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SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM

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About the medicine

How to use SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto: información para el usuario

Synalar rectal simple 0,1 mg/g crema rectal

Fluocinolona acetónido

Lea todo el prospecto detenidamente antes de empezar a usar este medicamento, porque contiene información importante para usted.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Synalar rectal simple y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Synalar rectal simple
  3. Cómo usar Synalar rectal simple
  4. Posibles efectos adversos
  5. Conservación de Synalar rectal simple
  6. Contenido del envase e información adicional
Doctor consultation

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1. Qué es Synalar rectal simple y para qué se utiliza

El principio activo es fluocinolona acetónido. Synalar rectal simple pertenece a un grupo de fármacos conocidos como agentes de uso tópico (uso externo) para el tratamiento de hemorroides, corticosteroides, que actúan reduciendo la inflamación ano-rectal y el picor anal asociado a las hemorroides.

Synalar rectal simple está indicado para el tratamiento local sintomático de la inflamación ano-rectal y picor (prurito) anal asociado con hemorroides en adultos.

2. Qué necesita saber antes de empezar a usar Synalar rectal simple

No use Synalar rectal simple:

  • si es alérgico a fluocinolona acetónido o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
  • si sufre una hemorragia hemorroidal (hemorroides sangrantes).
  • si tiene infección en la zona a tratar por bacterias, virus (ej., herpes) u hongos.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar Synalar rectal simple.

  • Los ancianos y enfermos en fase aguda debilitados deben tener especial precaución, ya que puede ser más sensibles a los efectos tóxicos de este medicamento.
  • El uso prolongado, en cura oclusiva (con materiales que no permiten la circulación del aire en la zona) o con pañales, de corticoides tópicos puede producir atrofia de la piel, mucosas y del tejido subcutáneo.
  • El uso prolongado o en grandes cantidades puede provocar la aparición de efectos sistémicos (los que se producen cuando el medicamento se absorbe y llega a sangre).
  • Si usted presenta infección en el área a tratar, debe ser tratada por separado. Si no se produce una rápida mejoría, debe suspender el tratamiento con Synalar rectal simple hasta que se haya controlado la infección. El uso de corticoides puede potenciar las infecciones de la piel.
  • Los enfermos con una mucosa gravemente dañada y/o infección en la zona de aplicación deben tener especial precaución.
  • Si el producto le causa irritación, debe suspender su aplicación.
  • Evite el contacto con los ojos o alrededor de ellos y las mucosas.
  • Póngase en contacto con su médico si presenta visión borrosa u otras alteraciones visuales.

Uso en deportistas

Se advierte a los deportistas que este medicamento contiene un componente, fluocinolona, que puede producir un resultado positivo en las pruebas de control de dopaje.

Niños y adolescentes

No se ha establecido la seguridad y eficacia de Synalar rectal simple en niños y adolescentes.

No se dispone de datos.

Otros medicamentos y Synalar rectal simple

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

No debe usted aplicarse otras preparaciones sobre el área tratada junto con Synalar rectal simple.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

No utilice Synalar rectal simple de forma prolongada si está embarazada. Su uso debe reservarse a casos en los que el beneficio terapéutico sea superior al posible riesgo.

De igual forma, se aconseja precaución si se tiene que emplear este medicamento si está amamantando a su bebé.

Conducción y uso de máquinas

Synalar rectal simple no influye en la capacidad para conducir y/o utilizar máquinas.

Synalar rectal simple contiene alcohol cetílico, alcohol estearílico, parahidroxibenzoato de metilo (E218) parahidroxibenzoato de propilo(E216) y propilenglicol(E1520)

Este medicamento puede producir reacciones locales en la piel (como dermatitis de contacto) porque contiene alcohol cetílico y alcohol estearílico.

Puede producir reacciones alérgicas (posiblemente retardadas) porque contiene parahidroxibenzoato de metilo E218 y parahidroxibenzoato de propilo E216.

Este medicamento contiene 150 mg de propilenglicol en cada gramo de crema.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

3. Cómo usar Synalar rectal simple

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Adultos

Aplicar la crema 1 o 2 veces al día, después de evacuar.

Antes de la aplicación de Synalar rectal simple debe limpiarse cuidadosamente la zona afectada, seque la zona y aplíquese una cantidad de crema equivalente a 2 cm en la zona anal y/o rectal mediante una gasa limpia.

Si usted presenta hemorroides internas y se tiene que aplicar la crema en el interior del recto, enrosque en el tubo la cánula que acompaña el envase e inserte la punta en el ano. A continuación, aplique una pequeña cantidad de crema ejerciendo una ligera presión sobre el tubo.

Si usa más Synalar rectal simple del que debe

El uso de demasiado Synalar rectal simple podría causar supresión adrenal (trastorno que origina una alteración de la producción normal de hormonas que se segregan en unas glándulas situadas junto a los riñones), con síntomas como obesidad en el tronco, cara redondeada, acumulación de grasa en la zona cervical, retraso en la cicatrización, etc.); otros síntoma puede ser cataratas. En este caso, se debe interrumpir el tratamiento y el médico deberá controlarle la función del eje suprarrenal hormonal.

Una ingestión accidental puede ocasionar cuadros de aceleración del ritmo del corazón (taquicardia) y elevaciones ocasionales de tensión arterial, que ceden sin necesidad de tratamiento médico.

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico, o llame al Servicio de Información Toxicológica, teléfono 91 562 04 20, o acuda a un centro médico indicando el medicamento y la cantidad utilizada.

Si olvidó usar Synalar rectal simple

No use una dosis doble para compensar las dosis olvidadas.

Si usted olvida aplicar Synalar rectal simple en el momento previsto, hágalo tan pronto como se acuerde y luego continúe como antes.

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.

Los posibles efectos adversos se enumeran según las siguientes categorías:

  • Raros: pueden afectar hasta 1 de cada 1.000 personas
  • Muy raros: pueden afectar hasta 1 de cada 10.000 personas
  • Frecuencia no conocida: no puede estimarse a partir de los datos disponibles

Efectos adversos raros

  • Atrofia cutánea con adelgazamiento de la epidermis (a menudo irreversible)
  • Dilatación de pequeños vasos sanguíneos en la superficie de la piel (telangiectasia)
  • Presencia de parches y manchas rojas en la piel (púrpura)
  • Estrías en la piel
  • Erupciones de tipo acné
  • Dermatitis perioral (pequeñas pápulas rojas alrededor de la boca)
  • Pérdida de coloración de la piel (despigmentación)
  • Erupciones en la piel (dermatitis y eczema, incluyendo dermatitis de contacto)
  • Sensación de quemazón
  • Efecto rebote

Efectos adversos muy raros

  • Supresión adrenal, que origina una alteración de la producción normal de hormonas producidas en glándulas situadas junto a los riñones (ver en la sección 3 "Si usa más Synalar rectal simple del que debe").

Efectos adversos de frecuencia no conocida

  • Hipersensibilidad (reacciones alérgicas)
  • Prurito (picor)
  • Sequedad de la piel
  • Maceración de la piel
  • Infección secundaria
  • Visión borrosa

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 Synalar rectal simple

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

Conservar por debajo de 25ºC.

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

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 ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Synalar rectal simple

  • El principio activo es fluocinolona acetónido. Cada gramo de crema contiene 0,1 mg de fluocinolona acetónido (0,01%).
  • Los demás componentes son: alcohol cetílico, alcohol estearílico, estearato de sorbitán, polisorbato 60 (E435), parafina líquida, parahidroxibenzoato de metilo (E218), parahidroxibenzoato de propilo (E216), propilenglicol (E1520), ácido cítrico anhidro (E330) y agua purificada.

Aspecto del producto y contenido del envase

Synalar rectal simple es una crema rectal, de color blanco. Se presenta en tubos de 30 y 60 gramos. El envase viene provisto de una cánula para su aplicación intrarrectal cuando se requiera.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización

Karo Pharma AB

Box 16184

103 24 Stockholm

Suecia

Responsable de la fabricación

Temmler Italia S.R.L.

Via delle Industrie, 2

280061 Carugate, Milan

Italia

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

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

España

Fecha de la última revisión de este prospecto:Diciembre 2018.

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

Online doctors for SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM

Discuss questions about SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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General medicine 21 years exp.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

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Yevgen Yakovenko

General surgery 12 years exp.

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Frequently Asked Questions

Is a prescription required for SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM?
SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM?
The active ingredient in SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM is fluocinolone acetonide. This information helps identify medicines with the same composition but different brand names.
Who manufactures SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM?
SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM is manufactured by Karo Pharma Ab. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SYNALAR RECTAL SIMPLE 0.1 mg/g RECTAL CREAM?
Other medicines with the same active substance (fluocinolone acetonide) include ABRASONE RECTAL, RECTAL CREAM, ANTIHEMORROIDAL CINFA RECTAL OINTMENT, COHORTAN 5 mg/g + 5 mg/g RECTAL OINTMENT. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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