Fingolimod Krka 0.5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fingolimod Krka 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Fingolimod Krka is

The active substance of this medicine is fingolimod.

What Fingolimod Krka is used for

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

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

Patients who rapidly develop severe MS.

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

What multiple sclerosis is

MS is a chronic disease affecting the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that surrounds nerves in the CNS, impairing normal nerve function. This process is known as demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms reflecting inflammation occurring in the CNS. Symptoms vary from patient to patient but typically 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 Krka works

This medicine 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 entering 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 taking Fingolimod Krka

Do not take Fingolimod Krka

if you have a weakened immune response (due to an immunodeficiency syndrome, an illness, 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 a severe active infection or a chronic active 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 past 6 months.
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows QT interval prolongation before starting treatment with this medicine.
if you are taking or have recently taken medications for irregular heartbeat (of the heart) 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 to any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions apply to you, inform your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor before starting this medicine:

if you have severe breathing problems while sleeping (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram.
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 area of vision (the macula) at the back of the eye (a condition 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 high blood pressure that cannot be controlled with medication.
if you have severe lung problems or "smoker's cough".

If any of the above conditions apply to you, inform your doctor before taking this medicine.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in case your previous dose of 0.25 mg once daily has been changed, this medicine causes a decrease in heart rate. As a result, you may feel dizzy or tired, become aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, inform your doctor immediately, as you may need urgent treatment. This medicine may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. Slow heart rate typically returns to normal within one month.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly pulse and blood pressure checks, after taking the first dose of this medicine or after taking the first 0.5 mg dose if your previous dose was changed from 0.25 mg once daily, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. You will need to 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 still have a very slow or decreasing heart rate, or if your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours and possibly overnight) until the issue resolves. The same may apply if you restart this medicine after a treatment interruption, depending on the duration of the interruption and how long you had been taking the medicine before the interruption.

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

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

If you are taking other medicines that can slow your heart rate, this medicine may not be suitable for you. A cardiologist must evaluate you and consider whether you can switch to alternative medicines that do not slow the heart rate to allow treatment with this medicine. If such a switch is not possible, the cardiologist will advise you on how to start treatment with this medicine, 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 against the virus, you will likely need to be vaccinated before starting treatment with this medicine. If so, your doctor will delay the start of treatment by one month after completing the vaccination series.

Infections

This medicine reduces the number of white blood cells in the blood (especially lymphocytes). White blood cells fight infections. During treatment with this medicine (and for up to two months after stopping treatment), you may be more likely to get infections. An existing infection may even worsen. Infections can be serious and potentially fatal. If you think you have an infection, have a fever, flu-like symptoms, herpes (shingles), or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits) (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), contact your doctor immediately, as this may be serious and life-threatening.

Infections with the human papillomavirus (HPV), including papilloma, dysplasia, warts, and HPV-related cancers, have been reported in patients treated with this medicine. 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 starting and during treatment to monitor the risk of PML.

If you think your MS is worsening or if you 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 difficulty speaking or communicating, inform your doctor as soon as possible. These may be symptoms of PML. Also, talk to your family members or caregivers about your treatment, as symptoms may appear without you noticing them.

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 cause worsening of your disease, including worsening brain function.

Macular edema

Before starting treatment with this medicine, your doctor may request an eye examination if you have or have had visual disorders or other signs of inflammation in the central area of vision (the macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting treatment with this medicine, your doctor may request an eye examination 3 to 4 months after starting treatment.

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

If you have diabetes or have had eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you to have regular eye examinations to detect macular edema.

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

Macular edema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may have no symptoms. You must report any changes in your vision to your doctor. Your doctor may want to perform an eye examination, especially if:

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

Liver function tests

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

If you experience any of these symptoms after starting treatment with this medicine, inform your doctor immediately.

Before, during, and after treatment, your doctor will order blood tests to monitor your liver function. You may need to stop treatment if test results indicate a liver problem.

High blood pressure

Since this medicine causes a slight increase in blood pressure, your doctor will want you to have your blood pressure monitored regularly.

Lung problems

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

Blood count

The expected effect of treatment with this medicine is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you have blood tests, inform your doctor that you are taking this medicine, as otherwise your doctor may not understand the test results. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with this medicine, your doctor will confirm that you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to stop treatment with this medicine.

Reversible posterior encephalopathy syndrome (PRES)

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

Cancer

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

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

Sun exposure and sun protection

This medicine weakens your immune system, increasing the risk of developing cancer, especially skin cancer. You should limit your exposure to sunlight and UV rays by:

wearing appropriate protective clothing.
regularly applying a 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 this medicine. In the case of severe relapses, your doctor will consider whether an MRI scan is needed to assess your condition and decide whether you need to stop taking this medicine.

Switching from other treatments to Fingolimod

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to this medicine if there are no signs of abnormalities caused by the previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with this medicine. To switch from teriflunomide, your doctor may advise you to wait or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is needed to determine whether this medicine is suitable for you.

Women of childbearing potential

If this medicine is used during pregnancy, it may harm the fetus. Before starting treatment, your doctor will explain the risks and ask you to take 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 this medicine and what you should do to avoid pregnancy. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping Fingolimod treatment

Do not stop taking this medicine or change your prescribed dose without first discussing it with your doctor.

Inform your doctor immediately if you think your MS is worsening after

stopping treatment with this medicine, as it may be serious (see section 3 “If you stop taking this medicine” and section 4 “Possible side effects”).

Elderly patients

Experience with this medicine in elderly patients (over 65 years) is limited. If in doubt, consult your doctor.

Children and adolescents

This medicine must not be given to children under 10 years of age, as it has not been studied in pediatric patients with MS in this age group.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children, adolescents, and their caregivers:

Before starting treatment with this medicine, your doctor will check your vaccination status. If you have not received certain vaccines, you may need to get them before starting treatment.
The first time you take this medicine, or when switching from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the section above “Slow heart rate (bradycardia) and irregular heartbeats”).
If you have seizures or fits before or while taking this medicine, inform your doctor.
If you have depression or anxiety, or if you feel depressed or anxious during treatment, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor if you are taking any of the following:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use this medicine together with these medicines, as this could intensify the effect on the immune system (see also “Do not take Fingolimod Krka”).
Corticosteroids, due to an additive effect on the immune system.
Vaccines. If you need a vaccine, inform your doctor first. During treatment with this medicine and for up to two months after stopping, you must not receive certain vaccines (live attenuated virus vaccines), as they may cause the infections they are meant to prevent. Other vaccines may not work as well if given during this period.
Medicines that slow the heart rate (e.g., beta-blockers such as atenolol). Using this medicine with these medicines may intensify the effect on heart rate during the first days after starting treatment.
Medicines to treat irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you take any of these medicines, you must not use this medicine, as this could intensify the effect on irregular heartbeats (see also the section “Do not take Fingolimod Krka”).
Other medicines:
protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
- carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of this medicine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not use this medicine during pregnancy, if you plan to become pregnant, or if you are a woman who could become pregnant and are not using an effective contraceptive method. If this medicine is used during pregnancy, there is a risk of harm to the fetus. The rate of congenital malformations observed in babies exposed to this medicine during pregnancy is approximately twice that observed in the general population (where the rate of congenital malformations is approximately 2–3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing potential:

before starting treatment with this medicine, your doctor will inform you of the risk to the fetus and request a pregnancy test to confirm you are not pregnant,
and, during treatment with this medicine and for two months after stopping it, you must use an effective contraceptive method to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a card explaining why you must not become pregnant while taking this medicine.

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

Breastfeeding

You must not breastfeed during treatment with this medicine. This medicine passes into breast milk and there is a risk that the baby may experience serious adverse effects.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive vehicles, including bicycles, and operate machinery safely. This medicine is not expected to affect your ability to drive or use machines.

However, at the start of treatment, you will need to remain at the doctor's office or hospital for 6 hours after taking the first dose of this medicine. During this time and possibly afterward, your ability to drive and use machines may be impaired.

3. How to take Fingolimod Krka

Treatment with this medicine will be supervised by a doctor experienced in the treatment of multiple sclerosis.

Always follow exactly the instructions for administration given by your doctor. If in doubt, please consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and above):

The dose depends on body weight:

Children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day.
Children and adolescents weighing more than 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start treatment with one 0.25 mg capsule per day and later reach a stable weight above 40 kg, the doctor will instruct them to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

This medicine is not available in a 0.25 mg dosage strength. For this dose, other fingolimod-containing medicines available on the market should be used.

Do not exceed the recommended dose.

This medicine is for oral use.

Take this medicine once daily with a glass of water. The capsules must always be swallowed whole and must not be opened. You may take this medicine with or without food.

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

If you have any doubts about how long your treatment with this medicine should last, consult your doctor or pharmacist.

If you take more Fingolimod Krka than you should

If you have taken more fingolimod than you should have, inform your doctor immediately. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Fingolimod Krka

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

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

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

If you stop taking Fingolimod Krka

Do not stop taking this medicine or change the dose without first discussing it with your doctor.

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

If you need to restart treatment with this medicine 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 treatment with this medicine after having stopped for more than two weeks without first consulting your doctor.

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

If you have any further questions about the use of 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

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

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 intense 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.
It is known that people with multiple sclerosis have higher rates of depression and anxiety, and these have also been reported in pediatric patients treated with this medicine.
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 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, which increases 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 over time may change 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 people):

A disease called reversible posterior encephalopathy syndrome (RPES). Symptoms may include sudden and severe onset of 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 scabby sore, or a new sore on an existing scar

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

Abnormality in the electrocardiogram (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 such as rash or hives with itching, swelling of lips, tongue or face, which are more likely to occur on the day treatment with this medicine 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 in the right side of the stomach area (abdomen), dark urine (brown-colored), loss of appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to the need for a liver transplant
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 not be noticeable by the patient, such as changes in mood or behavior, memory loss, or difficulties with speech and communication, 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 this medicine, 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 frequent (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
Blood tests showing abnormal levels of liver enzymes
Cough

Frequent (may affect up to 1 in 10 people)

Tinea versicolor (fungal infection of the skin)
Dizziness
Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, redness and burning of the skin (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 (this medicine 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 effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fingolimod Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on the aluminium blister after EXP. The expiry date refers to the last day of the month indicated.

Blister packs:

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Vials:

Do not store above 25°C.

Keep the vial tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fingolimod Krka

The active substance is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
The other components are: microcrystalline cellulose (E460), povidone, magnesium stearate (E470b) in the capsule contents; and titanium dioxide (E171), carrageenan, potassium chloride, hypromellose, yellow iron oxide (E172), and printing ink (shellac (E904), black iron oxide (E172)) in the capsule shell.

Appearance of the product and contents of the pack

The capsule cap is yellow-brown with a black mark “F” and “0.5 mg” and with the company logo in black. The capsule body is white. The capsule contents are white or almost white powder. Capsule length: 15 - 17 mm.

This medicine is available in packs containing:

7, 14, 28, 30, 98 and 100 hard capsules in non-perforated blisters.
30 x 1 and 100 x 1 hard capsules in perforated unit-dose blisters.
calendar pack: 7 x 1, 14 x 1, 28 x 1 and 98 x 1 hard capsules in perforated unit-dose blisters.

This medicine is also available in bottles containing 30 hard capsules in a box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Ardena Pamplona S.L.,

Polígono Mocholi, C/Noain No. 1,

Navarra,

Spain

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.,

Calle de Anabel Segura 10, 28108

Alcobendas, Madrid,

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Member State	Name of the medicinal product
Denmark	Fingolimod Krka
Austria	Fingolimod HCS 0.5 mg Hard Capsules
Belgium	Fingolimod Krka 0.5 mg hard capsules
Spain	Fingolimod Krka 0.5 mg hard capsules EFG
Finland	Fingolimod Krka 0.5 mg capsules, hard
France	Fingolimod HCS 0.5 mg, capsule
Ireland	Fingolimod Krka 0.5 mg hard capsules
Iceland	Fingolimod Krka 0.5 mg hard capsules
Italy	Fingolimod HCS
Netherlands	Fingolimod Krka 0.5 mg hard capsules
Norway	Fingolimod Krka
Portugal	Fingolimod Krka
Sweden	Fingolimod Krka 0.5 mg capsules, hard
United Kingdom	Fingolimod Krka 0.5 mg hard capsules

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

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/