Category Archives: ellaOne®

ellaOne^® is contra-indicated for women who:

Are hypersensitive to the active substance or to any of the excipients¹

Always refer to the ellaOne^® Summary of Product Characteristics if you are in any doubt.

Situations where ellaOne^® is not recommended

• Severe asthma treated by oral glucocorticoids¹

• Severe hepatic impairment¹

• For women taking CYP3A4 inducers¹

• For women with long-term use of ritonavir¹

• Concomitant use of EC containing levonorgestrel¹

• Breastfeeding is not recommended for one week after ellaOne^® intake¹

With ellaOne^®:

The majority of adverse events recorded during the complete development programme in 4,718 women were mild or moderate and resolved spontaneously¹
The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea¹
The tolerability profile is comparable to levonorgestrel²

ellaOne^® effect on the menstrual cycle

Most women had their next menstrual period at the expected time (74.6 % within ±7 days of expected time)¹

Early period – 6.8% had their period more than 7 days earlier than expected
Late period – 18.5% had a delay of more than 7 days¹

A minority of women (8.7%) reported intermenstrual bleeding lasting an average of 2.4 days. The majority was reported as spotting (88.2%).¹

Only 0.4% reported heavy intermenstrual bleeding¹

For full details of adverse events refer to the ellaOne^® Summary of Product Characteristics.

Adverse events should be reported. Healthcare professionals are asked to report any suspect adverse events via their national reporting system. Adverse events should also be reported to HRA Pharma at med.info.ie@hra-pharma.com

ellaOne^® significantly reduces the risk of unintended pregnancy vs levonorgestrel.¹

Two comparative non-inferiority studies showed ellaOne^® is at least as effective in preventing pregnancy as levonorgestrel.^1,2

A meta-analysis of these two studies comparing ellaOne^® with levonorgestrel showed that the risk of pregnancy was significantly reduced with ulipristal acetate compared to levonorgestrel:¹

For a woman who comes to you for help, what does this mean?

Her risk of getting pregnant is :

Intake within

of unprotected intercourse

With
no intervention
With
levonorgestrel
With
ellaOne^®

5.5 %
5.5 %
2.3 %
2.2 %
0.9 %
1.4 %

P- value: 0.035

P- value: 0.046

Intake within 24 hours of unprotected intercourse / 72 hours of unprotected intercourse

Ovulation is a result of a surge in luteinising hormone (LH). ellaOne^® delays ovulation by inhibiting or delaying the LH surge.¹

If the woman is due to ovulate tomorrow or the next day after unprotected sex, when the risk of pregnancy is highest, only ellaOne^® can delay ovulation.¹

This is when LH has started to surge but has not yet reached the peak. At this time, levonorgestrel will not prevent the follicle from rupturing whereas ellaOne^® is highly effective.¹

Intake after LH surge, but before peak¹

If she is due to ovulate 3 or more days after unprotected intercourse, both ellaOne and levonorgestrel can delay ovulation .¹ However, ellaOne^® remains more effective in preventing follicle rupture and therefore unintended pregnancy ¹.

Intake before LH surge¹

If the woman has already ovulated, or is due to ovulate, in the immediate 24 hours of unprotected intercourse, no emergency contraceptive pill help¹

This is because the LH has already peaked, meaning the ovulation process is at a point where it cannot be stopped, or has already happened.

This explains why:

• Speed of emergency contraceptive pill intake is critical

• Emergency contraception is not 100% effective

Intake after LH surge ¹

ellaOne^® can delay ovulation even when it is about to happen (when risk of fertilisation is highest)¹

intro-1-pack

ellaOne^® is the most effective emergency contraceptive pill, remember that:

ellaOne^® is the most effective oral EC
ellaOne^®effective when it matters most – effective right up to the point of ovulation
ellaOne^® is generally well tolerated
ellaOne^® is now available without prescription in pharmacy

And ellaOne^® is now available directly from you, without a prescription.

intro-1-cross

What is ellaOne^®?

ellaOne^® is an emergency contraceptive pill intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure²
ellaOne^® should be taken as soon as possible, but no later than 120 hours (5 days) after UPSI or contraceptive failure²
ellaOne^® is the most effective oral emergency contraceptive²
ellaOne^® is for women of reproductive age who want to avoid unintended pregnancy²

How to use ellaOne^®

The treatment consists of one tablet to be taken orally as soon as possible after UPSI or contraceptive failure²
ellaOne^® does not offer protection from pregnancy for subsequent acts of unprotected sex. Women should be advised to use a reliable barrier method until her next menstrual period.²
The tablet can be taken with or without food²
If vomiting occurs within 3 hours of ellaOne^® intake, another tablet should be taken²
ellaOne^® can be taken at any time during the menstrual cycle²

ellaOne^® is not a regular contraceptive, it is for occasional use only²
ellaOne^® does not cause abortion⁴
ellaOne^® does not protect from sexually transmitted infections⁵

ellaOne® is contra-indicated for women who:

Situations where ellaOne® is not recommended

With ellaOne®:

ellaOne® effect on the menstrual cycle

ellaOne® significantly reduces the risk of unintended pregnancy vs levonorgestrel.1

ellaOne® is the most effective emergency contraceptive pill, remember that: