Ella Special Precautions

Concomitant use of ulipristal acetate with an emergency contraceptive containing levonorgestrel is not recommended (see Interactions).
Use in women with severe asthma insufficiently controlled by oral glucocorticoid is not recommended.
Emergency contraception with Ella is an occasional method. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.
Although the use of Ella does not contraindicate the continued use of regular hormonal contraception, Ella may reduce its contraceptive action (see Interactions). Therefore, after using emergency contraception, it is recommended that subsequent acts of intercourse be protected by a reliable barrier method until the next menstrual period starts. If a woman wishes to initiate hormonal contraception as a regular contraception method, she can do so immediately after using Ella, but the woman should use a reliable barrier method until the next menstrual period.
Repeated administration of Ella within the same menstrual cycle is not advisable, as safety and efficacy of Ella after repeated administration within the same menstrual cycle has not been investigated.
Emergency contraception with Ella does not prevent pregnancy in every case. No data is available on the efficacy of Ella for women who have had unprotected intercourse more than 120 hours before Ella intake. 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. In case of doubt, delay of more than 7 days in next menstrual period, abnormal bleeding at the expected date of menses, or symptoms of pregnancy, pregnancy should be excluded by a pregnancy test.
If pregnancy occurs after treatment with Ella, as for all pregnancies, the possibility of an ectopic pregnancy should be considered. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.
After Ella intake menstrual periods can sometimes occur earlier or later than expected by a few days. 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.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant use of Ella with CYP3A4 inducers is not recommended due to potential for interaction (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, efavirenz, fosphenytoine, nevirapine, oxcarbazepine, primidone, rifabutine, St John's wort/Hypericum perforatum).
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal acetate.
Concomitant use is therefore not recommended.
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).