CYBELLE 2mg0.035mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Boleh didapati daripada:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Unit dalam pakej:

21tablet Tablets

Dikeluarkan oleh:

LABORATORIO LEON FARMA, S.A.

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
_______________________________________________________________________________________
1
CYBELLE 2MG / 0.035MG FILM-COATED TABLET
Cyproterone acetate 2mg / Ethinylestradiol 0.035mg
WHAT IS IN THIS LEAFLET
1.
WHAT CYBELLE IS
USED FOR
2.
HOW CYBELLE WORKS
3.
BEFORE YOU USE
CYBELLE
4.
HOW TO USE CYBELLE
5.
WHILE YOU ARE USING
IT
6.
SIDE EFFECTS
7.
STORAGE AND
DISPOSAL OF CYBELLE
8.
FURTHER
INFORMATION WHAT CYBELLE IS USED FOR
_NOTE: _
_CYBELLE _
_SHOULD _
_NOT _
_BE _
_PRESCRIBED _
_FOR _
_THE _
_PURPOSE _
_OF _
_CONTRACEPTION _
_ALONE. _
_HOWEVER, _
_WHEN _
_TAKEN _
_AS _
_RECOMMENDED, _
_CYBELLE _
_WILL _
_PROVIDE _
_RELIABLE _
_CONTRACEPTION IN PATIENTS TREATED _
_FOR THE ABOVE CLINICAL CONDITIONS. _
_IF _
_PATIENT _
_COMPLIANCE _
_IS _
_UNCERTAIN _
_AND _
_CONTRACEPTION _
_IS _
_NECESSARY, THEN A SUPPLEMENTARY _
_NON-HORMONAL _
_CONTRACEPTIVE _
_METHOD SHOULD BE CONSIDERED. _
_ _
Cybelle is used for the treatment
of
moderate
to
severe
acne
related
to
androgen-sensitivity
(with
or
without
seborrhoea)
and/or
excessive
hair
growth
(hirsutism)
in
women
of
reproductive
age.
This
includes
patients
with
polycystic
ovary
syndrome requiring treatment of
these symptoms.
For the treatment of acne, Cybelle
should only be used after courses
of
antibiotic
treatment
have
failed.
Since Cybelle is also a hormonal
contraceptive,
it
should
not
be
used in combination with other
hormonal contraceptives.
HOW CYBELLE WORKS
Cyproterone acetate is an anti-
androgen.
Your
ovaries
produce androgens (male sex
hormones)
to
change
into
oestrogens
(female
sex
hormones).
Androgens
can
stimulate
growth
of
hair
on
the
face
and
body,
and
production of sebum (oil from
your
skin).
If
your
skin
produces
too
much
oil,
the
pores
of
your
skin
will
become
blocked,
which
can
lead
to
acne.
Cyproterone
acetate acts by reducing the
amount of androgens released
by
your
ovaries
and
by
reducing the amount that can
act in your body.
Ethinylestradiol
is
an
oestrogen
(female
sex
hormone)
which
should
be
given
in
co

Ciri produk

Pharma Code
Read Directions
Pharma Code
Read Directions
FRONT SIDE / ANVERSO
222 x 680 1 mm
P032
100%
Dimensions:
Scale:
Material
type:
Leaflet
Drawing #:
Date:
Version:
F
xxxxx
27.05.19
-
PR CIPEE CYBELLE 2-0,035 1X21 EXELTIS MY
Laetus #:
Folded:
YES
NO
Substitutes
mat. #:
Material #/
Product :
LICONSA
LEON FARMA
X
Launch:
Internal change:
Customer change:
X
Pantones:
170 X 37 mm
die cut
black
0000
Signature:
Date:
With the signed proof of this file you commit to have had reviewed and
agreed with the following points as part of your
review:
- Keyline used.
- Free varnish areas.
- Colors.
- Text.
- Prefixes order for variable info (If the order is changed you
commint to clearly comunicate this change to
Chemo's artworks department, otherwise Chemo will not be responsible).
- Any other info included in the file.
DRAWED BY:
APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance)
EXAMPLE / EJEMPLO
Pharma Code
Read Directions
xxxx
CYBELLE 2 MG / 0.035 MG
FILM-COATED TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains cyproterone acetate
2 mg and ethinylestradiol 0.035 mg.
PHARMACEUTICAL FORM
Yellow round biconvex film-coated tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of moderate to severe acne related to
androgen- sensitivity (with or without seborrhoea)
and/or hirsutism in women of reproductive age. This
includes patients with polycystic ovary syndrome
requiring treatment of these symptoms.
For the treatment of acne, CYBELLE 2mg/0.035mg
should only be used after topical therapy or systemic
antibiotic treatments have failed.
Since CYBELLE 2mg/0.035mg is also a hormonal
contraceptive, it should not be used in combination with
other hormonal contraceptives (see section
‘Contraindications’).
POSOLOGY AND METHOD OF ADMINISTRATION
NOTE: CYBELLE 2MG/0.035MG SHOULD NOT BE
PRESCRIBED FOR THE PURPOSE OF CONTRACEPTION ALONE.
HOWEVER, WHEN TAKEN AS RECOMMENDED, CYBELLE
2MG/0.035MG WILL PROVIDE RELIABLE CONTRACEPTION IN
PATIENTS TREATED FOR THE ABOVE CLINICAL CONDITIONS