Estradiol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol hemihydrate 1.23mg;  

Available from:

Viatris Limited

Dosage:

75 mcg/24h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Estradiol hemihydrate 1.23mg   Excipient: Acrylic adhesive Dipropylene glycol Oleyl alcohol Pegoterate Polyolefin Povidone Silicone adhesive

Prescription type:

Prescription

Therapeutic indications:

Estradiol is indicated for the following: - Oestrogen replacement therapy for the treatment of the symptoms of natural or surgically induced menopause. - Prevention of postmenopausal osteoporosis.

Product summary:

Package - Contents - Shelf Life: Sachet, 25#C1S paper/7.5# LDPE/0.00035?foil/adhesive/2.0 mil PET pouch in cardboard carton - 8 patches - 24 months from date of manufacture stored at or below 25°C. Label states condition as 20°C to 25°C - Sachet, 35# C1S paper/7# LDPE/0.00035" foil/adhesive/1.25 mil Barex film pouch in cardboard carton - 8 patches - 24 months from date of manufacture stored at or below 25°C. Label states condition as 20°C to 25°C

Authorization date:

2023-05-16

Patient Information leaflet

Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ESTRADIOL TRANSDERMAL PATCHES (MYLAN)
_ESTRADIOL TRANSDERMAL PATCHES 0.025 MG/DAY, 0.05 MG/DAY, 0.075
MG/DAY, _
_0.1 MG/DAY_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Estradiol
Transdermal Patches.
This leaflet answers some common
questions about Estradiol
Transdermal Patches .
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 Estradiol
Transdermal Patches against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ESTRADIOL
TRANSDERMAL
PATCHES IS USED FOR
Estradiol Transdermal Patches are
a type of treatment called hormone
replacement therapy (HRT). It is a
stick-on patch that contains a
hormone called Estradiol.
Estradiol Transdermal Patches is
used for the short-term relief of
symptoms of the menopause.
HRT is not used for the long-term
maintenance of general health or to
prevent heart disease or dementia.
Estradiol Transdermal Patches is
not suitable for birth control and it
will not restore fertility
Estradiol (also known as oestradiol)
is a natural female sex hormone
called an oestrogen. It is the same
hormone that your ovaries were
producing before the menopause.
The menopause occurs naturally in
the course of a woman's life, usually
between the ages of 45 and 55. It
may happen sooner if the ovaries
are removed by surgery (e.g. total
hysterectomy).
After menopause, your body
produces much less oestrogen than
it did before. This can cause
unpleasant symptoms such as a
feeling of warmth in the face, neck
and chest, "hot flushes" (sudden,
intense feelings of heat and
sweating throughout the body),
sleep problems, irritability and
depression. Some women also
have problems with dryness of the
vagina causing discomfort

Summary of Product characteristics

Page 1 of 13
NEW ZEALAND DATA SHEET
ESTRADIOL TRANSDERMAL PATCHES (MYLAN)
1. PRODUCT NAME
Estradiol, 0.025 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day,
Transdermal Patches
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Estradiol Transdermal Patch contains 0.025 mg/day, 0.05 mg/day,
0.075 mg/day, 0.1 mg/day
of estradiol (also known as oestradiol).
•
The 0.025 mg/day is available as a 2.5 cm
2
system containing estradiol, USP hemihydrate
equivalent to 0.41 mg of estradiol for nominal delivery of 0.025 mg of
estradiol per day.
•
The 0.05 mg/day is available as a 5.0 cm
2
system containing estradiol, USP hemihydrate
equivalent to 0.82 mg of estradiol for nominal delivery of 0.05 mg of
estradiol per day.
•
The 0.075 mg/day is available as a 7.5 cm
2
system containing estradiol, USP hemihydrate
equivalent to 1.23 mg of estradiol for nominal delivery of 0.075 mg of
estradiol per day.
•
The 0.1 mg/day is available as a 10.0 cm
2
system containing estradiol, USP hemihydrate
equivalent to 1.64 mg of estradiol for nominal delivery of 0.1 mg of
estradiol per day.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
0.025 mg/day – Each rectangular patch with rounded corners consists
of an opaque, white to cream
adhesive layer, matte film backing randomly printed with ‘Estradiol
0.025 mg/day’ in brown ink, and
a clear release liner. The patch is contained in a square, flat,
notched, pouch.
0.05 mg/day – Each rectangular patch with rounded corners consists
of an opaque, white to cream
adhesive layer, matte film backing randomly printed with ‘Estradiol
0.05 mg/day’ in brown ink, and a
clear release liner. The patch is contained in a square, flat,
notched, pouch.
0.075 mg/day – Each rectangular patch with rounded corners consists
of an opaque, white to cream
adhesive layer, matte film backing randomly printed with ‘Estradiol
0.075 mg/day’ in brown ink, and
a clear release liner. The patch is contained in a square, flat,
notched, pouch.
0.1 mg/day – Each rectangular patch with ro