Posology : מינונים

4.2       Posology and method of administration

Method of administration:
For oral use.

Posology

The dosage of Visabelle 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 Visabelle. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method).
Management of missed tablets:


The efficacy of Visabelle may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occuring 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:
Visabelle is not indicated in children prior to menarche.

The safety and efficacy of Visabelle was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12-<18) with clinically suspected or confirmed endometriosis (see sections 4.4 and 5.1).


Geriatric population:
There is no relevant indication for use of Visabelle in the Geriatric population.

Patients with hepatic impairment:

Visabelle 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.