BRENDA-35 ED tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

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

Verfügbar ab:

Alphapharm Pty Ltd

Darreichungsform:

Tablet, sugar coated

Zusammensetzung:

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

Verabreichungsweg:

Oral

Einheiten im Paket:

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

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Brenda-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.,Brenda-35 ED 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 (i.e. androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Produktbesonderheiten:

Visual Identification: White, round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1996-05-09

Gebrauchsinformation

BRENDA-35 ED
_cyproterone acetate and ethinylestradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Brenda-35 ED.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or health clinic.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Brenda-35 ED
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT BRENDA-35 ED IS
USED FOR
Brenda-35 ED is used for the
treatment of signs of physical male
characteristics caused by the male
sex hormone, androgen, produced by
the male sex hormone, androgen,
produced in women in small amounts
(androgenisation), such as:
•
severe acne when 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.
Brenda-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.
Brenda-35 ED contains a
progestogen and an oestrogen
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 Brenda-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
Brenda-35 ED.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
_ _
_ _
BRENDA-35 ED
_Cyproterone acetate/ethinylestradiol _
1 NAME OF THE MEDICINE
Cyproterone acetate and Ethinylestradiol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Brenda-35 ED contains the
synthetic
progestogen,
cyproterone
acetate
and
the synthetic
estrogen,
ethinylestradiol.
Each beige active tablet, contains ethinylestradiol 35 µg and
cyproterone acetate 2 mg.
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
Brenda-35 ED tablets are available in blister packs of 28 tablets.
Each blister contains 21 beige round active
tablets followed by 7 white round placebo tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brenda-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.
•
Brenda-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 (i.e.
androgen-producing tumour or an adrenal enzyme defect) must be
clarified by differential diagnosis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1% per year.
Brenda-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 Brenda-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
Brenda-35 ED can lead to intermenstrual
bleeding and could deteriora