TRISEQUENS TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

(Blue Tablet) ESTRADIOL HEMIHYDRATE 2.07mg equivalent to; (Red Tablet) ESTRADIOL HEMIHYDRATE 1.03mg equivalent to; (White Tablet) ESTRADIOL as HEMIHYDRATE 2.07mg equivalent to; (White Tablet) NORETHISTERONE ACETATE

Available from:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC code:

G03FB05

Dosage:

2 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

(Blue Tablet) ESTRADIOL HEMIHYDRATE 2.07mg equivalent to 2 mg; (Red Tablet) ESTRADIOL HEMIHYDRATE 1.03mg equivalent to 1 mg; (White Tablet) ESTRADIOL as HEMIHYDRATE 2.07mg equivalent to 2 mg; (White Tablet) NORETHISTERONE ACETATE 1 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novo Nordisk A/S

Authorization status:

ACTIVE

Authorization date:

1991-06-03

Patient Information leaflet

TRISEQUENS
®

Film-coated tablets 

One blue film-coated tablet contains: Estradiol 2 mg (as estradiol
hemihydrate) 
One white film-coated tablet contains: Estradiol 2 mg (as estradiol
hemihydrate) and 
norethisterone acetate 1 mg 
One red film-coated tablet contains: Estradiol 1 mg (as estradiol
hemihydrate). 

TABLET CORE CONTAINS:   
Lactose monohydrate, maize
starch,    hydroxypropylcellulose, talc and magnesium stearate. 

FILM-COATING: 
Blue tablets: Hypromellose, talc, titanium dioxide (E171), indigo
carmine (E132) and macrogol 
400. 
White tablets: Hypromellose, triacetin and talc. 
Red tablets: Hypromellose, talc, titanium dioxide (E171), red iron
oxide (E172), and propylene 
glycol. 
Blue film-coated, biconvex tablets engraved with NOVO 280. Diameter:
6 mm. 
White film-coated, biconvex tablets engraved with NOVO 281.
Diameter: 6 mm. 
Red film-coated, biconvex tablets engraved with NOVO 282. Diameter:
6 mm. 

PRODUCT OWNER 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd   
Denmark 

THERAPEUTIC INDICATIONS 
Hormone Replacement Therapy (HRT) for oestrogen deficiency
symptoms in postmenopausal 
women at least 6 months since last menses. 
Prevention of osteoporosis in postmenopausal women at high risk
of future fractures, who are 
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of 
osteoporosis (see also _Special warnings and precautions for
use_). 
The experience treating women older than 65 years is limited. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Trisequens
®
 is a continuous sequential preparation for HRT. The oestrogen
is dosed continuously. 
The progestagen is added for 10 days of every 28 day cycle, in a
sequential manner. 
One tablet should be taken orally once a day without interruption,
preferably at the same time of 
the day starting with oestrogen therapy (blue film-coated tablet)
over 12 days followed by 10 
days of oestrogen/progest

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
TRISEQUENS
®
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Blue tablet: Estradiol 2 mg (as estradiol hemihydrate).
White tablet: Estradiol 2 mg (as estradiol hemihydrate) and
norethisterone acetate 1 mg.
Red tablet: Estradiol 1 mg (as estradiol hemihydrate).
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Blue film-coated, biconvex tablets engraved with NOVO 280. Diameter: 6
mm.
White film-coated, biconvex tablets engraved with NOVO 281. Diameter:
6 mm.
Red film-coated, biconvex tablets engraved with NOVO 282. Diameter: 6
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
with at least 6 months since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are
intolerant
of,
or
contraindicated
for,
other
medicinal
products
approved
for
the
prevention
of
osteoporosis (see section 4.4).
The experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Trisequens
®
is a continuous sequential HRT product. The oestrogen is dosed
continuously. The
progestagen is added for 10 days of every 28-day cycle, in a
sequential manner.
One tablet should be taken orally once a day without interruption,
preferably at the same time of the
day starting with oestrogen therapy (blue film-coated tablet) over 12
days, followed by 10 days of
oestrogen/progestagen therapy (white film-coated tablet) and 6 days of
oestrogen therapy (red film-
coated tablet). A regular shedding of the endometrium is usually
induced during the red tablet phase.
After intake of the last red tablet, treatment is continued with the
first blue tablet of a new pack on the
next day.
In women who are not taking HRT or women in transition from a
continuous combined HRT product,
treatment with Trisequens
®