ANGELIQ 1/2 tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 1.033 mg (Equivalent: estradiol, Qty 1 mg); drospirenone, Quantity: 2 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Drospirenone,estradiol hemihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; hypromellose; magnesium stearate; lactose monohydrate; purified talc; macrogol 6000; titanium dioxide; pregelatinised maize starch; maize starch; iron oxide red

Administration route:

Oral

Units in package:

28 tablets, 84 tablets, 112 tablets, 7 Tablets (Starter Pack), 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hormone Replacement therapy (HRT) for use in the short-term treatment in postmenopausal women with an intact uterus of the climacteric syndrome caused by deficient endogenous oestrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure.

Product summary:

Visual Identification: Small, round, medium red tablet, one side embossed with the letter DL in a regular hexagon.; Container Type: Blister Pack; Container Material: PVC/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:

Registered

Authorization date:

2004-11-30

Patient Information leaflet

ANGELIQ® 1/2 CMI V1.0
1
ANGELIQ® 1/2
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 ANGELIQ® 1/2?
ANGELIQ® 1/2 contains the active ingredients estradiol and
drospirenone. ANGELIQ® 1/2 provides hormone replacement
therapy (HRT) for the treatment of menopausal complaints in
postmenopausal women.
ANGELIQ® 1/2 IS NOT A CONTRACEPTIVE. IT WILL NOT PREVENT YOU FROM
FALLING PREGNANT.
For more information, see Section 1. Why am I using ANGELIQ® 1/2?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANGELIQ® 1/2?
Do not use if you have ever had an allergic reaction to estradiol,
drospirenone, 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, PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ANGELIQ® 1/2?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ANGELIQ® 1/2 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 ANGELIQ® 1/2?
Take one tablet daily at about the same time each day. Swallow the
tablets whole with a full glass of water. It does not matter
if you take this medicine before or after food.
More instructions can be found in Section 4. How do I use ANGELIQ®
1/2?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANGELIQ® 1/2?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ANGELIQ® 1/2.
•
Check your breasts each month and report any changes promptly to your
doctor.
THINGS YOU
SHOULD NOT DO
•
Do not take ANGELIQ® 1/2 to treat any other complaints unless your
doctor tells you to.
•
Do not

Summary of Product characteristics

ANGELIQ
®
1/2 PI V1.0 CCDS 12
1
AUSTRALIAN PRODUCT INFORMATION
ANGELIQ
® 1/2 (ESTRADIOL, DROSPIRENONE) TABLETS
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 Section 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 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 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 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
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