TRISEQUENS estradiol tablets and norethisterone acetate plus estradiol tablets dial dispenser pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

estradiol hemihydrate, Quantity: 2.07 mg (Equivalent: estradiol, Qty 2 mg); norethisterone acetate, Quantity: 1 mg

Saatavilla:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (Kansainvälinen yleisnimi):

estradiol hemihydrate,Norethisterone acetate

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin

Antoreitti:

Oral

Kpl paketissa:

28 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Short term symptomatic treatment of oestrogen deficiency associated with natural or artificial menopause (see DOSAGE AND ADMINISTRATION and CLINICAL TRIALS).

Tuoteyhteenveto:

Visual Identification: 10 white tablets, 6 millimetres in diameter engraved 'Novo/281'.; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2012-01-11

Pakkausseloste

Trisequens
®
tablets
Trisequens cmi-v10
Page
1
of
2
TRISEQUENS
®
_Estradiol/Norethisterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHEN YOU MUST NOT USE
TRISEQUENS
® .................................. 1
WHAT TRISEQUENS
® IS USED FOR ..... 1
BEFORE YOU TAKE TRISEQUENS
® ...... 1
HOW TO TAKE TRISEQUENS
® ............ 4
WHILE YOU ARE TAKING TRISEQUENS
® ....................................................... 4
SIDE EFFECTS .................................... 5
STORAGE .......................................... 6
PRODUCT DESCRIPTION .................... 7
FURTHER INFORMATION .................... 7
USER INSTRUCTIONS .......................... 8
This leaflet answers some common
questions about Trisequens
®
. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Trisequens
®
against the benefits they expect it
will have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
Trisequens
®
is available only by
prescription at pharmacies.
WHEN YOU MUST NOT
USE TRISEQUENS
®
DO NOT USE TRISEQUENS
® OR OTHER
ESTROGENS, WITH OR WITHOUT A
PROGESTAGEN TO PREVENT HEART
ATTACKS, STROKE OR DEMENTIA.
A study called the Women’s Health
Initiative indicated increased risk of
heart attack, stroke, breast cancer,
and blood clots in the legs or lungs
in women receiving treatment with
a product containing conjugated
estrogens 0.625 mg and the
progestagen medroxyprogesterone
acetate (MPA). The researchers
stopped the study after 5 years
when it was determined the risks
were greater than the benefits in this
group. The Women’s Health
Initiative Memory Study indicated
increased risk of dementia in
women aged 65-79 years taking
conjugated estrogens and MPA.
There are no comparable data
currently available for other doses
of conjugated estrogens and MPA
o

Valmisteyhteenveto

Trisequens-pi-v13
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
TRISEQUENS
®
ESTRADIOL TABLETS AND NORETHISTERONE ACETATE PLUS ESTRADIOL TABLETS
DIAL DISPENSER PACK.
WARNING
Estrogens and progestagens should not be used for the prevention of
cardiovascular disease or
dementia.
The Women’s Health Initiative (WHI) study reported increased risks
of myocardial infarction,
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with
conjugated estrogens
(0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative
to placebo (see
‘Section 5.1 Pharmacodynamic Properties’ - ‘Clinical trials’
and ‘Section 4.4 Special Warnings
and Precautions for Use’).
The WHI study reported increased risks of stroke and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 6.8 years of treatment with
conjugated estrogens
(0.625 mg) relative to placebo (see ‘Section 5.1 Pharmacodynamic
Properties’ - ‘Clinical trials’
and ‘Section 4.4 Special Warnings and Precautions for Use’).
The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older
during
4
to
5.2
years
of
treatment
with
conjugated
estrogens,
with
or
without
medroxyprogesterone acetate, relative to placebo. It is unknown
whether this finding applies
to younger postmenopausal women (see ‘Section 5.1 Pharmacodynamic
Properties’ - ‘Clinical
trials’ and ‘Section 4.4 Special Warnings and Precautions for
Use’).
Other doses of conjugated estrogens and medroxyprogesterone acetate,
and other combinations
and dosage forms of estrogens and progestagens were not studied in the
WHI clinical trials
and, in the absence of comparable data, these risks should be assumed
to be similar. Because
of these risks, estrogens with or without progestagens should be
prescribed at the lowest
effective doses and for the shortest duratio