ULIPRISTAL ARISTO 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ulipristal Aristo 30 mg film-coated tablets 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 other healthcare professional.
• 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 Ulipristal Aristo is and what it is used for
2. What you need to know before taking Ulipristal Aristo
3. How to take Ulipristal Aristo
4. Possible side effects
5. Storage of Ulipristal Aristo
6. Contents of the pack and further information

• Useful information about contraception

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

Ulipristal Aristo is an emergency contraceptive

Ulipristal Aristo 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) 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 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 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 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 two 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 Aristo

Do not take Ulipristal Aristo

• 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 is recommended for all women, regardless of their weight or BMI.

You are advised 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.

Using Ulipristal Aristo with other contraceptives

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 with another emergency contraceptive pill that contains levonorgestrel. Taking them together may reduce the effectiveness of this medication.

Other medications and Ulipristal Aristo

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 from working effectively. If you have used any of the following medications in the last 4 weeks, ulipristal may be less effective for you. Your doctor may prescribe a different 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).
• 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 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 take 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, 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 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 experience dizziness, drowsiness, blurred vision, or loss of concentration (see section 4 "Possible side effects"). If you experience these symptoms, do not drive or use machines.

Ulipristal Aristo contains lactose

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

Ulipristal Aristo contains sodium

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

3. How to take Ulipristal Aristo

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 the ulipristal 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 Aristo from working correctly (see section 2 "What you need to know before taking 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 a different type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD).

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 unprotected sex again after taking ulipristal

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

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 take 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 than you should

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

If you have any further questions about 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 you do not get your period and experience these symptoms after taking ulipristal, you should take 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, heartburn, 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 (itchy rash) or swelling of the face
• feeling of thirst

Reporting side effects

If you experience any side effects, consult your doctor or healthcare professional, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ulipristal Aristo

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 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 special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Contents and Additional Information

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, pregelatinized corn starch, sodium starch glycolate, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Appearance of the Product and Container Contents 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 box containing a transparent PVC/PVDC/aluminum blister pack with 1 film-coated tablet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

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 marketing authorization holder:

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 under 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

Date of the Last Revision of this Leaflet:March 2022

Detailed information about this medication is available on the European Medicines Agency website: 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 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:

Daily Methods

Birth control pill _____________________________________________________________________________

Weekly or Monthly Methods

Contraceptive patch Vaginal ring

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Long-term Methods

Contraceptive implant IUD (intrauterine device)

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