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Acétate d'ulipristal pour les fibromes utérins

Esmya

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

Type de médicament

A progesterone receptor modulator

Utilisé pour

Fibroids in the uterus

Aussi appelé

Esmya®

Disponible sous forme de

Comprimés

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 Contraception hormonale d'urgence.

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 vous êtes enceinte ou si vous allaitez.

  • If you have severe asthma.

  • Si vous avez des problèmes avec le fonctionnement de votre foie, ou des problèmes avec le fonctionnement de vos reins.

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

  • Si vous avez déjà eu une réaction allergique à un médicament.

  • Si vous prenez d'autres médicaments. Cela inclut tous les médicaments que vous prenez et qui sont disponibles à l'achat sans ordonnance, ainsi que les médicaments à base de plantes et les médecines complémentaires.

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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.

  • Essayez de respecter vos rendez-vous réguliers avec votre médecin. Cela permet à votre médecin de suivre vos progrès.

  • 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)

Que puis-je faire si je ressens cela ?

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)

Que puis-je faire si je ressens cela ?

Headache, other aches or pains

Buvez beaucoup d'eau et demandez à votre pharmacien de vous recommander un antidouleur approprié. Si la douleur persiste, informez votre médecin

Se sentir étourdi ou fatigué

Ne conduisez pas et n'utilisez pas d'outils ou de machines lorsque vous êtes affecté

Sensation de malaise (nausée), douleur au ventre (abdominale)

Stick to simple meals - avoid rich and spicy foods

Acne, increased weight, breast tenderness, hot flushes

Si l'un de ces éléments devient problématique, parlez-en à votre médecin

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 vous ressentez d'autres symptômes que vous pensez être dus aux comprimés, veuillez consulter votre médecin ou votre pharmacien pour obtenir des conseils supplémentaires.

  • Gardez tous les médicaments hors de la portée et de la vue des enfants.

  • Conserver dans un endroit frais et sec, à l'abri de la chaleur et de la lumière directes.

Informations importantes sur tous les médicaments

Ne prenez jamais plus que la dose prescrite. Si vous soupçonnez que vous ou quelqu'un d'autre avez pris une surdose de ce médicament, rendez-vous au service des urgences de votre hôpital local. Emportez le contenant avec vous, même s'il est vide.

Ce médicament est pour vous. Ne le donnez jamais à d'autres personnes, même si leur état semble être le même que le vôtre.

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.

Ne gardez pas de médicaments périmés ou indésirables. Apportez-les à votre pharmacie locale qui s'en débarrassera pour vous.

Si vous avez des questions concernant ce médicament, demandez à votre pharmacien.

Signaler les effets secondaires d'un médicament ou d'un vaccin

Si vous ressentez des effets secondaires, vous pouvez les signaler en ligne via le Yellow Card website.

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Lectures complémentaires et références

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Historique de l'article

Les informations sur cette page sont rédigées et examinées par des cliniciens qualifiés.

  • Next review due: 25 Sept 2027
  • 20 Sept 2024 | Dernière version

    Dernière mise à jour par

    Michael Stewart, MRPharmS

    Revu par

    Sid Dajani
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