Endovelle Dosage/Direction for Use

Method of Administration: For oral use.
Dosage Regimen: Tablet-taking can be started on any day of the menstrual cycle.
The dosage of ENDOVELLE is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken throughout 28 days without regard to bleeding. When a pack is finished the next one should be started without interruption.
The efficacy of ENDOVELLE may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occurring within 3-4 hours after tablet taking). In the event of missed tablet(s), the woman should take one tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet.
If a short acting, e.g. oral, hormonal treatment was prescribed before starting treatment with dienogest, treatment may be started on the first day of menstrual bleeding after cessation of treatment.
If a long-acting, i.e. injectable, hormonal treatment was administered before starting treatment with dienogest then dienogest may be started.
There is no experience with ENDOVELLE treatment for more than 15 months in patients with endometriosis.
Additional information on special populations: Children and adolescents: ENDOVELLE is not indicated in children prior to menarche. The safety and efficacy of ENDOVELLE in adolescent (menarche to 18 years) has not yet been established.
Geriatric population: There is no relevant indication for the use of ENDOVELLE in the geriatric population.
Patients with hepatic impairment: ENDOVELLE is contraindicated in patients with present or past severe hepatic disease (see Contraindications).
Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.