EVANTE 30 MG FILM-COATED TABLETS 1 TABLET IN PVC/PVDC/AL BLISTER

Name
EVANTE 30 mg film-coated tablets
Ulipristal acetate
Equivalent medicine


What is it and what is it used for?
EVANTE is an emergency contraceptive

EVANTE is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or following the failure of a contraceptive method. For example:
• if you have had unprotected sexual intercourse;
• if your or your partner's condom has broken, slipped off or leaked, or if you have forgotten to use it;
• if you have not taken the birth control pill as directed.

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 sperm can survive for up to 5 days inside the body after intercourse.

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

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

EVANTE 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.

EVANTE 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 EVANTE works

EVANTE contains the substance ulipristal acetate , which works by modifying the activity of the natural hormone progesterone, which is necessary for ovulation to occur. 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, this will not interrupt 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 EVANTE
• 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 EVANTE 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, breast-feeding 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, EVANTE 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 this medicine, 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 EVANTE, you should take a pregnancy test (see section 2 "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 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 eye sensation, redness of the eyes, sensitivity to light
• dry throat, taste disturbances
• hives (itchy rash), feeling thirsty
• allergic reactions such as skin rash, hives or swelling of the face.

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.