Estradot

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol hemihydrate 0.585mg equivalent 37.5 µg/24 hours

Available from:

Sandoz New Zealand Limited

INN (International Name):

Estradiol hemihydrate 0.585 mg (equivalent 37.5 µg/24 hours)

Dosage:

37.5 mcg/24h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Estradiol hemihydrate 0.585mg equivalent 37.5 µg/24 hours Excipient: Acrylic adhesive Dipropylene glycol Oleyl alcohol Povidone Silicone adhesive

Units in package:

Sachet, aluminium foil, laminate;, 2 patches

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

The Estradot regimen 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, aluminium foil, laminate; - 2 patches - 24 months from date of manufacture stored at or below 25°C protect from light - Sachet, aluminium foil, laminate; - 8 patches - 24 months from date of manufacture stored at or below 25°C protect from light - Sachet, aluminium foil, laminate; - 24 patches - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2001-09-06

Patient Information leaflet

__________________________________________________________________________________________________
Estradot®
1
ESTRADOT
®
_oestradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause
("change of life"), hormone
replacement therapy and Estradot.
It does not contain all the available
information. It does not take the place of
talking to your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP-TO-DATE INFORMATION ON THE
MEDICINE. YOU CAN ALSO DOWNLOAD THE
MOST UP-TO-DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using Estradot against the benefits
they expect it will provide.
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.
WHEN YOU MUST NOT USE
ESTRADOT
DO NOT USE ESTRADOT OR OTHER
OESTROGENS, WITH OR WITHOUT A
PROGESTOGEN 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 oestrogens 0.625
mg and the progestogen
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 oestrogens and MPA.
There are no comparable data currently
available for other doses of
conjugated oestrogens and MPA or other
combinations of oestrogens and
progestogens. The

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ESTRADOT® (oestradiol) 25, 37.5, 50, 75 & 100 mcg/24* hrs Transdermal
Patches
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.1.1.1 Active moiety
Oestradiol
2.1.1.1.2 Active substance(s)
Estradot is available in three sizes:
•
2.5 cm2 patch containing 0.39 mg oestradiol (as hemihydrate) with a
nominal in vivo
release rate of 25 micrograms oestradiol per day.
•
5 cm2 patch containing 0.78 mg oestradiol (as hemihydrate) with a
nominal in vivo release
rate of 50 micrograms oestradiol per day.
•
7.5 cm2 patch containing 1.17 mg estradiol hemihydrate with a nominal
in vivo release rate
of 75 micrograms estradiol per day.
•
10 cm2 patch containing 1.56 mg oestradiol (as hemihydrate) with a
nominal in vivo release
rate 100 micrograms oestradiol per day.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Transdermal patch.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The Estradot regimen is indicated for the following:
•
Oestrogen replacement therapy for the treatment of the symptoms of
natural or surgically
induced menopause.
•
Prevention of postmenopausal osteoporosis (see Dosage and
Administration and
Warnings and Precautions).
In women with an intact uterus, oestrogens should always be
supplemented by administration of
a progestogen.
2
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1.1.1 Adults and geriatric patients
Hormone replacement therapy (HRT) involving either oestrogen-only or
oestrogen-progestogen
combined therapy should only be continued as long as the benefits
outweigh the risks for the
individual.
Estradot should be applied every 3 to 4 days (i.e. twice weekly).
4.2.1.1.2 Climacteric symptoms
Treatment should be initiated with the lowest dose. Depending on the
clinical response the dose
should be adjusted to the woman’s individual needs. If, after three
months, there is an
insufficient response in the form of alleviated symptoms, the dose
should be increased. If
symptoms of overdose arise (e.g. tender breasts) the dose must be
d