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'Morning After Pill'.
Emergency contraception meant to prevent pregnancy after unprotected sex or a failure in contraception. EllaOne should be taken as soon as possible after having sex, and at most within 120 hours (5 days) following.
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1. What is ellaOne and what it is used
ellaOne is an emergency contraceptive.
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or a failure of the contraceptive method used. For example:
• if you have had unprotected sex;
• if, clear loose condoms used by you or your partner if they forget to use it or breaks, or;
• if it did not take the pill as recommended.
ellaOne should be taken as soon as possible after having sex, and at most within 5 days (120 hours) following.
That's because sperm can survive for up to 5 days inside your body after intercourse.
ellaOne is suitable for any woman of childbearing age, including teenagers.
You can take ellaOne at any time during the menstrual cycle.
ellaOne will not work if you are already pregnant
If you have a delay in your period, you may be pregnant. If your period is delayed or have symptoms of pregnancy (swollen breasts, morning sickness), should consult with a doctor or other health professional before taking ellaOne.
If you hold unprotected sex after taking ellaOne, it will not prevent you from getting pregnant.
Unprotected sex can cause a pregnancy at any time during the menstrual cycle.
ellaOne should not be used as a regular contraceptive method
If you do not have a regular contraceptive method, talk to your doctor or other health professional to help you choose the right one for you.
How it works ellaOne
ellaOne contains the active substance ulipristal acetate, which acts by modifying the activity of the natural hormone progesterone necessary for ovulation to occur. As a result, putting off ellaOne works ovulation. Emergency contraception is not effective in all cases. Of every 100 women taking ellaOne, approximately two will become pregnant. ellaOne is a contraceptive used to prevent pregnancy occurs. If you are already pregnant, will not disrupt existing pregnancy.
Emergency contraceptives do not protect against sexually transmitted infections.
Only the use of a condom can protect against sexually transmitted infections. ellaOne will not protect against HIV infection or any other sexually transmitted disease (eg chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B or syphilis). Consult a healthcare professional if you are concerned.
2. What you need to know before you start using ellaOne
Do not take ellaOne if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Consult your doctor, pharmacist or other health professional before you start taking ellaOne:
• if your period is late or have symptoms of pregnancy (swollen breasts, morning sickness), because it could already be pregnant (see section "Pregnancy, breast feeding and fertility");
• if you have severe asthma;
• if you have severe liver disease.
In all women emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that ellaOne may be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is recommended for all women regardless of their weight or BMI.
You are advised to consult a health care professional if you are concerned about any problems related to emergency contraception.
If you become pregnant despite taking ellaOne, it is important to see your doctor.
Using ellaOne with other contraceptive
ellaOne can temporarily reduce the effectiveness of the usual hormonal contraceptives, such as pills or patches. If you are currently using hormonal contraceptives, continues to use in the usual way after taking ellaOne, but be sure to use condoms whenever you have sex until your next period.
Do not use ellaOne along with another contraceptive pill containing levonorgestrel emergency. The fact taking them together could reduce the effectiveness of ellaOne.
Using ellaOne with other medicines
Tell your doctor, pharmacist or other health professional if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking any of the following medications because they make ellaOne not work equally well:
• Phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine (used to treat epilepsy).
• Ritonavir, efavirenz, nevirapine (used to treat HIV infection).
• rifampin, rifabutin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) or herbal remedies that contain (used for depression or anxiety).
Before taking ellaOne, if your period is late, talk to your doctor, pharmacist or other health professional or yourself a pregnancy test to make sure no longer pregnant. ellaOne is a contraceptive used to prevent pregnancy occurs. If you are already pregnant, will not disrupt existing pregnancy.
If you become pregnant despite taking ellaOne, there is no evidence that ellaOne will affect your pregnancy. However, it is important to see your doctor. As in any pregnancy, your doctor may want to check that the pregnancy is not ectopic. This is especially important if you have severe abdominal pain (stomach ache) or bleeding, or if you have previously had an ectopic pregnancy, an operation of the fallopian tubes or (chronic) genital infection long lasting.
If you take ellaOne while breast-feeding, do not give your baby breast during the week after using ellaOne. We recommend that, during that week, use a breast pump to maintain milk production but discard the milk extracted. the effect on the baby of breastfeeding in the week after taking ellaOne is unknown.
ellaOne does not affect your future fertility. If you hold unprotected sex after taking ellaOne, it will not prevent you from getting pregnant. Therefore, it is important to use condoms until its next period.
If you want to start to use or continue using a conventional method of contraception after using ellaOne, you can do but you must also use condoms until your next period.
Driving and using machines
After taking ellaOne, some women experience dizziness, drowsiness, blurred vision or loss of concentration (see section "Possible side effects"). If you experience these symptoms, do not drive or operate machinery.
ellaOne contains lactose
If your doctor or other health care professional has told you that you have an intolerance to some sugars, consult your pharmacist before taking this medicine.
3. Using ellaOne
Follow the instructions exactly this medicine in this leaflet or as your doctor, pharmacist or other health professional. If in doubt, refer back to your doctor or pharmacist.
Taking the ellaOne tablet
• Take one tablet by mouth as soon as possible, but no later than 5 days (120 hours) after unprotected sex or a failure of the contraceptive method used.
• Take the tablet without delay.
• You can take ellaOne at any time during the menstrual cycle.
• You can take ellaOne at any time of day, either before, during or after a meal.
If you vomit after taking ellaOne
If vomits (returns) within 3 hours after taking the tablet, take another tablet as soon as possible.
If sex again after taking ellaOne
If you hold unprotected sex after taking ellaOne, it will not prevent you from getting pregnant. After taking ellaOne and until the next period will come, you must use condoms whenever you have sex.
If your next period is delayed after taking ellaOne
After taking ellaOne, is normal for your next period will be delayed some days. However, if your period is delayed more than 7 days, it is scarcer or more abundant than usual, or if you experience symptoms such as abdominal pain (stomach ache), breast pain, vomiting or nausea, you may be pregnant. You should have a pregnancy test immediately. If you are pregnant, it is important to seek medical attention.
If you take more ellaOne than you should
No adverse effects have been reported for taking a higher dose of the recommended amount of this medication. However, consult your doctor, pharmacist or other health professional.
However, if you have any further questions on the use of this medicine, ask your doctor, pharmacist or other health professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms, such as breast tenderness (breast pain) and abdominal pain (stomach ache), vomiting (throwing up) and nausea (dizziness), are also possible signs of pregnancy. If the period does not come and experience these symptoms after taking ellaOne, you should have a pregnancy test (see section "Pregnancy, breast feeding and fertility").
Common side effects
(May affect up to 1 in 10 patients):
• nausea, abdominal pain or discomfort (stomach), vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, changes in mood
• muscle aches, back pain, tiredness
Uncommon side effects
(May affect up to 1 in 100 patients):
• diarrhea, heartburn, flatulence, dry mouth
• irregular vaginal bleeding or different than usual, heavy / prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased sexual desire
• changes in appetite, emotional disorders, anxiety, agitation, trouble sleeping, drowsiness, headaches, visual disorders
• acne, skin lesions, itching
• fever, chills, malaise
Rare side effects
(May affect up to 1 in 1,000 patients):
• lighter pain or genital itching, pain during sex, ruptured cyst ovulate periods than usual
• loss of concentration, dizziness, tremors, disorientation, fainting
• strange sensation in the eyes, red eyes, sensitivity to light
• dry throat, taste disorders
• hives (itchy rash), thirst
5. How to store ellaOne
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton and blister after "EXP". The expiry date is the last day of that month.
Store below 25 ° C. Store in the original package to protect from moisture. Keep the blister pack in the outer carton to protect it from light.
6. Contents of the pack and other information
Composition of ellaOne
• The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.
• The other ingredients are lactose, povidone K30, croscarmellose sodium, magnesium stearate.
Looks like and contents of the pack ellaOne
ellaOne is a round curved tablet, white to cream marble, with the code "she" engraved on both sides.
ellaOne is available in a box containing one blister of 1 tablet.
Holder of the marketing authorization
Laboratoire HRA Pharma
15, rue Béranger F-75003 Paris - France
Responsible for manufacturing
Lille Delpharm S.A.S.
Z.I. Roubaix-Est - Rue de Toufflers
59390 Lys-lez-Lannoy - France