Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example:
You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours).
This is because the sperm can survive up to 5 days in your body after intercourse.
This medicine is suitable for any woman of childbearing age, including adolescents.
You can take the tablet at any time in the menstrual cycle.
If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have symptoms of pregnancy (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.
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.
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.
Only condoms can protect you from sexually transmitted infections. This medicine will not protect you against HIV infection or any 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.
There is more information about contraception at the end of this leaflet.
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is still recommended for all women regardless of their weight or BMI.
You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
If you become pregnant despite taking the tablet, it is important that you see your doctor. See section “Pregnancy, breast-feeding and fertility” for more information.
This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective. If you are currently taking hormonal contraception, continue to use it as usual after taking this medicine, but be sure to use condoms every time you have sex until your next period.
Do not take this medicine together with another emergency contraceptive pill that contains levonorgestrel. By taking them both together, you might make this medicine less effective.
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.
Some medicines may prevent ellaOne from working effectively. If you have used any of the medicines listed below during the last 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD):
Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of the medicines stated above.
Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare professional, or do a pregnancy test in order to make sure you are not already pregnant (see section “Warning and precautions”).
This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant it will not interrupt an existing pregnancy.
If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is important that you see your doctor. As for any pregnancy, your doctor may want to check that the pregnancy is not outside the womb. This is especially important if you have severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the womb, tubal surgery or long term (chronic) genital infection.
If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your pregnancy in an official registry. You can also report this information on your own at www.hra-pregnancy-registry.com. Your information will remain anonymous – nobody will know it is information about you. Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.
If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after taking this medicine. During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk. The effect of breast-feeding your baby in the week after taking this medicine is not known.
This medicine will not affect your future fertility. If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Therefore it is important you use condoms until your next period. If you wish to start or continue with a regular method of contraception after using this medicine, you can do so but you should also use condoms until your next period.
After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4). If you experience these symptoms, do not drive or use machines.
If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist before taking this medicine.
Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you. Check with your pharmacist or doctor if you are not sure.
If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.
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.
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 unusually heavy; 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, it is important that you see your doctor. (See section "Pregnancy, breast-feeding and fertility").
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 the use of this medicine, ask your pharmacist, doctor or other healthcare professional.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (See section 2 "Pregnancy, breast-feeding and fertility").
(may affect up to 1 in 10 people)
(may affect up to 1 in 100 people)
(may affect up to 1 in 1,000 people)
If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can provide more information on the safety of this medicine.
Yellow Card Scheme
or search for MHRA Yellow Card in the Google Play or Apple App Store
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in the outer carton in order to protect from light.
Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
ellaOne is available in a carton containing one blister of 1 tablet.
LABORATOIRE HRA PHARMA
200, avenue de Paris
17, rue de Pontoise
Laboratorios León Farma S.A.
C/ La Vallina, s/n Pol. Ind. Navatejera
24008 Navatejera, León
Delpharm Lille S.A.S.
Parc d’activités Roubaix-Est
22, rue de Toufflers
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30
HRA Pharma UK & Ireland Limited
Tel: 0800 917 9548
This leaflet was last revised in November 2018
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Emergency contraception will not affect your fertility.
Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you from becoming pregnant if you have unprotected sex again. After you take emergency contraception and until your next period comes, you should use a condom every time you have sex.
If you have taken emergency contraception and you do not use a regular contraceptive method (or do not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice. There are many different types of contraception available, and you should be able to find the right method for you.
Examples of regular contraception methods:
Contraceptive patch Vaginal Ring
Contraceptive implant IUD (intrauterine device)