VIENOMET TABLETS 2MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dienogest

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

G03DB08

Pharmaceutical form:

TABLET

Composition:

Dienogest 2mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Naari Pharma Private Limited

Authorization status:

ACTIVE

Authorization date:

2023-01-25

Summary of Product characteristics

180 mm
300 mm
300 mm
600 mm
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FRONT
VIENOMET
1.
NAME OF THE MEDICINAL PRODUCT
Brand name: VIENOMET
Generic name: Dienogest tablets 2mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest
Excipient(s) 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 debossed
with “NC” on one side and “22” on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of endometriosis.
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 preferablyat 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