ELLAONE 30MG TABLET
1. Name of the medicinal product
ellaOne 30 mg tablet
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect:
Each tablet contains 237 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1
White to marble creamy, round curved tablet engraved with code “еllа” on both faces
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.
ellaOne can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of ellaOne 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 ellaOne is administered.
No dose adjustment is necessary.
In the absence of specific studies, no alternate dose recommendations for ellaOne can be made.
Severe hepatic impairment
In the absence of specific studies, ellaOne is not recommended.
There is no relevant use of ellaOne for children of prepubertal age in the indication emergency contraception.
Adolescents: ellaOne 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).
Method of administration
The tablet can be taken with or without food.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.
ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, ellaOne does not interrupt an existing pregnancy (see section 4.6).
ellaOne does not prevent pregnancy in every case.
In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ellaOne should contact their doctor (see section 4.6).
ellaOne inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, ellaOne is no longer effective. The timing of ovulation cannot be predicted and therefore ellaOne should be taken as soon as possible after unprotected intercourse.
No data are available on the efficacy of ellaOne when taken more than 120 hours (5 days) after unprotected intercourse.
Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
After ellaOne intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.
Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.5).
Contraception after ellaOne intake
ellaOne is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Although the use of ellaOne does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see section 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaOne, however, she should be advised to use a reliable barrier method until the next menstrual period.
Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Use in women with severe asthma treated by oral glucocorticoid is not recommended.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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