ELLAONE*1FC TAB 30MG

ellaOne 30 mg film-coated tablet
Ulipristal acetate

What it is and what it is used for
ellaOne is an emergency contraceptive
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or contraceptive failure. For example:
- if you have had unprotected sex;
- if your or your partner's condom broke or slipped off or came off, or if you forgot to use it;
- if you did not take your contraceptive pill as instructed.

You should take the tablet as soon as possible after intercourse, and within a maximum of 5 days (120 hours).
This is because it is more 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 pregnancy has already occurred.

If your period is late, there is a possibility of pregnancy. If your period is late 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 of the cycle can result in pregnancy.

ellaOne should not be used as a regular contraceptive

If you do not use a regular contraceptive method, 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 to occur. As a result, 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 from occurring. If you are already pregnant, ellaOne will not stop an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections.

Only the use of condoms provides protection against sexually transmitted infections. This medicine does not offer protection against HIV infection or other sexually transmitted diseases (e.g., Chlamydia, Genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). If you are concerned about this, consult a healthcare professional.

At the end of this leaflet, you will find more information about 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 sex. 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 about any issues related to taking emergency contraception, talk to a healthcare professional.

If you become pregnant despite taking the tablet, it is important that you see a doctor. See the section Pregnancy, breastfeeding and fertility for more information.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms, such as breast tenderness and abdominal pain (stomach ache), vomiting and discomfort (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 section Pregnancy, breastfeeding and fertility).

Common side effects (may affect up to 1 in 10 people)
- nausea, abdominal pain (stomach ache) 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, flatulence (intestinal gas), dry mouth;
- unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sex drive);
- hot flushes;
- changes in appetite, emotional disturbances, anxiety, agitation, difficulty sleeping, drowsiness, migraine, visual disturbances;
- flu;
- acne, skin lesions, itching;
- fever, chills, discomfort.

Rare side effects (may affect up to 1 in 1,000 people)
- genital pain or itching, pain during intercourse, ovarian cyst rupture, unusually light periods;
- loss of concentration, vertigo, tremors, disorientation, fainting;
- abnormal sensation in the eyes, redness of the eyes, sensitivity to light;
- dry throat, taste disturbances;
- allergic reactions such as rash, hives or facial swelling;
- feeling of thirst.

Reporting of side effects
If you get 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.