DIMETRUM TABLET 2MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dienogest

Available from:

PHARMED IMPORT & EXPORT PTE LTD

ATC code:

G03DB08

Pharmaceutical form:

TABLET

Composition:

Dienogest 2mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Cyndea Pharma, S.L.

Authorization status:

ACTIVE

Authorization date:

2023-01-26

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
DIMETRUM TABLET 2 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of dienogest.
Excipient with known effect: each tablet contains 62.81 mg lactose
monohydrate. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to slightly yellowish round tablet marked with “D2” on one
side and without marking on the other side,
with a diameter of approximately 7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 Dimetrum 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 Dimetrum 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
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
diarrhea 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 _
Dimetrum is not indicated in children prior to menarche period.
The efficacy of Dimetrum has been demonstrated in the treatment of
endometriosis – associ