What is it and how is it used?
ellaOne is an oral emergency contraceptive, which means that it can be used to prevent pregnancy after unprotected sex or if your contraceptive method has failed, for example:
You can use ellaOne up to 120 hours (5 days) after unprotected sex or failure of a contraceptive method.
ellaOne acts by modifying the activity of the natural hormone progesterone. ellaOne is thought to work by stopping your ovaries from releasing an egg. ellaOne is not effective in every case: of 100 women receiving ellaOne up to 5 days after unprotected sex, approximately 2 will become pregnant.
ellaOne is not suitable as a regular method of contraception.
What do you have to consider before using it?
Do not use ellaOne
Take special care with ellaOne
Emergency contraception is a backup method for preventing pregnancy and should only be used occasionally. Only limited information is available concerning the safety and efficacy of repeated use of ellaOne; therefore, you are advised not to use ellaOne more than once in the same menstrual cycle. Your doctor or healthcare provider can tell you about long-term methods of contraception that may be appropriate for you.
Tell your doctor, healthcare provider or pharmacist if you have liver disease. It is not recommended to use ellaOne in case of severe liver disease.
Tell your doctor if you have severe asthma.
After using ellaOne, if you want to have sex, you should use a reliable barrier contraceptive method such as condom. This is because ellaOne will not work if you have unprotected sex again.
If you are currently taking hormonal contraception (for example birth control pills), you can continue as usual immediately after taking ellaOne but you should use a reliable barrier contraceptive method such as condom until your next period (see “Taking other medicines”)
After taking ellaOne, most women have a normal period at the expected time, but some may have their period later or earlier than normal (see paragraph 4 “POSSIBLE SIDE EFFECTS”). If your period is more than 7 days late or is unusually light or unusually heavy or if you experience symptoms such as abdominal pain, nausea, vomiting or breast pain or if you have any doubt about being pregnant, you should perform a pregnancy test to make sure you are not pregnant.
If you do become pregnant after taking ellaOne, it is important to contact your doctor. Your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain or bleeding after taking ellaOne or if you have previously had an ectopic pregnancy, Fallopian tube surgery or long term (chronic) genital infection (pelvic inflammatory disease).
If you are worried about sexually transmitted diseases: ellaOne will not protect you against HIV infection (AIDS) or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). Only condoms can protect you from these diseases. Ask your doctor or healthcare provider for advice if you are worried about this.
Taking other medicines
Please tell your doctor, healthcare provider or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Be sure to tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can make ellaOne less effective in preventing pregnancy:
ellaOne may also make regular hormonal contraceptives less effective. Therefore you should use a reliable barrier contraceptive method such as condom until your next period.
ellaOne should not be used together with emergency contraceptives containing levonorgestrel.
The activity of ellaOne may be increased if you are taking certain medicines such as medicines to treat fungal infections (for example, ketoconazole, itraconazole), or certain infections (for example, telithromycin, clarithromycin) as they may increase the amount of ellaOne in your body.
Pregnancy and breast-feeding
ellaOne is not to be taken if you are already pregnant. Using ellaOne while pregnant might affect your pregnancy. In case of doubt about a pregnancy, you should perform a pregnancy test (see ”Take special care with ellaOne”).
If you do become pregnant after taking this medicine, it is important that you contact your doctor, healthcare provider or pharmacist.
If you are breast-feeding
Breast-feeding is not recommended in the 36 hours following ellaOne intake: if you take ellaOne while breast-feeding, you should breast-feed your baby immediately before taking the ellaOne tablet, then pump and discard your milk for 36 hours after ellaOne intake. Breast-feeding can be resumed after 36 hours.
Driving and using machines
After ellaOne intake, some women experience dizziness, drowsiness, blurred vision and/or disturbance in attention (see paragraph 4 “POSSIBLE SIDE EFFECTS”): do not drive or use machines if you experience these symptoms.
Important information about some of the ingredients of ellaOne
ellaOne contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How is it used?
Always use ellaOne exactly as your doctor, healthcare provider or pharmacist has told you. You should check with your doctor, healthcare provider or pharmacist if you are not sure.
If you use more ellaOne than you should
There have been no reports of serious harmful effects from taking several doses of this medicine at once. You should nonetheless ask your doctor, healthcare provider or pharmacist for advice.
If you have any further questions on the use of this product, ask your doctor, healthcare provider or pharmacist.
What are possible side effects?
Like all medicines, ellaOne can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention: 20
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
Common side effects:
Uncommon side effects:
Rare side effects:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, healthcare provider or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use ellaOne after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
Keep the blister in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
