DIANE-35 TABLET

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Dostupné s:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC kód:

G03HB01

Dávkování:

2 mg

Léková forma:

TABLET, SUGAR COATED

Složení:

CYPROTERONE ACETATE 2 mg; ETHINYLESTRADIOL 0.035 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

BAYER WEIMAR GMBH UND CO. KG

Stav Autorizace:

ACTIVE

Datum autorizace:

1990-06-11

Informace pro uživatele

Diane 35 PI_SG_CCDS 12, 15 &16_23 May 2014 

1.  NAME OF THE MEDICINAL PRODUCT 

Diane-35 tablet    

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

21 hormone-containing beige coated tablets: 
Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg
cyproterone acetate. 

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, Diane-35 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.  
Diane-35 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 Diane-35 _

Diane-35  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  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 Diane-35 can lead to intermenstrual 
bleedings and could
 deteriorate the therapeutic and contracept

Charakteristika produktu

Diane 35 PI_SG_CCDS 17_5 Dec 2016
1.
NAME OF THE MEDICINAL PRODUCT
Diane-35 tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 hormone-containing beige coated tablets:
Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg
cyproterone acetate.
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, Diane-35 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.
Diane-35 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 Diane-35 _
Diane-35 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 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 Diane-35 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 tablet is to be taken daily for
21 consecutive days.
Each subsequent pack is started after a 7-day tablet-free interval,
during which time a
withdrawal bleed usually occurs. This usually starts on day 2-3 after
the last tablet and
may not have finished before the next pack is started.
Diane 35 PI_SG_CCDS 17_5 Dec 2016
_How to start Diane-35 _
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