ELLAONE 30 MG FILM-COATED TABLET FOR ORAL USE BLISTER (PVC/PVDC/ALL) 1 TABLET

Name
ellaOne 30 mg film-coated tablet
Ulipristal acetate


What is it and what is it for?
ellaOne is an emergency contraceptive
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or after contraceptive failure. For example:
- if you have had unprotected sex;
- if your or your partner's condom breaks, slips off, or comes out, or if you forget to use it;
- if you have not taken the birth control pill according to the instructions.

You should take the tablet as soon as possible after sexual intercourse, and in any case within a maximum of 5 days (120 hours).
This is because it is most effective if taken as soon as possible after unprotected sex.

This medicine is suitable for any woman of childbearing age, including adolescents.

The tablet can be taken at any time during the menstrual cycle.

ellaOne does not work if you are already pregnant.

If your period is delayed, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (heavy breasts, morning sickness), you should consult a doctor or healthcare professional before taking the tablet.

If you have unprotected sex after taking the tablet, the medicine will not prevent pregnancy.

Unprotected sex at any time during your cycle can cause pregnancy.

ellaOne should not be used as a regular contraceptive

If you are not using regular contraception, talk to a doctor or healthcare professional to choose one that is right for you.

How ellaOne works

ellaOne contains the substance ulipristal acetate , which works by modifying the activity of the natural hormone progesterone, which is necessary for ovulation. Consequently, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, approximately 2 become pregnant.

This medicine is a contraceptive used to prevent pregnancy. If you are already pregnant, ellaOne will not terminate an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections .

Only the use of a condom guarantees protection from sexually transmitted infections. This medicine does not protect against HIV infection or other sexually transmitted diseases (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). If you are concerned about this, talk to a healthcare professional.

At the end of this leaflet you will find further information on contraception.


What you need to know before taking the medicine
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
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine:
- if your period is late or if you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section "Pregnancy, breastfeeding and fertility");
- if you suffer from severe asthma;
- if you suffer from severe liver disease.

For all women, emergency contraception should be taken as soon as possible after unprotected intercourse. Some data suggest that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive.
Therefore, ellaOne is recommended for all women regardless of weight or BMI.

If you are concerned that you may have problems taking emergency contraception, talk to a healthcare provider.

If you become pregnant despite taking the tablet, it is important to see your doctor. See the section "Pregnancy, breastfeeding, and fertility" for further information.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting, and nausea, are also possible signs of pregnancy. If you miss a period and experience these symptoms after taking ellaOne, you should take a pregnancy test (see "Pregnancy, breastfeeding, and fertility" section).

Common side effects ( may affect up to 1 in 10 people )
- nausea, abdominal pain (stomach ache) or discomfort, vomiting;
- painful periods, pelvic pain, breast pain;
- headache, dizziness, mood swings;
- muscle pain, back pain, tiredness.

Uncommon side effects ( may affect up to 1 in 100 people )
- diarrhea, heartburn, flatulence (intestinal gas), dry mouth;
- unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sexual desire);
- hot flashes;
- changes in appetite, emotional disturbances, anxiety, agitation, difficulty falling asleep, drowsiness, migraine, visual disturbances;
- flu;
- 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 sexual intercourse, ruptured ovarian cyst, unusually light menstrual periods;
- loss of concentration, dizziness, tremors, disorientation, fainting;
- abnormal sensation in the eyes, redness of the eyes, sensitivity to light;
- dry throat, taste disturbances;
- allergic reactions such as skin rash, hives or swelling of the face;
- feeling of thirst.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.