Evafact Dosage/Direction for Use

Method of Administration: For oral use.
Posology: The dosage of Evafact 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.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of Evafact. If contraception is required, non-hormonal methods of contraception should be used (e.g., barrier method).
Management of missed tablets: The efficacy of Evafact 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 populations: Evafact is not indicated in children prior to menarche. The safety and efficacy of Evafact was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12-<18) with clinically suspected or confirmed endometriosis.
The use of Evafact in adolescent patients over a treatment period of 12 months was associated with a mean decrease in Bone Mineral Density (BMD) in the lumbar spine of 1.2%. After cessation of treatment, BMD increased towards pre-treatment levels over a period of 6 months in a subset of patients with decreased BMD (mean change from baseline-0.6%).
Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life.
Therefore, the treating physician should weigh the benefits of Evafact against the possible risks of use in each individual adolescent patient.
Geriatric populations: There is no relevant indication for use of Evafact in the Geriatric population.
Patients with hepatic impairment: Evafact is contraindicated in patients with present or past severe hepatic disease.
Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.