Leaflet: information for the user

Fingolimod Tarbis 0.5 mg hard capsules EFG

Read this 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, consult your doctor or pharmacist.
  This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Fingolimod Tarbis

3. How to take Fingolimod Tarbis

4. Possible side effects

5. Storage of Fingolimod Tarbis

6. Contents of the pack and additional information

What is Fingolimod Tarbis

The active ingredient of this medication is fingolimod.

What is Fingolimod Tarbis used for

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

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

or

• Patients who rapidly develop severe MS.

Fingolimod 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), consisting of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS and prevents nerves from functioning correctly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of CNS symptoms that are a reflection of the inflammation that occurs in the CNS. Symptoms vary from patient to patient, but generally include difficulties walking, numbness in some part of the body (tingling), vision problems, or balance disorders. Symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Fingolimod Tarbis 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 nerve damage attributed to MS. Fingolimod also reduces some of the body's immune responses.

Do not take Fingolimod Tarbis

• if you have a weakened immune system(due to immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have an active severe infection or an active chronic infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke, transient ischemic attack, or any type of heart failure.
• if you have any type of irregular or abnormal heart rhythm(arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before startingtreatment with Fingolimod.
• if you are taking or have recently taken medications for irregular heartbeats (such as quinidine, disopyramide, amiodarone, or sotalol).
• if you are pregnant orif you are a woman of childbearing potential and do not use an effective contraceptive method.
• if you are allergicto fingolimod or to any of the other components of this medication(including those listed in section 6).

If any of the above cases apply to you,inform your doctor without taking Fingolimod Tarbis.

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 slow heart rhythm (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 ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• if you have a history of sudden loss of consciousness or fainting (syncope).
• if you plan to be vaccinated.
• if you have never had chickenpox.
• if you have or have had eye inflammation or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as macular edema, see below), or if you have diabetes (which can cause eye problems).
• if you have liver problems.
• if you havehigh blood pressure that cannot be controlled with medication.
• if you havesevere lung problems or "smoker's cough."

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

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 changed the previous dose of 0.25 mg once a day using another medication that contains fingolimod, which are available in lower resistance, 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, inform your doctor or you may need immediate treatment.Fingolimod can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within a day. Slow heart rate usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation or hospital for a minimum of 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of this medication or after taking the first dose of 0.5 mg, in the case that you have changed the previous dose of 0.25 mg once a day, using another medication that contains fingolimod, which are available in lower resistance, to take the necessary measures in case of adverse effects that appear at the start of treatment. You will need to have an electrocardiogram before the first dose of this medication 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 restarting this medication after a pause in treatment, depending on both the duration of the pause and how long you were taking this medication before the pause.

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

If you have had sudden fainting spells in the past or decreased heart rate, Fingolimod Tarbis 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 monitoring during the night.

If you are taking other medications that can slow your heart rate, this medication may not be suitable for you. It is necessary for a cardiologist to evaluate you, and it is they who will decide if you can switch to alternative medications that do not slow your heart rate to allow treatment with this medication. If the aforementioned change is impossible, the cardiologist will advise you on how to start treatment with this medication, including monitoring during the night.

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, your doctor will probably delay starting treatment with this medication for a month after completing the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells in the blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medication (and for up to two months after stopping treatment), you may be more susceptible to infections. You may even have a worsening of an existing infection. Infections can be severe and potentially life-threatening. If you think you have contracted an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or herpes virus), contact your doctor immediately because it can be severe and life-threatening. If you think your MS is worsening (e.g. weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking this medication.

A human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, has been reported in patients treated with fingolimod. Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema

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

After starting treatment with Fingolimod, your doctor may request that you have 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 clearly. Fingolimod 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 Fingolimod.

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 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 an MS attack (optic neuritis). At first, you may not have any symptoms. It is necessary to communicate any changes you notice in your vision to your doctor. Your doctor may want to have 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 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 perceive any symptoms, but if you notice a yellowish tone of the skin or the white part of the eyes, abnormally dark urine (brown), abdominal pain on the right side, fatigue, decreased appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

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

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

High blood pressure

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

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 count

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, inform your doctor that you are taking Fingolimod, as if you do not, the doctor may not understand the results of the blood tests. For certain blood tests, your doctor may need to take more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

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

Cases of lymphoma, a type of cancer of the lymphatic system, have been reported in patients with MS who have been treated with Fingolimod.

Exposure to the sun and sun protection

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

• using protective clothing.
• regularly applying a high-protection sunscreen.

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 evaluate the need for an MRI scan to assess your condition and decide if you need to stop taking Fingolimod.

Switching from other treatments to Fingolimod Tarbis

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod if there are no signs of abnormalities caused by previous treatment. Your doctor may need to have a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with Fingolimod. To switch from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if Fingolimod is suitable for you.

Women of childbearing potential

If Fingolimod is used during pregnancy, it may be harmful to the fetus. Before starting treatment with Fingolimod, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking this medication. They will also explain 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 "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod Tarbis

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

Inform your doctor immediately if you think your MS is worsening after stopping treatment with Fingolimod, as it can be severe (see section 3 "If you stop taking Fingolimod Tarbis" and also section 4 "Possible side effects").

Older adults

The experience with fingolimod in patients over 65 years old is limited. If you have any doubts, consult your doctor.

Children and adolescents

Fingolimod 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 Fingolimod, your doctor will check your vaccination status. If you have not been vaccinated, you may need to have the vaccinations before starting treatment with Fingolimod.
• The first time you take Fingolimod, or when you change from a daily dose of 0.25 mg to a daily dose using another medication that contains fingolimod, which are available in lower resistance, 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, inform your doctor.
• If you experience depression or anxiety or feel depressed or anxious during treatment with Fingolimod, inform your doctor. You may need more follow-up.

Other medications and Fingolimod Tarbis

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

• Medications that suppress or modulate the immune system, includingothermedications used for the treatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use Fingolimod with these medications, as this could intensify the effect on the immune system (see also "Do not take Fingolimod Tarbis").
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with Fingolimod and for up to two months after stopping treatment, you should not be given certain types of vaccines (vaccines made with live, attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not have the desired effect if given during this period of time.
• Medications that slow heart rate(e.g. beta-blockers such as atenolol). The use of Fingolimod with these medications may intensify the effect on heart rate during the first few days after starting treatment with Fingolimod.
• Medications for irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medications, you should not use Fingolimod, as this could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Tarbis").
• Other medications:
• • protease inhibitors, antifungals 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, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Do not use Fingolimod during pregnancy, or if you are a woman of childbearing potential and do not use an effective contraceptive method. If Fingolimod is used during pregnancy, there is a risk of causing harm to the fetus. The rate of congenital malformations observed in babies exposed to Fingolimod during pregnancy is approximately twice that of the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included heart, kidney, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing potential:

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

and,

• during treatment with Fingolimod and for two months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss contraceptive options with your doctor.

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

If you become pregnant while taking Fingolimod Tarbis, inform your doctor immediately.Your doctor will decide to stop treatment (see section 3 "If you stop taking Fingolimod Tarbis" and also section 4 "Possible side effects"). You will have a specific prenatal follow-up.

Breastfeeding

Do not breastfeedwhile taking Fingolimod Tarbis. Fingolimod passes into breast milk, and there is a risk of severe adverse effects in the baby.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive vehicles, including bicycles, and use machines safely. Fingolimod is not expected to have an impact on your ability to drive and use machines.

However, after taking the first dose of Fingolimod Tarbis, you will need to stay in the consultation or hospital for 6 hours. During this period and possibly afterwards, your ability to drive and use machines may be impaired.

Fingolimod Tarbis contains sodium

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

The treatment with Fingolimod will be supervised by a doctor with experience in treating multiple sclerosis.

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

The recommended dose is:

Adults:

The dose is one capsule of 0.5 mg per day.

Children and adolescents (10 years of age and older):

The dose depends on body weight:

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

Fingolimod Tarbis 0.5 mg hard capsules are not suitable for pediatric patients with a weight ≤ 40 kg. Other medications containing fingolimod are available in lower doses (such as 0.25 mg capsules).

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

Children and adolescents who start with one capsule of 0.25 mg per day using anothermedication that contains fingolimod, which are available in lower resistance and later reach a stable weight over 40 kg, the doctor will instruct them to switch to one capsule of 0.5 mg per day. In this case, it isrecommended to repeat the observation period of the first dose.

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 must always be swallowed intact, without opening. You can take Fingolimod with or without food.

Taking Fingolimod 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 this medication, consult your doctor or pharmacist.

If you take more Fingolimod Tarbis than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

If you forget to take Fingolimod Tarbis

If you have been taking Fingolimod for less than 1 month and forget to take 1 dose for an entire 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 Fingolimod for at least 1 month and forget 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 forget 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 compensate for missed doses.

If you interrupt treatment with Fingolimod Tarbis

Do not stop taking Fingolimod or change the dose that should be taken without consulting your doctor first.

Fingolimod will remain in your body for up to 2 months after treatment is discontinued. 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 will still occur. After discontinuing treatment with Fingolimod, you may need to wait 6-8 weeks before starting a new treatment with EM.

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

Your doctor will decide if you need to be followed up after discontinuing treatment with Fingolimod and how. Inform your doctor immediately if you think your MS is worsening after discontinuing treatment with Fingolimod, as it could be serious.

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

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

Some side effects can be serious or potentially serious

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

• Cough with mucus (phlegm), chest discomfort, fever (signs of lung changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms that may occur are fever and weakness in the early stages 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 presents 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.

Less frequent(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 loss of vision in the center of the visual field, blurry 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 over time can change in size, shape, thickness, or color, or the formation of new moles.
• Convulsions, seizures (more common in children and adolescents than in adults)

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

• A condition called reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms may include sudden and intense 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 present as a firm, red nodule, a sore with a scab, or a new sore over an existing scar

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

• Electrocardiogram anomaly (T wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency unknown(cannot be estimated from available data):

• Allergic reactions, including symptoms such as rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to occur on the day treatment with Fingolimod begins
• Signs of liver disease (including liver failure), such as yellowing of the skin or white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown), loss of appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. They may also include symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, 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 people close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiffness in the neck, 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, red or pink nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm or soft nodule or mass. Long-term exposure to sunlight and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with Fingolimod, MS symptoms may return and may be worse than before or during treatment.
• Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed

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

Other side 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
• Sensation of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test with altered liver enzyme levels
• 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 white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching rash, skin redness, and burning (eczema)
• Itching
• Increased levels of certain lipids in the blood (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema under the title "Some side effects can be serious or potentially serious")
• Hypertension (Fingolimod may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Less frequent(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):

• Lymphoma (cancer of the lymphatic system)

Frequency unknown(cannot be estimated from available data):

• Peripheral inflammation

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

Reporting side effects

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

Keep this medication out of the 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.

Store below 30°C

Do not use any packaging that is damaged or shows signs of having been manipulated.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Fingolimod Tarbis Composition

The active ingredient is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).

The other components are:

Capsule content: powdered cellulose (E460), titanium dioxide (E171), magnesium stearate (E470b).

Capsule coating: gelatine (E441), yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate (E487).

Black printing ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide (E527).

Blue printing ink:shellac (E904), propylene glycol (E1520), indigo carmine (E 132).

Appearance of the product and contents of the pack

Fingolimod Tarbis 0.5 mg hard capsules have a bright yellow cap and an opaque white body. The cap has a black imprint “H” and “F7” in the body marked with blue ink.

Fingolimod Tarbis 0.5 mg hard capsules are available in packs containing 7, 28 or 98 capsules or in a perforated unit dose blister pack containing 7 x 1 hard capsules in multiple packs containing 84 capsules (3 packs of 28 capsules).

Only some pack sizes may be marketed in your country.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany:Fingolimod Amarox 0.5 mg Hartkapseln

Netherlands:Fingolimod Amarox 0.5 mg harde capsules

Spain: Fingolimod Tarbis 0.5 mg hard capsules EFG

Sweden:Fingolimod Amarox 0.5 hårda kapslar

Last revision date of this leaflet: July 2021.

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