FINGOLIMOD TECNIGEN 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fingolimod TecniGen 0.5 mg hard capsules EFG

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.

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

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

What is Fingolimod TecniGen

The active substance of Fingolimod TecniGen is fingolimod.

What fingolimod is used for

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

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

or

• Patient 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), 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 difficulties walking, 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 fingolimod works

Fingolimod helps to combat the attacks of the immune system 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 starting to take Fingolimod TecniGen

Do not take fingolimod

• if you have a weakened immune system(due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have a severe active or chronic infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• 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 fingolimod.
• if you are taking or have recently taken medications for an irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you are pregnantor if you are a woman of childbearing age and are not using an effective contraceptive method.
• if you are allergicto fingolimod or to any of the other components of this medication (included in section 6).

If any of the above cases apply to you, tell your doctor before taking fingolimod.

Warnings and precautions

Consult your doctor before starting to take fingolimod:

• if you have severe respiratory problems when you sleep (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 ivabradine, 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 disordersor other signs of inflammation in the central vision area (the macula) of the eye (a condition known as macular edema, see below) or inflammation or infection of the eye (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, tell your doctor before taking fingolimod.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that you have changed the previous dose of 0.25 mg once a day, fingolimod produces 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. 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.

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 changed the 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 should have an electrocardiogram before the first dose of fingolimod 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, it may be necessary 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 suffered from sudden fainting in the past or a decrease in heart rate, 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 nighttime monitoring.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. It is necessary for a cardiologist to evaluate you and determine if you can switch to alternative medications that do not decrease heart rate to allow treatment with fingolimod. If the aforementioned change is impossible, the cardiologist will advise you on how to start treatment with fingolimod, 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 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 the number of 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 have a worsening of an infection you already have. 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 because it can be serious and life-threatening. If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, tell your doctor immediately, as they can 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 assess the need for an MRI to evaluate your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, 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.

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 (the macula) of the eye, 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 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 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 in an MS attack (optic neuritis). At first, you may not have symptoms. It is necessary that you communicate any changes you notice in your vision to your doctor. 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 fingolimod. Fingolimod can affect liver function. You may not notice any symptoms, but if you notice a yellowish tint to your skin or the white part of your eyes, unusually 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 fingolimod, tell your doctor immediately.

Before, during, and after treatment, your doctor will request blood tests to check liver function. You may need to interrupt treatment with fingolimod if the results of your 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 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, tell your doctor that you are taking fingolimod, as they may not understand the results of the tests otherwise. For certain blood tests, your doctor may need to draw more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with MS 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 because it can be serious.

Cancer

There have been reports of skin cancer in patients with MS treated with fingolimod. Tell your doctor immediately if you notice any nodules on the 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 for any skin nodules. 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.

There have been reports of a type of cancer of the lymphatic system (lymphoma) in patients with MS 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

There have been reports of rare cases of large and unusual brain lesions associated with MS relapses in patients treated with fingolimod. In the case of severe relapses, your doctor will assess the need for an MRI 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 of time 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 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 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 treatment with fingolimod" 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

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 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

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 fingolimod with these medications because it can intensify the effect on the immune system (see also "Do not use fingolimod").
• Corticosteroidsdue 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 (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 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 for treating irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use fingolimod, as it can intensify the effect on irregular heartbeats (see also the section "Do not take fingolimod").
• Other medications:

• protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or Hi

2. Advertencias y precauciones especiales de uso

Interacciones con otros medicamentos y formas de interacción

• erba de San Juan (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 do not use 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 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 explaining why you should not become pregnant while taking fingolimod.

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

Breastfeeding

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

Driving and usingmachines

Your doctor will inform you if your condition 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 TecniGen

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

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, 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 of age and older):

The dose depends on body weight:

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

Fingolimod is taken orally.

Take fingolimod once a day with a glass of water. Fingolimod capsules should always be swallowed whole, without opening them. 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 fingolimod, consult your doctor or pharmacist.

If you takemore fingolimod 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 immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take fingolimod

If you have been taking fingolimod for less than 1 month and 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 fingolimod for at least 1 month and 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 missed doses.

If you stop treatment with fingolimod

Do not stop taking fingolimod or change the dose to be taken 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 the blood (lymphocyte count) may remain low during this period, and it is possible that the side effects described in this leaflet may still occur. After stopping treatment with fingolimod, you may have to wait for 6-8 weeks before starting a new treatment for MS.

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 MS 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 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 experience 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 at the back of the eye) with symptoms such as shadows or a blind spot or no vision in the field of vision, 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 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. Long-term sun exposure and a weakened immune system can affect the risk of developing squamous cell carcinoma.

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

• Abnormality in the electrocardiogram (T-wave inversion).
• 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 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 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 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 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, MS 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 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 abnormal liver enzyme levels.
• Cough.

Common(may affect up to 1 in 10 people)

• Fungal skin infection (tinea versicolor).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine).
• Low level 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.
• 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 (fingolimod may cause a slight increase in blood pressure).
• Muscle pain.
• Joint pain.

Uncommon(may affect up to 1 in 100 people)

• Low levels of certain white blood cells (neutrophils).
• 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 side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod TecniGen

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

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

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. 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 TecniGen

• The active ingredient is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are:

Capsule content:microcrystalline cellulose, magnesium stearate.

Capsule shell:gelatin, titanium dioxide (E171).

Appearance and packaging of the product

Hard gelatin capsules with white opaque body and cap.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

O

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Date of last revision of thisleaflet:May 2023

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/.