Ulipristal Stada 30 mg 1 comprimido

What Ulipristal Stada is and what it is used for
Ulipristal Acetate is an emergency contraceptive
Ulipristal Acetate is a contraceptive intended to prevent pregnancy after unprotected intercourse or failure of the contraceptive method used. For example:
- if you have had unprotected sex
- if the condom used by you or your partner breaks, detaches or drops, or if you forget to use it
- if you did not take the contraceptive pill as recommended
You should take the tablet as soon as possible after having sexual intercourse, and within a maximum of 5 days (120 hours).
That's because sperm can survive up to 5 days inside your body after having sex.
This medicine is suitable for any woman of childbearing age, including adolescents.
You can take the tablet at any time during the menstrual cycle.
Ulipristal acetate does not work if you are already pregnant
If you have a delay in your menstrual period, you could be pregnant. If your period is late or you have pregnancy symptoms (swollen breasts, morning sickness), you should consult a doctor or other healthcare professional before taking the tablet.
If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant.
Unprotected sex can lead to pregnancy at any time during the menstrual cycle.
Ulipristal acetate should not be used as a regular contraceptive method
If you don't have a regular method of contraception, talk to your doctor or other healthcare professional to help you choose the one that's right for you.

How Ulipristal Acetate Works
Ulipristal acetate contains the active substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone necessary for ovulation to occur. As a result, this medication works by postponing ovulation. Emergency contraception is not effective in all cases. Of every 100 women who take this medicine, approximately two will become pregnant.
This medication is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not end the existing pregnancy.
Emergency contraceptives do not protect against sexually transmitted infections.
Only the use of a condom can protect her from sexually transmitted infections. This medicine will not protect you 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 this concerns you.

What you need to know before taking Ulipristal Stada
Do not take Ulipristal Stada 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 doctor, pharmacist or other healthcare professional before taking this medicine:
- if your period is late or you have symptoms of pregnancy (swollen breasts, morning sickness), because you could already be pregnant (see section "Pregnancy, lactation 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 having unprotected sex. There is some evidence that this medication may be less effective in increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ulipristal acetate is recommended for all women regardless of weight or BMI.
You are advised to consult a healthcare professional if you are concerned about a problem related to emergency contraception.
If you become pregnant despite taking the tablet, it is important to see your doctor. See the “Pregnancy, Lactation, and Fertility” section for more information.

Using Ulipristal Stada with other contraceptives
This medication may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills or patches.
If you are currently using hormonal contraceptives, continue to use them as usual after taking this medication, but be sure to use condoms whenever you have sex until your next period.
Do not take this medicine together with another emergency contraceptive pill containing levonorgestrel. Taking them together may reduce the effectiveness of this medicine.

Taking Ulipristal Stada with other medicines
Tell your doctor, pharmacist, or other healthcare professional if you are taking or have recently taken any other medications, including over-the-counter medications or herbal medications.
Some medicines can prevent ulipristal acetate from working effectively. If you have used any of the following medications in the past 4 weeks, ulipristal acetate may be less effective. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper intrauterine device (Cu-IUD):
Medicines used to treat epilepsy (for example primidone, phenobarbital, phenytoin, phosphenytoin, carbamazepine, oxcarbazepine, and barbiturates)
Medicines used to treat tuberculosis (for example, rifampicin and rifabutin).
A treatment for HIV (ritonavir, efavirenz, nevirapine)
A medicine to treat fungal infections (griseofulvin)
Herbal Medicines Containing St. John's Wort (Hypericum perforatum)
Consult your doctor or pharmacist before using ulipristal acetate if you use (or have recently used) any of the medications listed.

Pregnancy, lactation and fertility

Pregnancy
Before taking this medication, if your period is late, talk to your doctor, pharmacist or other healthcare professional or take a pregnancy test to make sure you are not already pregnant (see section "Warnings and precautions").
This medication is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not end the existing pregnancy.
If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is important that you see your doctor. As with any pregnancy, your doctor may want to verify that the pregnancy is not extrauterine. This is especially important if you have severe abdominal (stomach) pain or bleeding, or if you have previously had an extrauterine pregnancy, a fallopian tube operation, or a long-term (chronic) genital infection.
If you become pregnant despite taking ulipristal acetate, we encourage you to speak to your doctor about registering your pregnancy in an official registry. You can also report the information yourself at www.ulipristal-pregnancy-registry.com. Your information will be kept anonymous, no one will know that the information refers to you. Sharing this information can help other women to understand ulipristal acetate safety or risks during pregnancy in the future.

Lactation
If you take this medicine while breastfeeding, do not breast-feed your baby during the week after taking this medicine. We recommend that during this week you use a breast pump to maintain milk production but discard the expressed milk. The effect on breastfeeding in the week after taking this medication is unknown.

Fertility
This medicine does not affect your future fertility. If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant. Therefore, it is important that you use condoms until your next period.
If you want to start using or continue using a conventional contraceptive method after using this medicine, you can, but you should also use condoms until your next period.

Driving and using machines
After taking this medicine, some women experience dizziness, drowsiness, blurred vision, or loss of concentration (see section 4). If you experience these symptoms, do not drive or use machines.

Ulipristal Stada contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ulipristal Stada contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet; that is, essentially "sodium free"

How to take Ulipristal Stada
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or other healthcare professional has told you. If in doubt, consult your doctor or pharmacist again.

How to take Ulipristal Stada tablet
Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected sex or failure of the contraceptive method used. Take the tablet without delay
you can take the tablet at any time during the menstrual cycle
you can take the tablet at any time of the day, well before, during or after a meal
if you are using one of the medicines that can prevent ulipristal acetate from working properly (see section 2 “What you need to know before you start taking Ulipristal Stada”) or if you have used one of these medicines in the last 4 weeks, ulipristal acetate it may be less effective for you. Consult your doctor or pharmacist before using ulipristal acetate. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e. a Cu-IUD.
 
If you vomit after taking Ulipristal Stada
If you vomit within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have sex again after taking Ulipristal Stada
If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant. After taking the tablet and until the next period comes, you should use condoms whenever you have sex.

If your next period is delayed after taking Ulipristal Stada
After taking the tablet, it is normal for your next period to be delayed for a few days. However, if your period is delayed by more than 7 days, is shorter or more abundant than usual, or if you experience symptoms such as abdominal (stomach) pain, breast pain, vomiting, or nausea, you could be pregnant. You should have a pregnancy test immediately. If you are pregnant, it is important to see a doctor (see section "Pregnancy, lactation and fertility").

LEAFLET