JULIET-35 ED tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: macrogol 6000; lactose monohydrate; sucrose; povidone; purified talc; calcium carbonate; glycol montanate; maize starch; magnesium stearate

Administration route:

Oral

Units in package:

1 x 28 tablets (1 x 21 beige, 1 x 7 white), 3 x 28 tablets (3 x 21 beige, 3 x 7 white)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Juliet-35 ED is indicated 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. Juliet-35 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. 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. Juliet-35 ED 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 summary:

Visual Identification: White round tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2000-10-05

Patient Information leaflet

2101 JULIET-35
®
ED CMI
1
JULIET
®
-35 ED
(JOO·LEE
⋅
ET EE
⋅
DEE)
_cyproterone acetate and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Juliet-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
Juliet-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 JULIET-35 ED IS
USED FOR
Juliet-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.
Juliet-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. Juliet-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 Juliet-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 Juliet-35 ED.

Summary of Product characteristics

210122 Juliet-35 ED PI
1
Australian Product Information
JULIET
®
-35 ED (CYPROTERONE ACETATE / ETHINYLESTRADIOL) TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate and ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JULIET-35 ED contains the synthetic progestogen, cyproterone acetate
and the synthetic
estrogen, ethinylestradiol.
Each beige active tablet contains cyproterone acetate 2 mg and
ethinylestradiol 35 µg.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate.
_For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS _
3
PHARMACEUTICAL FORM
Tablet, sugar coated
JULIET-35 ED tablets are available in blister packs of 28 tablets.
Each blister contains 21
round beige active tablets followed by 7 round white placebo tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
JULIET-35 ED is indicated 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.
•
JULIET-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.
210122 Juliet-35 ED PI
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly have a failure rate
of approximately 1%
per year.
JULIET-35 ED is to be taken regularly in order to achieve therapeutic
efficacy and the
required
contraceptive
protection.
Previously used
hormonal
contraception
should
be
discontinued. The dose regimen of JULIET-35 ED is similar to the usual
regimen of most
of the COCs. Thus, the same administration rules must be considered.
The irregular intake
of JULIET-35 ED can l