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Ulipristal acetate for uterine fibroids

Esmya

Nota del autor clínico: Michael Stewart 04/03/2021: following a temporary licence suspension and review into liver safety, additional restrictions and safety measures are now in place for Esmya® (ulipristal).

  • Rare cases of serious liver damage have occurred in people taking Esmya® (ulipristal) for uterine fibroids

  • Blood tests are needed before, during and after treatment with Esmya® to check your liver is working normally

  • If you notice any signs of liver damage, including yellowing of the skin or eyes, dark urine, or nausea or vomiting, stop taking Esmya® and contact your doctor immediately

Your doctor will discuss both the risks and benefits of your treatment. A patient alert card describing the risk of liver injury should be given to you with your packet of medicine.

Nota del autor clínico: Michael Stewart 20/02/2018: temporary safety measures have been put in place for Esmya® (ulipristal) following five reports of serious liver injury in women taking this medicine for uterine fibroids. Contact your doctor or pharmacist for advice if you have any concerns. This issue does not affect ulipristal when taken as a single one-off dose for emergency contraception using EllaOne®.

Ulipristal acetate is a female hormone treatment.

Take one tablet daily.

The most common side-effects are no periods, hot flushes, and headache.

Videos seleccionados para Tratamiento del desequilibrio hormonal

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About ulipristal acetate for uterine fibroids

Tipo de medicamento

A progesterone receptor modulator

Usado para

Fibroids in the uterus

También llamado

Esmya®

Disponible como

Comprimidos

Ulipristal acetate works by blocking the effects of the female hormone progesterone. There are two brands of ulipristal acetate tablets available. The two brands of tablet have different uses and contain different amounts of ulipristal acetate. Low-strength tablets (Esmya® brand containing 5 mg ulipristal acetate) are used to treat heavy or painful periods caused by uterine fibroids. This leaflet discusses ulipristal acetate when it is prescribed for this purpose. More information is available about the higher strength of ulipristal acetate tablet (EllaOne® brand) in the medicine leaflet called Emergency hormonal contraception.

Fibroids (which are also known as myomas) are non-cancerous growths in the womb (uterus). They can sometimes cause heavy or painful periods, tummy swelling and urinary problems. Surgery is the most common treatment for fibroids which cause symptoms. Ulipristal acetate is prescribed to reduce the size of the fibroids before the surgery.

The female hormone progesterone is thought to play a role in the development of fibroids. Ulipristal acetate works by blocking the effects of progesterone. This stops the fibroids from growing and they shrink in size.

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking ulipristal acetate for uterine fibroids it is important that your doctor knows:

  • Si estás embarazada o amamantando.

  • If you have severe asthma.

  • Si tienes algún problema con el funcionamiento de tu hígado, o algún problema con el funcionamiento de tus riñones.

  • If you have breast cancer, or cancer of the womb (uterus), neck of the womb (cervix), or ovaries.

  • Si alguna vez has tenido una reacción alérgica a un medicamento.

  • Si está tomando otros medicamentos. Esto incluye cualquier medicamento que esté tomando y que esté disponible para comprar sin receta, así como medicamentos herbales y complementarios.

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  • Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about ulipristal acetate and will provide you with a full list of the side-effects which you may experience from taking it.

  • Take ulipristal acetate exactly as your doctor tells you to. You will be asked to start taking the tablets during a week you are having a period. Continue to take one 5 mg tablet each day. You will be prescribed the tablets for a maximum of four months, possibly on two occasions.

  • You can take ulipristal acetate tablets before or after food. Swallow the tablets with a drink of water.

  • If you forget to take a dose, take it as soon as you remember unless you are more than 12 hours late. If you are more than 12 hours late, leave out the forgotten dose and take your next tablet at the usual time. Do not take two tablets together to make up for a missed dose.

  • Intenta mantener tus citas regulares con tu médico. Esto es para que tu médico pueda verificar tu progreso.

  • You should avoid getting pregnant both while you are taking ulipristal acetate and for at least 12 days after stopping taking it. Please use a barrier method of contraception (such as a condom), as hormonal methods of contraception are not suitable with ulipristal acetate. If you need further contraceptive advice, please speak with your doctor.

  • Do not drink grapefruit juice while you are on ulipristal acetate. This is because a chemical in grapefruit juice can increase the amount of ulipristal acetate in your bloodstream. This could make side-effects more likely.

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Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with ulipristal acetate. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Very common ulipristal acetate side-effects (these affect more than 1 in 10 women)

¿Qué puedo hacer si experimento esto?

No periods during the treatment and for a few weeks afterwards, thickening of the lining of the womb (uterus)

Your doctor will discuss these with you before you start the treatment

Common ulipristal acetate side-effects (these affect fewer than 1 in 10 women)

¿Qué puedo hacer si experimento esto?

Headache, other aches or pains

Bebe mucha agua y pide a tu farmacéutico que te recomiende un analgésico adecuado. Si el dolor persiste, informa a tu médico

Sensación de mareo o cansancio

No conduzca ni utilice herramientas o máquinas mientras esté afectado

Feeling sick (nausea), tummy (abdominal) pain

Stick to simple meals - avoid rich and spicy foods

Acne, increased weight, breast tenderness, hot flushes

Si alguno de estos se vuelve problemático, hable con su médico

Importante: rare cases of serious liver damage have occurred in people taking Esmya® (ulipristal) for uterine fibroids:

  • Blood tests are needed before, during and after treatment with Esmya® to check your liver is working normally.

  • If you notice any signs of liver damage, including yellowing of the skin or eyes, dark urine, or nausea or vomiting, stop taking Esmya® and contact your doctor immediately.

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice.

  • Mantenga todos los medicamentos fuera del alcance y la vista de los niños.

  • Almacenar en un lugar fresco y seco, lejos del calor y la luz directos.

Información importante sobre todos los medicamentos

Nunca tome más de la dosis prescrita. Si sospecha que usted u otra persona podría haber tomado una sobredosis de este medicamento, acuda al departamento de accidentes y emergencias de su hospital local. Lleve el envase con usted, incluso si está vacío.

Este medicamento es para ti. Nunca lo des a otras personas, incluso si su condición parece ser la misma que la tuya.

If you are having an operation or dental treatment, please tell the person carrying out the treatment which medicines you are taking.

If you buy any medicines, check with a doctor or pharmacist that they are suitable for you to take with your other medicines.

No guardes medicamentos caducados o no deseados. Llévalos a tu farmacia local, que se encargará de desecharlos por ti.

Si tienes alguna pregunta sobre este medicamento, consulta a tu farmacéutico.

Informar efectos secundarios de un medicamento o vacuna

Si experimenta efectos secundarios, puede reportarlos en línea a través de sitio web de la Tarjeta Amarilla.

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Lecturas adicionales y referencias

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Historial del artículo

La información en esta página está escrita y revisada por pares por clínicos calificados.

  • Next review due: 25 Sept 2027
  • 20 Sept 2024 | Última versión

    Última actualización por

    Michael Stewart, MRPharmS

    Revisado por pares por

    Sid Dajani
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