FINGOLIMOD MEDOCHEMIE 0.5 mg HARD CAPSULES EFG

Introduction

Package Leaflet: Information for the User

Fingolimod Medochemie 0.5mghard capsules EFG

fingolimod

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

Keep this leaflet, you may need to read it again.

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

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

What is Fingolimod Medochemie

Fingolimod Medochemie contains the active substance fingolimod.

What is Fingolimod Medochemie used for

This medicine 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 are a reflection of the inflammation that occurs in the CNS. The symptoms vary from one patient to another, but usually consist of difficulties in walking, loss of sensitivity in some part of the body (numbness), vision problems, or balance disorders. The symptoms of a relapse may disappear completely when the relapse is over, but some problems may persist.

How Fingolimod Medochemie 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 taking Fingolimod Medochemie

Do not take Fingolimod Medochemie

• 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 infection or a chronic active infection such 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, chest pain, stroke, or warning signs of a stroke, or any type of heart failure.
• if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with fingolimod.
• if you are taking or have recently taken medications for an 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 to any of the other components of this medication

(including those listed in section 6).

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

Warnings and precautions

Consult your doctor before starting to take fingolimod:

• 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

cardiac(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 (a condition known as macular edema, see below) or eye inflammation or infection (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 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 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 your heartbeats to become irregular, 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 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, 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 this medication before the pause.

If you have or are at risk of irregular or abnormal heartbeats, if your electrocardiogram is abnormal, or if you have heart disease or heart failure, this medication 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 this medication, including nighttime monitoring.

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 determine if you can switch to alternative medications that do not decrease heart rate to allow treatment with fingolimod. If such a change is not possible, 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 this medication. 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 convulsions (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.

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 scan to evaluate your condition and decide if you need to stop taking this medication.

It has been reported that patients treated with fingolimod have developed infections with the human papillomavirus (HPV), including papilloma, dysplasia, warts, and HPV-associated cancer. 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 check-ups.

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, eye inflammation or infection (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. This medication can cause inflammation of the macula, and this condition is known as macular edema. The inflammation usually occurs within the first four months of treatment with this medication.

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 this medication.

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

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

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 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 this medication, as they 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 this medication, 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 this medication.

Posterior reversible encephalopathy syndrome (PRES)

A rare condition called posterior reversible encephalopathy syndrome (PRES) has been 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, as it can be serious.

Cancer

Cases of skin cancer have been reported 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 this medication, 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.

Cases of a type of cancer of the lymphatic system (lymphoma) have been reported 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 a high-UV-protection sunscreen 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 for an MRI scan to evaluate your condition and decide if you need to stop taking this medication.

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 this medication, 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").

MS worsening after stopping treatment with Fingolimod

Do not stop taking this medication 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 Medochemie" 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, it may be necessary to administer them before you can start treatment with this medication.
• 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 during treatment with this medication you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medications and Fingolimod Medochemie

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 could intensify the effect on the immune system (see also "Do not use Fingolimod Medochemie").
• 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 (vaccines made with live attenuated viruses) 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(such as beta-blockers like 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 could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Medochemie").
• Other medications:

or protease inhibitors, anti-infectives such as ketoconazol, azole antifungals,

clarithromycin

3. Cómo tomar Fingolimod Medochemie

El tratamiento con este medicamento será supervisado por un médico con experiencia en el tratamiento de la esclerosis múltiple.

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico.

En caso de duda, consulte de nuevo a su médico.

La dosis recomendada es:

Adultos:

La dosis es de una cápsula de 0,5 mg al día.

Niños y adolescentes (de 10 años de edad y en adelante):

La dosis depende del peso corporal:

• Niños y adolescentes con un peso igual o inferior a 40 kg: una cápsula de 0,25 mg al día.
• Niños y adolescentes con un peso superior a 40 kg: una cápsula de 0,5 mg al día.

Este medicamento no es adecuado para pacientes pediátricos con un peso corporal ≤ 40 kg. Otros medicamentos que contienen fingolimod están disponibles en una concentración menor (como cápsulas de 0,25 mg).

Los niños y adolescentes que comienzan con una cápsula de 0,25 mg al día y luego alcanzan un peso corporal estable por encima de los 40 kg recibirán instrucciones de su médico para que cambien a una cápsula de 0,5 mg al día. En este caso, se recomienda repetir el período de observación de la primera dosis.

No exceda la dosis recomendada.

Este medicamento se usa por vía oral.

Tome fingolimod una vez al día con un vaso de agua. Las cápsulas de fingolimod siempre se deben tragar intactas, sin abrirlas. Puede tomar este medicamento con o sin alimentos. La toma de fingolimod cada día a la misma hora le ayudará a recordar el momento en que debe tomar el medicamento.

Si tiene dudas sobre la duración del tratamiento con este medicamento, consulte con su médico o su farmacéutico.

Si toma más Fingolimod Medochemie del que debe

Si ha tomado más fingolimod de lo que debiera, informe a su médico inmediatamente.

Si olvidó tomar Fingolimod Medochemie

Si ha estado tomando fingolimod durante menos de 1 mes y olvida tomar 1 dosis durante un día entero, hable con su médico antes de tomar la siguiente dosis. Su médico puede decidir mantenerle bajo observación en el momento en que tome la siguiente dosis.

Si ha estado tomando fingolimod durante al menos 1 mes y se ha olvidado de tomar su tratamiento durante más de 2 semanas, hable con su médico antes de tomar la siguiente dosis. Su médico puede decidir mantenerle bajo observación en el momento en que tome la siguiente dosis. Sin embargo, si se ha olvidado de tomar su tratamiento durante un período de hasta 2 semanas, puede tomar la siguiente dosis tal y como lo tenía previsto.

Nunca tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Fingolimod Medochemie

No deje de tomar fingolimod ni cambie la dosis que se debe tomar sin comentarlo antes con su médico.

Fingolimod permanecerá en su organismo hasta dos meses después de la interrupción del tratamiento. El número de glóbulos blancos de la sangre (recuento de linfocitos) puede permanecer bajo durante este período y es posible que todavía se manifiesten los efectos adversos descritos en este prospecto.

Después de interrumpir el tratamiento con este medicamento podría tener que esperar durante 6-8 semanas antes de iniciar un nuevo tratamiento con EM.

Si debe reanudar el tratamiento con fingolimod tras una pausa de más de dos semanas, el efecto sobre el ritmo cardiaco que puede darse al inicio del tratamiento puede repetirse y será necesario que se le monitorice en la consulta médica para reiniciar el tratamiento. No reinicie el tratamiento con este medicamento después de que lo haya interrumpido durante más de dos semanas sin pedir consejo a su médico.

Su médico decidirá si es necesario hacerle un seguimiento tras la interrupción del tratamiento con fingolimod y de qué modo. Informe a su médico inmediatamente si cree que su EM está empeorando después de haber interrumpido el tratamiento con fingolimod, ya que podría ser grave.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Algunos efectos adversos pueden ser graves o potencialmente graves

Frecuentes(pueden afectar hasta 1 de cada 10 personas)

• Tos con expectoración (flema), molestias en el pecho, fiebre (signos de alteraciones pulmonares)

• Infección por virus del herpes (culebrilla o herpes zóster) con síntomas como ampollas, escozor, picor o dolor de la piel, especialmente en la parte superior del cuerpo o la cara. Otros síntomas que puede tener son fiebre y debilidad en la fase temprana de la infección, seguida de insensibilidad, picor o manchas rojas con dolor intenso.
• Latido lento del corazón (bradicardia), ritmo del corazón irregular
• Un tipo de cáncer de piel conocido como carcinoma de células basales (CCB) que a menudo se presenta en forma de nódulo con apariencia de perla, aunque también puede tener otras formas
• Se sabe que la población con esclerosis múltiple tiene depresión y ansiedad con mayor frecuencia y también se han notificado en pacientes pediátricos tratados con fingolimod.

• Pérdida de peso.

Poco frecuentes(pueden afectar hasta 1 de cada 100 personas)

• Neumonía, con síntomas como la fiebre, tos, dificultad para respirar
• Edema macular (inflamación en la zona de la visión central de la retina en el fondo del ojo) con síntomas como sombras o una mancha ciega o sin visión en el dentro del campo visual, visión borrosa, problemas para ver colores o detalles
• Disminución del número de plaquetas sanguíneas lo que aumenta el riesgo de sangrado o hematomas
• Melanoma maligno (un tipo de cáncer de piel que normalmente se desarrolla a partir de un lunarinusual). Los signos posibles de melanoma incluyen lunares que con el tiempo pueden cambiar de tamaño, forma, grosor o color, o la formación de nuevos lunares. Los lunares pueden producir picor, sangrar o ulcerarse
• Convulsiones, ataques (más frecuentes en niños y adolescentes que en adultos)

Raros(pueden afectar hasta 1 de cada 1.000 personas)

• Una enfermedad llamada síndrome de encefalopatía posterior reversible (SEPR). Los síntomas pueden incluir el inicio repentino e intenso de dolor de cabeza, confusión, convulsiones y/o alteraciones visuales
• Linfoma (un tipo de cáncer que afecta el sistema linfático)
• Carcinoma de células escamosas: un tipo de cáncer de piel que se puede presentar en forma de bulto (nódulo) firme de color rojo, una llaga con costra, o una nueva llaga sobre una cicatriz existente

Muy raros(pueden afectar hasta 1 de cada 10.000 personas)

• Anomalía en el electrocardiograma (inversión de la onda T)
• Tumor relacionado con la infección por el virus del herpes humano 8 (sarcoma de Kaposi)

Frecuencia no conocida(no puede estimarse a partir de los datos disponibles)

• Reacciones alérgicas, incluyendo síntomas de erupción o urticaria con picor, hinchazón de labios, lengua o cara, que es más probable que aparezcan el día que comienza el tratamiento con fingolimod.
• Signos de enfermedad del hígado (incluyendo insuficiencia hepática), tales como tono amarillento de la piel o de la parte blanca de los ojos (ictericia), náuseas o vómitos, dolor en el lado derecho de la zona del estómago (abdomen), orina oscura (de color marrón), menos apetito de lo habitual, cansancio y resultados anómalos de las pruebas de la función del hígado. En un número pequeño de casos, la insuficiencia hepática podría conllevar un trasplante de hígado.

• Riesgo de una infección cerebral rara llamada leucoencefalopatía multifocal progresiva (LMP).

Los síntomas de la LMP pueden ser similares a los de un brote de la EM. También podrían surgir síntomas que podría no advertir por sí mismo, tales como cambios de humor o de comportamiento, pérdidas de memoria, dificultades del habla y de la comunicación, que su médico podría tener que investigar con más detenimiento para descartar una LMP. Por lo tanto, si cree que su EM está empeorando o si usted o las personas cercanas a usted advierten cualquier síntoma nuevo o inusual, es muy importante que informe a su médico lo antes posible.

Infecciones criptocócicas (un tipo de infección por hongos), incluyendo meningitis criptocócica con síntomas como dolor de cabeza acompañado de rigidez en la nuca, sensibilidad a la luz, náuseas y/o confusión

• Carcinoma de células de Merkel (un tipo de cáncer de piel). Los signos posibles de carcinoma de células de Merkel incluyen la formación de un bulto (nódulo) indoloro de color carne o rojo azulado, generalmente en la cara, cabeza o cuello. El carcinoma de células de Merkel también se puede presentar en forma de nódulo o masa firme e indolora. La exposición solar a largo plazo y un sistema inmunológico débil pueden afectar el riesgo de desarrollar carcinoma de células de Merkel.
• Tras la interrupción del tratamiento con fingolimod, pueden reaparecer los síntomas de la EM y pueden ser peores de lo que eran antes o durante el tratamiento.
• Forma autoinmune de anemia (descenso en la cantidad de glóbulos rojos) en la que se destruyen los glóbulos rojos (anemia hemolítica autoinmune).

Si tiene cualquiera de estos síntomas, informe a su médico inmediatamente.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento

5. Conservación de Fingolimod Medochemie

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase y en el blíster de aluminio después de CAD/. La fecha de caducidad es el último día del mes que se indica.

No requiere condiciones especiales de conservación.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Fingolimod Medochemie

• El principio activo es fingolimod.

Cada cápsula contiene 0,5 mg de fingolimod (como hidrocloruro).

• Los demás componentes son:

Contenido de la cápsula:Almidón pregelatinizado (maíz), Laurilsulfato de sodio

Cubierta de la cápsula:Óxido de hierro amarillo (E172), Dióxido de titanio (E171), Gelatina

Tinta de impresión:Goma laca, Propilenglicol, Solución de amoniaco concentrado, Óxido de hierro negro (E172), Hidróxido de potasio

Aspecto del Fingolimod Medochemie y contenido del envase

Cápsulas de gelatina de aproximadamente 14 mm impresas en negro, con “TV 7820” en la tapa blanca opaca de la cápsula y “TV 7820” en el cuerpo amarillo de la cápsula.

OPA/Al/PVC//Blíster de Al y blíster de OPA/Al/PVC//Papel/PET/Al.

Tamaños de envase: 7, 10, 28, 30 y 98 cápsulas duras en blísters o cápsulas duras de 7x1, 10x1, 28x1, 30x1 y 98x1 en blísters unidosis perforados.

Puede que solamente estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización

Medochemie Limited

1-10 Constantinoupoleos

3011 Limassol,

Chipre

Responsable de la fabricación

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

Zetjun 3000,

Malta

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

ESPAÑA

Este medicamento está autorizado en los Estados miembros del EEE con los siguientes nombres:

Fecha de la última revisión de este prospecto:Enero 2022.

La información detallada y actualizada de este medicamento está disponible en la página web de la Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (http://www.aemps.gob.es)