DIENOMET TABLET 2MG [SIN16854P]

Product Info

DIENOMET TABLET 2MG

[SIN16854P]

4.1 Indication(s)

Treatment of endometriosis.

4.2 Dosage and method of administration

Method of Administration:

For oral use.

Dosage Regimen

Tablet-taking can be started on any day of the menstrual cycle.

The dosage of Dienomet 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.

The efficacy of Dienomet may be reduced in the event of missed tablets, vomiting and/or diarrhoea (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 diarrhoea 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 once metabolism/excretion of the previously administered drug is expected to complete.

Additional information on special populations

Paediatric population

Dienomet is not indicated in children prior to menarche.

The efficacy of Dienomet 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 Dienomet 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 Dienomet 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 Dienomet.

Geriatric population

There is no relevant indication for the use of Dienomet in the geriatric population.

Patients with hepatic impairment

Dienomet is contraindicated in patients with present or past severe hepatic disease (see section Contraindications).

Patients with renal impairment

There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

4.3 Contraindications

Dienomet should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Dienomet, treatment must be discontinued immediately.

• Active venous thromboembolic disorder

• Arterial and cardiovascular disease, present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease)

• Diabetes mellitus with vascular involvement

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal

• Presence or history of liver tumors (benign or malignant)

• Known or suspected sex hormone-dependent malignancies

• Undiagnosed vaginal bleeding

• Hypersensitivity to the active substance or to any of the excipients