Visanne tablets

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

dienogest (micronised)

Dostępny od:

Bayer Weimar GmbH & Co. KG

Kod ATC:

G03DB08

INN (International Nazwa):

dienogest (micronised)

Dawkowanie:

2mg

Forma farmaceutyczna:

tablets

Sztuk w opakowaniu:

(28/2x14/) blisters

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2019-05-07

Charakterystyka produktu

Visanne NL/H/1569/001/II/035_SmPC EU common
Valid as per APR 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Visanne 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest
Excipient with known effect: each tablet contains 62.8 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
White to off-white, round, flat-faced, bevelled-edge tablets with a
debossed “B” on one side and a diameter
of 7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of endometriosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration: _
For oral use.
_Posology _
The dosage of Visanne 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
Visanne. If contraception is required,
non-hormonal methods of contraception should be used (e.g. barrier
method).
_Management of missed tablets: _
Visanne NL/H/1569/001/II/035_SmPC EU common
2
Valid as per APR 2020
The efficacy of Visanne 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: _
Visanne is not indicated in children prior to menarche
The safety and efficacy of Visanne was investigated in an uncontrolled
clinical trial over 12 months in 111
adolescent women (12-<18) with clinica