Ulipristal 30 mg film-coated tablet

ulipristal acetate

Ulipristal 30 mg film-coated tablet is an emergency contraceptive

Ulipristal 30 mg film-coated tablet is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example:

• if you had sex without protection;
• if your or your partner’s condom tore, slipped or came off, or if you forgot to use one;
• if you did not take your contraceptive pill as recommended.

You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours).

This is because the sperm can survive up to 5 days in your body after intercourse.

This medicine is suitable for any woman of childbearing age, including adolescents.

You can take this tablet at any time in the menstrual cycle.

Ulipristal 30 mg film-coated tablet does not work if you are already pregnant.

If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have symptoms of pregnancy (heavy 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 stop you from becoming pregnant.

Unprotected sex at any time during your cycle can lead to pregnancy.

Ulipristal 30 mg film-coated tablet is not to be used for regular contraception

If you do not have a regular method of contraception, talk to your doctor or healthcare professional to choose one that is suitable for you.

How Ulipristal 30 mg film-coated tablet works

Ulipristal 30 mg film-coated tablet contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur. As a result, this medicine works by postponing ovulation. Emergency contraception is not effective in every case. Of 100 women who take this medicine approximately 2 will become pregnant.

This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant, it will not interrupt an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections

Only condoms can protect you from sexually transmitted infections. This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you are worried about this.

There is more information about contraception at the end of this leaflet.

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you. Check with your pharmacist or doctor if you are not sure.

How to take the Ulipristal 30 mg film-coated tablet

• Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure. Take the tablet without delay.
• You can take this medicine at any time in your cycle.
• You can take this medicine at any time of the day either before, during or after a meal.
• If you are using one of the medicines that may prevent Ulipristal 30 mg film-coated tablet from working properly (see section above “Other medicines and Ulipristal 30 mg film-coated tablet”) or if you have used one of these medicines in the past 4 weeks, Ulipristal 30 mg film-coated tablet may work less effectively for you.

Speak to your doctor or pharmacist before using Ulipristal 30 mg film-coated tablet. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD).

If you vomit after taking Ulipristal 30 mg film-coated tablet

If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have sex again after taking Ulipristal 30 mg film-coated tablet

If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. After you take the tablet and until your next period comes, you should use condoms every time you have sex.

If your next period is late after taking Ulipristal 30 mg film-coated tablet

After taking the tablet, it is normal for your next period to be a few days late.

However, if your period is more than 7 days late; if it is unusually light or unusually heavy; or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you may be pregnant. You should do a pregnancy test right away. If you are pregnant, it is important that you see your doctor. (See section “Pregnancy, breast-feeding and fertility”)

If you take more Ulipristal 30 mg film-coated tablet than you should

There have been no reports of harmful effects from taking a higher dose than recommended of this medicine, however do ask your pharmacist, doctor or other healthcare professional for advice.

If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other healthcare professional.

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

Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy.

If you miss your period and experience such symptoms after taking Ulipristal 30 mg film-coated tablet, you should do a pregnancy test (See section “Pregnancy, breastfeeding and fertility”).

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

• nausea, abdominal (stomach) pain or discomfort, vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, mood swings
• muscle pain, back pain, tiredness

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

• diarrhoea, heartburn, wind, dry mouth
• unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive
• hot flushes
• appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine
• visual disturbances
• influenza
• 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 sex, rupture of an ovarian cyst, unusually light period
• loss of concentration, vertigo, shaking, disorientation, fainting
• unusual sensation in eye, red eye, sensitivity to light
• dry throat, disturbance in taste
• feeling thirsty
• allergic reactions such as rash, hives or swelling of the face

Reporting of side effects

If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme, at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play of Apple App Store. By reporting side effects, you can provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via waste water.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.