Ella 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.
Ella is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, Ella does not interrupt an existing pregnancy (see Overdosage).
Ella 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 Ella should contact their doctor (see Overdosage).
Ella inhibits or postpones ovulation (see Pharmacology: Pharmacodynamics under Actions). If ovulation has already occurred, Ella is no longer effective. The timing of ovulation cannot be predicted and therefore Ella should be taken as soon as possible after unprotected intercourse.
No data are available on the efficacy of Ella when taken more than 120 hours (5 days) after unprotected intercourse.
Limited and inconclusive data suggest that there may be reduced efficacy of Ella with increasing body weight or body mass index (BMI) (see Pharmacology: Pharmacodynamics under Actions). 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 Ella 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 Interactions).
Contraception after Ella intake: Ella 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 Ella does not contraindicate the continued use of regular hormonal contraception, Ella may reduce its contraceptive action (see Interactions). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so when possible no sooner than 5 days after using Ella, however, the patient should be advised to use a reliable barrier method until the next menstrual period.
Specific populations: Concomitant use of Ella with CYP3A4 inducers is not recommended due to interaction barbituriates (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.
Effects on ability to drive and use machines: Ella may have minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after Ella intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported. The patient should be informed not to drive or use machines if they are experiencing such symptoms (see Adverse Reactions).