Estelle-35 table

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Saadav alates:

SCHMIDT BIOMEDTECH SDN BHD

INN (Rahvusvaheline Nimetus):

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Ühikuid pakis:

21Pill Pills; 63Pill Pills

Valmistatud:

DOUGLAS MANUFACTURING LTD

Infovoldik

ESTELLE-35 TABLET
(Cyproterone acetate 2mg and ethinyloestradiol 0.035mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What ESTELLE tablet is used for
2.
How ESTELLE tablet works
3.
Before you use ESTELLE tablet
4.
How to take ESTELLE tablet
5.
While you are using ESTELLE
tablet
6.
Side effects
7.
Storage and Disposal of ESTELLE
tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What ESTELLE tablet is used for
ESTELLE tablet is used to treat women
who suffer from conditions arising from
increased secretion of or increased
response to androgen (male) hormones.
Such conditions include acne, or
moderately increased growth of facial
and body hair (hirsutism).
ESTELLE tablet should be withdrawn 3
to 4 cycles after the treated condition has
been completely resolved.
ESTELLE tablet provides effective oral
contraception in women being treated for
androgen-dependent diseases.
How ESTELLE tablet works
ESTELLE tablet contains two
ingredients, ethinylestradiol and
cyproterone. Ethinylestradiol is an
oestrogen, which is a female sex
hormone. Cyproterone is an anti-
androgen. Androgens are responsible for
stimulating the glands on your skin
which produce sebum (grease) and they
also encourage hair growth. Too much
androgen can cause the glands in your
skin to become blocked and inflamed,
causing acne spots to develop
ESTELLE tablet works by reducing the
amount of androgen you produce, which
helps to clear acne and reduces excess
hair growth.
Before you use ESTELLE tablet
- When you must not use it
Do not take ESTELLE tablet if:

You are pregnant or breast-feeding.

You have had severe disturbances of
liver function, jaundice (yellowing
of the skin) or other problems
associated with the liver.

You have or have had blood clots in
your legs.

You have or have had any pro-
coagulant disorder such as Protein C
deficiency, Protein S deficiency,
Leiden Factor V mutation,
Antithrombin III deficiency or other
familial disorders.

You have or

Toote omadused

ESTELLE
TM
-35 AND ESTELLE
TM
-35 ED
Cyproterone Acetate / Ethinylestradiol Tablets
PRESENTATION
ESTELLE™-35: 21 active tablets that are described as yellow buff,
round
biconvex coated plain tablets, plain on both faces. Tablet diameter is
approximately 5.6 mm.
ESTELLE™-35 ED: 21 active tablets that are described as yellow buff,
round biconvex coated plain tablets, plain on both faces. Tablet
diameter is approximately 5.6 mm.
7 placebo tablets that are described as white, round, biconvex
tablets,
plain on both sides with a diameter of approximately 7.1 mm.
USES
_ACTIONS_
The substance cyproterone acetate contained in ESTELLE™-35 and
ESTELLE™-35 ED inhibits the influence of the androgens, which are
also produced by the female system. It is thus possible to treat
diseases caused by either an increased production of androgens or a
particular sensitivity to these hormones.
While ESTELLE™-35 and ESTELLE™-35 ED is being taken, the increased
sebaceous gland function, which plays an important role in the
development of acne and seborrhoea, is reduced. This leads - usually
after 3 to 4 months of therapy - to the healing of existing acne
efflorescence. The excessive greasiness of the hair and skin generally
disappears earlier. The loss of hair, which frequently accompanies
seborrhoea likewise diminishes.
Treatment
with
ESTELLE™-35
and
ESTELLE™-35
ED
is
indicated
in
women of child-bearing age who exhibit mild forms of hirsutism, and
in particular in slightly increased facial hair; results do not,
however,
become apparent until after several months of use.
Apart from the described antiandrogen effect, cyproterone acetate
also has a pronounced progestational action. The sole administration
of cyproterone acetate would thus lead to cycle disturbances, which
are avoided by its combination with ethinylestradiol in ESTELLE™-35
and ESTELLE™-35 ED. This holds true as long as the preparation is
taken cyclically according to the instructions. The contraceptive
effect of ESTELLE™-35 and ESTELLE™-35 ED is based