Fingolimod Kern Pharma 0.5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fingolimod Kern Pharma 0.5 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fingolimod Kern Pharma is and what it is used for

What Fingolimod Kern Pharma is

The active substance is fingolimod.

What fingolimod is used for

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

Patients who do not respond to treatment despite receiving therapy for MS.

Patients who rapidly develop severe MS.

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

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS, preventing the nerves from functioning properly. This process is known as demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms, reflecting the inflammation occurring in the CNS. Symptoms vary from patient to patient, but generally include difficulty walking, loss of sensation in parts of the body (numbness), vision problems, or balance disorders. Symptoms of a relapse may completely disappear when the relapse ends, although some problems may persist.

How fingolimod works

Fingolimod helps combat immune system attacks on the CNS by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from reaching the brain and spinal cord. This limits nerve damage caused by multiple sclerosis. Fingolimod also reduces some of the immune responses in your body.

2. What you need to know before starting Fingolimod Kern Pharma

Do not take fingolimod

if you have a reduced immune response (due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
if your doctor suspects you may have a rare brain infection known as progressive multifocal leukoencephalopathy (PML), or if you have been diagnosed with PML.
if you have an active serious or chronic infection such as hepatitis or tuberculosis.
if you have active cancer.
if you have severe liver problems.
if you have had a heart attack, angina, stroke, transient ischemic attack (TIA), or any type of heart failure within the last 6 months.
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows QT interval prolongation before starting fingolimod treatment.
if you are taking or have recently taken medications for irregular heartbeat (such as quinidine, disopyramide, amiodarone, or sotalol).
if you are pregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method.
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of the above apply to you or you are unsure, inform your doctor before taking fingolimod.

Warnings and precautions

Talk to your doctor before starting fingolimod:

if you have severe breathing problems during sleep (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you have symptoms of a slow heartbeat (e.g., dizziness, nausea, or palpitations).
if you are taking or have recently taken medications that slow your heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
if you have a history of sudden loss of consciousness or fainting (syncope).
if you are planning to get vaccinated.
if you have never had chickenpox.
if you have or have had disorders or other signs of inflammation in the central vision area (the macula) of the back of the eye (an eye disorder known as macular edema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause eye problems).
if you have liver problems.
if you have uncontrolled high blood pressure despite medication.
if you have severe lung problems or "smoker's cough."

If any of the above apply to you or you are unsure, inform your doctor before taking fingolimod.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, especially if you have been switched from a previous dose of 0.25 mg once daily, fingolimod causes a reduction in heart rate. As a result, you may feel dizzy or fatigued, become aware of your heartbeat, or experience a drop in blood pressure. If these effects are severe, inform your doctor immediately, as you may require immediate treatment. Fingolimod may also cause irregular heartbeats, particularly after the first dose. Irregular heartbeats usually return to normal within less than a day. Slow heart rate typically normalizes within one month. During this time, clinically significant cardiac effects are generally not expected.

Your doctor will ask you to remain in the clinic or hospital for at least 6 hours, with hourly monitoring of pulse and blood pressure, after taking the first dose of fingolimod or the first 0.5 mg dose after switching from 0.25 mg once daily, so that appropriate measures can be taken if adverse effects occur at the start of treatment. You will have an electrocardiogram (ECG) before the first dose and again after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate or your ECG shows abnormalities, you will need extended monitoring (at least 2 additional hours, possibly overnight) until the issue resolves. The same may apply if you are restarting fingolimod after a treatment interruption, depending on the duration of the interruption and how long you had previously taken fingolimod.

If you have or are at risk of irregular or abnormal heartbeats, if your ECG is abnormal, or if you have heart disease or heart failure, fingolimod may not be suitable for you.

If you have previously experienced sudden fainting or slow heart rate, fingolimod may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start fingolimod treatment, including overnight monitoring.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. A cardiologist must evaluate you and determine whether you can switch to alternative medications that do not reduce heart rate to allow fingolimod treatment. If such a switch is not possible, the cardiologist will advise on how to start fingolimod treatment, including overnight monitoring.

If you have never had chickenpox

If you have never had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected, you may need to be vaccinated before starting fingolimod treatment. If so, your doctor will delay the start of fingolimod treatment by one month after completing the vaccination series.

Infections

Fingolimod reduces the number of white blood cells in the blood (especially lymphocytes). White blood cells fight infections. During treatment with fingolimod (and for up to two months after stopping), you may be more susceptible to infections. An existing infection may worsen. Infections can be serious and potentially fatal. If you suspect you have an infection, have a fever, flu-like symptoms, herpes (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), contact your doctor immediately, as this could be serious and life-threatening.

Human papillomavirus (HPV) infections, including warts, dysplasia, HPV-related warts, and HPV-related cancers, have been reported in patients treated with fingolimod. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screening.

PML

PML is a rare brain disorder caused by an infection that can lead to severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) scans before and during treatment to monitor the risk of PML.

If you think your MS is worsening or notice any new symptoms—such as changes in mood or behavior, worsening or new weakness on one side of the body, vision changes, confusion, memory problems, or speech and communication difficulties—inform your doctor immediately. These could be symptoms of PML. Also, discuss your treatment with family members or caregivers, as symptoms may appear without your awareness.

If you develop PML, it can be treated, and your fingolimod treatment will be stopped. Some people experience an inflammatory reaction when fingolimod is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may worsen your condition, including brain function.

Macular edema

Before starting fingolimod, your doctor may order an eye examination if you have or have had visual disorders or signs of inflammation in the central vision area (macula) of the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting fingolimod, your doctor may schedule an eye examination 3 to 4 months into treatment.

The macula is a small area of the retina at the back of the eye that allows you to see shapes, colors, and fine details clearly. Fingolimod can cause inflammation of the macula, known as macular edema. This usually occurs within the first four months of treatment.

If you have diabetes or a history of eye inflammation (uveitis), you are at higher risk of macular edema. In such cases, your doctor will recommend regular eye exams to detect macular edema.

If you have had macular edema, discuss with your doctor before continuing fingolimod treatment.

Macular edema can cause visual symptoms similar to those of an MS attack (optic neuritis). You may not have symptoms at first. Report any changes in vision to your doctor. Your doctor may recommend an eye examination, especially if:

The center of your visual field becomes blurry or shadowy;
A blind spot appears in the center of your visual field;
You have difficulty seeing colors or fine details.

Liver function tests

Do not take fingolimod if you have severe liver problems. Fingolimod may affect liver function. You may not notice symptoms, but if you develop yellowing of the skin or whites of the eyes, abnormally dark (brown-colored) urine, pain in the upper right abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.

If you experience any of these symptoms after starting fingolimod, inform your doctor immediately.

Before, during, and after treatment, your doctor will order blood tests to monitor liver function. Treatment may need to be stopped if test results indicate liver problems.

High blood pressure

Since fingolimod causes a slight increase in blood pressure, your doctor will want to monitor your blood pressure regularly.

Lung problems

Fingolimod has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to experience adverse effects.

Blood counts

Fingolimod is expected to reduce the number of white blood cells in your blood. This effect usually resolves within 2 months after stopping treatment. If you have blood tests, inform your doctor that you are taking fingolimod, as otherwise your doctor may not interpret the results correctly. For certain blood tests, your doctor may need more blood than usual.

Before starting fingolimod, your doctor will confirm you have adequate white blood cell levels and may repeat checks regularly. If your white blood cell count is too low, you may need to stop fingolimod treatment.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, a condition called posterior reversible encephalopathy syndrome (PRES) has been reported in multiple sclerosis patients treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during fingolimod treatment, as it could be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Inform your doctor immediately if you notice skin nodules (e.g., shiny, pearl-like nodules), spots, or open sores that do not heal for weeks. Skin cancer symptoms may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change in color, shape, or size over time. A skin examination is required before starting fingolimod to check for skin nodules. Your doctor will also perform periodic skin checks during treatment. If skin problems arise, your doctor may refer you to a dermatologist, who may recommend regular visits.

A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with fingolimod.

Sun exposure and sun protection

Fingolimod weakens your immune system, increasing the risk of cancer, especially skin cancer. Limit sun and UV exposure by:

Wearing appropriate protective clothing.
Regularly applying high-SPF sunscreen.

Unusual brain lesions associated with MS relapses

Rare cases of large, unusual brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In cases of severe relapses, your doctor will consider performing an MRI to assess your condition and decide whether to stop fingolimod.

Switching from other treatments to fingolimod

Your doctor may switch directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod if there are no signs of abnormalities from prior treatment. Your doctor may perform blood tests to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting fingolimod. When switching from teriflunomide, your doctor may advise waiting or undergoing an accelerated elimination procedure. If you have been treated with alemtuzumab, a careful evaluation is needed to determine whether fingolimod is suitable for you.

Women of childbearing potential

Fingolimod may harm the fetus if used during pregnancy. Before starting treatment, your doctor will explain the risks and perform a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking fingolimod and what steps to take to avoid pregnancy. During treatment and for 2 months after stopping, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

If you become pregnant while taking fingolimod, inform your doctor immediately. Your doctor will decide to stop treatment (see section 3 “If you stop taking fingolimod” and section 4 “Possible side effects”). You will receive specific prenatal follow-up.

Breastfeeding

You must not breastfeed during treatment with fingolimod. Fingolimod passes into breast milk and may cause serious adverse effects in the infant.

Driving and using machines

Your doctor will advise whether your condition allows you to safely drive (including bicycles) and operate machinery. Fingolimod is not expected to affect your ability to drive or use machines.

However, after taking the first dose of fingolimod, you must remain in the clinic or hospital for 6 hours. During this time and possibly afterward, your ability to drive or use machines may be impaired.

Fingolimod Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially "sodium-free."

3. How to take Fingolimod Kern Pharma

Treatment with fingolimod will be supervised by a physician experienced in the treatment of multiple sclerosis.

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule daily.

Children and adolescents (aged 10 years and older):

The dose depends on body weight:

Children and adolescents with body weight ≤ 40 kg: one 0.25 mg capsule daily.

Fingolimod Kern Pharma 0.5 mg hard capsules are not suitable for pediatric patients with body weight ≤ 40 kg. Other medicines containing fingolimod are available in a lower concentration (such as 0.25 mg capsules).

Children and adolescents with body weight > 40 kg: one 0.5 mg capsule daily.

For children and adolescents who initially take one 0.25 mg capsule daily and later reach a stable body weight above 40 kg, the physician will instruct them to switch to one 0.5 mg capsule daily. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.

Fingolimod is administered orally.

Take fingolimod once daily with a glass of water. Fingolimod capsules must always be swallowed whole, without opening them. You may take fingolimod with or without food.

Taking fingolimod at the same time each day will help you remember when to take the medicine.

If you have any questions about the duration of treatment with fingolimod, consult your doctor or pharmacist.

If you take more fingolimod than you should

If you have taken more fingolimod than you should, inform your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Fingolimod Kern Pharma

If you have been taking fingolimod for less than 1 month and miss a dose for a full day, speak with your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.

If you have been taking fingolimod for at least 1 month and have missed treatment for more than 2 weeks, speak with your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed treatment for up to 2 weeks, you may take the next dose as originally scheduled.

Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Kern Pharma

Do not stop taking fingolimod or change your dose without first discussing it with your doctor.

Fingolimod will remain in your body for up to two months after stopping treatment. The number of white blood cells (lymphocyte count) may remain low during this period, and adverse effects described in this leaflet may still occur. After stopping fingolimod treatment, you may need to wait 6–8 weeks before starting a new treatment for MS.

If you need to restart fingolimod treatment after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and you will need to be monitored by your doctor when restarting treatment. Do not restart fingolimod treatment after a break of more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up is needed after stopping fingolimod treatment and how this should be carried out. Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment, as this could be serious.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious or potentially serious

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

Cough with sputum (phlegm), chest discomfort, fever (signs of pulmonary disorders)
Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, stinging, itching, or skin pain, especially on the upper body or face. Other symptoms may include fever and weakness in the early phase of infection, followed by numbness, itching, or red spots with severe pain.
Slow heartbeat (bradycardia), irregular heart rhythm.
A type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other forms.
Depression and anxiety are known to occur more frequently in patients with multiple sclerosis, and have also been reported in pediatric patients treated with fingolimod.
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 central vision area of the retina at the back of the eye), with symptoms such as shadows or a blind spot or loss of vision in the center of the visual field, blurred vision, problems seeing colors or details.
Decrease in the number of blood platelets, increasing the risk of bleeding or bruising.
Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change over time in size, shape, thickness, or color, or the formation of new moles. Moles may itch, bleed, or ulcerate.
Seizures, fits (more frequent in children and adolescents than in adults).

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

A condition called reversible posterior encephalopathy syndrome (RPES). 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 firm, red nodule, a crusted sore, or a new sore on an existing scar.

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

Abnormal electrocardiogram (ECG) finding (T-wave inversion)
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma)

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

Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which are more likely to occur on the day treatment with fingolimod is started.
- Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark (brown-colored) urine, loss of appetite, fatigue, and abnormal results in liver function tests. In a small number of cases, liver failure could lead to liver transplantation.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory loss, or speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening, or if you or people close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
- Inflammatory disorder after stopping treatment with fingolimod (known as immune reconstitution inflammatory syndrome or IRIS).
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and/or confusion.
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless flesh-colored or bluish-red nodule, usually on the face, head, or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
After stopping treatment with fingolimod, MS symptoms may reappear and may be worse than before or during treatment.
Autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these symptoms, contact your doctor immediately.

Other adverse effects

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
Blood tests showing abnormal liver enzyme levels
Cough

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

Pityriasis versicolor (fungal skin infection)
Dizziness
Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, skin redness, and burning sensation (eczema)
Itching
Increased blood levels of certain lipids (triglycerides)
Hair loss
Difficulty breathing
Depression
Blurred vision (see also the section on macular edema under the heading "Some adverse effects may be serious or potentially serious")
Hypertension (fingolimod may cause a slight increase in blood pressure)
Muscle pain
Joint pain

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

Low levels of certain white blood cells (neutrophils)
Depressed mood
Nausea

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

Cancer of the lymphatic system (lymphoma)

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

Peripheral inflammation

If you consider any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fingolimod Kern Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the aluminium blister after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C (PVC/PVDC/Aluminium blister)
This medicine does not require any special storage conditions (PVC/PE/PVDC/Aluminium blister)
Do not use any pack that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Medicines and their empty containers should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fingolimod Kern Pharma

The active substance is fingolimod.

Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are:

Capsule contents: calcium hydrogen phosphate dihydrate, sodium croscarmellose, hypromellose, and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172).

Printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonium solution, black iron oxide (E172), potassium hydroxide.

Appearance of the product and contents of the pack

Hard gelatin capsules with an opaque yellow cap and an opaque white body; printed in black ink with "FD 0.5 mg" on the cap.

Fingolimod 0.5 mg capsules are available in packs containing 28 capsules.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Genepharm S.A

18th km Marathonos Avenue,

153 51 Pallini Attiki

Greece

Date of the most recent review of this leaflet: August 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.