Ulipristal aristo

Patient Information Leaflet

Ulipristal Aristo, 30 mg, film-coated tablet
Ulipristal acetate
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your
pharmacist or doctor has advised.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents:

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

Ulipristal Aristo is an emergency contraceptive medicine.
Ulipristal Aristo is an emergency contraceptive intended to prevent pregnancy after unprotected sexual intercourse or when the contraceptive method used has failed. For example:

• after unprotected sexual intercourse;
• if a condom broke, slipped or fell off, or was not used;
• if a regular oral contraceptive pill was not taken according to instructions.

The tablet should be taken as soon as possible after unprotected intercourse, within a maximum of 5 days (120 hours) after intercourse.
The medicine is most effective when taken as soon as possible after unprotected intercourse.
This medicine is suitable for all women of reproductive age, including adolescents.
It may be taken on any day of the menstrual cycle.
Ulipristal Aristo is not effective if pregnancy has already occurred.
If a menstrual period is delayed, pregnancy is possible. If menstruation is delayed or symptoms of pregnancy occur (e.g. breast tenderness, morning nausea), consult your doctor or pharmacist before taking the tablet.
If unprotected sexual intercourse occurs after taking the tablet, the medicine will not prevent pregnancy.
Unprotected sexual intercourse on any day of the menstrual cycle may result in pregnancy.
Ulipristal Aristo is not intended for use as a regular contraceptive method.
If you do not have a regular contraceptive method, please consult your doctor or pharmacist to select an appropriate method.

How Ulipristal Aristo works
Ulipristal Aristo contains the active substance ulipristal acetate, which affects the activity of the natural hormone progesterone, required 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, approximately 2 will become pregnant.
This medicine is a contraceptive method used to prevent pregnancy. It will not terminate an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections (STIs).
Only condoms protect against sexually transmitted infections. This medicine does not protect against infection with HIV or other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis). If you have any concerns, please consult your doctor or pharmacist.
Additional 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 the patient is 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:

• the patient’s menstrual period is late or if she has symptoms of pregnancy (breast enlargement, morning sickness) suggesting she may be pregnant (see section “Pregnancy, breastfeeding and fertility”);
• she has severe asthma;
• she has severe liver disease.

All women should use emergency contraception as soon as possible after unprotected intercourse.
There is evidence that this medicine may be less effective in women with increased body weight or higher body mass index (BMI), although data are limited and inconclusive. For this reason, Ulipristal Aristo is still recommended for all women, regardless of body weight or BMI.
If in doubt or if any problems arise regarding the use of emergency contraception, consultation with a doctor or pharmacist is recommended.
If pregnancy occurs despite taking this medicine, it is important to consult a doctor. See section “Pregnancy, breastfeeding and fertility” for further information.

Other contraceptive medicines and Ulipristal Aristo
This medicine may temporarily reduce the effectiveness of regularly used hormonal contraceptives, such as: oral contraceptives and contraceptive patches.
If using hormonal contraception, you may continue taking it as usual after taking the tablet, but condoms must be used for every act of sexual intercourse until the start of the next menstrual period.
In an emergency, do not take Ulipristal Aristo together with other emergency contraceptive tablets containing levonorgestrel.
Concurrent use may reduce the effectiveness of this medicine.

Ulipristal Aristo and other medicines
Tell your pharmacist or doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, or herbal medicines.
Some medicines may reduce the effectiveness of Ulipristal Aristo. If the patient has taken any of the following medicines within the last 4 weeks, Ulipristal Aristo may not be suitable. The doctor may prescribe another type of (non-hormonal) 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);
• a medicine used to treat fungal infections (griseofulvin);
• herbal medicines containing St John's wort (Hypericum perforatum).

Before using Ulipristal Aristo, speak to your doctor or pharmacist if you are taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility
Pregnancy
Before taking this medicine, if the menstrual period is late, inform your pharmacist or doctor, or perform a pregnancy test to exclude pregnancy (see “Warnings and precautions”).
This medicine is an emergency contraceptive intended to prevent pregnancy. It does not terminate an existing pregnancy.
If pregnancy occurs despite using this medicine, there is no scientific evidence that the medicine affects the pregnancy. However, you should consult your doctor. As in other cases, your doctor may want to check whether an ectopic pregnancy has occurred. This is particularly important if you experience severe lower abdominal (abdominal) pain, bleeding, or if you have previously had an ectopic pregnancy, tubal surgery or chronic pelvic infection.
If pregnancy occurs after taking Ulipristal Aristo, we encourage the doctor to register the pregnancy in the official registry. You may also report this information yourself at http://www.ulipristal-pregnancy-registry.com. Information will remain anonymous – no one will know the report refers to a specific individual. Sharing information may help women in the future understand the safety or risks of using Ulipristal Aristo during pregnancy.

Breastfeeding
If this medicine is used while breastfeeding, do not breastfeed for one week after taking the medicine. During this time, it is recommended to use a breast pump to maintain milk production, but the expressed milk should be discarded. The effect on a breastfed infant during the week after taking this medicine is unknown.

Fertility
This medicine does not affect future fertility. If unprotected intercourse occurs after taking this medicine, it will not prevent pregnancy. Therefore, it is important to use condoms until the next menstrual period.
If you wish to start or continue using a regular contraceptive method after taking this medicine, you may 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 reduced concentration after taking this medicine (see section 4 “Possible side effects”). If these symptoms occur, do not drive or operate machinery.

Ulipristal Aristo contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

Ulipristal Aristo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “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 your doctor, pharmacist, or other qualified healthcare professional.
If in doubt, consult your pharmacist or doctor.
How to take Ulipristal Aristo tablets

• Take one tablet orally as soon as possible, no later than 5 days (120 hours) after unprotected sexual intercourse or in case of contraceptive failure. The medicine should be taken without delay.
• The tablet may be taken on any day of the menstrual cycle.
• The tablet may be taken at any time of day, with or without food.
• If the patient is taking any medicines that may interfere with the proper action of Ulipristal Aristo (see section 2 "Important information before taking Ulipristal Aristo") or if the patient has taken any of these medicines within the last 4 weeks, Ulipristal Aristo may not be suitable. Consult your doctor or pharmacist before using Ulipristal Aristo. Your doctor may prescribe another type of (non-hormonal) emergency contraception, such as a copper intrauterine device (Cu-IUD).

Vomiting after taking Ulipristal Aristo
If vomiting occurs (nausea, vomiting) within 3 hours after taking the tablet, another tablet should be taken as soon as possible.
Unprotected intercourse after taking Ulipristal Aristo
If unprotected sexual intercourse occurs after taking the tablet, it will not prevent pregnancy. After taking the tablet, until the next menstrual period, condoms should be used during every sexual intercourse.
Delayed menstruation after taking Ulipristal Aristo
A delay of a few days in the onset of menstruation after taking the tablet is normal.
However, if menstruation is delayed by more than 7 days, is unusually light or unusually heavy, or if symptoms such as abdominal pain, breast tenderness, nausea or vomiting occur, pregnancy may have occurred. A pregnancy test should be performed immediately. If the patient is pregnant, it is important to consult a doctor (see section "Pregnancy, breastfeeding and effects on fertility").
Taking more than the recommended dose of Ulipristal Aristo
There have been no reports of harmful effects following overdose.
Nevertheless, consult your pharmacist, doctor, or other qualified healthcare professional.
If in doubt about the use of this medicine, consult your pharmacist, doctor, or other qualified healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some symptoms such as breast tenderness and abdominal pain, nausea and vomiting may also be possible signs of pregnancy. If menstruation does not occur and any of the above symptoms appear after taking Ulipristal Aristo, a pregnancy test should be performed (see section "Pregnancy, breastfeeding and fertility").

Frequent adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

• diarrhoea, heartburn, flatulence, dry mouth;
• unusual or irregular vaginal bleeding, heavy or prolonged menstrual bleeding, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido;
• hot flushes;
• appetite disturbances, emotional disturbances, anxiety, restlessness, sleep disorders, somnolence, migraine, visual disturbances;
• influenza-like symptoms;
• acne, skin changes, itching;
• fever, chills, malaise.

Rare adverse reactions (may affect up to 1 in 1,000 people)

• pain or itching of genital organs, pain during intercourse, ovarian cyst rupture, abnormally light menstrual bleeding;
• difficulty concentrating, dizziness, tremor, disorientation, fainting;
• abnormal sensation in the eye, eye congestion, photophobia;
• dry throat, taste disturbances;
• allergic reactions such as rash, urticaria (itchy rash) or facial swelling, thirst.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ulipristal Aristo

Keep this 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 specified month. The batch number is indicated on the carton and blister after the abbreviation "Lot".
Store in the original packaging to protect from light.
No special temperature storage conditions are required for this medicinal product.
Medicines must not be disposed of via the sewage system. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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: monohydrate lactose, pregelatinized starch (corn), sodium carboxymethyl starch (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 the imprint “U30” engraved on one side.
Ulipristal Aristo is available in a cardboard pack containing 1 coated tablet
in a transparent blister made of PVC/PVDC/aluminium foil.

Marketing Authorisation 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 medicinal product is authorised 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 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
Poland Ulipristal Aristo
Portugal Ulipristal Aristo 30 mg Comprimido revestido por película
United Kingdom
(Northern Ireland) Ulipristal Aristo 30 mg film-coated tablet
Spain Ulipristal Aristo 30 mg comprimido recubierto con película EFG

USEFUL INFORMATION ABOUT CONTRACEPTION
ADDITIONAL INFORMATION ABOUT EMERGENCY CONTRACEPTION
The sooner emergency contraception is used, the greater the chance of avoiding pregnancy.
Emergency contraception does not affect fertility.
Emergency contraception may delay ovulation in the current menstrual cycle,
but it will not prevent pregnancy if unprotected sexual intercourse occurs again.
After using emergency contraception and until the next menstrual period, condoms must be used during every sexual intercourse.

ADDITIONAL INFORMATION ABOUT REGULAR CONTRACEPTIVE METHODS
If emergency contraception has been used and you are not using, or do not have an appropriate, regular contraceptive method, you should consult your doctor or a family planning clinic for advice.
There are many different contraceptive methods available, allowing you to choose the most suitable one for yourself.

Examples of regular contraceptive methods:

Daily methods
Oral contraceptive pill

Weekly or monthly methods
Contraceptive patch
Vaginal ring

Long-acting methods
Contraceptive implant
Intrauterine device