Trisequens film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol; Estradiol; Norethisterone acetate; Estradiol

Available from:

Novo Nordisk A/S

ATC code:

G03FB; G03FB05

INN (International Name):

Estradiol; Estradiol; Norethisterone acetate; Estradiol

Dosage:

2 2 1 1 mg/tablet

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Progestogens and estrogens, sequential preparations; norethisterone and estrogen

Authorization status:

Marketed

Authorization date:

1977-05-21

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRISEQUENS
FILM-COATED TABLETS
estradiol/norethisterone acetate
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trisequens is and what it is used for
2.
What you need to know before you take Trisequens
3.
How to take Trisequens
4.
Possible side effects
5.
How to store Trisequens
6.
Contents of the pack and other information
1.
WHAT TRISEQUENS IS AND WHAT IT IS USED FOR
Trisequens is a sequential combined Hormone Replacement Therapy (HRT)
which is taken
every day without interruption. Trisequens is used in postmenopausal
women with at least 6
months_ _since their last natural period.
Trisequens contains 2 hormones, an oestrogen (estradiol) and a
progestagen (norethisterone
acetate). The estradiol in Trisequens is identical to the estradiol
produced in the ovaries of
women, and is classified as a natural oestrogen. Norethisterone
acetate is a synthetic
progestagen, which acts in a similar manner as progesterone, another
important female sex
hormone.
Trisequens is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This
can cause symptoms such as hot face, neck and chest (‘hot
flushes’). Trisequens alleviates
these symptoms after menopause. You will only be prescribed Trisequens
if your symptoms
seriously hinder your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should
disc

Summary of Product characteristics

Health Products Regulatory Authority
06 February 2024
CRN00F3C4
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
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).
Excipients with known effect:
Each blue film-coated tablet contains lactose monohydrate 36.8mg.
Each white film-coated tablet contains lactose monohydrate 36.3mg.
Each red film-coated tablet contains lactose monohydrate 37.3mg.
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
in