Lindynette 20 tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gestodene, ethinylestradiol

Available from:

Gedeon Richter PLC

ATC code:

G03AA10

INN (International Name):

gestodene, ethinylestradiol

Dosage:

0,02mg+ 0,075mg

Pharmaceutical form:

tablets coated

Units in package:

(21/1x21/) and (63/3x21/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-27

Patient Information leaflet

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Read the complete document

Summary of Product characteristics

Sunrnrary
of
Product
Chrrracteristics
1.,
N,A.ME
OF
TI{E
MEDICINAI,I'RODIjCT
Lindynette
20
2,
QUAI,ITATIVE
ANDQUAI\TITATTVBCOMPOS]TION
Each table.ts
contains:
Aclive
sabsktncas:
0,0^15
rng
of
gestodene
and
0,02 mg
of
etlrinylestr.adiol
in
each
goatecl
tablst.
Excfuients:
Sodiurn
calciLurt
edetate,
nragnesiuLn
stearate,
sitica
colloiclal
anhyclrous,
pgvidone
l(-30,
naize
starch,
lactose
rronohydrate
Filnt-coating,'
Quinoline"
Yellorv
(E
104),
povidone
K-90F,
xitaniurn
dioxicle
(8171),rnacrogol
6000,
talc,
calciutn
carbon
ate,
sucrose.
3,
PI-IAITNTACEUTICAL
FORM
Pale
yellow,
round,
biconvex
sugar-coetecl
tablets,
withourt
sign
o1
the
botli
sides,
4,
CI"INICALPARTICUI,ARS
4.1
Tlrerapeutic
indications
Oral
contraception.
The
decision
to
prescribe
Lindynette
should
talie
jnto
consiileration
the
jndiviciual
woman,s
currenr
risk
factors,
partlcr"rlarly
those
for
venoils
flrronrboernbolisnr
(VTE),
and
horry
the
|isk
of
VTE
rvittr
Lindynefte
conlpares
rvith
other
cornbined
hormonal
contraceptjves
(see
sections
4.3
and
4.4).
4,2
Fosology
and
methocl of
adnrinlstr.ation
P:'egnancy
should
be
exch"rded
before starting
Lindynette.
Posology
The
tablets
tlust
be
taken
every
dai,
a1
o6ort
the
same
tine,
.in
the
olclel
shorvn
on
the
blister
pack.
One
tablet
is
to
be
taken daily
for
2l
consecutive
days,
rvhich
is
follor.ved
by
a T-clay
tablet-fiee
interval'
Each
subsequgnt
p^lr"k.
is
stafted
lle
da,y
after tho
tablet-free
intsrval.
Withdrarval
bleecling
usually
stalts
on
the
2od
or
3"r
day after
taking
tire iast
tabJet,
and
txay
uot
stop
before
the
next
pack
is
stalted.
florv
to
stirrt
Lintlynette
No
hopronal
contracentjve
usg_fv,illr
j.n
thqptecedhe
Eo[!h
The
user
shoulcl
begin
taking.Lindynette
on
clay
I
of
her
natural
rrrenslrual
cycle
(i,e.
the
11.st
day
ot
the
nrenstlual
blecding),
Beginning
Lindyrette
use
on
days
2-7
of
the
nrenstiual
cycle
(e.g.
starling
on
a
Sunday)
is
also
allowed;
horvevel
a
non-honnonal
back-up
rnethocl
of
bir.th
control
[o,glcondon:rs,
spermicide]
is
recorr:mencled
cluring
tlre
first
?
ctays
of
Linclyne