EllaOne

190.00

Description

EllaOne is a medicine that contains the active substance ulipristal acetate. It is available as tablets (30 mg)

ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.

ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, ellaOne does not interrupt an existing pregnancy.

ellaOne does not prevent pregnancy in every case.

In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ellaOne should contact our doctor.

ellaOne inhibits or postpones ovulation . If ovulation has already occurred, ellaOne is no longer effective. The timing of ovulation cannot be predicted and therefore ellaOne should be taken as soon as possible after unprotected intercourse.

No data are available on the efficacy of ellaOne when taken more than 120 hours (5 days) after unprotected intercourse.

Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing body weight or body mass index (BMI) . In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI.

After ellaOne intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.

Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.

Contraception after ellaOne intake

ellaOne is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.

Although the use of ellaOne does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action . Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaOne, however, she should be advised to use a reliable barrier method until the next menstrual period.

HOW DOES ELLAONE WORKS?

For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb. The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.

The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator. This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect. Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation. If ovulation has already occurred, ellaOne is no longer effective.

HOW HAS ELLAONE BEEN STUDIED ?

In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure. The main measure of effectiveness was the number of women who did not become pregnant. This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive. This number was calculated from published pregnancy rates.

An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception). This study included women who took the medicine within two days of unprotected sex or contraceptive failure.

WHAT BENEFITS HAS ELLAONE SHOWN DURING THE STUDIES ?

EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies. Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant. This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive. EllaOne therefore prevented about three-fifths of the pregnancies.

The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne. In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.

WHAT IS THE RISK ASSOCIATED WITH ELLAONE ?

The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains). For the full list of all side effects and restrictions, see the package leaflet.

WHAT MEASURES ARE BEING TAKEN TO ENSURE THE SAFE AND EFFECTIVE USE OF ELLAONE?

A risk management plan has been developed to ensure that ellaOne is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, including the appropriate precautions to be followed by healthcare professionals and patients.

 

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