Evante

Package leaflet: Information for the user

EVANTE

30 mg film-coated tablets
Ulipristal acetate
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist,
doctor, or other healthcare professional has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your pharmacist, doctor, or other healthcare professional. See section 4.

Contents of this leaflet:

1. What EVANTE is and what it is used for
2. What you need to know before taking EVANTE
3. How to take EVANTE
4. Possible side effects
5. How to store EVANTE
6. Contents of the pack and other information
   • Useful information about contraception

1. What EVANTE is and what it is used for

EVANTE is an emergency contraceptive
EVANTE is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or following failure of a contraceptive method. For example:

• if you had unprotected sexual intercourse;
• if your or your partner’s condom broke, slipped off or came out, or if you forgot to use it;
• if you did not take your oral contraceptive according to the instructions.

You should take the tablet as soon as possible after intercourse, and no later than 5 days (120 hours).
This is because spermatozoa can survive up to 5 days inside the body after intercourse.
This medicine is suitable for any woman of reproductive age, including adolescents.
The tablet can be taken at any time during the menstrual cycle.
EVANTE does not work if pregnancy is already present
If your menstrual period is delayed, pregnancy is possible. If you have a delayed period or experience symptoms of pregnancy (such as breast tenderness, morning nausea), you must consult a doctor or healthcare provider before taking the tablet.
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent pregnancy.
Unprotected sexual intercourse at any time during the cycle may result in pregnancy.
EVANTE must not be used as a regular contraceptive
If you are not using a regular contraceptive method, speak with a doctor or healthcare provider to choose one appropriate for you.
How EVANTE works
EVANTE 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, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, pregnancy occurs in approximately 2 cases.
This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not terminate the 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 protect against HIV infection or other sexually transmitted diseases (for example, Chlamydia, genital Herpes, genital warts, gonorrhoea, hepatitis B and syphilis).
If you are concerned about this, please consult a healthcare provider.
Additional information about contraception can be found at the end of this leaflet.

2. What you need to know before taking EVANTE

Do not take EVANTE

• if you are allergic to ulipristal acetate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your pharmacist, doctor, or another healthcare provider before taking EVANTE if your
periods are late or if you have symptoms of pregnancy (such as breast tenderness, morning nausea),
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.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
According to some data, this medicine may be less effective with increasing body weight or body mass index (BMI), but these data are limited and not conclusive. Therefore, EVANTE is recommended for all women regardless of weight or BMI.
If you are concerned about potential problems related to taking emergency contraception, speak with a healthcare provider.
If you become pregnant despite taking this medicine, it is important that you see your doctor. See section “Pregnancy, breastfeeding and fertility” for further information.
Other contraceptives and EVANTE
This medicine may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills and patches.
If you are taking a hormonal contraceptive, continue using it regularly after taking the tablet, but use condoms every time you have sexual intercourse until your next menstrual period.
Do not take EVANTE together with another emergency contraceptive pill containing levonorgestrel.
Taking both medicines together may reduce the effectiveness of this medicine.
Other medicines and EVANTE
Inform your pharmacist, doctor, or another healthcare provider if you are taking or have recently
taken any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines may prevent EVANTE from working effectively. If you have taken any of the medicines listed below during the past 4 weeks, EVANTE may be less suitable for you. Your doctor may prescribe another type (non-hormonal) of emergency contraception, namely a copper intrauterine device (Cu-IUD):

• medicines used to treat epilepsy (e.g. primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, and barbiturates)
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
• treatments for HIV (ritonavir, efavirenz, nevirapine)
• a medicine used to treat fungal infections (griseofulvin)
• herbal preparations containing St. John’s wort ( Hypericum perforatum )

Talk to your doctor or pharmacist before using EVANTE if you are currently using (or have recently used) any of the medicines listed above.
Pregnancy, breastfeeding and fertility
Pregnancy
Before taking this medicine, if your period is late, inform your pharmacist, doctor, or another healthcare provider, or perform a pregnancy test to make sure you are not already pregnant (see section “Warnings and precautions”).
This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not terminate the existing pregnancy.
If you become pregnant despite taking EVANTE, ask your doctor to register your pregnancy in an official registry. You may also report this information directly yourself through the reporting system at https://ulipristal-pregnancy-registry.com/it/. Your information will remain anonymous – no one will know the information concerns you. Sharing this information may help women in the future understand the safety or risks of EVANTE during pregnancy.
Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking EVANTE.
During this period, it is recommended that you express milk to stimulate and maintain milk production, but discard the milk. The effects of breastfeeding on your baby during the week following intake of this medicine are unknown.
Fertility
This medicine will not have negative effects on your future fertility. If you have unprotected sexual intercourse after taking this medicine, it will not prevent pregnancy. It is therefore important to use a condom until your next menstrual period.
If you wish to start or continue using a regular contraceptive method after using this medicine, you may do so, but you must also use a condom until your next menstrual period.
Driving and using machines
After taking this medicine, some women report dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4 “Possible side effects”). If you experience these symptoms, do not drive and do not operate machinery.
EVANTE contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
EVANTE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take EVANTE

Take this medicine exactly as described in this leaflet, or as instructed by your pharmacist, doctor, or other healthcare professional. If you have any doubts, consult your pharmacist or doctor.

How to take the EVANTE film-coated tablet

• Take one tablet orally as soon as possible, and in any case within and no later than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablet.
• This medicine can be taken at any time during the menstrual cycle.
• This medicine can be taken at any time of the day, before, during, or after a meal.
• If you are taking any of the medicines that may prevent EVANTE from working effectively (see the previous section “Other medicines and EVANTE”), or if you have taken any of these medicines within the last 4 weeks, EVANTE may be less effective for you. Consult your doctor or pharmacist before using EVANTE. Your doctor may prescribe another type of emergency contraception (non-hormonal), specifically a copper intrauterine device (Cu-IUD).

In case of vomiting after taking EVANTE
If you vomit within 3 hours after taking the tablet, take another tablet as soon as possible.

If you have unprotected sexual intercourse after taking EVANTE
If you have unprotected sexual intercourse after taking the tablet, this medicine will not prevent pregnancy. After taking the tablet and until your next menstrual period, you must always use condoms for every sexual intercourse.

If your next menstrual period is delayed after taking EVANTE
It is normal for your next menstrual period to be delayed by a few days after taking the tablet. However, if your period is more than 7 days late, if the bleeding is unusually light or unusually heavy, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should perform a pregnancy test immediately. If pregnancy occurs, it is important that you see your doctor (see section “Pregnancy, breastfeeding and fertility”).

If you take more EVANTE than you should
No harmful effects have been reported following intake of a higher dose of this medicine than recommended. Nevertheless, consult your pharmacist, doctor, or other healthcare professional for advice.

If you have any doubts about how to use this medicine, consult your pharmacist, doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea), may also be possible signs of pregnancy. If you miss a period and experience these symptoms after taking EVANTE, you must carry out 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 menstruation, pelvic pain, breast pain
• 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 or prolonged menstruation, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sex drive)
• hot flushes
• changes in appetite, emotional disorders, anxiety, restlessness, difficulty sleeping, drowsiness, migraine, visual disturbances
• flu-like symptoms
• 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, rupture of ovarian cyst, unusually light menstruation
• difficulty concentrating, dizziness, tremors, disorientation, fainting
• abnormal eye sensation, eye redness, light sensitivity
• dry throat, taste disturbances
• urticaria (itchy rash), feeling thirsty
• allergic reactions such as skin rash, urticaria, or facial swelling

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

5. How to store EVANTE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EVANTE contains

• The active substance is ulipristal acetate. One film-coated tablet contains 30 milligrams of ulipristal acetate.
• The other components are monohydrate lactose, pregelatinized starch (maize), sodium starch glycolate, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Description of the appearance of EVANTE and contents of the pack
EVANTE is a white, round, biconvex, film-coated tablet with a diameter of 9.0–9.2 mm,
imprinted with “ U30 ” on one side.
EVANTE is available in a box containing one transparent PVC/PVDC/aluminum blister with 1
tablet.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster, Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Netherlands: EVANTE, 30 mg filmomhulde tablet
Italy: EVANTE

USEFUL INFORMATION ON CONTRACEPTION

ADDITIONAL INFORMATION ON EMERGENCY CONTRACEPTION
The shorter the time between unprotected intercourse and taking emergency contraception, the greater the chance of avoiding pregnancy.
Emergency contraception will not have any negative effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but it will not prevent pregnancy if you have another unprotected sexual intercourse. After taking emergency contraception and until your next menstrual period, you must always use a condom for every sexual intercourse.

ADDITIONAL INFORMATION ON REGULAR CONTRACEPTION
If you have taken emergency contraception and you are not using a regular contraceptive method (or have not yet found a suitable contraceptive method for you), please speak to your doctor or visit a family planning clinic.
There are many different types of contraceptives available, and you should be able to find one that suits you.
Examples of regular contraceptive methods:

Daily methods
Oral contraceptive pill

Weekly or monthly methods
Contraceptive patch
Vaginal ring

Long-acting methods
Contraceptive implant
IUD (intrauterine device)