Ulipristal Aristo: detailed information

Package leaflet: Information for the user

Ulipristal Aristo 30 mg film-coated tablet

Ulipristal acetate
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you to do.

Keep this leaflet. You may need to read it again.
If you need more advice or information, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your pharmacist, doctor or other healthcare professional. See section 4.

Contents of this leaflet

What Ulipristal Aristo is and what it is used for
What you need to know before you take Ulipristal Aristo
How to take Ulipristal Aristo
Possible side effects
How to store Ulipristal Aristo
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
Ulipristal Aristo is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or following failure of a contraceptive method. For example:

if you had unprotected sexual intercourse;
if you or your partner’s condom broke, slipped off or came out, or if you forgot to use it;
if you missed taking your contraceptive pill as instructed.

You must take the tablet as soon as possible after intercourse, and no later than 5 days (120 hours).
This is because sperm can survive up to 5 days inside the body after intercourse.
This medicine is suitable for any woman of fertile age, including adolescents.
The tablet can be taken at any time during the menstrual cycle.
Ulipristal Aristo does not work if pregnancy is already established
If your period is late, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (such as breast tenderness, morning nausea), you must consult a doctor or healthcare provider before taking the tablet.
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent pregnancy.
Unprotected sexual intercourse at any time during the cycle can lead to pregnancy.
Ulipristal Aristo must not be used as a regular contraceptive
If you are not using a regular contraceptive method, speak with a doctor or healthcare provider to choose one suitable for you.
How Ulipristal Aristo works
Ulipristal Aristo contains the active substance ulipristal acetate, which works by altering the activity of the natural hormone progesterone, necessary for ovulation to occur. As a result, this medicine acts by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, approximately 2 will become pregnant.
This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not interrupt an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom provides protection against sexually transmitted infections.
This medicine does not offer protection against HIV infection or other sexually transmitted diseases (for example, chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis).
If you are concerned about this, please consult a healthcare provider.
Further information about contraception can be found at the end of this leaflet.

2. What you should know before taking Ulipristal Aristo

Do not take Uliprist  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 pharmacist, doctor or other healthcare professional before taking Ulipristal Aristo

if your period is late or if you have symptoms of pregnancy (heavy breasts, morning nausea), as you might already be pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you suffer from severe asthma;
if you suffer from severe liver disease.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. According to some data, this medicine may be less effective with increasing body weight or body mass index (BMI), but these data are limited and not conclusive. Therefore, Ulipristal Aristo is recommended for all women regardless of weight or BMI. If you are concerned about potential problems related to taking emergency contraception, speak with a healthcare professional.
If you become pregnant despite taking this medicine, it is important that you see your doctor. See section “Pregnancy, breastfeeding and fertility” for further information.

Other contraceptives and Ulipristal Aristo
This medicine may temporarily reduce the effectiveness of regular hormonal contraceptives such as pills and patches.
If you are taking a hormonal contraceptive, continue using it regularly after taking the tablet, but use condoms every time you have sexual intercourse until your next period.
Do not take Ulipristal Aristo together with another emergency contraceptive pill containing levonorgestrel.
Taking both medicines together could reduce the effectiveness of this medicine.

Other medicines and Ulipristal Aristo
Tell your pharmacist, doctor or other healthcare professional if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines may prevent Ulipristal Aristo from working effectively. If you have taken any of the medicines listed below during the past 4 weeks, Ulipristal Aristo may be less suitable for you. Your doctor may prescribe another type (non-hormonal) of emergency contraception, 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, rifabutin)
treatment for HIV (ritonavir, efavirenz, nevirapine)
a medicine used to treat fungal infections (griseofulvin)
herbal preparations containing St. John’s wort (Hypericum perforatum)

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

Pregnancy, breastfeeding and fertility
Pregnancy
Before taking this medicine, if your period is late, inform your pharmacist, doctor or other healthcare professional, or perform 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 from occurring. If you are already pregnant, it will not terminate the existing pregnancy.
If you become pregnant despite taking Ulipristal Aristo, ask your doctor to register your pregnancy in an official registry. You may also report this information yourself through the marketing authorisation holder’s reporting system. Your information will remain anonymous – no one will know the information concerns you. Sharing this information may help women in the future understand the safety or risks of Ulipristal Aristo during pregnancy.

Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking it. During this period, it is recommended that you express milk to maintain milk production, but discard the milk. The effects of breastfeeding on your baby during the week following intake of this medicine are unknown.

Fertility
This medicine will not have any negative effects on your future fertility. If you have unprotected sexual intercourse after taking this medicine, it will not prevent pregnancy. It is therefore important to use a condom until your next period.
If you wish to start or continue using a regular contraceptive method after using this medicine, you may do so, but you must also use condoms until your next period.

Driving and using machines
After taking this medicine, some women report dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4 “Possible side effects”). If you experience these symptoms, do not drive and do not operate machinery.

Ulipristal Aristo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Ulipristal Aristo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Ulipristal Aristo

Take this medicine exactly as described in this leaflet or as directed by your pharmacist, doctor, or other healthcare professional. If you have any doubts, consult your pharmacist or doctor.

How to take the Ulipristal Aristo film-coated tablet

Take one tablet orally as soon as possible, and no later than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablet.
This medicine can be taken at any time during the menstrual cycle.
This medicine can be taken at any time of day, before, during, or after a meal.
If you are taking any medicines that may reduce the effectiveness of Ulipristal Aristo (see the previous section “Other medicines and 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 Aristo. Your doctor may prescribe another type of emergency contraception (non-hormonal), namely a copper intrauterine device (IUD-Cu).

In case of vomiting after taking Ulipristal Aristo
If you vomit within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have unprotected sexual intercourse after taking Ulipristal Aristo
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent a pregnancy from occurring. After taking the tablet and until your next menstrual period, you must always use condoms for every act of sexual intercourse.

If your next menstrual period is delayed after taking Ulipristal Aristo
After taking the tablet, it is normal for your next menstrual period to be delayed by a few days. However, if your period is more than 7 days late, if the bleeding is unusually light or unusually heavy, or if you experience symptoms such as abdominal pain (stomach ache), breast tenderness, vomiting, or nausea, you may be pregnant. You should perform a pregnancy test immediately. If pregnancy occurs, it is important that you see your doctor (see section “Pregnancy, breastfeeding and fertility”).

If you take more Ulipristal Aristo than you should
No harmful effects have been reported following intake of a higher dose than recommended of this medicine. Nevertheless, consult your pharmacist, doctor, or other healthcare professional for advice.

If you have any doubts about how to use this medicine, consult your pharmacist, doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea),
may also be signs of pregnancy. If you miss a period and experience these symptoms after taking
Ulipristal Aristo, you should perform a pregnancy test (see section 2 “Pregnancy, breastfeeding and
fertility”).

Common side effects (may affect up to 1 in 10 people)

nausea, abdominal pain (stomach ache) or discomfort, vomiting, painful menstruation, pelvic pain, breast pain
headache, dizziness, mood swings
muscle pain, back pain, fatigue

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

diarrhoea, heartburn, flatulence (intestinal gas), dry mouth
unusual or irregular vaginal bleeding, prolonged or heavy menstruation, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sexual desire)
hot flushes
changes in appetite, emotional disturbances, anxiety, restlessness, difficulty sleeping, drowsiness, migraine, visual disturbances
influenza-like symptoms
acne, skin lesions, itching
fever, chills, malaise

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

genital pain or itching, pain during sexual intercourse, rupture of ovarian cyst, unusually light menstruation
difficulty concentrating, vertigo, tremors, disorientation, fainting
abnormal sensation in the eyes, eye redness, light sensitivity
dry throat, taste disturbances
urticaria (itchy rash), feeling of thirst

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help 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 which is stated on the carton and blister after
"Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ulipristal Aristo contains

The active substance is ulipristal acetate. One film-coated tablet contains 30 milligrams of ulipristal acetate.
The other ingredients are lactose monohydrate, pregelatinized starch (maize), sodium starch glycolate, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Description of the appearance of Ulipristal Aristo and contents of the pack
Ulipristal Aristo is a white, round, biconvex film-coated tablet with a diameter of 9.0–9.2 mm, marked with "U30" on one side.
Ulipristal Aristo is available in a box containing one transparent PVC/PVDC/aluminium blister with 1 tablet.

Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria Ulipristal Aristo 30 mg Filmtablette
Germany Ulipristal Aristo 30 mg Filmtablette
Italy Ulipristal Aristo
Netherlands Ulipristal Aristo 30 mg filmomhulde tablet
Poland Ulipristal Aristo
Portugal Ulipristal Aristo
United Kingdom Ulipristal Aristo 30 mg film-coated tablet
Czech Republic Ulipristal acetate Aristo
Spain Ulipristal Aristo 30 mg comprimido recubierto con película EFG

USEFUL INFORMATION ON CONTRACEPTION

ADDITIONAL INFORMATION ON EMERGENCY CONTRACEPTION
The sooner emergency contraception is taken after unprotected sex, the more effective it is at preventing pregnancy.
Emergency contraception will not have any negative effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but it will not prevent pregnancy if you have another unprotected sexual intercourse. After taking emergency contraception and until your next menstrual period, you must always use a condom for every sexual intercourse.

ADDITIONAL INFORMATION ON REGULAR CONTRACEPTION
If you have taken emergency contraception and you are not using a regular contraceptive method (or have not found a suitable contraceptive method for you), speak to your doctor or visit a family planning clinic.
There are many different types of contraceptives available, and you should be able to find one that suits you.
Examples of regular contraceptive methods:

Daily methods
Oral contraceptive pill

Weekly or monthly methods
Contraceptive patch
Vaginal ring

Long-acting methods
Contraceptive implant
IUD (intrauterine device)