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

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

cyproterone acetate,ethinylestradiol

Tersedia dari:

Aspen Pharma Pty Ltd

INN (Nama Internasional):

cyproterone acetate,ethinylestradiol

Status otorisasi:

Registered

Selebaran informasi

LAILA-35 ED- Consumer Medicine Information
Page 1 of 7
Laila-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 (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LAILA-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 LAILA-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 LAILA-35 ED IS
USED FOR
LAILA-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. LAILA-35 ED
works by blocking the action of
these hormones.
LAILA-35 ED is also an effective oral
contraceptive, commonly known as
the "Pill" or "birth control pill".
As a contraceptive, LAILA-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 LAILA-
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 tubal

Karakteristik produk

LAILA-35 ED – Product Information
Page 1 of 14
Laila-35 ED
PRODUCT INFORMATION
NAME OF THE MEDICINE
Cyproterone acetate and ethinyloestradiol
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
ETHINYLOESTRADIOL
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 is a 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
0
C.
Ethinyloestradiol is a 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
0
C.
Laila-35 ED is a memo-pack containing 21 yellow active tablets,
containing 2 mg of cyproterone
acetate and 35 microgram (µg) ethinyloestradiol. The pack also
contains 7 white inactive (placebo)
tablets.
LAILA-35 ED – Product Information
Page 2 of 14
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
Laila-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
ovulation inhib