VIENOMET TABLETS 2MG

TABLET

**4.2 Posology and method of administration** _Method of administration:_ For oral use. Posology Tablet-taking can be started on any day of the menstrual cycle. "There is no experience with Dienogest 2mg tablets treatment >15 months in patients with endometriosis" The dosage of Dienogest tablets 2mg is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption. 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 once metabolism/excretion of the previously administered drug is expected to complete. _Management of missed tablets:_ The efficacy of Dienogest tablets 2mg 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:_ Dienogest tablets 2mg is not indicated in children prior to menarche. The efficacy of Dienogest tablets 2mg has been demonstrated in the treatment of endometriosis – associated pelvic pain in adolescent patients (12–18 years), with an overall favorable safety and tolerability profile. The use of Dienogest tablets 2mg in adolescents 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 again in these patients. 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 Dienogest 2mg against the possible risks of use in each individual adolescent patient (see sections ‘Special warnings and precautions for use’, ‘Pharmacodynamic properties’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If clinically warranted, BMD may be monitored, and the results used in the risk-benefit assessment of use of Dienogest tablets 2mg. _Geriatric population:_ There is no relevant indication for use of Dienogest tablets 2mg in the Geriatric population. _Patients with hepatic impairment:_ Dienogest tablets 2mg is contraindicated in patients with present or past severe hepatic disease (see section 4.3). _Patients with renal impairment:_ There are no data suggesting the need for a dosage adjustment in patients with renal impairment.