GAXENIM 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gaxenim 0.5 mg hard capsules EFG

fingolimod

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Gaxenim and what is it used for
2. What you need to know before you take Gaxenim
3. How to take Gaxenim
4. Possible side effects
5. Storing Gaxenim
6. Contents of the pack and other information

1. What is Gaxenim and what is it used for

What is Gaxenim

Gaxenim contains the active substance fingolimod.

What is Gaxenim used for

Gaxenim is used in adults and in children and adolescents (from 10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (a disease where the immune system attacks the protective covering of the nerves), particularly in:

• Patient who do not respond to treatment despite MS treatment.
• Patient who rapidly develop severe MS.

Gaxenim does not cure MS, but it helps to reduce the number of relapses and slow down the progression of physical disabilities due to MS.

What is multiple sclerosis

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

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect inflammation occurring in the CNS. The symptoms vary from one patient to another, but usually include difficulties walking, loss of sensation in some part of the body (numbness), vision problems, or balance disorders. The symptoms of a relapse may disappear completely when the relapse is over, but some problems may persist.

How Gaxenim works

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

2. What you need to know before you take Gaxenim

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• if you have a weakened immune system(due to an immune deficiency syndrome, a disease, or medications that suppress the immune system).
• if your doctor suspects that you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if you have been confirmed to have PML
• if you have a severe active infection or a chronic active infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.

-i, if in the last 6 months, you have had a heart attack, angina, stroke, or warning signs of a stroke, or any type of heart failure

• if you have any type of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Gaxenim.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.

- i are pregnantor if you are a woman of childbearing age and are not using an effective contraceptive method

• if you are allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of the above applies to you or if you are not sure, tell your doctor before taking Gaxenim.

A

Consult your doctor before starting to take Gaxenim:

-i you have severe respiratory problems when sleeping (severe sleep apnea).

• if you have been told you have an abnormal electrocardiogram.
• if you have symptoms of a slow heart rate(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, or ivabradina, digoxin, anticholinesterase agents, or pilocarpine).

-i you have a history of sudden loss of consciousness or fainting (syncope).

• if you plan to get vaccinated.
• if you have never had chickenpox.
• if you have or have had visual disordersor other signs of inflammation in the central vision area (macula) of the eye (a condition known as macular edema, see below) or an eye inflammation or infection (uveitis) or if you havediabetes(which can 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 problemsor "smoker's cough).

If any of the above cases apply to you or if you are unsure, tell your doctor before taking Gaxenim.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once a day has been changed, Gaxenim causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop. If these effects are severe, tell your doctor as you may need immediate treatment.Gaxenim can also cause your heartbeats to become irregular, especially after the first dose. Irregular heartbeats usually return to normal in less than a day. The slow heart rate usually returns to normal within a month. During this period, clinically significant effects on heart rate are not expected.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Gaxenim or after taking the first dose of 0.5 mg, in the case that your previous dose of 0.25 mg once a day has been changed, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You will have an electrocardiogram before the first dose of Gaxenim and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight, until this is resolved). The same may apply if you are resuming Gaxenim after a pause in treatment, depending on both the duration of the pause and how long you were taking Gaxenim before the pause.

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

If you have suffered from sudden fainting spells in the past or a decrease in heart rate, Gaxenim may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with Gaxenim, including nighttime monitoring.

If you are taking other medications that can slow down your heart rate, Gaxenim may not be suitable for you. You need to be evaluated by a cardiologist, who will assess whether you can switch to alternative medications that do not decrease heart rate to allow treatment with Gaxenim. If the aforementioned change is impossible, the cardiologist will advise you on how to start treatment with Gaxenim, including nighttime monitoring.

If you have never had chickenpox

If you have not 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 Gaxenim. If so, your doctor will delay the start of treatment with Gaxenim until one month after the vaccination cycle is completed.

Infections

Gaxenim reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with Gaxenim (and up to two months after treatment is stopped), you may be more likely to get infections. You may even have a worsening of an infection you already have. Infections can be serious and potentially life-threatening.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, has been reported in patients treated with fingolimod. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have HPV screenings.

LMP

LMP is a rare brain disorder caused by an infection, which can cause severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) before starting treatment and during treatment to monitor the risk of LMP.

If you think your MS is getting worse or if you notice any new symptoms, such as changes in your mood or behavior, worsening or appearance of weakness on one side of your body, changes in vision, confusion, memory problems, or difficulties with speech and communication, tell your doctor as soon as possible. These may be symptoms of LMP. Also, talk to your family members or caregivers to inform them about your treatment. Symptoms may appear without you realizing it.

If you develop LMP, it can be treated, and your treatment with Gaxenim will be stopped. Some people have an inflammatory reaction when Gaxenim is removed from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can cause a worsening of your disease, including a worsening of brain function.

Macular edema

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

After starting treatment with Gaxenim, your doctor may request an eye examination after 3 or 4 months of 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. Gaxenim can cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first four months of treatment with Gaxenim.

If you have diabetesor 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 checks to detect macular edema.

If you have had macular edema, consult your doctor before continuing treatment with Gaxenim.

Macular edema can cause the same visual symptoms as those produced in an MS attack (optic neuritis). At first, you may not have symptoms. You should inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• The center of your field of vision becomes blurry or has shadows;
• A blind spot appears in the center of your field of vision;
• You have problems seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take Gaxenim. Gaxenim can affect liver function. You may not notice any symptoms, but if you notice a yellowish tone in your skin or the white part of your eye, abnormally dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, tell your doctor immediately.

If you have any of these symptoms after starting treatment with Gaxenim, tell your doctor immediately.

Before, during, and after treatment, your doctor will request blood tests to check your liver function. You may need to stop treatment with Gaxenim if the results of your tests indicate a problem with your liver.

High blood pressure

Since Gaxenim causes a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

Gaxenim 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 Gaxenim 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 need to have blood tests, tell your doctor that you are taking Gaxenim, as your doctor may not understand the results of the tests otherwise. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with Gaxenim, your doctor will check if 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 Gaxenim.

Posterior reversible encephalopathy syndrome (PRES)

A rare condition called posterior reversible encephalopathy syndrome (PRES) has been reported in MS patients treated with fingolimod. Symptoms may include sudden onset of severe headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment with Gaxenim, as it can be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Tell your doctor immediately if you notice any nodules on your skin (e.g., shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Before starting treatment with Gaxenim, a skin examination is required to check if you have any nodules on your skin. Your doctor will also perform regular skin checks during treatment with Gaxenim. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is important to visit you regularly.

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, which increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by:

• wearing protective clothing.
• applying sunscreen with a high UV protection index regularly.

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In the case of severe relapses, your doctor will assess the need to perform a magnetic resonance imaging (MRI) scan to evaluate your condition and decide if you need to stop taking Gaxenim.

Switching from other treatments to Gaxenim

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Gaxenim if there are no signs of treatment-related abnormalities. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with Gaxenim.

To switch from teriflunomide, your doctor may advise you to wait for a period or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is necessary, and you should discuss it with your doctor to decide if Gaxenim is suitable for you.

Women of childbearing age

If Gaxenim is used during pregnancy, it may harm the fetus. Before starting treatment with Gaxenim, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking Gaxenim and what you should do to avoid becoming pregnant while taking Gaxenim. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

MS worsening after stopping treatment with Gaxenim

Do not stop taking Gaxenim or change the dose your doctor has prescribed without discussing it with your doctor first.

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with Gaxenim, as it can be serious (see section 3 "If you stop treatment with Gaxenim" and also section 4 "Possible side effects").

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

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Gaxenim should not be administered to children under 10 years of age, as it has not been studied in 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 and adolescents and their caregivers:

• Before starting treatment with Gaxenim, your doctor will check your vaccination status. If you have not received certain vaccinations, it may be necessary to administer them before you can start treatment with Gaxenim.
• The first time you take Gaxenim, or when you switch 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 previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or attacks before taking or while taking Gaxenim, tell your doctor.
• If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with Gaxenim, tell your doctor. You may need closer monitoring.

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Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Tell your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use Gaxenim with these medications because it could intensify the effect on the immune system (see also "Do not take Gaxenim").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with Gaxenim and up to two months after stopping treatment, you should not receive certain types of vaccines (live attenuated virus vaccines) because they can cause the infections they are intended to prevent. Other vaccines may not be effective if administered during this period.
• Medications that slow down your heart rate(e.g., beta-blockers such as atenolol). Using Gaxenim with these medications can intensify the effect on heart rate during the first few days after starting treatment with Gaxenim.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use Gaxenim, as it could intensify the effect on irregular heartbeats (see also the section "Do not take Gaxenim").

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• 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 efficacy of Gaxenim).

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

Pregnancy

Do not use Gaxenim during pregnancy, or if you plan to become pregnant, or if you are a woman who can become pregnant and do not use an effective contraceptive method. If Gaxenim is used during pregnancy, there is a risk of harm to the fetus. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately 2 times higher than that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing age:

• before starting treatment with Gaxenim, your doctor will inform you about the risk to the fetus and ask you to take a pregnancy test to ensure you are not pregnant

and

• during treatment with Gaxenim and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Talk to your doctor about reliable contraceptive methods.

Your doctor will give you a card that explains why you should not become pregnant while taking Gaxenim.

If you become pregnant during treatment with Gaxenim, tell your doctor immediately.Your doctor will decide to stop treatment (see section 3 "If you stop treatment with Gaxenim" and also section 4 "Possible side effects"). You will receive specific prenatal follow-up.

Breastfeeding

Do not breastfeed during treatment with Gaxenim.Gaxenim passes into breast milk, and there is a risk that the baby may have serious side effects.

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Your doctor will inform you if your illness allows you to drive vehicles, including bicycles, and use machines safely. It is not expected that Gaxenim will have an influence on your ability to drive and use machines.

However, at the start of treatment, you will have to stay in the doctor's office or hospital for 6 hours after taking the first dose of Gaxenim. During this time period and possibly afterwards, your ability to drive and use machines may be altered.

Excipients

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule. This is essentially "sodium-free".

3. How to take Gaxenim

Treatment with Gaxenim will be supervised by a doctor with experience in the treatment of multiple sclerosis.

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults

The dose is 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 weight equal to or less than 40 kg: one 0.25 mg capsule per day.
• Children and adolescents with a weight greater than 40 kg: one 0.5 mg capsule per day.

Since 0.5 mg hard capsules are not suitable for pediatric patients with a body weight ≤40 kg, other medications containing fingolimod are available in a lower concentration (such as 0.25 mg capsules).

For children and adolescents who start with a 0.25 mg capsule per day and later reach a stable weight greater than 40 kg, the doctor will indicate that they switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period of the first dose.

Do not exceed the recommended dose. Gaxenim is used orally.

Take Gaxenim once a day with a glass of water. Gaxenim capsules should always be swallowed whole, without opening them. You can take Gaxenim with or without food.

Taking Gaxenim every day at the same time will help you remember when to take the medication.

If you have doubts about the duration of treatment with Gaxenim, consult your doctor or pharmacist.

If you take more Gaxenim than you should

If you have taken more Gaxenim than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the toxicology information service, phone 91 562 04 20.

If you forget to take Gaxenim

If you have been taking Gaxenim for less than 1 month and you forget to take 1 dose during a whole day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Gaxenim for at least 1 month and you have forgotten to take your treatment for more than 2 weeks, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have forgotten to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

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

If you interrupt treatment with Gaxenim

Do not stop taking Gaxenim or change the dose to be taken without discussing it with your doctor first.

Gaxenim will remain in your body for up to two months after treatment is interrupted. The number of white blood cells in the blood (lymphocyte count) may remain low during this period, and it is possible that the adverse effects described in this prospectus may still occur. After interrupting treatment with Gaxenim, you may have to wait during 6-8 weeks before starting a new treatment for MS.

If you need to resume treatment with Gaxenim after a pause of more than two weeks, the effect on heart rate that may occur at the start of treatment may repeat, and it will be necessary for you to be monitored in the doctor's office to restart treatment. Do not restart treatment with Gaxenim after interrupting it for more than two weeks without consulting your doctor.

Your doctor will decide if it is necessary to monitor you after interrupting treatment with Gaxenim and how to do it. Inform your doctor immediately if you think your MS is getting worse after interrupting treatment with Gaxenim, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Some side effects may be serious or potentially serious.

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

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stage of the infection, followed by numbness, itching, or red spots with intense pain.
• Slow heart rate (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC) that often appears as a pearl-like nodule, although it can also have other forms.
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and it has also been reported in pediatric patients 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 (inflammation in the central vision area of the retina in the back of the eye) with symptoms such as shadows or a blind spot or no vision in the center of the visual field, blurred vision, problems seeing colors or details.
• Decreased 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 change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate.
• Seizures, attacks (more frequent in children and adolescents than in adults).

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

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures, and/or visual disturbances.
• Lymphoma (a type of cancer that affects the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar.

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

• Abnormality in the electrocardiogram (inversion of the T wave).
• Tumor related to 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 appear on the day treatment with Gaxenim begins.
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown color), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).

The symptoms of PML may be similar to those of an MS relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important that you inform your doctor as soon as possible.

Other side effects

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

• Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever.
• Sensation of pressure or pain in the cheeks and forehead (sinusitis).
• Headache.
• Diarrhea.
• Back pain.
• Blood tests with altered liver enzyme levels.
• Cough.

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

• Verseicolor tinea (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.
• Rash with itching, redness of the skin, and burning (eczema).
• Itching.
• Increased blood levels of certain lipids (triglycerides).
• Hair loss.
• Breathing difficulties.
• Depression.
• Blurred vision (see also the section on macular edema under the heading "Some side effects can be serious or potentially serious").
• Hypertension (Gaxenim 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).
• Depressive mood.
• Nausea.

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

• Lymphatic system cancer (lymphoma).

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

• Peripheral inflammation.

If you consider that any of the side effects you are experiencing is serious, inform your doctor. Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Gaxenim

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the aluminum blister after CAD/EXP.

The expiration date is the last day of the month indicated.

For PVC/PVDC/aluminum blister:Do not store above 30°C.

For PVC/PE/PVDC/aluminum blister:This medication does not require special storage conditions.

Do not use this medication if you notice that the packaging is damaged or shows signs of tampering.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gaxenim

The active ingredient is fingolimod.

Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.

The other components are:

Capsule content: calcium phosphate dihydrate, sodium croscarmellose, hydroxypropylcellulose (E463), magnesium stearate (E470b).

Capsule shell - body: gelatin, titanium dioxide (E171).

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

Printing ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide (E525).

Appearance of Gaxenim and package contents

Gaxenim 0.5 mg hard capsules EFG are presented as 15.9 mm capsules with a yellow cap and an opaque white body; printed with black ink "FD 0.5 mg" on the cap.

Gaxenim 0.5 mg hard capsules EFG are available in packages containing 28 or 98 capsules. Only some package sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited.

3013 Lake Drive.

Citywest Business Campus.

Dublin 24, D24PPT3.

Ireland.

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue.

153 51 Pallini Attiki.

Greece.

Bausch Health Poland sp. z o.o.

ul. Kosztowska 21.

41-409 Myslowice.

Poland.

Date of the last revision of this prospectus: April 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.