Description

WHAT IS ELLAONE?

Ulipristal acetate (trade name ellaOne) is a prescription only medication that was launched in the UK and licensed for use throughout all of Europe. It consists of one tablet with a primary mechanism of inhibiting or delaying ovulation, to help prevent pregnancy.

EFFECTIVENESS?

Recent studies have shown that ellaOne can be effective if taken, up to five days after unprotected sex, but is more effective when taken as quickly as possible. However, if vomiting occurs within three hours of taking the medication, a replacement dose should be taken, and a doctor, nurse of pharmacist should be consulted.

Uses / Instructions

One tablet should be taken orally, no later than 120 hours after unprotected sex or contraceptive failure. Ulipristal acetate can be taken with or without food, however if vomiting occurs within 3 hours of taking the tablet, another dose should be taken. It is not recommended to take it again during the same menstrual cycle, and alternative contraceptive methods should be used, until your next cycle.

Warnings

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 their 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.

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.

See patient information leaflet for more information.

Side Effects

When used for emergency contraception, Ulipristal acetate can cause side effects. The most commonly reported side effects are: abdominal pain, back pain, diarrhoea, dizziness, headache and vomiting.

If you feel you are suffering from any uncommon side effects, contact your doctor for advice straight away.

Read the patient information leaflet for a full list of side effects

Ingredients

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.