Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: LABORATOIRE HRA PHARMA, 200 avenue de Paris, 92320, CHATILLON, France
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken.
If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before the tablet is administered.
No dose adjustment is necessary.
In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be made.
In the absence of specific studies, ulipristal acetate is not recommended.
There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception.
Adolescents: ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, including adolescents. No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1).
Oral use.
The tablet can be taken with or without food.
Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used in women without safety concern. Such high doses were well-tolerated; however, these women had a shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in some women, the duration of bleeding was prolonged, although not excessive in amount (spotting). There are no antidotes and further treatment should be symptomatic.
3 years.
Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in the outer carton in order to protect from light.
PVC-PE-PVDC-Aluminium blister of 1 tablet.
PVC-PVDC-Aluminium blister of 1 tablet.
Each carton contains one blister.
Not all pack sizes may be marketed.
No special requirements.
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