5X

ULIPRISTAL ACETATE [FOR EMERGENCY CONTRACEPTION]

Emergency contraception is a rescue method which is aimed to prevent fertilization in case of unprotected intercourse. This contraception is used within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure, particularly If you have had a sexual intercourse whereas either yourself or your partner did not use a contraceptive method If you have forgotten to take consecutive 3 regular contraceptive pills If your partner's condom has broken, slipped or been improperly removed or if he has forgotten to use it If you fear that your intrauterine device has been expelled If your vaginal diaphragm or your contraceptive cap has moved or if have removed it too easily If you are afraid that the method of coitus interruptus has failed or if you have had sexual intercourse during the period when you are supposed to be fertile while using the rhythm method In the event of rape

Drugs acting on the Uterus, Emergency Contraceptive Pill

One tablet (30 mg) should be taken orally with a glass of water.The treatment necessitates the intake of one tablet. The Ulipristal Acetate tablet must be taken as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. The tablet can be taken with or without food. If vomiting occurs within 3 hours of Ulipristal Acetate intake, consideration should be given to repeating the dose. Ulipristal Acetate can be taken at any time during the menstrual cycle. After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, cervical cap) until the next menstrual period resume.The use of Ulipristal Acetate does not contraindicate the continuation of regular hormonal contraception. If you have used this medicine while you were using an oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill free period following the use of Ulipristal Acetate, a pregnancy test should be performed to rule out a pregnancy.

Simultaneous administration of certain anticonvulsant agents (phenobarbiton, phenytoin, primidone, carbamazepin), also other medications such as rafimpicin and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.

Should not use this medicine- If you have hypersensitivity to Ulipristal Acetate or its any excipients Do not use more than one time in the same menstrual cycle If you are already pregnant

Undesirable effects which have been observed are: Nausea and vomiting Dizziness, fatigue, headache Abdominal pain A feeling of breast tenderness Bleeding can occur after taking this medicine

Pregnancy Category X. Use of Ulipristal Acetate is contraindicated during an existing or suspected pregnancy. Use of Ulipristal Acetate by breastfeeding women is not recommended.

No acute toxicity has been demonstrated with this medicine in case of intake of several doses.

Emergency contraception must be used exceptionally, since The associated hormonal overdosing is not advisable in case of regular intake It cannot replace a regular contraception After taking Ulipristal Acetate, menstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this tablet, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of expected period or in case of menstrual delay of more than 5 days. The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission.

Store in a cool & dry place, protected from light. Keep out of reach of children.