FINGOLIMOD TILLOMED 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fingolimod Tillomed 0.5 mg hard capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fingolimod Tillomed and what is it used for
2. What you need to know before taking Fingolimod Tillomed
3. How to take Fingolimod Tillomed
4. Possible side effects
5. Storage of Fingolimod Tillomed
6. Package contents and additional information

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

What is Fingolimod Tillomed

This medication contains the active ingredient fingolimod.

What is Fingolimod Tillomed used for

This medication is used in adults and in children and adolescents (10 years and older) to treat relapsing-remitting multiple sclerosis (MS) (that occurs with relapses), particularly in:

• Patients who do not respond to treatment despite MS treatment.

or

• Patients who rapidly develop severe MS.

This medication does not cure MS, but it helps to reduce the number of relapses and slow 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 consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that covers 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 the inflammation occurring in the CNS. Symptoms vary from patient to patient but usually include difficulty 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 ends, but some problems may persist.

How Fingolimod Tillomed works

Fingolimod helps to combat the immune system's attacks on the CNS by reducing the ability of some 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. Fingolimod also reduces some of the immune responses of your body.

2. What you need to know before taking Fingolimod Tillomed

Do not take Fingolimod Tillomed

• if you have a weakened immune system (due to an immunodeficiency 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 infection such as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if you have had a heart attack, chest pain, stroke, or stroke warning in the last 6 months.
• if you have any type of irregular heartbeat or abnormal heart rhythm (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with fingolimod.
• 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 age and do not use an effective contraceptive method.
• if you are allergic to fingolimod or any of the other components of this medication (listed in section 6).

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

Warnings and precautions

Consult your doctor before starting to take this medication:

• if you have severe respiratory problems when sleeping (severe sleep apnea).
• if you have been told that 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).
• if 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 disorders or other signs of inflammation in the central vision area (macula) of the eye, an inflammation or infection of the eye (uveitis), or if you have diabetes (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 problems or "smoker's cough."

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

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 you have been changed from a previous dose of 0.25 mg once a day, fingolimod 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 immediately, as you may need immediate treatment.Fingolimod can also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually normalize in less than a day. The slow heart rate usually normalizes within a month. During this period, no clinically significant effect on heart rate is usually 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 fingolimod or after taking the first dose of 0.5 mg, in the case that you have been changed from a previous dose of 0.25 mg once a day, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You will need to have an electrocardiogram before the first dose of fingolimod and after the 6-hour monitoring period. Your doctor may need to 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 fingolimod after a pause in treatment, depending on both the duration of the pause and how long you were taking fingolimod 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, fingolimod may not be suitable for you.

If you have had sudden fainting spells or a slow heart rate in the past, fingolimod 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 fingolimod, including overnight monitoring.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. You will need to be evaluated by a cardiologist, who will determine if you can switch to alternative medications that do not slow the heart rate to allow treatment with fingolimod. If such a switch is not possible, the cardiologist will advise you on how to start treatment with fingolimod, including overnight 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 fingolimod. If so, your doctor will delay the start of treatment with fingolimod for one month after completing the vaccination cycle.

Infections

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

PML

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

If you think your multiple sclerosis (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 can be symptoms of PML. Also, talk to your family members or caregivers about your treatment. Symptoms can appear without you realizing it.

Macular edema

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

After starting treatment with fingolimod, 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. Fingolimod can cause inflammation of the macula, and this disorder is known as macular edema. Inflammation usually occurs within the first four months of treatment with fingolimod.

If you have diabetesor have had an 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 fingolimod.

Macular edema can cause the same visual symptoms as those produced by an MS attack (optic neuritis). At first, you may not have symptoms. You should tell your doctor about 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 trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take fingolimod. Fingolimod can affect liver function. You may not notice any symptoms, but if you notice a yellowish tone to your skin or the white part of your eyes, unusually dark urine (brown-colored), 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 fingolimod, tell your doctor immediately.

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

High blood pressure

Since fingolimod can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

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

Blood tests

The expected effect of treatment with fingolimod is to reduce the number of white blood cells in your blood. This effect usually normalizes within two months after stopping treatment. If you need to have blood tests, tell your doctor that you are taking fingolimod, as your doctor may not understand the results of the tests if you do not. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with fingolimod, 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 interrupt treatment with fingolimod.

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Cases of skin cancer have been reported in patients with MS who have been 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 can include abnormal growth or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Before starting treatment with fingolimod, 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 fingolimod. 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 patients with MS who have been 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:

• using suitable protective clothing.
• applying a 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 an MRI scan to evaluate your condition and decide if you need to stop taking fingolimod.

Switching from other treatments to fingolimod

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod 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 fingolimod. 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 fingolimod is suitable for you.

Women of childbearing age

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

Worsening of MS after stopping treatment with fingolimod

Do not stop taking fingolimod 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 fingolimod, as it can be serious (see section 3 "If you stop taking Fingolimod Tillomed" and also section 4 "Possible side effects").

Elderly

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

Children and adolescents

This medication should not be given 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 fingolimod, your doctor will check your vaccination status. If you have not received certain vaccinations, you may need to receive them before you can start treatment with fingolimod.
• The first time you take fingolimod, 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 fingolimod, tell your doctor.
• If you suffer from depression or anxiety or if you feel depressed or anxious during treatment with fingolimod, tell your doctor. You may need closer monitoring.

Other medications and Fingolimod Tillomed

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 this medication with these medications, as it may intensify the effect on the immune system (see also "Do not use Fingolimod Tillomed").
• Corticosteroids, due to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with fingolimod and up to two months after stopping treatment, you should not receive certain types of vaccines (vaccines made with live attenuated viruses), as they can cause the infections they are intended to prevent. Other vaccines may not be effective if administered during this time.
• Medications that slow the heart rate(e.g., beta blockers such as atenolol). The use of fingolimod with these medications can intensify the effect on the heart rate during the first days after starting treatment with fingolimod.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use fingolimod, as it may intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Tillomed").
• Medications that may interact with fingolimod, such as ketoconazole, voriconazole, posaconazole, or clarithromycin. Your doctor may need to monitor you more closely or adjust the dose of fingolimod if you are taking any of these medications.

Other medications

• protease inhibitors, antivirals such as ketoconazole, azole antifungals, clarithromycin or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz or St. John's Wort (potential risk of reduced efficacy of fingolimod).

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 medication.

Pregnancy

Do not use fingolimod during pregnancy, or if you plan to become pregnant, or if you are a woman who can become pregnant and are not using an effective contraceptive method. If fingolimod 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 included cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing age:

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

and,

• during treatment with fingolimod and for 2 months after stopping it, 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 leaflet explaining why you should not become pregnant while taking this medication.

If you become pregnant during treatment with this medication, inform your doctor immediately.Your doctor will decide whether to stop treatment (see section 3 "If you stop treatment with Fingolimod Tillomed" and also section 4 "Possible side effects"). You will receive specific prenatal monitoring.

Breastfeeding

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

Driving and using machines

Your doctor will inform you if your illness allows you to drive vehicles, including bicycles, and use machines safely. It is not expected that fingolimod will affect your ability to drive and use machines.

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

3. How to take Fingolimod Tillomed

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

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (from 10 years and older):

The dose depends on body weight:

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

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

Do not exceed the recommended dose.

This medication is taken orally.

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

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

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

If you take more Fingolimod Tillomed than you should

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

If you forget to take Fingolimod Tillomed

If you have been taking this medication for less than 1 month and you forget to take 1 dose for 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 this medication 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 stop treatment with Fingolimod Tillomed

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

Fingolimod will remain in your body for up to 2 months after stopping treatment. The number of white blood cells in your blood (lymphocyte count) may remain low during this period, and it is possible that side effects may still occur. After stopping treatment with fingolimod, you may have to wait for 6-8 weeks before starting a new treatment with another medication.

If you need to restart treatment with fingolimod after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur, and you will need to be monitored in the doctor's office to restart treatment. Do not restart treatment with fingolimod after interrupting it for more than 2 weeks without consulting your doctor.

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

If you have any other questions 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 everyone will experience them.

Some side effects can be serious or potentially serious

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

• 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 experience include fever and weakness in the early stage of infection, followed by numbness, itching or red spots with severe 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 these 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 (inflammation 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 field of vision, blurred vision, problems seeing colors or details.
• Decreased platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible 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 patients):

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden and 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 patients):

• 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 fingolimod 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 abdominal area, dark urine (brown color), decreased appetite, fatigue and abnormal liver function test results. In a small number of cases, liver failure may require a liver transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML can be similar to those of a multiple sclerosis relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication problems, which your doctor may need to investigate further to rule out PML. Therefore, if you think your multiple sclerosis is getting worse or if you or those 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 nodule of flesh-colored or blue-red color, usually on the face, head or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with fingolimod, multiple sclerosis symptoms may recur and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

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

Other side 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 test with abnormal liver enzyme levels.
• Cough.

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

• Verseicolor tinea (fungal skin infection).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting and sensitivity to light (migraine).
• Low white blood cell count (lymphocytes, leukocytes).
• Weakness.
• Rash with itching, redness of the skin and burning (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 side effects can be serious or potentially serious").
• Hypertension (this medication may cause a slight increase in blood pressure).
• Muscle pain.
• Joint pain.

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

• Low levels of certain white blood cells (neutrophils).
• Depressive mood.
• Nausea.

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

• Lymphatic system cancer (lymphoma).

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

• Peripheral inflammation.

If you consider any of the side effects you are experiencing to be serious, inform your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online system: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod Tillomed

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

Do not use this medication after the expiration date shown on the packaging and blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Tillomed

The active ingredient is fingolimod.

Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).

The other ingredients are:

Capsule content: anhydrous calcium hydrogen phosphate, magnesium stearate.

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

Printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), potassium hydroxide, black iron oxide (E172).

Appearance of the product and package contents

Hard capsule of 15.8 mm with a bright yellow opaque cap with "HP 334" printed in black ink and a white opaque body

This medication is available in blister packs of 7x1, 28x1, 30x1, 98x1 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Tillomed Spain S.L.U.

C/ Cardenal Marcelo Spínola 8, Planta 1ª, puerta F

28016 Madrid

Spain

Manufacturer

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

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

Germany: Fingolimod Tillomed 0.5 mg Hartkapseln

Italy: Fingolimod Tillomed

Netherlands: Fingolimod Tillomed 0.5 mg harde capsules

Austria: Fingolimod Tillomed 0.5 mg Hartkapseln

Portugal: Fingolimod Tillomed

Denmark: Fingolimod Tillomed

Finland: Fingolimod Tillomed 0.5 mg kova kapseli

Norway: Fingolimod Tillomed

Sweden: Fingolimod Tillomed 0.5 mg hårda kapslar

Ireland: Fingolimod Tillomed 0.5 mg hard capsules

Date of last revision of this leaflet:July 2025

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