ellaOne contains the active medicinal ingredient ulipristal acetate. It modifies the action of progesterone and works by delating ovulation.
ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed.
– 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 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.
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 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.
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.
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 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.
What you need to know before you take ellaOne
Do not take ellaOne – if you are allergic to ulipristal acetate or any of the other ingredients of this medicine.
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 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.
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.
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.
Warning and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine:
– if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant
– if you suffer from severe asthma;
– if you suffer from severe liver disease.
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.
Possible interactions with other contraceptives and ellaOne
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.
Speak to your doctor if you have used any of the medicines listed below during the last 4 weeks, as ellaOne may be less suitable for you.
– medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin, fosphenytoine, carbamazepine, oxcarbazepine and barbiturates)
– medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
– a treatment for HIV (ritonavir, efavirenz, nevirapine)
– a medicine used to treat fungal infections (griseofulvin)
– herbal remedies containing St John’s wort (Hypericum perforatum).
Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD):
Pregnancy, breast-feeding and fertility
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.
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 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.
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.
Common side effects (may affect up to 1 in 10 people)
– nausea, abdominal (stomach) pain or discomfort, vomiting
– painful periods, pelvic pain, breast tenderness
– headache, dizziness, mood swings
– muscle pain, back pain, tiredness
Uncommon side effects (may affect up to 1 in 100 people)
– diarrhoea, heartburn, wind, dry mouth
– unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive
– hot flushes
– appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine visual disturbances
– acne, skin lesions, itching
– fever, chills, malaise
Rare side effects (may affect up to 1 in 1,000 people)
– genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
– loss of concentration, vertigo, shaking, disorientation, fainting
– unusual sensation in eye, red eye, sensitivity to light
– dry throat, disturbance in taste – hives (itchy rash), feeling thirsty
Reporting of side effects
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 via the national reporting system: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Download the attached patient information leaflet for more details.