ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
26-10-2021
Summary of Product characteristics
(SPC)
24-09-2021
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
estradiol hemihydrate, Quantity: 2.07 mg (Equivalent: estradiol, Qty 2 mg)
Available from:
Novo Nordisk Pharmaceuticals Pty Ltd
INN (International Name):
estradiol hemihydrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; maize starch; purified talc; magnesium stearate; titanium dioxide; hypromellose; hyprolose; indigo carmine; macrogol 400
Administration route:
Oral
Units in package:
28 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Short term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. In women with intact uteri, use of opposed therapy must be considered.
Product summary:
Visual Identification: blue tablets, 6 millimetres in diameter, stamped with 'Novo 280'; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2011-11-17
Patient Information leaflet
Estrofem
®
tablets
Page 1 of 6
Estrofem cmi-v10
ESTROFEM
® 1 MG TABLETS
ESTROFEM
® 2 MG TABLETS
_Estradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT ESTROFEM
® IS USED FOR ........ 1
BEFORE YOU TAKE ESTROFEM
® ......... 1
HOW TO TAKE ESTROFEM
® ................ 4
WHILE YOU ARE TAKING ESTROFEM
® 4
SIDE EFFECTS .................................... 4
STORAGE .......................................... 5
PRODUCT DESCRIPTION .................... 5
USER INSTRUCTIONS .......................... 6
This leaflet answers some common
questions about Estrofem
®
. 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 Estrofem
®
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.
Estrofem
®
is available only by
prescription at pharmacies.
WHAT ESTROFEM
® IS
USED FOR
Estrofem
®
is a hormone
replacement therapy (HRT) that is
used for the short-term symptomatic
treatment of women who have had
their womb surgically
removed
(which is called hysterectomy) and
who have signs and symptoms of
estrogen deficiency.
A woman’s last menstrual period is
called the menopause and usually
occurs between the ages of 45 and
55 years. Around the time of the
menopause, the body slowly stops
producing the two sex hormones
called estrogen and progesterone.
Periods become irregular until they
finally stop.
If a woman has surgical or natural
menopause the production of these
hormones is diminished or stopped.
Estrofem
®
replaces the hormone
called estrogen which your body
stops making after surgical or
natural menopause.
The falling or reduced hormone
levels may cause you to experience
uncomfortable symptoms such as
hot flushes, night sweats,
sleeplessness, dry vagina, urinary
problems, headaches, mood swings,
lack of conce
Read the complete document
Summary of Product characteristics
Estrofem-pi-v13
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
ESTROFEM
® ESTRADIOL (AS HEMIHYDRATE) 1 MG TABLET DIAL DISPENSER PACK
ESTROFEM
® ESTRADIOL (AS HEMIHYDRATE) 2 MG TABLET DIAL DISPENSER PACK
1.
NAME OF THE MEDICINE
Estradiol hemihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estrofem is an estrogen preparation comprising 28 tablets. Each tablet
contains 1 mg or 2 mg
estradiol (as hemihydrate). The estrogen component of Estrofem
substitutes for the loss of
endogenous estrogen production due to natural or surgical menopause in
hysterectomised
women.
Excipient with known effect: lactose monohydrate. For the full list of
excipients, see ‘Section
6.1 List of Excipients.’
3.
PHARMACEUTICAL FORM
Film coated tablet.
Estrofem 1 mg are red tablets marked NOVO 282 on one side, blank on
the other side, with a
diameter of 6 mm.
Estrofem 2 mg are blue tablets marked NOVO 280 on one side, blank on
the other side, with
a diameter of 6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term symptomatic treatment of estrogen deficiency due to natural
or surgical
menopause in hysterectomised postmenopausal women (see ‘Section 4.2
Dose and Method of
Administration’ and ‘Section 5.1 Pharmacodynamic Properties’ -
‘Clinical trials’).
In women with intact uteri, use of opposed therapy must be considered.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
The initial dose for relief of symptoms of estrogen deficiency is 1 mg
or 2 mg daily.
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a
progestagen in hysterectomised women.
In postmenopausal women with normal uteri Estrofem should be given
with a progestagen
for at least 10 consecutive days of the 28 day cycle. This will
usually induce a withdrawal
bleed.
Estrofem-pi-v13
Page 2 of 17
In hysterectomised post-menopausal women Estrofem may be started on
any convenient day.
In oligomenorrhoea, treatment should be started on day 5 of bleeding.
If symptoms such as hot flushes have ceased, consideration of
transferring t
Read the complete document
