CHELSEA-35 ED cyproterone acetate 2 mg and ethinylestradiol 35 micrograms tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

cyproterone acetate,ethinylestradiol

Saatavilla:

Aspen Pharma Pty Ltd

INN (Kansainvälinen yleisnimi):

cyproterone acetate,ethinylestradiol

Valtuutuksen tilan:

Registered

Pakkausseloste

CHELSEA-35 ED
1
CHELSEA
®
-35 ED
_Contraceptive tablets for women _
_Contains: _
_21 yellow tablets, each containing the active ingredients cyproterone
acetate and ethinyloestradiol (2 _
_mg/35 microgram (µg)) _
_7 white placebo tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CHELSEA
®
-35 ED.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking CHELSEA
®
-35
ED against the benefits they expect it
will have 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 THIS MEDICINE IS
USED FOR
CHELSEA
®
-35 ED is a hormonal
preparation used to treat the
following androgen-dependent
conditions in women:
•
severe acne when other
treatments have failed
•
mild to moderate increased
growth of facial or body hair
(hirsutism).
Androgens are male sex hormones,
produced by women in small
amounts. If a woman's body
produces too much of these
hormones or is overly sensitive, then
androgen-dependent conditions
occur. CHELSEA
®
-35 ED works by
blocking the action of these
hormones.
CHELSEA
®
-35 ED is also an
effective oral contraceptive,
commonly known as the "Pill" or
"birth control pill".
As a contraceptive, CHELSEA
®
-35
ED prevents pregnancy by:
•
preventing ovulation
•
thickening the cervical mucus to
act as a barrier to sperm
•
making the lining of the uterus
less suitable for implantation of
the fertilised egg.
Oral contraceptives such as
CHELSEA
®
-35 ED may have the
following theoretical benefits:
•
a decrease in the amount of blood
you lose each cycle during your
period
•
a decrease in anaemia
•
a decrease in period pain
•
a reduced risk of pelvic
inflammatory disease
•
a reduced risk of developing
ovarian cysts
•
an improvement in acne
•
a reduced risk of tu

Valmisteyhteenveto

CHELSEA-35 ED – Product Information
Page 1 of 15
Chelsea-35 ED
PRODUCT INFORMATION
NAME OF THE MEDICINE
Cyproterone acetate and ethinylestradiol
CYPROTERONE ACETATE
The chemical name for cyproterone acetate is 6-chloro-17
α
-hydroxy-1
α
,2
α
- methylene-pregna-4,6-
diene- 3,20-dione acetate. Its structural formula is:
C
24
H
29
ClO
4
Molecular weight: 416.96
CAS No.: 427-51-0
ETHINYLESTRADIOL
The chemical name for ethinyloestradiol is 19-nor-17
α
-pregna-1,3,5,(10)-triene-20-yne-3,17
β
-diol.
Its structural formula is:
C
20
H
24
O
2
Molecular weight: 296.41
CAS No.: 57-63-6
DESCRIPTION
Cyproterone acetate: - white to pale yellow crystalline powder, which
is very soluble in chloroform
and dioxane, freely soluble in acetone and benzene, soluble in
ethanol, methanol and ethyl acetate,
sparingly soluble in solvent hexane and almost insoluble in water. The
melting point is 206 – 213
O
C.
Ethinyloestradiol: - white to slightly yellowish white crystalline
powder, which is practically insoluble
in water, freely soluble in ethanol (96%) and ether, sparingly soluble
in chloroform. It dissolves in
dilute alkaline solutions. The melting point is 181 – 185
O
C.
CHELSEA-35 ED – Product Information
Page 2 of 15
Chelsea-35 ED is a memo-pack containing 21 yellow active tablets,
containing 2 mg of cyproterone
acetate and 35 microgram (µg) ethinylestradiol. The pack also
contains 7 white inactive (placebo)
tablets.
The tablets also contain the following excipients: lactose, povidone,
purified talc, magnesium
stearate, sucrose, calcium carbonate, titanium dioxide, macrogol 6000,
glycerol, glycol montanate.
maize starch (active tablets only) and iron oxide yellow (active
tablets only). The tablets are gluten
free.
PHARMACOLOGY
Chelsea-35
ED
is
a
progestogen/oestrogen
combination
for
the
treatment
of
signs
of
androgenisation in women. At the same time, it is a reliable
contraceptive for women who suffer
primarily from these signs, or in whom acne and similar conditions
occur or deteriorate under the
use of other ovulatio