ULIPRISTAL AUROVITAS 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ulipristal Aurovitas 30 mg film-coated tablet EFG

Ulipristal acetate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

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

Contents of the Package Leaflet

1. What is Ulipristal Aurovitas and what is it 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. Package contents and additional information

-Useful information regarding contraception.

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

Ulipristal Aurovitas is an emergency contraceptive.

Ulipristal Aurovitas is a contraceptive intended to prevent pregnancy after unprotected sex or when a contraceptive method fails. For example:

• if you have had unprotected sex;
• if the condom used by you or your partner breaks, slips, or is not used;
• if you did not take the contraceptive pill as recommended.

You should take the tablet as soon as possible after having unprotected sex, and no later than 5 days (120 hours) after.

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 woman of childbearing age, 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 period, you may be pregnant. If your period is delayed or you have symptoms of pregnancy (breast tenderness, 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 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 works 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. Out of 100 women who take this medication, approximately 2 will become pregnant.

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

2. What you need to know before taking Ulipristal Aurovitas

Do not take Ulipristal Aurovitas

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

Warnings and precautions

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

• if your period is delayed or you have symptoms of pregnancy (breast tenderness, morning sickness), as you may already be pregnant (see section "Pregnancy, breastfeeding, 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 with increasing weight or body mass index (BMI), but these data were limited and not conclusive. Therefore, ulipristal acetate is recommended for all women, regardless of their weight or BMI.

We advise you to consult a healthcare professional if you are concerned about any issues related to emergency contraception.

If you become pregnant despite taking this medication, it is essential that you consult your doctor. See the section "Pregnancy, breastfeeding, and fertility" for more information.

Other contraceptives and Ulipristal Aurovitas

This medication may temporarily reduce the effectiveness of your 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 every time 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 medication.

Other medications and Ulipristal Aurovitas

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

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

• Medications used to treat epilepsy (e.g., primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, and barbiturates).
• Medications used to treat tuberculosis (e.g., rifampicin and rifabutin).
• A treatment for HIV (ritonavir, efavirenz, nevirapine).
• A medication for treating 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 mentioned medications.

Pregnancy, breastfeeding, and fertility

Pregnancy

Before taking this medication, if your period is delayed, talk to your doctor, pharmacist, or other healthcare professional or have a pregnancy test to ensure 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 interrupt the existing pregnancy.

If you become pregnant despite taking this medication, there is no evidence that it will affect your pregnancy. However, it is essential that you consult 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, tubal surgery, or a long-standing 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 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. By sharing this information, you can help other women understand the safety or risks of ulipristal acetate during pregnancy.

Breastfeeding

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

Fertility

This medication does not affect your future fertility. If you have unprotected sex after taking this medication, 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 using this medication, you can do so, but you must also use condoms until your next period.

Driving and using machines

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

Ulipristal Aurovitas contains lactose

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

Ulipristal Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ulipristal Aurovitas

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor, pharmacist, or other healthcare professional. If in doubt, consult your doctor or pharmacist again.

How to take Ulipristal Aurovitas film-coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after having unprotected sex or when a contraceptive method fails. Take the tablet without delay.
• You can take the tablet at any time during your menstrual cycle.
• You can take the tablet at any time of day, either before, during, or after a meal.
• If you are using one of the medications that may prevent ulipristal acetate from working correctly (see section 2 "What you need to know before taking Ulipristal Aurovitas") or if you have used one of these medications in the last 4 weeks, ulipristal acetate 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 copper IUD.

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 sex again after taking Ulipristal Aurovitas

If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant. 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 by a few days. However, if your period is delayed by more than 7 days, is shorter or longer than usual, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should have a pregnancy test immediately. If you are pregnant, it is essential that you consult your doctor (see section "Pregnancy, breastfeeding, and fertility").

If you take more Ulipristal Aurovitas than you should

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Some symptoms, such as breast tenderness and abdominal pain, vomiting, and nausea, are also possible signs of pregnancy. If your period does not arrive and you experience these symptoms after taking this medication, you should have a pregnancy test (see section "Pregnancy, breastfeeding, and fertility").

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

• nausea, abdominal pain or discomfort, vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, mood changes
• muscle pain, back pain, fatigue

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

• diarrhea, stomach upset, flatulence, dry mouth
• irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido
• hot flashes
• changes in appetite, emotional disorders, anxiety, agitation, sleep disorders, drowsiness, migraines, visual disturbances
• flu
• acne, skin lesions, itching
• fever, chills, malaise

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

• genital pain or itching, pain during sex, rupture of an ovarian cyst, lighter periods than usual
• loss of concentration, vertigo, tremors, disorientation, fainting
• strange sensation in the eyes, red eyes, sensitivity to light
• dry throat, taste disorders
• allergic reactions such as rash, hives, or swelling of the face
• feeling of thirst

Reporting of side effects

If you experience any side effects, consult your pharmacist, doctor, or healthcare professional, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ulipristal Aurovitas

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

Do not use this medication after the expiration date stated on the carton and blister pack after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light.

This medication does not require any special storage temperature.

Medications should not be disposed of via wastewater or household waste. Return any unused medication to a pharmacy for proper disposal. If in doubt, consult your pharmacist on how to dispose of unused medication and packaging. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ulipristal Aurovitas

• The active ingredient is ulipristal acetate. Each film-coated tablet contains 30 milligrams of ulipristal acetate.
• The other components are: lactose monohydrate, pregelatinized corn starch, sodium carboxymethyl starch (type A) (potato), magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Product Appearance and Container Content

Ulipristal Aurovitas is a white, round, biconvex film-coated tablet, 9.0-9.2 mm in diameter, with "U30" engraved on one side.

Ulipristal Aurovitas is marketed in a box containing a transparent PVC/PVDC/aluminum blister pack with 1 tablet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

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

Date of the Last Revision of this Prospectus:October 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (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 given menstrual cycle, but it will not prevent you from getting pregnant if you have unprotected sex 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 include: