What is EllaOne Emergency Contraception

ellaOne is an emergency contraceptive

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

• if you had sex without protection;
• if your or your partner’s condom tore, slipped or came off, or if you forgot to use one;
• if you did not take 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). This is because it is more effective if you take it as soon as possible after unprotected sex.

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

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

ellaOne does not work if you are already pregnant.

If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have pregnancy symptoms (heavy breasts, morning sickness), you should consult a doctor or other healthcare professional before taking the tablet.

If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Unprotected sex at any time during your cycle can lead to pregnancy.

ellaOne is not to be used for regular contraception

If you do not have a regular method of contraception, talk to your doctor or healthcare professional to choose one that is suitable for you.

How ellaOne works

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

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

Emergency contraception does not protect against sexually transmitted infections.

Only condoms can protect you from sexually transmitted infections. This medicine will not protect you against HIV infection or other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you are worried about this.

How to take EllaOne Emergency Contraception

• Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure. Take the tablet without delay.
• You can take the tablet at any time in your cycle.
• You can take the tablet at any time of the day, either before, during or after a meal.
• If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you. Speak to your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking ellaOne

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

If you have sex again after taking ellaOne

If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. After you take the tablet and until your next period comes, you should use condoms every time you have sex.

If your next period is late after taking ellaOne

After taking the tablet, it is normal for your next period to be a few days late.

However, if your period is more than 7 days late, if it is unusually light or cumbersome, or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you may be pregnant. You should do a pregnancy test right away. If you are pregnant, you must see your doctor. (See section “Pregnancy, breast-feeding and fertility”)

If you take more ellaOne than you should

There have been no reports of harmful effects from taking a higher dose than recommended of this medicine. However, do ask your pharmacist, doctor or other healthcare professional for advice. If you have any further questions on using this medicine, ask your pharmacist, doctor or other healthcare professional.

What does EllaOne Emergency Contraception contain

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

The other ingredients are:

• Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate
• Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate (E555)