may harm the unborn baby. Before starting treatment with Fingolimod Pharmaselect, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod Pharmaselect.

Pregnancy and breastfeeding

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

Pregnancy

Fingolimod Pharmaselect should not be used during pregnancy if the patient is trying to become pregnant or may become pregnant and is not using effective contraception. If Fingolimod Pharmaselect is used during pregnancy, there is a risk of harm to the unborn baby. The incidence of birth defects in children exposed to Fingolimod Pharmaselect during pregnancy is about twice as high as in the general population (in which the incidence of birth defects is about 2-3%). The most commonly reported birth defects include heart, kidney, and musculoskeletal abnormalities.

Therefore, if the patient is of childbearing age:

• before starting treatment with Fingolimod Pharmaselect, the doctor will inform the patient about the risk to the unborn baby and ask them to perform a pregnancy test to rule out pregnancy.
• the patient should use effective contraception during treatment with Fingolimod Pharmaselect and for 2 months after stopping treatment to avoid becoming pregnant.

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

If the patient becomes pregnant while taking Fingolimod Pharmaselect

The patient should inform their doctor immediately. The doctor will decide whether to stop treatment (see "Stopping Fingolimod Pharmaselect" in section 3 and section 4 "Possible side effects"). The patient will also need to undergo prenatal check-ups.

Breastfeeding

Fingolimod Pharmaselect should not be used during breastfeeding. Fingolimod Pharmaselect 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, including riding a bicycle, and operate machinery. It is not expected that Fingolimod Pharmaselect will affect the ability to drive vehicles and operate machinery.

3. How to take Fingolimod Pharmaselect

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

This medication should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor.

Adults

The recommended dose is one hard capsule per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

The recommended dose is one hard capsule of 0.5 mg per day for children and adolescents weighing more than 40 kg.

Other strengths of this medication are suitable for children and adolescents aged 10 years and older who weigh 40 kg or less; the patient should ask their doctor or pharmacist about the availability of hard capsules with fingolimod of other strengths.

The patient should not exceed the recommended dose.

Fingolimod Pharmaselect is intended for oral use.

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

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

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

If the patient takes more Fingolimod Pharmaselect than they should

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

If the patient misses a dose of Fingolimod Pharmaselect

If the patient takes Fingolimod Pharmaselect for less than 1 month and forgets to take 1 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 during the next dose.

If the patient takes Fingolimod Pharmaselect for at least 1 month and forgets to take the medication 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 during the next dose. However, if the patient forgets to take the medication for up to 2 weeks, they can take the next dose as planned.

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

Stopping Fingolimod Pharmaselect

The patient should not stop taking Fingolimod Pharmaselect or change the dose without consulting their doctor first.

Fingolimod Pharmaselect stays in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Pharmaselect, the patient should wait 6-8 weeks before starting new MS treatment.

If the patient restarts treatment with Fingolimod Pharmaselect after more than 2 weeks of stopping the medication, the heart rate effect observed after the first dose may recur, and the patient's condition should be monitored in a doctor's office or clinic due to the restart of treatment. The patient should not restart treatment with Fingolimod Pharmaselect after a break of more than 2 weeks without consulting their doctor.

The doctor will decide whether and how to monitor the patient after stopping treatment with Fingolimod Pharmaselect. If the patient thinks their MS is getting worse after stopping treatment with Fingolimod Pharmaselect, they should inform their doctor immediately, as this situation can be serious.

4. Possible side effects

Like all medications, Fingolimod Pharmaselect can cause side effects, although not everyone will experience them.

Some side effects may be or may become severe.

Common(may affect up to 1 in 10 people):

• Cough with expectoration, unpleasant feeling in the chest, fever (respiratory disorders).
• Infections with herpes viruses (shingles or herpes) with symptoms such as blisters, burning, itching, or skin pain, usually above the upper body or face. Other symptoms may include fever and weakness at the onset of infection, followed by numbness, itching, or red spots with severe pain.
• Slow heartbeat (bradycardia), irregular heartbeat.
• A type of skin cancer called basal cell carcinoma, which often occurs as a pearl-like lump, although it can also have a different appearance.
• Depression and anxiety, which are more common in the MS population and have also been reported in children and adolescents treated with fingolimod.
• Weight loss.

Uncommon(may affect up to 1 in 100 people):

• Pneumonia with symptoms such as fever, cough, difficulty breathing.
• Macular edema (swelling in the center of the visual field in 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 seeing colors and details.
• Reduced platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible symptoms of melanoma include moles that change color, shape, or size over time.
• Seizures, epileptic seizures (more common in children and adolescents than in adults).

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

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include severe headache, confusion, seizures, and vision changes.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red lump, an ulcer covered with a scab, or a fresh ulcer in the area of an existing scar.

Very rare(may affect up to 1 in 10,000 people):

• Abnormalities in the ECG recording (inversion of the T wave).
• A tumor associated with human herpesvirus 8 (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 Pharmaselect.
• 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 upper abdomen, fatigue, decreased appetite, and abnormal liver function test results. In very rare cases, liver failure may require a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to an MS relapse. They may also include symptoms that the patient is not aware of, such as changes in mood or behavior, transient memory loss, difficulty speaking and communicating, which the doctor should assess 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 inform their doctor as soon as possible.
• Fungal infections (such as cryptococcal infections), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion.
• Cancer of the skin (such as Merkel cell carcinoma). Possible symptoms of Merkel cell carcinoma include a painless lump with a raw meat color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass.
• After stopping treatment with Fingolimod Pharmaselect, MS symptoms may relapse and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition in which red blood cells are destroyed).

If the patient experiences any of these side effects, they should inform their doctor immediately.

Other side effects

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

• 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 up to 1 in 10 people):

• Fungal skin infections (such as ringworm).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms).
• Low white blood cell count (lymphocytes, leukocytes).
• Weakness.
• Itchy, red, burning rash (rash).
• Itching.
• Increased triglyceride levels in the blood.
• Excessive 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").
• Hypertension (Fingolimod Pharmaselect may cause a mild increase in blood pressure).
• Muscle pain.
• Joint pain.

Uncommon(may affect up to 1 in 100 people):

• Low neutrophil count.
• Depressed mood.
• Nausea.

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

• Lymphoma (a type of cancer affecting the lymphatic system).

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

• Peripheral edema.

If any of these symptoms occur with severe intensity, the patient should inform their doctor.

5. How to store Fingolimod Pharmaselect

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and blister pack after “Expiry date (EXP)” / “EXP”. The expiry date refers to the last day of the month.
There are no special precautions for storage of this medicinal product.
Do not use this medicinal product if you notice that the packaging is damaged or shows signs of opening.
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. Package contents and other information

What Fingolimod Pharmaselect contains

• The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Filler:calcium phosphate, stearic acid Capsule shell:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) Ink:shellac, black iron oxide (E 172)

What Fingolimod Pharmaselect looks like and contents of the pack

Fingolimod Pharmaselect 0.5 mg hard capsules are available as a white to almost white powder in hard gelatin capsules, size 3, approximately 16 mm in length, consisting of a yellow, opaque cap and a white, opaque body, with the printing “0.5 mg” in black ink on the cap.
Fingolimod Pharmaselect 0.5 mg hard capsules are packaged in a cardboard box containing the appropriate number of PVC/PE/PVDC/Aluminum blisters, the appropriate number of capsules, and a patient information leaflet.
Pack sizes:
Cardboard boxes containing 7, 14, 28, 84 or 98 hard capsules.
Not all pack sizes may be marketed in every country.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna, Austria
Phone: +43 (0) 1 786 03 86-00

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

Denmark:
Fingolimod Pharmaselect
Austria:
Fingolimod Pharmaselect 0.5 mg Hartkapseln
Bulgaria:
ФИНГОЛИМОД ФАРМАСЕЛЕКТ 0.5 mg Твърди капсули
Croatia:
Fingolimod Pharmaselect 0.5 mg tvrde kapsule
Czech Republic:
Fingolimod Pharmaselect 0.5 mg tvrdé tobolky
Finland:
Fingolimod Pharmaselect 0.5 mg kovat kapselit
Hungary:
Fingolimod Pharmaselect 0.5 mg kemény kapszula
Ireland:
Fingolimod Pharmaselect 0.5 mg Hard capsules
Norway:
Fingolimod Pharmaselect
Poland:
Fingolimod Pharmaselect
Slovakia:
Fingolimod Pharmaselect 0.5 mg tvrdé kapsuly
Slovenia:
Fingolimod Pharmaselect 0.5 mg trde kapsule
Sweden:
Fingolimod Pharmaselect 0.5 mg hårda kapslar

Date of last revision of the leaflet: