ZUMENON estradiol (as hemihydrate) 2mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 2.06 mg (Equivalent: estradiol, Qty 2 mg)

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; hypromellose; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; iron oxide black; macrogol 400

Administration route:

Oral

Units in package:

3 x 28 tablets, 1 x 28 tablets, 2 x 28 tablets, 1 x 7 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised post menopausal women. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use. In women with an intact uteri, use of opposed therapy must be considered.

Product summary:

Visual Identification: Round, biconvex, brick-red film-coated tablet with the inscription "379" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-09-08

Patient Information leaflet

ZUMENON
®
Z
U
M
E
N
O
N
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHEN YOU MUST NOT USE ZUMENON?
Do not use ZUMENON or other estrogens, with or without progestogen to
prevent heart attacks, stroke or dementia. Talk regularly
with your doctor about whether you still need treatment with ZUMENON.
For more information, see Section 1. When you must not use ZUMENON? in
the full CMI.
2.
WHY AM I USING ZUMENON?
ZUMENON contains the active ingredient estradiol hemihydrate. ZUMENON
is a type of treatment called hormone replacement
therapy (HRT) that helps to relieve the symptoms many women feel
during and after menopause.
For more information, see Section 2. Why am I using ZUMENON? in the
full CMI.
3.
WHAT SHOULD I KNOW BEFORE I USE ZUMENON?
Do not use if you have ever had an allergic reaction to any medicine
containing estradiol or any of the ingredients listed at the end
of this leaflet. HRT should only be used if you have been fully
informed of the risks. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 3. What should I know before I use
ZUMENON? in the full CMI.
4.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZUMENON and affect how it works.
A list of these medicines is in Section 4. What if I am taking other
medicines? in the full CMI.
5.
HOW DO I USE ZUMENON?
•
The usual dose is one tablet daily.
•
Swallow the tablet whole with a glass of water. Take ZUMENON at about
the same time each day.
More instructions can be found in Section 5. How do I use ZUMENON? in
the full CMI.
6.
WHAT SHOULD I KNOW WHILE USING ZUMENON?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ZUMENON.
•
Tell your doctor that you are using ZUMENON well in advance of any
expected hospitalisation or s

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ZUMENON
®
_estradiol hemihydrate tablets _
1
NAME OF THE MEDICINE
Estradiol hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZUMENON tablets are immediate-release, film-coated tablets for oral
use containing 2 mg of micronised
estradiol (equivalent to 2.06 mg estradiol hemihydrate).
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Round, biconvex, brick red, film-coated tablets of 7 mm diameter each
containing 2 mg estradiol bearing the
inscription “379” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of estrogen deficiency due to natural or
surgical menopause in hysterectomised post
menopausal women.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the
shortest duration should be used with the goal being short term use.
(see Section 4.2 DOSE AND
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 sub-study of
WHI, reported increased risk
of developing probable dementia in postmenopausal w