Ulipristal Aristo 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ulipristal Aristo 30 mg film-coated tablets EFG

Ulipristal acetate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Follow exactly the instructions for taking this medicine contained in this leaflet or those provided 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 side effects not listed in this leaflet. See section 4.

Contents of this 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. How to store Ulipristal Aristo
6. Contents of the pack and other information

• Useful information regarding 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 if there has been a failure of the contraceptive method used. For example:

• if you had unprotected sex;
• if the condom used by you or your partner broke, slipped, or was not used correctly, or if you forgot to use it;
• if you did not take your contraceptive pill as recommended.

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

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

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

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

Ulipristal Aristo does 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 sex can lead to pregnancy at any time during the menstrual cycle.

Ulipristal Aristo 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 Aristo works

Ulipristal Aristo contains the active substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone, necessary 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 two will become pregnant.

This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not terminate 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 becoming infected with HIV or any other sexually transmitted infection (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis). Please 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 Aristo

Do not take Ulipristal Aristo

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

Warnings and precautions

Talk to 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), because you may already be pregnant (see section "Pregnancy, breastfeeding and fertility");
• if you have severe asthma;
• if you have severe liver disease.

For 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 weight or body mass index (BMI), but this data was limited and inconclusive. Therefore, Ulipristal 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. 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 using 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 together with another emergency contraceptive pill containing levonorgestrel. Taking them together could reduce the effectiveness of this medicine.

Other medicines and Ulipristal Aristo

Tell 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 from working effectively. If you have used any of the following medicines within the past 4 weeks, ulipristal may be less effective. Your doctor may prescribe another type of emergency contraception (non-hormonal), namely 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 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 affect 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, you are encouraged to speak with your doctor so 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 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. We recommend that during this week, you use a breast pump to maintain milk production but discard the expressed milk. The effect on the infant 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 you should 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 "Possible side effects"). If you experience these symptoms, do not drive or operate machinery.

Ulipristal Aristo contains lactose

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

Ulipristal Aristo contains sodium

This medicine 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 exactly the instructions for use of this medicine 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 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 experiencing 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 eating).
• If you are taking any of the medicines that may reduce the effectiveness of Ulipristal Aristo (see section 2 "What you need to know before taking Ulipristal Aristo") or if you have taken any of these medicines within 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 (Cu-IUD).

If you vomit after taking ulipristal

If you vomit within 3 hours after 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 starts, 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 lighter or heavier 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 important that you see a 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 than recommended dose 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 will experience them.

Some symptoms, such as breast tenderness (sore breasts) and abdominal pain (stomach pain), vomiting, and nausea (feeling sick), may also be possible signs of pregnancy. If your period does not occur and you experience these symptoms after taking ulipristal, 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, 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 sex drive
• hot flushes
• changes in appetite, emotional disorders, anxiety, restlessness, sleep disturbances, drowsiness, migraine, visual disturbances
• 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, vertigo, tremors, disorientation, fainting
• unusual sensation in the eyes, red eyes, light sensitivity
• dry throat, taste disturbances
• allergic reactions such as rashes
• hives (itchy rash) or facial swelling
• feeling thirsty

Reporting of adverse effects

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

5. Ulipristal Aristo Storage Instructions

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "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 conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ulipristal Aristo

• The active substance 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 contents of the pack of Ulipristal Aristo

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

Ulipristal Aristo is marketed in a box containing one transparent PVC/PVDC/aluminum blister 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
48159 Münster
Germany

or

Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicine 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 most recent review of this leaflet: March 2022

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

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 pregnancy 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), speak to your doctor or a family planning clinic. There are many different types of contraceptives available, and you should be able to find one that is right for you.

Examples of regular contraceptive methods:

Daily methods

Oral contraceptive pill
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Weekly or monthly methods

Contraceptive patch Vaginal ring
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Long-term methods

Contraceptive implant IUD (intrauterine device)
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