Diane-35 ED

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Cyproterone acetate 2mg; Ethinylestradiol 0.035mg

Beszerezhető a:

Bayer New Zealand Limited

INN (nemzetközi neve):

Cyproterone acetate 2 mg

Gyógyszerészeti forma:

Film coated tablet

Összetétel:

Active: Cyproterone acetate 2mg Ethinylestradiol 0.035mg Excipient: Calcium carbonate Glycerol Glycol montanate Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose

db csomag:

Blister pack, 1 x(21+7) sample pack, 28 tablets

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Bayer AG

Terápiás javallatok:

· 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.

Termék összefoglaló:

Package - Contents - Shelf Life: Blister pack, 3 x (21+7) pack - 84 tablets - 60 months from date of manufacture stored at or below 25°C

Engedély dátuma:

1992-03-31

Betegtájékoztató

2103 DIANE-35
®
ED CMI
1
DIANE
®
-35 ED
(DI·ANNE EE·DEE)
_cyproterone acetate and ethinyloestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Diane-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
Diane-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 DIANE-35 ED IS
USED FOR
Diane-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.
Diane-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. Diane-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 Diane-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 Diane-35 ED.
ASK YOUR DOCTOR I

Termékjellemzők

210308 Diane-35 ED DS
1
RESTRICTED
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DIANE
®
35 ED cyproterone acetate 2 mg, ethinylestradiol 35 micrograms, film
coated
tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active beige tablet contains:
Cyproterone acetate
2 mg
Ethinylestradiol
35 micrograms
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
21 beige, round active tablets.
7 white, round placebo tablets.
All tablets have a lustrous sugar coating. Tablets cannot be halved.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
DIANE-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 (androgen-producing tumour or an adrenal-enzyme
defect) must be
clarified by differential diagnosis.
210308 Diane-35 ED DS
2
RESTRICTED
4.2
DOSE AND METHOD OF ADMINISTRATION
DIANE-35 ED is to be taken regularly in order to achieve the
therapeutic efficacy and
the required contraceptive protection. Previously used hormonal
contraception should
be discontinued. The dose regimen of DIANE-35 ED is similar to the
usual regimen of
most combined oral contraceptives. Thus, the same administration rules
must be
considered. Combined oral contraceptives, when taken correctly, have a
failure rate of
approximately 1 % per year.
The irregular intake of DIANE-35 ED can lead to intermenstrual
bleeding and could
deteriorate the therapeutic and contraceptive reliability.
LENGTH OF USE
Treatment will probably need to be continued for about 6 months and
probably much
longer to gain an acceptable therapeutic effect, especially if
Diane-35 ED is being