Ulipristal Stada 30 mg film-coated tablet EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ulipristal Stada 30 mg film-coated tablet EFG
Ulipristal acetate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for taking the 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 adverse reactions, consult your doctor, pharmacist, or other healthcare professional, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ulipristal Stada is and what it is used for
- What you need to know before taking Ulipristal Stada
- How to take Ulipristal Stada
- Possible side effects
- How to store Ulipristal Stada
- Contents of the pack and other information
- Useful information regarding contraception
1. What Ulipristal Stada is and what it is used for
Ulipristal acetate is an emergency contraceptive
Ulipristal acetate is a contraceptive intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure. For example:
- if you have had unprotected sex
- if a condom used by you or your partner broke, slipped, or was not used
- if you missed taking your regular contraceptive pill as directed
You should take the tablet as soon as possible after having unprotected sex, and no later than 5 days (120 hours) afterwards.
This is because sperm can survive up to 5 days inside your body after sexual intercourse.
This medicine is suitable for any woman of reproductive age, including adolescents.
You may take the tablet at any time during your menstrual cycle.
Ulipristal acetate does not work if you are already pregnant
If your menstrual period is delayed, you might be pregnant. If your period is late or you experience 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 sexual intercourse can lead to pregnancy at any time during the menstrual cycle.
Ulipristal acetate 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 acetate works
Ulipristal acetate 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 disease (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 Stada
DO NOT take Ulipristal Stada
- 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 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 sex. There is some evidence that this medicine may be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ulipristal acetate 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 the tablet, it is important that you see your doctor. See section “Pregnancy, breastfeeding and fertility” for more information.
Use of Ulipristal Stada 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 this medicine, but make sure to use condoms every time you have sex until your next period.
Do not take this medicine together with another emergency contraceptive pill containing levonorgestrel. Taking them together could reduce the effectiveness of this medicine.
Taking Ulipristal Stada with other medicines
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 acetate from working effectively. If you have taken any of the following medicines within the past 4 weeks, ulipristal acetate may be less effective. Your doctor may prescribe another type of emergency (non-hormonal) contraception, i.e., 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)
Talk to your doctor or pharmacist before using ulipristal acetate 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 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 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 acetate, you are encouraged to inform your doctor so that 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 acetate during pregnancy.
Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed your baby during the week after taking this medicine. We recommend that, during that week, you use a breast pump to maintain milk production but discard the expressed milk. The effect on the baby of breastfeeding during the week after taking this medicine is unknown.
Fertility
This medicine does not affect your future fertility. If you have unprotected sex after taking the tablet, 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 must also use condoms until your next period.
Driving and use of machines
After taking this medicine, some women experience dizziness, drowsiness, blurred vision, or difficulty concentrating (see section 4). If you experience these symptoms, do not drive or operate machinery.
Ulipristal Stada contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Ulipristal Stada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free.”
3. How to take Ulipristal Stada
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 Stada 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, either before, during, or after a meal
- if you are taking any of the medicines that may prevent ulipristal acetate from working properly (see section 2 “What you need to know before taking Ulipristal Stada”) or if you have taken any of these medicines within the last 4 weeks, ulipristal acetate may be less effective for you. Consult your doctor or pharmacist before using ulipristal acetate. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., a copper IUD
If you vomit after taking Ulipristal Stada
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 Stada
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 Stada
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 Stada 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.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the 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 experiences them.
Some symptoms, such as breast tenderness and abdominal pain (stomach pain), vomiting, and nausea (feeling sick), may also be possible signs of pregnancy. If your period does not come and you experience these symptoms after taking ulipristal acetate, you should take a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).
Frequent (may affect up to 1 in 10 people):
- nausea, abdominal pain or discomfort (stomach), vomiting
- painful periods, pelvic pain, breast tenderness
- headache, dizziness, mood changes
- muscle pain, back pain, fatigue
Uncommon (may affect up to 1 in 100 people):
- diarrhoea, heartburn, flatulence, dry mouth
- irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased sexual desire
- hot flushes
- changes in appetite, emotional disorders, anxiety, restlessness, sleep problems, drowsiness, migraine, visual disturbances
- flu-like symptoms
- acne, skin lesions, itching
- fever, chills, malaise
Rare (may affect up to 1 in 1,000 people):
- 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
- itchy rash, feeling thirsty
- allergic reactions such as rashes, hives, or swelling of the face
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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. Storage of Ulipristal Stada
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 temperature.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ulipristal Stada
- The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.
- The other components are monohydrate lactose, pregelatinized maize starch, sodium carboxymethyl starch (type A) (from potato), 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 Stada
Ulipristal Stada is a film-coated tablet, round, biconvex, 9.0 – 9.2 mm in diameter, white in colour, marked with "U30" on one side.
Ulipristal Stada is marketed in a box containing one transparent PVC/PVDC/aluminium blister with 1 tablet.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
or
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
or
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
Netherlands
or
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Date of the most recent review of this leaflet: May 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/
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 you from becoming pregnant 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 do not use a regular contraceptive method (or do not have a suitable contraceptive method), consult 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 suitable for you.
Examples of regular contraceptive methods include:
Daily methods
Oral contraceptive pill
Weekly or monthly methods
Contraceptive patch
Vaginal ring
Long-term methods
Contraceptive implant
IUD (intrauterine device)