ESTELLE-35ED TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CYPROTERONE ACETATE; ETHINYLOESTRADIOL

Available from:

APEX PHARMA MARKETING PTE. LTD.

ATC code:

G03HB01

Dosage:

2 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

CYPROTERONE ACETATE 2 mg; ETHINYLOESTRADIOL 0.035 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

DOUGLAS PHARMACEUTICALS LTD

Authorization status:

ACTIVE

Authorization date:

2002-06-04

Patient Information leaflet

ESTELLE
TM
-35ED  
Summary of Product Characteristics 

1.  NAME OF THE MEDICINAL PRODUCT 
Estelle-35ED tablet 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
21 hormone-containing small, yellow coated tablets: 
Each coated tablet contains 0.035 mg ethinylestradiol, 2.0
mg cyproterone acetate. 
7 large non-active white coated tablets: 
Each coated non-active tablet contains lactose, microcrystalline
cellulose, magnesium stearate. 

3.  PHARMACEUTICAL FORM 
Coated tablet. 

4.  CLINICAL PARTICULARS 
4.1 Indications 
For the treatment of androgen-dependent diseases in women,
such as moderate to severe acne, 
and mild forms of hirsutism. 

When used for the treatment of acne, Estelle-35ED should only be used after topical therapy or 
systemic antibiotic treatments have failed. 

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. 

Estelle-35ED should not be prescribed for the purpose of
contraception alone. 

4.2 Dosage and Method of Administration 
_Method of Administration_ 
Oral use. 

_Dosage Regimen_ 
_How to take Estelle-35ED_ 
Estelle-35ED  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 Estelle-35ED is similar to  the usual  regimen of most of  the 
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  Estelle-35ED 

Summary of Product characteristics

ESTELLE
TM
-35ED
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Estelle-35ED tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
21 hormone-containing small, yellow coated tablets:
Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg
cyproterone acetate.
7 large non-active white coated tablets:
Each coated non-active tablet contains lactose, microcrystalline
cellulose, magnesium stearate.
3. PHARMACEUTICAL FORM
Coated tablet.
4. CLINICAL PARTICULARS
4.1 Indications
For the treatment of androgen-dependent diseases in women, such as
moderate to severe acne,
and mild forms of hirsutism.
When used for the treatment of acne, Estelle-35ED should only be used
after topical therapy or
systemic antibiotic treatments have failed.
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.
Estelle-35ED should not be prescribed for the purpose of contraception
alone.
4.2 Dosage and Method of Administration
_Method of Administration_
Oral use.
_Dosage Regimen_
_How to take Estelle-35ED_
Estelle-35ED 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 Estelle-35ED is similar to the usual
regimen of most of the
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 Estelle-35ED can lead to
intermenstrual bleedings and could
deteriorate the therapeutic and contraceptive reliability.
Tablets must be taken in the order directed on the package every day
at about the same time
with some liquid as needed. One yellow tablet is to be taken daily for
21 consecutive days,
followed by one white tablet for 7 days during which time a withdrawal
bleed usually occurs.
This u