Information on the correct use of OTC emeregency contraception containing ulipristal acetate and levonorgestrel
The emergency contraception for preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. There are two oral emergency contraceptives without prescription currently authorised in Croatia. In order to ensure its correct and safe use, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to inform healthcare providers and users with information related to the use of these medicines:
- The emergency contraception ellaOne contains ulipristal acetate as active substance and emergency contraception Escapelle 1.5 mg tablets contains levonorgestrel as active substance.
- It is not recommended to concomitantly use the ulipristal-containing emergency contraception and levonrgestrel-containing emergency contraception.
- Levonorgestrel is used for preventing unintended pregnancy if taken as soon as possible and no later than 72 h (three days) after an unprotected sexual intercourse or contraceptive failure. Ulipristal acetate is used for preventing unintended pregnancy if take as soon as possible and no later than 120 h (five days) after an unprotected sexual intercourse or contraceptive failure. Ulipristal acetate delays the LH peak even after increase of the LH wave.
- These medicines have a comparable safety profile.
- Levonorgestrel is not recommended for women with an increased risk of ectopic pregnancy (salpingitis or ectopic pregnancy in anamnesis).
- Escapelle 1.5 tablets may be dispensed only to women of 16 years and above.
- Further information on the correct use is available in the summary of product characteristics and package leaflet of these medicines.
HALMED would like to remind that the emergency contraception with Escapelle 1.5 mg tablets or ellaOne are methods that may be used only occasionally and should not replace the regular contraception.
The emergency contraception ellaOne is authorised via centralised procedure in the European Union and its reclassification status from prescription only to non-prescription, in pharmacy, was changed based on Commission’s Decision from January 2015. The emergency contraception Escapelle 1.5 mg tablets is authorised via national procedure in the Republic of Croatia and September 2015 the variation was approved to reclassify the medicine from the prescription only status to non-prescription, in pharmacy.
The decision on reclassification of Escapelle 1.5 mg tablets HALMED adopted in in September 2015 based on the application of marketing authorisation holder, where it was concluded that the benefit/risk ratio was positive for non-prescription status, in pharmacy. The packaging of this medicine intended for non-prescription use has yet to be placed on the Croatian market. The prerequisite for the beginning of non-prescription status will be fulfilled, after the marketing authorisation holder for Escapelle has prepared and produced the packaging, summary of product characteristics and package leaflet in Croatian adapted for non-prescription use. HALMED will promptly inform the public on the beginning of placing on the market of this non-prescription packaging of this medicine. The remaining stocks of Escapelle intended to be used as prescription only that may still be found in Croatian pharmacy, will be further dispensed as prescription only until they have run out.