ESTELLE-35 ED tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

cyproterone acetate, Quantity: 2 mg; ethinylestradiol, Quantity: 35 microgram

Fáanlegur frá:

Arrotex Pharmaceuticals Pty Ltd

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate

Stjórnsýsluleið:

Oral

Einingar í pakka:

84 tablets (3 Blister packs), 28 tablets (1 Blister pack contains 21 yellow active tablet and 7 white placebo tablets)

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.,Estelle-35ED will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see CONTRAINDICATIONS),If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Vörulýsing:

Visual Identification: White, round, biconvex tablet, plain on both surfaces.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2003-05-30

Upplýsingar fylgiseðill

ESTELLE-35 ED
1
ESTELLE
®
-35 ED
_cyproterone acetate and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Estelle-35 ED. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed the risks of
you taking Estelle-35 ED against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS OR ARE
UNSURE ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST FOR
MORE ADVICE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ESTELLE-35
ED IS USED FOR
Estelle-35 ED is used for the
treatment of signs of physical male
characteristics caused by the male
sex hormone, androgen, produced by
in women in small amounts
(androgenisation), such as:
•
severe acne where other
treatments have not been
successful
•
for excessive growth of facial or
body hair (known as hirsutism) of
a mild to moderate degree, where
no underlying cause has been
found.
Estelle-35 ED can also be used as a
contraceptive to prevent pregnancy in
women who are taking it for the
treatment of signs of physical male
characteristics as described above.
Estelle-35 ED contains a progestogen
and an estrogen hormone, and
therefore works similarly to the
combined oral contraceptive birth
control pill, also known as ‘the Pill’.
It should not be used in combination
with another hormonal contraceptive.
While taking Estelle-35 ED you may
also experience the following
benefits:
•
more regular and lighter periods -
potentially resulting in a
decreased risk in anaemia (iron
deficiency)
•
a decrease in period pain
•
reduction of greasiness in skin
and hair.
Some conditions such as pelvic
inflammatory disease, ovarian cysts,
ectopic pregnancy (where the foetus
is carried outside of your womb),
lumpy breasts and cancer of the
uterus (womb) and ovaries may be
less common in women taking
Estelle-35 ED.
ASK YOUR DOCTOR IF YOU HAVE ANY
Q

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION
ESTELLE
®
-35 ED (CYPROTERONE ACETATE/ETHINYLESTRADIOL) TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estelle-35 ED contains the synthetic progestogen, cyproterone acetate
and the synthetic estrogen,
ethinylestradiol.
Each yellow active tablet contains cyproterone acetate 2.0 mg and
ethinylestradiol 35 µg.
List of excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Estelle-35 ED consists of 21 yellow active tablets and 7 white
inactive tablets (placebos).
Yellow active film-coated tablet is a yellowish buff, round, biconvex
tablet, plain on both faces.
White inactive film-coated tablet (placebo) is a white, round,
biconvex tablet, plain on both surfaces.
The calendar-pack consists of a foil backed blister platform
containing twenty-eight tablets. On the
foil reverse side of the platform, the tablets are allocated to days
of the week in calendar format. The
starting sector is coloured red.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of signs of androgenisation in women such as severe
acne (involving inflammation
or nodularity or risk of scarring) where prolonged oral antibiotics or
local treatment alone has not
been successful or idiopathic hirsutism of mild to moderate degree.
Estelle-35 ED will also provide effective oral contraception in this
patient group. It should not be used
in combination with other hormonal contraceptives (see SECTION 4.3
CONTRAINDICATIONS).
If the hirsutism has only recently appeared or has lately intensified
to a considerable extent the cause
(androgen producing tumour or an adrenal enzyme defect) must be
clarified by differential diagnosis.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives (COCs), when taken correctly have a
failure rate of approximately 1%
per year.
Estelle-35 ED is to be taken regularly in order to achieve therapeutic
efficacy and