Prospect: Information for the User

Ulipristal Exeltis 30mg coated tablet

Ulipristal acetate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or other healthcare professional.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any type of adverse effect, consult your pharmacist, doctor, or healthcare professional, even if it is a possible adverse effect not listed in this prospect. See section4.

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

2.What you need to know before starting to take Ulipristal Exeltis

3.How to use Ulipristal Exeltis

4.Possible adverse effects

5.Storage of Ulipristal Exeltis

6.Contents of the package and additional information

- Useful information related to contraception

Ulipristal Exeltis is an emergency contraceptive

Ulipristal Exeltis is a contraceptive intended to prevent pregnancy after having unprotected sex or a failure in the contraceptive method used. For example:

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

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

This is because sperm can survive up to 5days inside your body after having 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 Exeltis does not work if you are already pregnant.

If you have a delayed menstrual period, you may be pregnant. If your period is delayed or you have symptoms of pregnancy (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 lead to pregnancy at any time during your menstrual cycle.

Ulipristal Exeltis 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 Exeltis works

Ulipristal Exeltis contains the active ingredientulipristal 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 two 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 Exeltis

• if you are allergic to ulipristal acetate or any of the other ingredients of this medication (listed in section6).

Warnings and precautions

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

• if your period is delayed or you have symptoms of pregnancy (enlarged breasts, morning sickness), because you may already be pregnant (see section “Pregnancy, breastfeeding, and fertility”);
• if you have severe asthma;
• if you have severe liver disease.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that this medication may be less effective with weight gain or increased body mass index (BMI), but these data were limited and inconclusive. Therefore, ulipristal 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 medication, it is essential that you see your doctor. See the section “Pregnancy, breastfeeding, and fertility” for more information.

Use of Ulipristal Exeltis 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 the tablet, but make sure to use condoms every time you have sex until your next period.

Do not take ulipristal with another emergency contraceptive pill that contains levonorgestrel.

Taking them together may reduce the effectiveness of this medication.

Use of Ulipristal Exeltis with other medications

Inform your doctor, pharmacist, or other healthcare professional if you are taking or have recently taken any other medication, including over-the-counter medications or herbal medications.

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

• 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 to treat fungal infections (griseofulvin).
• Herbal medications containing St. John's Wort (Hypericum perforatum).

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

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 an emergency contraceptive used to prevent pregnancy. 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 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 tubal ligation, or a long-standing genital infection (chronic).

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

Breastfeeding

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

Fertility

This medication does not affect your future fertility. If you have sex without protection 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 make sure to use condoms until your next period.

Driving and operating machinery

After taking this medication, some women experience dizziness, drowsiness, blurred vision, or loss of concentration (see section4 “Possible side effects”). Do not drive or operate machinery if you are experiencing these symptoms.

Ulipristal Exeltis contains lactose

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

Ulipristal Exeltis contains sodium

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

Follow exactly the administration instructions of the 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 the Ulipristal Exeltis coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected sex or a failure in the contraceptive method used. Take the tablet without delay.
• You can take the medication at any time during your menstrual cycle.
• You can take the medication at any time of the day, either before, during or after a meal.
• If you are using one of the medications that may prevent ulipristal from working correctly (see previous section “Taking Ulipristal Exeltis with other medications”) or if you have used one of these medications in the last 4 weeks, ulipristal may be less effective for you. Consult your doctor or pharmacist before using ulipristal. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper intrauterine device (IUD-Cu).

If you vomit after taking Ulipristal Exeltis

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

If you have sex again after taking Ulipristal Exeltis

If you have unprotected sex 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 Exeltis

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 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 the section “Pregnancy, breastfeeding and fertility”)

If you take more Ulipristal Exeltis than you should

No adverse effects have been reported due to 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine can 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 have your period and experience those symptoms after taking ulipristal, you should have a pregnancy test (see section “Pregnancy, breastfeeding and fertility”).

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

• nausea, abdominal pain (stomach pain), vomiting
• menstrual cramps, pelvic pain, breast tenderness
• headache, dizziness, changes in mood
• muscle pain, back pain, fatigue

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

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

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

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

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 prospectus. You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 after the mark “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.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Ulipristal Exeltis Composition

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

Appearance of Ulipristal Exeltis and packaging contents

Ulipristal Exeltis is a biconvex, round, white, film-coated tablet with a diameter of 9.0 to 9.2 mm and a "U30" engraving on one side.

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

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Exeltis Healthcare S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares.

Guadalajara, Spain.

Manufacturer:

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2021

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/

USEFUL INFORMATION ABOUT CONTRACEPTION

MORE ABOUT EMERGENCY CONTRACEPTION

The sooner you take emergency contraception, the more likely you are to prevent 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 unprotected sex again. After taking emergency contraception and until your next period, you should use condoms whenever 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: