Acetato de ulipristal para los miomas uterinos
Esmya
Revisado por Sid DajaniÚltima actualización por Michael Stewart, MRPharmSÚltima actualización 20 Sept 2024
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Clinical author's note: 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.
Clinical author's note: 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.
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About ulipristal acetate for uterine fibroids
Tipo de medicamento | A progesterone receptor modulator |
Utilizado para | Fibroids in the uterus |
También llamado | Esmya® |
Disponible como | Tabletas |
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.
Before taking ulipristal acetate for uterine fibroids
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 está embarazada o en periodo de lactancia.
If you have severe asthma.
Si tiene algún problema con el funcionamiento del hígado o de los riñones.
If you have breast cancer, or cancer of the womb (uterus), neck of the womb (cervix), or ovaries.
Si alguna vez ha tenido una reacción alérgica a un medicamento.
Si está tomando otros medicamentos. Esto incluye cualquier medicamento que esté tomando y que pueda adquirirse sin receta, así como medicamentos a base de plantas y complementarios.
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How to take ulipristal acetate for uterine fibroids
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.
Aproveche al máximo su tratamiento
Procure acudir a las citas periódicas con su médico. Así podrá comprobar su evolución.
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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Can ulipristal acetate tablets cause problems?
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 me ocurre 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 me ocurre esto? |
Headache, other aches or pains | Bebe mucha agua y pide a tu farmacéutico que te recomiende un analgésico adecuado. Si el dolor persiste, informe a su médico |
Sensación de mareo o cansancio | No conduzca ni utilice herramientas o máquinas mientras esté afectado |
Sensación de malestar (náuseas), dolor de barriga (abdominal) | Comidas sencillas: evite las comidas ricas y picantes. |
Acne, increased weight, breast tenderness, hot flushes | Si alguno de ellos le resulta molesto, hable con su médico |
Important: 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.
Si experimenta cualquier otro síntoma que crea que puede deberse a los comprimidos, consulte a su médico o farmacéutico.
How to store ulipristal acetate
Mantenga todos los medicamentos fuera del alcance y de 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
Información importante sobre todos los medicamentos
No tome nunca más de la dosis prescrita. Si sospecha que usted u otra persona ha tomado una sobredosis de este medicamento, acuda al servicio de urgencias de su hospital. Llévese el envase, aunque esté vacío.
Este medicamento es para usted. Nunca se lo dé a otras personas aunque su enfermedad parezca ser la misma que la suya.
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 guarde medicamentos caducados o que no desee. Llévelos a su farmacia local, que se encargará de eliminarlos por usted.
Si tiene cualquier duda sobre este medicamento pregunte a su farmacéutico.
Informar de los efectos secundarios de un medicamento o vacuna
Si experimenta efectos secundarios, puede notificarlos en línea a través del sitio web de la Tarjeta Amarilla.
Lecturas complementarias y referencias
- Manufacturer's PIL, Esmya® 5 mg tablets (ulipristal acetate); Gedeon Richter (UK) Ltd, The electronic Medicines Compendium. Dated January 2021.
- Medicamentos BNF completa 89ª edición; Asociación Médica Británica y Real Sociedad Farmacéutica de Gran Bretaña, Londres.
Historia del artículo
La información de esta página ha sido redactada y revisada por médicos cualificados.
Fecha de la próxima revisión: 25 de septiembre de 2027
20 Sept 2024 | Última versión

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