Package Insert: Information for the User

Ulipristal Aristo 30 mg Film-Coated Tablets

Ulipristal Acetate

Read this package insert carefully before starting to use this medicine, as it contains important information for you.

• Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor, pharmacist, or other healthcare professional.
• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or other healthcare professional, even if they are not listed in this package insert. See section 4.

- Useful information related to contraception

Ulipristal Aristo is an emergency contraceptive

Ulipristal Aristo is a contraceptive intended to prevent pregnancy after having unprotected sex or a failure in 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 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 woman of childbearing age, including adolescents.

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

Ulipristal Aristo 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 Aristo 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 Aristo works

Ulipristal Aristo 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 on contraception at the end of this prospectus.

Do not take Ulipristal Aristo

• 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 a 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 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 the section «Pregnancy, breastfeeding and fertility» for more information.

Use of Ulipristal Aristo 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 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 medicine.

Other medicines and Ulipristal Aristo

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 from working effectively. If you have used any of the following medicines in the last 4 weeks, ulipristal may be less effective. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., 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 medicines 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 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 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 (chronic) genital infection.

If you become pregnant despite taking ulipristal, 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, no one will know that the information refers to you.Sharing this information may help future women understand the safety or risks of ulipristal during pregnancy.

Breastfeeding

If you take this medicine while breastfeeding, do not breastfeed your baby for a week after taking this medicine. We recommend that, during that week, 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 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 «Possible side effects»). If you experience these symptoms, do not drive or operate machines.

Ulipristal Aristo contains lactose

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

Ulipristal Aristo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet; this 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 film-coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected sex or failure of 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 Ulipristal Aristo from working correctly (see section 2 "What you need to know before starting to take Ulipristal Aristo") or if you have used one of these medications in the last 4 weeks, Ulipristal Aristo 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

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

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

It is normal for your next period to be delayed for a few days after taking the tablet.

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 section "Pregnancy, breastfeeding and fertility").

If you take more ulipristal 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, and nausea, are also possible signs of pregnancy.If you do not get 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 or discomfort, 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 libido
• migraines
• changes in appetite, emotional disorders, anxiety, agitation, sleep problems, drowsiness, migraines, visual disorders
• 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, 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
• allergic reactions such as rashes
• hives or facial swelling
• feeling of thirst

Reporting side effects

If you experience any type of side effect, consult your 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 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 «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 special storage conditions.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Ulipristal Aristo

• The active ingredient is ulipristal acetate. Each film-coated tablet contains 30 milligrams of ulipristal acetate.

• The other components are: lactose monohydrate, maize pregelatinized starch, sodium glycolate starch, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Appearance of the product and contents of the package of Ulipristal Aristo

Ulipristal Aristo is a film-coated, biconvex, rounded tablet, white in color, 9 mm to 9.2 mm in diameter, marked with "U30" on one side.

Ulipristal Aristo is marketed in a transparent PVC/PVDC/aluminum blister pack containing 1 film-coated tablet.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

Haupt Pharma

Münster GmbH

Schleebrüggenkamp, 15

Münster, 48159, Germany

or

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

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

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

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

Netherlands:Ulipristal Aristo 30 mg filmomhulde tablet

Austria:Ulipristal Aristo 30 mg Filmtablette

Czech Republic:Ulipristal acetate Aristo 30 mg potahovaná tableta

Germany:Ulipristal Aristo 30 mg Filmtablette

Italy:Ulipristal Aristo 30 mg Compressa rivestita con film

Poland:Ulipristal Aristo 30 mg tabletka powlekana

Spain:Ulipristal Aristo 30 mg comprimidos recubiertos con película EFG

Portugal:Ulipristal Aristo 30 mg Comprimido revestido por película

Last review date of this leaflet:March 2022

More detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

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 you from becoming pregnant 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:

Daily methods

Oral contraceptive pill_____________________________________________________________________________

Weekly or monthly methods

Contraceptive patchVaginal ring

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Long-term methods

Implantable contraceptiveIntrauterine device (IUD)

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