Visanne Tablet 2mg

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Dienogest, micronized

Dostopno od:

BAYER (SOUTH EAST ASIA) PTE LTD

Koda artikla:

G03DB08

Odmerek:

2.0 Mg

Farmacevtska oblika:

TABLET

Sestava:

Dienogest, micronized 2.0 Mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Bayer Weimar GmbH und Co. KG

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2010-10-29

Navodilo za uporabo

1. 
NAME OF THE MEDICINAL PRODUCT 
Visanne 2 mg tablets 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 2 mg dienogest. 
Excipients: each tablet contains 63mg lactose monohydrate. 

For a full list of excipients, see section 6.1 List
of excipients. 
_ _
3. 
PHARMACEUTICAL FORM 
Tablet 
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 
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 Visanne 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 Visanne 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. 
Visanne 2.0mg tablets/ CCDS 4 & 5/6 June 2013 

1 
There is no experience with Visanne 

Lastnosti izdelka

Visanne 2.mg tablets/ CCDS 6_v1_14December2021
1
1.
NAME OF THE MEDICINAL PRODUCT
Visanne 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest.
Excipients: each tablet contains 63mg lactose monohydrate.
For a full list of excipients, see section 6.1 List of excipients.
_ _
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat-faced, bevelled-edge tablets, marked
with the letter with a “B” on
one side and a diameter of 7 mm.
4.
CLINICAL PARTICULARS
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 Visanne 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 Visanne 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.
Visanne 2.mg tablets/ CCDS 6_v1_14December2021
2
_ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _
_Paediatric population _
Visanne is not indicated in children prior to menarche.
The efficacy of Visa