Jene-35 ED tablets film-coated

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

I tablet-cyproterone (cyproterone acetate), ethinylestradiol, II tablet-inactive

Verfügbar ab:

Eris Pharmaceuticals (Australia) Pty Ltd

ATC-Code:

G03HB01

INN (Internationale Bezeichnung):

I tablet-cyproterone (cyproterone acetate), ethinylestradiol, II tablet-inactive

Dosierung:

2mg+ 0.035mg

Darreichungsform:

tablets film-coated

Einheiten im Paket:

(28/1x28/ 21 (I) tablets+ 7(II) tablets/), in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2016-02-26

Gebrauchsinformation

UNINTERRUPTED FOR 7 DAYS.
IF YOU HAVE BEEN TAKING THE YELLOW ACTIVE
TABLETS FOR 7 UNINTERRUPTED DAYS AND MISS A
YELLOW ACTIVE TABLET, TAKE THE MISSED TABLET AS
SOON AS YOU REMEMBER, THEN GO BACK TO
TAKING YOUR MEDICINE AS YOU WOULD NORMALLY,
EVEN IF THIS MEANS TAKING TWO TABLETS IN ONE
DAY AT THE SAME TIME.
You will not need to use
additional barrier contraceptive precautions.
The chance of pregnancy after missing a yellow active
tablet depends on when you missed the tablet.
THERE IS A HIGHER RISK OF BECOMING PREGNANT IF
YOU MISS A YELLOW TABLET AT THE BEGINNING OR
END OF A PACK.
IF AFTER TAKING YOUR MISSED TABLET YOU HAVE
LESS THAN 7 DAYS OF YELLOW ACTIVE TABLETS LEFT IN
A ROW, YOU SHOULD FINISH THE ACTIVE TABLETS IN
YOUR PACK BUT SKIP THE WHITE INACTIVE TABLETS
AND START A NEW PACK WITH THE YELLOW ACTIVE
TABLETS CORRESPONDING TO THE CORRECT DAY OF
THE WEEK.
This is the best way to maintain contraceptive protection.
However, you may not have a period until the end of the
yellow active tablets of the second pack. You may have
spotting or breakthrough bleeding on tablet taking days.
IF YOU HAVE BEEN TAKING THE YELLOW ACTIVE
TABLETS FOR LESS THAN 7 DAYS AND MISS A YELLOW
ACTIVE TABLET, TAKE THE MISSED TABLET AS SOON
AS YOU REMEMBER, THEN GO BACK TO TAKING
YOUR MEDICINE AS YOU WOULD NORMALLY, EVEN IF
THIS MEANS TAKING TWO TABLETS IN ONE DAY AT
THE SAME TIME. IN ADDITION, YOU MUST ALSO USE
ADDITIONAL BARRIER CONTRACEPTIVE PRECAUTIONS
(E.G. CONDOMS OR A DIAPHRAGM) FOR THE NEXT 7
DAYS.
If you have had sexual intercourse in the preceding 7
days, there is a possibility of pregnancy and you may
need emergency contraception. You should discuss this
with your doctor or pharmacist.
IF YOU FORGET TO TAKE MORE THAN ONE YELLOW
ACTIVE TABLET, SEEK ADVICE FROM YOUR DOCTOR OR
PHARMACIST ABOUT WHAT TO DO.
If you have had sexual intercourse in the week before
missing your tablets, there is a possibility of becoming
pregnant. You should discuss this with your doctor or
pharmacist.
IF YOU FORGET TO TAKE A WHITE INACTIVE TABLET,
TAKE I

Fachinformation

ERIS
i
r..,n,
,.,,-
I
SUMMARY
OF
PRODUCT
CHARACTERISTICS
JENE-35
EDTM
1.
NAME
OF
THE MEDICINAL
PRODUCT
Jene-35
ED
2
mg/35
microgram film-coated
tablets.
2.
QUALITATIVE
AND
QUANTITI\TIVE
COMPOSITION
Each
yellow
active film-coated
tablet
contains
cyproterone
acetate
2
mg
and
ethinyloestradiol
35
microgram.
Jene-35
ED
tablets
also
contain
the
following
core
excipients:
lactose,
microcrystalline
cellulose,
povidone,
croscarmellose
sodium, magnesium
stearate and
ethanol.
Each white
placebo
tablet
contains
lactose,
microcrystalline cellulose
and magnesium
siearate.
For
a
full list
of
excipients,
see section
6.'1.
3.
PHARMACEUTICAL
FORM
Film-coated
tablets.
A
yellowish
buff,
round,
biconvex
tablet,
plain
on
both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
For
the
treatmeni
of
signs
of
androgenisation
in
women
such
as
severe
acne
(involving
inflammation
or nodularity
or
risk
of
scarring) where
prolonged
oral antibiotics
or
localtreatment
alone
has not been successful,
or idiopathic
hirsutism of
mild
to
moderate
degree.
Jene-35
ED will
also
provide
effective
oral contraception in
this
patient
group.
It should not
be
used in combination with other
hormonal
contraceptives
(see
section
4.3).
lf
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.
4.2
POSOLOGY
AND
METHOD
OF
ADMINISTRATION
Combined
oral
contraceptives,
when taken
correctly have
a
failure
rate
of
approxirnately
1%
per year.
Jene-35 ED is
to
be
taken
regularly
in
order
to
achieve
therapeutic
efficacy
and
the
required
contraceptive
protection.
Previously
used hormonal contraception
should
be.d15c-ontinued,
The
dose regimen
of
Jene-3s
ED
is
similar
to
the
usual regimen
of
mosl
of
.Ifie'cgmbined
oral
contraceptives. Thus, the same administration
rules
must
be
considered',.Tfie
ir#gijlbr
intake
of
El,cc
2
c,:
.:a.
:,
4Z::1L
lf,
^
.a
Jene-35
ED
can
lead
to
intermenstrual
bleeding
and could
deteriorate
the