Product Use
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 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.
Instructions
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.
How to take the ellaOne film-coated tablet
– 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. 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 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.
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 the use of this medicine, ask your pharmacist, doctor or other
healthcare professional.
Cautions
Do not take ellaOne
– if you are allergic to ulipristal acetate or any of the other ingredients of this medicine
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 this medicine, it is important that you see your doctor.
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
the tablet, but be sure to use condoms every time you have sex until your next period.
Do not take ellaOne together with another emergency contraceptive pill that contains levonorgestrel.
By taking them both together, you might make this medicine less effective.
Other medicines and ellaOne
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.
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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):
– 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).
Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of
the medicines stated above.
Ingredients
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)
