Ulipristal Aurovitas 30 mg film-coated tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ulipristal Aurovitas 30 mg film-coated tablet EFG

Ulipristal acetate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Always follow exactly the instructions for taking this medicine as described in this leaflet or as provided by your doctor, pharmacist, or nurse.

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

Contents of the leaflet

1. What Ulipristal Aurovitas is 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. How to store Ulipristal Aurovitas
6. Contents of the pack and other information

-Useful information regarding contraception.

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

Ulipristal Aurovitas is an emergency contraceptive.

Ulipristal Aurovitas is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure. For example:

• if you had unprotected sex;
• if a condom used by you or your partner broke, slipped, or was not used;
• if you missed taking your contraceptive pill as recommended.

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

This is because it is more effective the sooner you take it after unprotected sexual intercourse.

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

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

Ulipristal Aurovitas will not work if you are already pregnant.

If your menstrual period is delayed, you may be pregnant. If your period is late or you have symptoms of pregnancy (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 sexual intercourse can result in pregnancy at any time during the menstrual cycle.

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

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

How Ulipristal Aurovitas works

This medicine contains the active substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone required for ovulation to occur. As a result, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. Out of every 100 women who take this medicine, approximately 2 will become pregnant.

This medicine 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 medicine will not protect you from HIV infection or any other sexually transmitted disease (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis). Consult a healthcare professional if you are concerned about this.

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

2. What you need to know before taking Ulipristal Aurovitas

Do not take Ulipristal Aurovitas

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

Warnings and precautions

Consult your doctor, pharmacist, or other healthcare professional before taking this medicine

• if your period is delayed or you have symptoms of pregnancy (swollen breasts, 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 unprotected intercourse. There is some evidence that this medicine may be less effective with increasing body 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.

You are advised to consult a healthcare professional if you have concerns about any issues related to emergency contraception.

If you become pregnant despite taking this medicine, it is important that you see your doctor. Refer to the section "Pregnancy, breastfeeding and fertility" for further 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 using them as usual after taking the tablet, but make sure to use condoms whenever you have sexual intercourse until your next period.

Do not take ulipristal acetate together with another emergency contraceptive pill containing 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 medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent ulipristal acetate from working effectively. If you have taken any of the following medicines within the past 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 (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 and rifabutin).
• HIV treatment (ritonavir, efavirenz, nevirapine).
• A medicine used 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 are taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy

Before taking this medicine, if your period is delayed, speak with your doctor, pharmacist, or other healthcare professional or take a pregnancy test to ensure 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 terminate the existing pregnancy.

If you become pregnant despite taking this medicine, there is no evidence that it will harm your pregnancy. However, it is important 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 previously had an ectopic pregnancy, tubal surgery, or a chronic genital infection.

If you become pregnant after taking ulipristal acetate, you are encouraged to inform your doctor so that your pregnancy can be registered in an official registry. You may also report the information yourself at www.ulipristal-pregnancy-registry.com. Your information will remain anonymous; no one will know the information refers to you. By sharing this information, you can help other women understand the safety or risks of ulipristal acetate during pregnancy in the future.

Breastfeeding

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

Fertility

This medicine does not affect your future fertility. If you have unprotected intercourse after taking this medicine, it will not prevent you from becoming pregnant. Therefore, it is important to use condoms until your next period.

If you wish to start or continue using a conventional contraceptive method after using this medicine, you may do so but must also use condoms until your next period.

Driving and use of machines

After taking this medicine, some women may experience dizziness, drowsiness, blurred vision, or difficulty concentrating (see section 4). If you experience these symptoms, do not drive or operate machinery.

Ulipristal Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of 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; essentially "sodium-free".

3. How to take Ulipristal Aurovitas

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or other healthcare professional. If in doubt, consult your doctor or pharmacist again.

How to take Ulipristal Aurovitas coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Take the tablet without delay.
• You may take the tablet at any time during your menstrual cycle.
• You may take the tablet at any time of day, regardless of meals (before, during, or after).
• If you are taking any of the medicines that may reduce the effectiveness of ulipristal acetate (see section 2 "What you need to know before taking Ulipristal Aurovitas"), or if you have taken any of these medicines within the past 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 (Cu-IUD).

If you vomit after taking Ulipristal Aurovitas

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

If you have unprotected sexual intercourse again after taking Ulipristal Aurovitas

If you have unprotected sexual intercourse 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 sexual intercourse.

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 unusually light or heavy, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should take a pregnancy test immediately. If you are pregnant, it is important that you see a doctor (see section "Pregnancy, breastfeeding and fertility").

If you take more Ulipristal Aurovitas than you should

No harmful effects have been reported following an overdose of this medicine. Nevertheless, consult your doctor, pharmacist, or other healthcare professional.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

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

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

• diarrhea, heartburn, flatulence, dry mouth
• irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased sexual desire
• hot flushes
• changes in appetite, emotional disorders, anxiety, restlessness, sleep disturbances, drowsiness, migraine, visual disorders
• flu-like symptoms
• acne, skin lesions, itching
• fever, chills, malaise

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

• genital pain or itching, pain during sex, rupture of an ovarian cyst, lighter-than-usual periods
• difficulty concentrating, dizziness, tremors, disorientation, fainting
• unusual sensation in the eyes, red eyes, light sensitivity
• dry throat, taste disturbances
• allergic reactions such as rashes, hives, or facial swelling
• feeling of thirst

Reporting of adverse effects

If you experience any type of adverse effect, talk to your pharmacist, doctor, or healthcare professional, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ulipristal Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ulipristal Aurovitas

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

Appearance of the product and contents of the pack

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

Ulipristal Aurovitas is marketed in a box containing one transparent PVC/PVDC/aluminum blister 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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the most recent review of this leaflet: October 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)

USEFUL INFORMATION ON CONTRACEPTION

MORE ABOUT EMERGENCY CONTRACEPTION

The sooner you take emergency contraception, the more likely it is to prevent 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 becoming pregnant if you have unprotected sex again. After taking emergency contraception and until your next period starts, you must use condoms every time you have sex.

MORE ABOUT REGULAR CONTRACEPTION

If you have taken emergency contraception and you are not using a regular contraceptive method (or do not have a suitable contraceptive method), 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: