Package Leaflet: Information for the User

Ulipristal Stada 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 other healthcare professional.

• 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 Stada and what it is used for

2. What you need to know before taking Ulipristal Stada

3. How to take Ulipristal Stada

4. Possible side effects

5. Storage of Ulipristal Stada

6. Contents of the pack and additional information

- Useful information related to contraception

Ulipristal Acetate is an emergency contraceptive

Ulipristal acetate is a contraceptive intended to prevent pregnancy after unprotected sex or failure of the used contraceptive method. 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 pill as soon as possible after having unprotected sex, and no later than 5 days (120 hours) after.

This is because sperm can survive up to 5 days inside your body after having unprotected sex.

This medication is suitable for any woman of childbearing age, including adolescents.

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

Ulipristal acetate does not work if you are already pregnant

If you have a missed period, you may be pregnant. If your period is late or you have symptoms of pregnancy (enlarged breasts, morning sickness), you should consult a doctor or other healthcare professional before taking the pill.

If you have unprotected sex after taking the pill, it will not prevent pregnancy.

Unprotected sex can result in pregnancy at any time during your menstrual cycle.

Ulipristal acetate 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 acetate works

Ulipristal acetate 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. 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 on contraception at the end of this leaflet.

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

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

• if your period is delayed or you have symptoms of pregnancy (swollen breasts, morning sickness), because you might 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 medicine may be less effective if you have a higher 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 the tablet, it is essential that you see your doctor. See the section “Pregnancy, breastfeeding, and fertility” for more information.

Use of Ulipristal Stada with other contraceptives

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 this medicine, but make sure to use condoms every time you have sex until your next period.

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

Use of Ulipristal Stada with other medicines

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

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), that is, a copper intrauterine device (IUD-Cu):

• 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)
• A treatment for HIV (ritonavir, efavirenz, nevirapine)
• A medicine to treat fungal infections (griseofulvin)
• Herbal remedies containing St. John's Wort (Hypericum perforatum)

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

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 an 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 tubal ligation, or a long-standing genital infection (chronic).

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 report the information yourself onwww.ulipristal-pregnancy-registry.com. Your information will be kept anonymous, and no one will know that the information refers to you. Sharing this 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 for a week after taking this medicine. We recommend that you use a breast pump to maintain milk production but discard the extra 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 the tablet, 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 medicine, you can do so, but make sure to use condoms until your next period.

Driving and operating machinery

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 machinery.

Ulipristal Stada contains lactose

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

Ulipristal Stada 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 the Ulipristal Stada 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 tablet at any time during your menstrual cycle
• You can take the tablet at any time of the day, either before, during or after a meal
• If you are using one of the medications that may prevent acetate of ulipristal from working correctly (see section 2 “What you need to know before starting to take Ulipristal Stada”) or if you have used one of these medications in the last 4 weeks, acetate of ulipristal may be less effective for you. Consult your doctor or pharmacist before using acetate of ulipristal. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper IUD

If you vomit after taking Ulipristal Stada

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 Stada

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 StadaStada

After taking the tablet, it is normal for your next period to be delayed for 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 StadaStadathan 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the 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 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 acetate, you should have a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).

Frequent(can affect up to 1 in 10 patients):

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

Infrequent(can affect up to 1 in 100 patients):

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

Rare(can affect up to 1 in 1,000 patients):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ulipristal Stada

• The active ingredient is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate
• The other components are lactose monohydrate, cornstarch pregelatinized, carboxymethylcellulose sodium (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 Ulipristal Stada packaging

Ulipristal Stada is a film-coated tablet, round, biconvex, 9.0 – 9.2 mm in diameter, white in color, marked with “U30” on one side.

Ulipristal Stada is 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

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Last review date of this leaflet:May 2022

The detailed and updated information on 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 again without protection. 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:

Long-term methods

Implantable contraceptiveDIU (intrauterine contraceptive device)