Lindynette 20 tablets coated

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

ethinylestradiol, gestodene

Disponible des:

Gedeon Richter PLC

Codi ATC:

G03AA10

Designació comuna internacional (DCI):

ethinylestradiol, gestodene

Dosis:

0,02mg+ 0,075mg

formulario farmacéutico:

tablets coated

Unidades en paquete:

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

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2023-06-21

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LINDYNETTE 20
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains:
_ACTIVE SUBSTANCES:_ 0,075 mg of gestodene and 0,02 mg of
ethinylestradiol in each coated tablet.
_EXCIPIENTS: _Sodium calcium edetate, magnesium stearate, silica
colloidal anhydrous, povidone K-30,
maize starch, lactose monohydrate
_Film-coating:_ Quinoline” Yellow (E 104), povidone K-90F, titanium
dioxide (E171), macrogol 6000, talc,
calcium carbonate, sucrose.
_ _
3.
PHARMACEUTICAL FORM
Pale yellow, round, biconvex sugar-coated tablets, without sign on the
both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Lindynette should take into consideration
the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Lindynette compares with other combined hormonal contraceptives (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pregnancy should be excluded before starting Lindynette.
Posology
The tablets must be taken every day at about the same time, in the
order shown on the blister pack.
One tablet is to be taken daily for 21 consecutive days, which is
followed by a 7-day tablet-free
interval. Each subsequent pack is started the day after the
tablet-free interval. Withdrawal bleeding
usually starts on the 2
nd
or 3
rd
day after taking the last tablet, and may not stop before the next
pack is
started.
HOW TO START LINDYNETTE
No hormonal contraceptive use within the preceding month
The user should begin taking Lindynette on day 1 of her natural
menstrual cycle (i.e. the first day of
the menstrual bleeding). Beginning Lindynette use on days 2-7 of the
menstrual cycle (e.g. starting on
a Sunday) is also allowed; however a non-hormonal back-up method of
birth control [e.g. condoms,
spermicide] is recommended during the first 7 days of Lindynette 20
use.
Switching from another combined contraceptive _(combined oral
contraceptives