UlliOnce 30 mg 1 film-coated tablet

UlliOnce is an emergency contraceptive.

UlliOnce is a contraceptive used to prevent pregnancy after unprotected sexual intercourse or failure of the contraceptive method. For example:

• if you have had unprotected sexual intercourse;
• if your partner's condom has broken, slipped or come off completely, or if you have forgotten to use a condom;
• if you have not taken your birth control pill as recommended.

The film-coated tablet should be taken as soon as possible after sexual intercourse, but no later than 5 days (120 hours) afterwards.
The reason for this is that sperm can survive in your body for up to 5 days after sexual intercourse.

This medicine is suitable for all women of childbearing age, including adolescents.

You can take the film-coated tablet at any time during the menstrual cycle.

UlliOnce is not effective if you are already pregnant.

If your period is late, there is a possibility that you are pregnant. If your period is late, or if you experience symptoms of pregnancy (heavy breasts, morning sickness), talk to a doctor or other healthcare professional before taking the film-coated tablet.

If you have unprotected sex after taking the film-coated tablet, you can still become pregnant. You can become pregnant if you have unprotected sex at any time during your cycle.

UlliOnce is not suitable for regular contraception.

If you are not using a regular method of birth control, talk to your doctor or nurse to choose a method that is suitable for you.

Contraindications

DO NOT take UlliOnce if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).

Interactions

Other contraceptives and UlliOnce

This medicine may temporarily make regular hormonal contraceptives such as birth control pills and patches work.
If you are currently taking hormonal contraceptives, continue to take them as usual after taking the film-coated tablet, but use condoms every time you have sex until your next period.

Do not use UlliOnce with other emergency contraception that contains levonorgestrel. Taking them
together could reduce the effect of this medicine.
Other medicines and UlliOnce
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 can make UlliOnce less effective. If you have taken any of the following medicines within the last 4 weeks, UlliOnce may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraception, such as a copper IUD:

• Medicines used to treat epilepsy (for example primidone, phenobarbital, phenytoin, phosphenytoin, carbamazepine, oxcarbazepine and barbiturates),
• Medicines used to treat tuberculosis (for example rifampicin, rifabutin),
• Medicines to treat HIV infection (ritonavir, efavirenz, nevirapine),
• a medicine for treating fungal infections (griseofulvin),
• herbal medicines containing St. John's wort (Hypericum perforatum).

Before taking UlliOnce, contact your doctor or pharmacist if you are taking (or have recently taken) any of the above medicines.

Pregnancy, breast-feeding and fertility

Pregnancy
If your period is late, talk to your doctor, pharmacist or other healthcare professional before taking this medicine, or do a pregnancy test to make sure you are not already pregnant (see section “Warnings and precautions”).

This medicine is a contraceptive to prevent pregnancy from occurring. If you are already pregnant, taking it will not terminate the existing pregnancy.

If you become pregnant despite taking UlliOnce, ask your doctor to register your pregnancy in an official database. You can also enter this information yourself at www.ulipristal-pregnancy-registry.com. Your information will be treated confidentially, meaning no one will know that this information came from you. By sharing your information, you will help other women understand the safety and risks of UlliOnce during pregnancy.

Breastfeeding
If you take this medicine while you are breast-feeding, do not breast-feed your baby for one week after taking UlliOnce. During this period, you are advised to express breast milk to maintain milk production, but to discard it. The effects of breastfeeding on the baby during the first week after taking this medicine are not known.

Fertility
This medicine has no effect on your future fertility. If you have unprotected sex after taking this medicine, it will not prevent a possible pregnancy. Therefore, it is important that you use condoms until your next period.
If you want to start or continue a regular method of contraception after taking this medicine, you can do so, but be sure to use condoms as well until your next period.

Application

• Take a film-coated tablet as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure. Do not delay taking the tablet.
• You can take this medicine at any time during your menstrual cycle.
• You can take this medicine at any time of the day and before, with or after a meal.
• If you are taking any of the medicines that may reduce the effectiveness of UlliOnce (see section “Taking UlliOnce with other medicines” above) or if you have taken any of these medicines in the past 4 weeks, UlliOnce may affect you be less effective. Before taking UlliOnce, talk to your doctor or pharmacist. Your doctor may prescribe another (non-hormonal) type of emergency contraception, such as a copper IUD.

If you vomit after taking UlliOnce
If you vomit (vomit) within 3 hours of taking the film-coated tablet, take a second film-coated tablet as soon as possible.

If you have sexual intercourse again after taking UlliOnce
If you have unprotected sexual intercourse again after taking the film-coated tablet, this will not prevent pregnancy. For this reason, use condoms every time you have sexual intercourse after taking the film-coated tablet until your next period.

If your next period is delayed after taking UlliOnce
After taking the film-coated 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, if it is unusually light or unusually heavy, or if you experience symptoms such as abdominal (belly) pain, breast tenderness, vomiting or nausea, there is a possibility that you are pregnant. If this happens, take a pregnancy test immediately. If you are pregnant, be sure to consult your doctor (see section “Pregnancy, breast-feeding and fertility”).

If you take more UlliOnce than you should
No harmful effects have been reported after taking a higher dose than recommended for this medicine. However, in such a case, please contact your doctor, pharmacist or other medical professional.

If you have any further questions about taking this medicine, ask your doctor, pharmacist or other healthcare professional.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some symptoms, such as breast tenderness and abdominal (stomach) pain, vomiting (vomiting), nausea (feeling sick), can also be signs of pregnancy. If you miss your period and experience the symptoms described after taking UlliOnce, take a pregnancy test (see “Pregnancy, breast-feeding and fertility” section).

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

• Nausea, abdominal pain or discomfort in the stomach area, vomiting,
• Menstrual pain, pelvic pain, breast tenderness,
• Headache, dizziness, mood swings,
• Muscle pain, back pain, fatigue.

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

• Diarrhoea, heartburn, flatulence, dry mouth,
• abnormal or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal inflammation or discharge, decreased or increased libido,
• Hot flashes,
• Changes in appetite, emotional disturbances, anxiety, general physical restlessness, sleep disturbances, sleepiness, migraines, visual disturbances,
• Influenza,
• acne, rash, itching,
• Fever, chills, feeling unwell.

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

• Pain or itching in the genital area, pain during intercourse, detachment of an ovarian cyst, unusually light periods,
• Loss of concentration, dizziness, tremors, confusion, fainting,
• unusual feeling in the eyes, red eye, sensitivity to light,
• dry throat, impaired sense of taste,
• Hives, feeling thirsty.

composition

The active ingredient is: ulipristal acetate.
One film-coated tablet contains 30 mg ulipristal acetate

The other ingredients are:
lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, magnesium stearate, hypromellose (E464), hydroxypropyl cellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).