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Posology: The dosage of ENDOVELLE is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food.
Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.
There is no experience with ENDOVELLE treatment >15 months in patients with endometriosis. Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of ENDOVELLE. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method).
Management of missed tablets: 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 one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet.
Additional information on special populations: Paediatric population: ENDOVELLE is not indicated in children prior to menarche.
Dienogest has been studied in children ≥12 years and adolescents for up to 12 months of therapy.
Geriatric population: There is no relevant indication for 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.
Method of administration: For oral use.
