ULIPRISTAL 30 mg Tabletki Powlekane

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1. Ulipristal Aristo 30 mg film-coated tablet
   1. What is Ulipristal Aristo and what is it 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. Package contents and other information

Ulipristal Aristo 30 mg film-coated tablet

Ulipristal acetate

Generic Medicine
Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your pharmacist, doctor or other healthcare professional. 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 you use Ulipristal Aristo
• 3. How to use 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
Ulipristal Aristo is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or following the failure of a contraceptive method. For example:

• if you have had unprotected sexual intercourse;
• if your condom or your partner's condom has broken, slipped or come out, or if you have forgotten to use it;
• if you have not taken the contraceptive pill according to the instructions.

You should take the tablet as soon as possible after sexual intercourse, and in any case within a maximum of 5 days (120 hours).
This is because sperm can survive for up to 5 days inside the body after intercourse.
This medicine is suitable for any woman of childbearing age, including adolescents.
The tablet can be taken at any time of the menstrual cycle.
Ulipristal Aristo does not work if a pregnancy is already in progress
If your period is delayed, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (heavy breasts, morning sickness), you should consult a doctor or healthcare professional 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 of the cycle can cause pregnancy.
Ulipristal Aristo should not be used as a regular contraceptive
If you are not using a regular contraceptive method, talk to a doctor or healthcare professional to choose one that is suitable for you.
How Ulipristal Aristo works
Ulipristal Aristo contains the substance ulipristal acetate,which works by changing the activity of the natural hormone progesterone, which is necessary for ovulation to occur. Consequently, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, a pregnancy occurs in approximately 2 cases.
This medicine is a contraceptive used to prevent a pregnancy from occurring. If you are already pregnant, this will not terminate an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom guarantees protection against sexually transmitted infections.
This medicine does not offer protection against infection with HIV or other sexually transmitted diseases (for example, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis).
If you are concerned about this, please contact a healthcare professional.
You will find further information on 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 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 (tender breasts, morning sickness), as you may 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 an increase in body weight or body mass index (BMI), but this data is limited and not conclusive.
Therefore, Ulipristal Aristo is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, talk to a healthcare professional.
If you become pregnant despite taking this medicine, it is important to 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 to use it regularly after taking the tablet, but use condoms every time you have intercourse until your next period.
Do not take Ulipristal Aristo together with another emergency contraceptive pill containing levonorgestrel.
Taking the two medicines together may reduce the effectiveness of this medicine.

Other medicines and Ulipristal Aristo
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines may prevent Ulipristal Aristo from working effectively. If you have used any of the medicines listed below during the last 4 weeks, Ulipristal Aristo may be less suitable for you. Your doctor may prescribe you another type (non-hormonal) of emergency contraception, namely

• medicines used for the treatment of epilepsy (e.g. primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
• medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
• a treatment for HIV (ritonavir, efavirenz, nevirapine)
• a medicine used for the treatment of 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 using (or have recently used) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy
Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare professional, or take 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. If you are already pregnant, it will not terminate an existing pregnancy.
If you should become pregnant despite taking Ulipristal Aristo, ask your doctor to register your pregnancy in an official register. You can also report this information yourself through the marketing authorisation holder’s reporting system. Your information will remain anonymous - no one will know that the information concerns you. Sharing the information can help women in the future to 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 to express and discard milk to stimulate and maintain production, but discard it.
The effects of breastfeeding on your baby in the week following taking this medicine are unknown.

Fertility
This medicine will not have any adverse effects on your subsequent fertility. If you have unprotected 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 method of contraception after using this medicine, you can do so, but you should also use a condom until your next period.

Driving and operating machinery
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 or operate machinery.

Ulipristal Aristo contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ulipristal Aristo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially “sodium-free”.

3. How to take Ulipristal Aristo

Take this medicine following exactly what is stated in this leaflet or the instructions
of the pharmacist, doctor or other healthcare professional. If you have any doubts, consult your pharmacist or
doctor.
How to take the film-coated tablet of Ulipristal Aristo

• Take one tablet orally as soon as possible and in any case no later than 5 days (120 hours) after unprotected sexual intercourse or failure of the contraceptive method. Do not delay taking the tablet.
• This medicine can be taken at any time of the menstrual cycle.
• This medicine can be taken at any time of the day, before, during or after a meal.
• If you are using any of the medicines that may prevent Ulipristal Aristo from working properly (see the previous paragraph “Other medicines and Ulipristal Aristo”) or if you have used any of these medicines in 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 you 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 one as soon as possible.
If you have another sexual intercourse after taking Ulipristal Aristo
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent the start
of a pregnancy. After taking the tablet and until your next period, you should always use
condoms for each sexual intercourse.
If your next period is delayed after taking Ulipristal Aristo
After taking the tablet, it is normal for your next period to be delayed by a few days.
However, if your period appears after more than 7 days; if the bleeding is unusually light or
unusually heavy; or if you experience symptoms such as abdominal pain (stomach ache), breast pain,
vomiting or nausea, you may be pregnant. You should take a pregnancy test immediately. If
a pregnancy occurs, it is important that you see your doctor (see paragraph “Pregnancy, breastfeeding and
fertility”).
If you take more Ulipristal Aristo than you should
No harmful effects have been reported in case of taking a higher dose of this medicine
than recommended. However, ask for advice from your pharmacist, doctor or other healthcare
professional.
If you have any doubts about the use of this medicine, ask your pharmacist, 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 pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea)
are also possible 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 periods, 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, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sexual desire)
• hot flushes
• changes in appetite, emotional disturbances, anxiety, agitation, difficulty sleeping, drowsiness, migraine, visual disturbances
• flu
• acne, skin lesions, itching
• fever, chills, feeling unwell

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after
“Exp.” The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Ulipristal Aristo contains

• The active ingredient is ulipristal acetate. One film-coated tablet contains 30 milligrams of ulipristal acetate.
• The other ingredients are lactose monohydrate, pregelatinized starch (corn), 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 package contents
Ulipristal Aristo is a white, round, biconvex film-coated tablet of 9.0 - 9.2 mm in
diameter with "U30" imprinted on one side.
Ulipristal Aristo is available in a carton containing a transparent PVC / PVDC / aluminum blister
containing 1 tablet.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straβe 8-10
13435 Berlin
Germany

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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 ABOUT CONTRACEPTION
FURTHER INFORMATION ABOUT EMERGENCY CONTRACEPTION
The less time that passes between sexual intercourse and taking emergency contraception,
the greater the chances of avoiding pregnancy.
Emergency contraception will not have any negative effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but will not
prevent pregnancy if you have another unprotected sexual intercourse. After taking
emergency contraception and until your next menstruation, you should always use a condom for
every sexual intercourse.

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

Daily methods
Contraceptive pill

Weekly or monthly methods
Contraceptive patch Vaginal ring

Long-acting methods
Contraceptive implant IUD (intrauterine device)