Package Leaflet: Information for the User

Ulipristal Aurovitas 30 mg Film-Coated Tablet

Ulipristal Acetate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

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

1. What is Ulipristal Aurovitas and what it is used for

2. What you need to know before taking Ulipristal Aurovitas

3. How to take Ulipristal Aurovitas

4. Possible side effects

5. Storage of Ulipristal Aurovitas

6. Contents of the pack and additional information

-Useful information regarding contraception.

Ulipristal Aurovitasis an emergency contraceptive.

Ulipristal Aurovitasis a contraceptive intended to prevent pregnancy after unprotected sex or failure of the used contraceptive method. For example:

You should take the tablet as soon as possible after having unprotected sex, and at most within 5 days (120 hours) afterwards.

This is because it is more effective if you take it as soon as possible after having unprotected sex.

This medication is suitable for any fertile woman, including adolescents.

You can take the tablet at any time during your menstrual cycle.

Ulipristal Aurovitas does not work if you are already pregnant.

If you have a delayed menstrual period, you could be pregnant. If your period is delayed or you have pregnancy symptoms (enlarged 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 result in pregnancy at any time during your menstrual cycle.

Ulipristal Aurovitas should not be used as a regular contraceptive method.

If you do not have a regular contraceptive method, talk to your doctor or other healthcare professional to help you choose the most suitable one for you.

How Ulipristal Aurovitas works

This medication contains the active ingredient ulipristal acetate, which acts by modifying the activity of the natural hormone progesterone necessary for ovulation to occur. As a result, this medication works by delaying ovulation. Emergency contraception is not effective in all cases. Approximately 2 out of 100 women who take this medication will become pregnant.

This medication is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not interrupt an existing pregnancy.

Emergency contraceptives do not protect against sexually transmitted infections.

Only the use of a condom can protect you from sexually transmitted infections. This medication will not protect you from HIV or any other sexually transmitted disease (e.g. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis). Consult a healthcare professional if this concerns you.

You will find more information about contraception at the end of this leaflet.

Do not take Ulipristal Aurovitas

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

Warnings and precautions

Consult your doctor, pharmacist or other healthcare professional before starting to take this medicine

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that this medicine may be less effective with increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ulipristal acetate is recommended for all women regardless of their weight or BMI.

We recommend that you consult a healthcare professional if you are concerned about any problem related to emergency contraception.

If you become pregnant despite taking this medicine, it is essential that you see your doctor. See section «Pregnancy, breastfeeding and fertility» for more information.

Other contraceptives and Ulipristal Aurovitas

This medicine 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 the tablet, but make sure to use condoms whenever you have sex until your next period.

Do not take ulipristal acetate with another emergency contraceptive pill that contains levonorgestrel. Taking them together may reduce the effectiveness of this medicine.

Other medicines and Ulipristal Aurovitas

Inform your doctor, pharmacist or other healthcare professional if you are taking or have recently taken any other medicine, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent ulipristal acetate from working effectively. If you have used any of the following medicines in the last 4 weeks, ulipristal acetate may be less effective. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e. a copper intrauterine device (IUD-Cu):

Consult your doctor or pharmacist before using ulipristal acetate if you are using (or have recently used) any of the medicines mentioned.

Pregnancy, breastfeeding and fertility

Pregnancy

Before taking this medicine, if your period is delayed, talk to your doctor, pharmacist or other healthcare professional or have 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. If you are already pregnant, it will not interrupt the existing pregnancy.

If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is essential that you see your doctor. As with any pregnancy, your doctor may want to check that the pregnancy is not ectopic. This is especially important if you have severe abdominal pain or bleeding, or if you have had a previous ectopic pregnancy, a Fallopian tube operation or a long-standing (chronic) genital infection.

If you become pregnant despite taking ulipristal acetate, we encourage you to talk to your doctor to register your pregnancy in an official register. You can also notify the information yourself onwww.ulipristal-pregnancy-registry.com. Your information will be kept anonymous, no one will know that the information refers to you. Sharing that information may help future women understand the safety or risks of ulipristal acetate during pregnancy.

Breastfeeding

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

Fertility

This medicine does not affect your future fertility. If you have sex without protection after taking this medicine, it will not prevent you from becoming pregnant. Therefore, it is essential that you use condoms until your next period.

If you want to start using or continue using a conventional contraceptive method after taking this medicine, you can do so, but make sure to use condoms until your next period.

Driving and operating 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 operate machines.

Ulipristal Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Ulipristal Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist or other healthcare professional. In case of doubt, consult your doctor or pharmacist again.

How to take Ulipristal Aurovitas coated tablet

If you vomit after taking Ulipristal Aurovitas

If you vomit (regurgitate) within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have unprotected sex again after taking Ulipristal Aurovitas

If you have unprotected sex again after taking the tablet, it will not prevent pregnancy. After taking the tablet and until your next period, you must use condoms every time you have sex.

If your next period is delayed after taking Ulipristal Aurovitas

After taking the tablet, it is normal for your next period to be delayed a few days. However, if your period is delayed more than 7 days, is lighter or heavier than usual, or if you experience symptoms such as abdominal pain, breast pain, vomiting or nausea, you may be pregnant. You must do a pregnancy test immediately. If you are pregnant, it is essential that you see your doctor (see section "Pregnancy, breastfeeding and fertility").

If you take more Ulipristal Aurovitas than you should

No adverse effects have been reported from taking a higher dose than recommended of this medication. However, consult your doctor, pharmacist or other healthcare professional.

If you have any other questions about the use of this medication, ask your doctor, pharmacist or other healthcare professional.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some symptoms, such as breast tenderness (breast pain) and abdominal pain (stomach pain), vomiting (returning) and nausea (dizziness), are also possible signs of pregnancy. If you do not get your period and experience those symptoms after taking this medicine, you should have a pregnancy test (see section "Pregnancy, breastfeeding and fertility").

Frequent side effects(may affect up to 1 in 10 patients):

Less frequent side effects(may affect up to 1 in 100 patients):

Rare side effects(may affect up to 1 in 1,000 patients):

Reporting side effects

If you experience any type of side effect, consult your pharmacist, doctor, or healthcare professional, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after «CAD». The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ulipristal Aurovitas

Appearance of the product and contents of the package

Ulipristal Aurovitasis a white, round, biconvex film-coated tablet of 9.0-9.2 mm in diameter with “U30” engraved on one side.

Ulipristal Aurovitasis marketed in a transparent PVC/PVDC/aluminum blister pack containing 1 tablet.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Last review date of this leaflet:October 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)

USEFUL INFORMATION ABOUT CONTRACEPTION

MORE ABOUT EMERGENCY CONTRACEPTION

The sooner you take emergency contraception, the more likely you are to avoid pregnancy. Emergency contraception does not affect your fertility.

Emergency contraception may delay ovulation within a certain menstrual cycle, but it will not prevent pregnancy if you have sex without protection again. After taking emergency contraception and until your next period, you should use condoms every time you have sex.

MORE ABOUT REGULAR CONTRACEPTION

If you have taken emergency contraception and do not use a regular contraceptive method (or do not have a contraceptive method that suits you), consult your doctor or a family planning clinic. There are many different types of contraceptives and you should be able to find one that is suitable for you. Examples of regular contraceptive methods are: