Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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.

Ulipristal acetate 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 section 4.6).

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 ulipristal acetate should contact their doctor (see section 4.6).
 ulipristal acetate inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, it is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse.

No data are available on the efficacy of ulipristal acetate 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 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 the tablet 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 Ella intake

Ulipristal acetate 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 ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, Ella 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 Ella, however, she 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 (e.g.
barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products 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 medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Effects on Driving

4.7   Effects on ability to drive and use machines
Ulipristal acetate has 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 section 4.8).