LABORATOIRE HRA

ELLAONE 30MG X 1 TABLET

Composition.

The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.

The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate.

Therapeutic indications.

ellaOne contains the substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone, which is necessary for ovulation. As a result, this medicine works by delaying ovulation. Emergency contraception is not effective in every case. Out of 100 women who take this medicine, approximately 2 will become pregnant.

This medicine is a contraceptive used to prevent pregnancy. If you are already pregnant, it will not terminate an existing pregnancy.

ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your method of contraception has failed. For example:

if you have had unprotected sex;

if your or your partner's condom broke, slipped, came off or if you forgot to use a condom;

if you have not taken your contraceptive pill as recommended.

You should take the tablet as soon as possible after sex and within a maximum of 5 days (120 hours).

The reason for this is that sperm can survive for up to 5 days in your body after sex.

This medicine is suitable for any woman of childbearing potential, including adolescents.

You can take the tablet at any time during your menstrual cycle.

Dosage and method of administration.

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or nurse has told you. Check with your pharmacist or doctor if you are not sure.

How to take the ellaOne tablet

Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after you have had unprotected sex or in case of contraceptive failure. Take the tablet without delay.

You can take the tablet at any time during your menstrual cycle.

You can take the tablet at any time of day, either before, during or after a meal.

If you are taking any of the medicines that may stop ellaOne from working properly (see section 2 "What you need to know before you take ellaOne") or if you have taken any of these medicines in the last 4 weeks, ellaOne may be less effective for you. Talk to your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e. a Cu-IUD.

If you vomit after taking ellaOne

If you vomit (feel sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.

Precautions.

Before taking this medicine, talk to your pharmacist, doctor or nurse

-if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant;

-if you have severe asthma;

-if you have severe liver disease.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, ellaOne is still recommended for all women regardless of their body weight or BMI.

Special warnings.

Pregnancy, breast-feeding, fertility

Pregnancy

Before taking this medicine, if your period is late, talk to your pharmacist, doctor or nurse or do a pregnancy test, to make sure that you are not already pregnant (see section "Warnings and precautions").

This medicine is a contraceptive used to prevent pregnancy. If you are already pregnant, it will not terminate an existing pregnancy.

If you do become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is important to consult your doctor. As with any pregnancy, your doctor will want to check that the pregnancy is not located outside the womb. This is especially important if you have abdominal (stomach) pain or heavy bleeding or if you have had a previous ectopic pregnancy, surgery on your fallopian tubes or a long-term (chronic) genital infection.

Breast-feeding

If you take this medicine while you are breast-feeding, stop breast-feeding for one week after taking this medicine. During this time, it is recommended that you use a breast pump to maintain

milk production, but discard the pumped milk. The effect of breast-feeding in the week following administration of this medicine is not known.

Fertility

This medicine will not affect your future fertility. If you have unprotected sex after taking the tablet, the medicine will not prevent a possible pregnancy. Therefore, it is important to use condoms until your next period.

Driving and using machines

After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or loss of concentration. If you experience these symptoms, do not drive or use machines.

Packaging. ellaOne is available in a box containing a blister with 1 tablet

 

Page updated on: 09.06.2021