CLIMARA 75 estradiol 75 microgram/day transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol, Quantity: 5.69 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: ethyl oleate; isopropyl myristate; glyceryl laurate; acrylates/acrylamide copolymer

Administration route:

Transdermal

Units in package:

4 sachets, 12 sachets, 1 sachet, 8 sachets, 2 sachets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OTHER CONDITIONS: Do not remove from primary pack except for immediate use. For short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. Oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. In women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,For short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. For the prevention of post menopausal bone mineral density loss. When prescribed solely for the prevention of post menopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who, are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. Lifestyle modifications and the risk benefit profile of CLIMARA should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing (see precautions and dosage and administration sections). In women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

Product summary:

Visual Identification: Oval shaped patch (approx 5.5cmx4.1cm=18.75cm2) consisting of translucent polyethylene backing& pressure sensitive acrylate adhesive/drug matrix. The patch is mounted on clear, split release liner; Container Type: Sachet; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2000-10-16

Patient Information leaflet

CLIMARA® CMI V1.0
1
CLIMARA®
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING CLIMARA®?
CLIMARA® contains the active ingredient estradiol. CLIMARA® is used
for the treatment of menopausal symptoms due to
estrogen deficiency during menopause or after a surgical procedure,
where estrogen production is decreased.
For more information, see Section 1. Why am I using CLIMARA®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CLIMARA®?
Do not use if you have ever had an allergic reaction to estradiol or
any of the ingredients listed at the end of the CMI.
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 2. What should I know before I use
CLIMARA®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CLIMARA® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CLIMARA®?
CLIMARA® patches are usually worn continuously, and replaced every 7
days. You should only wear one patch at a time, unless
your doctor tells you otherwise.
The best place to apply CLIMARA® patches is on your lower abdomen or
buttocks. Never put CLIMARA® patches on your
breasts.
More instructions can be found in Section 4. How do I use CLIMARA®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CLIMARA®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CLIMARA®.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take CLIMARA® to treat any other complaints unless your doctor
tells you to.
•
Do not give you

Summary of Product characteristics

CLIMARA PI V1.0, CCDS 16
1
AUSTRALIAN PRODUCT INFORMATION
CLIMARA
® (ESTRADIOL) TRANSDERMAL DRUG DELIVERY SYSTEM
WARNING
Estrogens
with
or
without
progestogens
should
not
be
used
for
the
prevention
of
cardiovascular disease or dementia.
The Women’s Health Initiative (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 4.4 Special warnings and precautions
for use).
The 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 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 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 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
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
Estradiol
2
QUALITATIVE