ESTALIS CONTINUOUS 50/140 estradiol 50mcg/day norethisterone acetate 140mcg/day patch sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

norethisterone acetate, Quantity: 2.7 mg (Equivalent: estradiol, Qty 50 microgram; Equivalent: norethisterone acetate, Qty 140 microgram); estradiol, Quantity: 0.62 mg (Equivalent: estradiol, Qty 50 microgram)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: oleic acid; dipropylene glycol; povidone; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-N-(trimethylsilyl)silanamine; dimeticonol; polyethylene terephthalate; polyvinylidene flouride; ethyl acetate; ethanol; acrylates/VA copolymer; ethylene/vinyl acetate copolymer

Administration route:

Transdermal

Units in package:

2 patches sample pack, 8 patches

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. For prevention of postmenopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. When prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for non-oestrogen products approved for prevention of bone mineral density loss. Lifestyle modifications and the risk-benefit profile of Estalis Continous should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing. Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

Product summary:

Visual Identification: An off-white translucent patch with a removable pre-cut liner: 9cm2 round patch.; Container Type: Sachet; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-10-11

Patient Information leaflet

ESTALIS
® CONTINUOUS
_estradiol / norethisterone acetate (NETA)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause (the
"change of life"), hormone
replacement therapy and Estalis
Continuous.
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.NOVARTIS.COM.AU.
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 this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT 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 ESTALIS
CONTINUOUS
DO NOT USE ESTALIS CONTINUOUS OR
OTHER ESTROGENS, 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
estrogens 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
estrogens and MPA. There are no
comparable data currently available
for other doses of conjugated
estrogens and MPA or other
combinations of estrogens and
progestogens. Therefore, you should
assume the risks will be si

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ESTALIS® CONTINUOUS
(ESTRADIOL/NORETHISTERONE ACETATE)
WARNING
Estrogens and progestogens 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 progestogens were not
studied in the WHI
Section 5.1 PHARMACODYNAMIC PROPERTIES 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 progestogens should be prescribed at the
lowest effective doses and
for the shortest duration consistent with treatment goals and risks
for the individual woman.
1
NAME OF THE MEDICINE
Estr