Ulipristal Aristo

Leaflet accompanying the packaging: information for the user

Ulipristal Aristo, 30 mg, coated tablet

Ulipristal acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the pharmacist or doctor.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ulipristal Aristo and what is it used for
• 2. Important information 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 about contraception

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

Ulipristal Aristo is an emergency contraceptive intended for use in cases of unprotected sex or contraceptive failure. Ulipristal Aristo is an emergency contraceptive intended for use to prevent pregnancy after unprotected sex or when the contraceptive method used has failed. For example:

• in cases of unprotected sex;
• if a condom has broken, slipped, or been misused, or if it has not been used;
• if a regular contraceptive pill has not been taken as directed.

The tablet should be taken as soon as possible after unprotected sex, within a maximum of 5 days (120 hours) after sex. The medicine is most effective the sooner it is taken after unprotected sex. This medicine is suitable for all women of childbearing age, including adolescents. The tablet can be taken at any time during the menstrual cycle. Ulipristal Aristo is not effective if pregnancy has already occurred. If there is a delay in menstruation, there is a possibility of pregnancy. If menstruation is delayed or symptoms of pregnancy (breast tenderness, morning sickness) occur, consult a doctor or pharmacist before taking the tablet. If unprotected sex occurs after taking the tablet, it will not prevent pregnancy. Unprotected sex at any time during the menstrual cycle can lead to pregnancy. Ulipristal Aristo is not intended for use as a regular contraceptive method. If there is no regular contraceptive method in place, consult a doctor or pharmacist for advice on choosing an appropriate method. How Ulipristal Aristo works Ulipristal Aristo contains the active substance ulipristal acetate, which affects the activity of the natural hormone progesterone, which is necessary for ovulation to occur. As a result, the medicine delays ovulation. Emergency contraception is not always effective. Out of 100 women who take this medicine, about 2 will become pregnant. This medicine is a contraceptive method used to prevent pregnancy. If pregnancy occurs, it will not terminate the pregnancy. Emergency contraception does not protect against sexually transmitted infections. Only condoms protect against sexually transmitted infections. This medicine does not protect against HIV or other sexually transmitted diseases (such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). If you have concerns, consult a doctor or pharmacist. More information about contraception can be found at the end of this leaflet.

2. Important information before taking Ulipristal Aristo

When not to 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

Before taking Ulipristal Aristo, discuss with your doctor, pharmacist, or other healthcare professional if:

• you have a delayed menstruation or symptoms of pregnancy (breast tenderness, morning sickness) suggesting you may be pregnant (see section "Pregnancy, breastfeeding, and fertility");
• you have severe asthma;
• you have severe liver disease.

All women should take emergency contraception as soon as possible after unprotected sex. There is evidence that this medicine may be less effective in women with a higher body mass index (BMI) or weight, but the data are limited and inconclusive. Therefore, Ulipristal Aristo is still recommended for all women, regardless of weight or BMI. If you have any doubts or concerns about emergency contraception, consult a doctor or pharmacist. If you become pregnant despite taking this medicine, it is essential to consult a doctor. See section "Pregnancy, breastfeeding, and fertility" for more information.

Other contraceptive medicines and Ulipristal Aristo

This medicine may temporarily reduce the effectiveness of regular contraceptive methods, such as pills and patches. If you are taking hormonal contraception after taking the tablet, you can continue to take it as usual, but you should use condoms during each act of sex until the next menstrual period. Do not take Ulipristal Aristo with other emergency contraceptive pills containing levonorgestrel. Taking them together may reduce the effectiveness of this medicine.

Ulipristal Aristo and other medicines

Tell your pharmacist or doctor about all medicines you are taking, including those obtained without a prescription or herbal medicines. Some medicines may reduce the effectiveness of Ulipristal Aristo. If you have taken any of the following medicines in the last 4 weeks, Ulipristal Aristo may not be suitable for you. Your doctor may prescribe a different type of emergency contraception, such as 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, rifabutin);
• medicines used to treat HIV infection (ritonavir, efavirenz, nevirapine);
• medicines used to treat fungal infections (griseofulvin);
• herbal medicines containing St. John's Wort (Hypericum perforatum).

Before taking Ulipristal Aristo, consult your doctor or pharmacist if you are taking (or have recently taken) any of these medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy
Before taking this medicine, if your menstruation is delayed, tell your pharmacist or doctor, or perform a pregnancy test to rule out pregnancy (see "Warnings and precautions"). This medicine is a contraceptive method used to prevent pregnancy. It does not terminate an existing pregnancy. If you become pregnant despite taking this medicine, there is no scientific evidence that the medicine affects the pregnancy. However, you should consult a doctor. As with other cases, the doctor will want to check if you have an ectopic pregnancy. This is especially important if you experience severe abdominal pain, bleeding, or if you have had an ectopic pregnancy, tubal surgery, or pelvic infection in the past. If you become pregnant despite taking Ulipristal Aristo, we encourage you to register your pregnancy with your doctor in the official registry. You can also report this information yourself on the website http://www.ulipristal-pregnancy-registry.com. This information will remain anonymous - no one will know that it concerns a specific person. Sharing this information may help women in the future understand the safety or risks of taking Ulipristal Aristo during pregnancy.
Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking the medicine. During this time, use a breast pump to maintain milk production, but discard the expressed milk. The effect on the breastfed child within one week of taking this medicine is unknown.
Fertility
This medicine does not affect future fertility. If you have unprotected sex after taking this medicine, it will not prevent pregnancy. Therefore, it is essential to use condoms until the next menstrual period. If you want to start or continue using a regular contraceptive method after taking this medicine, you can do so, but you should also use condoms until the next menstrual period.

Driving and using machines

Some women may experience dizziness, drowsiness, blurred vision, and (or) decreased concentration (see section 4 "Possible side effects") after taking this medicine. If you experience these symptoms, do not drive or operate machinery.

Ulipristal Aristo contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

Ulipristal Aristo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially "sodium-free".

3. How to take Ulipristal Aristo

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist, or other healthcare professional. If you have any doubts, consult a pharmacist or doctor. How to take the Ulipristal Aristo coated tablet

• Take one tablet as soon as possible, no later than 5 days (120 hours) after unprotected sex or contraceptive failure. Take the medicine without delay.
• The tablet can be taken at any time during the menstrual cycle.
• The tablet can be taken at any time of day, before, after, or during a meal.
• If you are taking any medicines that may reduce the effectiveness of Ulipristal Aristo (see section 2 "Important information before taking Ulipristal Aristo") or if you have taken any of these medicines in the last 4 weeks, Ulipristal Aristo may not be suitable for you. Before taking Ulipristal Aristo, consult your doctor or pharmacist. Your doctor may prescribe a different type of emergency contraception, such as a copper intrauterine device (Cu-IUD).

Vomiting after taking Ulipristal Aristo If you vomit within 3 hours of taking the tablet (nausea, vomiting), take another tablet as soon as possible. Unprotected sex after taking Ulipristal Aristo If you have unprotected sex after taking the tablet, it will not prevent pregnancy. After taking the tablet and until your next menstrual period, use condoms during each act of sex. Delayed menstruation after taking Ulipristal Aristo A few days' delay in menstruation after taking the tablet is normal. However, if your menstruation is delayed by more than 7 days; is unusually light or heavy; or if you experience symptoms such as abdominal pain, breast tenderness, nausea, or vomiting, you may be pregnant. Take a pregnancy test immediately. If you are pregnant, it is essential to consult a doctor (see section "Pregnancy, breastfeeding, and fertility"). Taking more Ulipristal Aristo than recommended There have been no reports of harmful effects after taking more than the recommended dose of this medicine. However, consult a pharmacist or doctor, or other healthcare professional. If you have any doubts about taking this medicine, consult a pharmacist or doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms, such as breast tenderness and abdominal pain, nausea (feeling sick), may also be signs of pregnancy. If your menstruation is delayed and you experience these symptoms after taking Ulipristal Aristo, take a pregnancy test (see section "Pregnancy, breastfeeding, and fertility"). Common side effects (may affect up to 1 in 10 people)

• nausea, abdominal pain, discomfort, vomiting;
• painful menstruation, pelvic pain, breast tenderness;
• headache, dizziness, mood swings;
• muscle pain, back pain, fatigue.

Uncommon side effects (may affect up to 1 in 100 people)

• diarrhea, heartburn, gas, dry mouth;
• unusual or irregular vaginal bleeding, heavy or prolonged menstrual bleeding, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido;
• hot flashes;
• appetite disorders, emotional disorders, anxiety, agitation, sleep disorders, drowsiness, migraine, vision disorders;
• flu;
• acne, skin changes, itching;
• fever, chills, malaise.

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

• genital pain or itching, pain during sex, ovarian cyst rupture, unusually light menstrual bleeding;
• decreased concentration, dizziness, tremors, disorientation, fainting;
• abnormal sensation in the eye, eye redness, photophobia;
• dry throat, taste disorders;
• allergic reactions, such as rash, urticaria (itchy rash), or facial edema, thirst.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ulipristal Aristo

Keep the medicine out of the 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. The batch number is stated on the carton and blister after "Lot". Store in the original packaging to protect from light. There are no special storage instructions for this medicinal product. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ulipristal Aristo contains

• The active substance is ulipristal acetate. Each coated tablet contains 30 milligrams of ulipristal acetate.
• The other ingredients are lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate, hypromellose, hydroxypropylcellulose, stearic acid, talc, titanium dioxide (E171).

What Ulipristal Aristo looks like and contents of the pack

Ulipristal Aristo is a white, round, biconvex coated tablet with a diameter of 9.0-9.2 mm, with "U30" engraved on one side. Ulipristal Aristo is available in a carton containing 1 coated tablet in a transparent blister, made of PVC/PVDC/aluminum.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o., ul. Baletowa 30, 02-867 Warsaw, tel: +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH, Wallenroder Str. 8 – 10, 13435 Berlin, Germany, Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Ulipristal Aristo 30 mg film-coated tablet, Austria: Ulipristal Aristo 30 mg film tablet, Czech Republic: Ulipristal acetate Aristo 30 mg coated tablet, Germany: Ulipristal Aristo 30 mg film tablet, Italy: Ulipristal Aristo, Poland: Ulipristal Aristo, Portugal: Ulipristal Aristo 30 mg film-coated tablet, United Kingdom (Northern Ireland): Ulipristal Aristo 30 mg film-coated tablet, Spain: Ulipristal Aristo 30 mg film-coated tablet EFG

Date of last revision of the leaflet:

USEFUL INFORMATION ABOUT CONTRACEPTION

ADDITIONAL INFORMATION ABOUT EMERGENCY CONTRACEPTION

IN CASES OF UNPROTECTED SEX

Taking emergency contraception as soon as possible increases the chance of avoiding pregnancy. Emergency contraception does not affect fertility. Emergency contraception may delay ovulation in the current menstrual cycle but will not prevent pregnancy if you have unprotected sex again. After taking emergency contraception and until your next menstrual period, use condoms during each act of sex.

ADDITIONAL INFORMATION ABOUT REGULAR CONTRACEPTIVE METHODS

If you have taken emergency contraception and are not using a regular contraceptive method (or do not have an appropriate method), consult a doctor or family planning clinic for advice. There are many different contraceptive methods available to choose from. Examples of regular contraceptive methods:

Methods used daily

Contraceptive pill

Methods used once a week or once a month

Contraceptive patch, Vaginal ring

Long-acting methods

Contraceptive implant, Intrauterine device