JENE-35 ED tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

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

Beschikbaar vanaf:

Strides Pharma Science Pty Ltd

INN (Algemene Internationale Benaming):

cyproterone acetate,ethinylestradiol

farmaceutische vorm:

Tablet

Samenstelling:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate

Toedieningsweg:

Oral

Eenheden in pakket:

28 tablets (1 Blister pack contains 1x 21 yellow active tablets and 1x7 white placebo tablets), 28 tablets x 3 (3x 21 yellow active tablets and 3x7 white placebo tablets)

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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. Jene-35ED will also provide effective oral contraception in this patient group. 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.

Product samenvatting:

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

Autorisatie-status:

Licence status A

Autorisatie datum:

2008-05-15

Bijsluiter

1
JENE-35 ED
TM
JENE-35 ED™
_contains the active ingredient cyproterone acetate and
ethinylestradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Jene-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 Jene-35 ED™
against the benefits this medicine is
expected to 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 JENE-35 ED™ IS
USED FOR
Jene-35 ED is used for the treatment
of signs of androgenisation in
women, such as severe acne where
other treatments have not been
successful, or for excessive growth
of facial or body hair (known as
hirsutism) of a mild to moderate
degree, where no underlying cause
has been found.
Jene-35 ED can also be used as a
contraceptive to prevent pregnancy
in women who are taking it for the
treatment of signs of androgenisation
as described above. Jene-35 ED
contains a progestogen and an
oestrogen hormone, and therefore
works similarly to the combined oral
contraceptive birth control pill. It
should not be used in combination
with another hormonal contraceptive.
While taking Jene-35 ED you may
also experience the following
benefits:
•
more regular and lighter periods
– potentially resulting in a
decrease 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, fibrocystic breast
changes and cancer of the uterus
(womb) and ovaries may be less
common in women taking Jene-35
ED.
Your doctor, however may have
prescribed Jene-35 ED for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION
JENE-35 ED™ (CYPROTERONE ACETATE 2 MG AND
ETHINYLESTRADIOL 35 MICROGRAM) TABLETS
1
NAME OF THE MEDICINE
cyproterone acetate and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each yellow active tablet contains cyproterone acetate 2 mg and
ethinylestradiol 35 microgram.
Cyproterone acetate is a white or almost white, crystalline powder,
practically insoluble in water, very
soluble in methylene chloride, freely soluble in acetone, soluble in
methanol, sparingly soluble in
ethanol. It melts at about 210°C.
Ethinylestradiol is a white or slightly yellowish-white, crystalline
powder, practically insoluble in
water, freely soluble in alcohol. It dissolves in dilute alkaline
solutions. It shows polymorphism.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
Tablet, film coated (active): A yellowish buff, round, biconvex
tablet, plain on both faces.
Tablet (placebo): White, round, biconvex tablet, plain on both
surfaces.
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.
Jene-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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly have a failure rate
of approximately 1% per year.
Jene-35 ED is to be taken regularly in order to achieve therapeutic
efficacy and the required
contraceptive protection. Pr