About ulipristal acetate for uterine fibroids

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 miomas uterinos. 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 Contracepção hormonal de emergência.

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:

• Se você está grávida ou amamentando.

• If you have severe asthma.

• Se você tiver algum problema com o funcionamento do seu fígado, ou qualquer problema com o funcionamento dos seus rins.

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

• Se você já teve uma reação alérgica a um medicamento.

• Se você estiver tomando outros medicamentos. Isso inclui quaisquer medicamentos que você esteja tomando e que estejam disponíveis para compra sem receita médica, bem como medicamentos fitoterápicos e complementares.

• 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.

• Se você esquecer de tomar uma dose, tome-a assim que se lembrar, a menos que já tenham passado mais de 12 horas. Se estiver mais de 12 horas atrasado, pule a dose esquecida e tome o próximo comprimido no horário habitual. Não tome dois comprimidos juntos para compensar uma dose esquecida.

• Tente manter suas consultas regulares com seu médico. Isso é para que seu médico possa verificar seu progresso.

• 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.

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.

Se você sentir quaisquer outros sintomas que acha que podem ser causados pelos comprimidos, por favor, fale com seu médico ou farmacêutico para mais orientações.

• Mantenha todos os medicamentos fora do alcance e da vista das crianças.

• Armazene em local fresco e seco, longe de calor e luz diretos.