Kosidina 0,075 mg/0,020 mg 21+7, tabletten

Riik: Holland

keel: hollandi

Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Toimeaine:

ETHINYLESTRADIOL 0,02 mg/stuk ; GESTODEEN 0,075 mg/stuk

Saadav alates:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC kood:

G03AA10

INN (Rahvusvaheline Nimetus):

ETHINYLESTRADIOL 0,02 mg/stuk ; GESTODEEN 0,075 mg/stuk

Ravimvorm:

Tablet

Koostis:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLACRILINE KALIUM ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLACRILINE KALIUM ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Manustamisviis:

Oraal gebruik

Terapeutiline ala:

Gestodene And Ethinylestradiol

Toote kokkuvõte:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLACRILINE KALIUM; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Loa andmise kuupäev:

1900-01-01

Infovoldik

Sandoz B.V.
Kosidina 0,075 mg/0,020 mg 21+7, tabletten
Page 1/17
RVG 116280
1313-v8
1.3.1.3 Bijsluiter
Oktober 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
KOSIDINA 0,075 MG/0,020 MG 21+7, TABLETTEN
Gestodene / Ethinylestradiol
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
-
They are one of the most reliable reversible methods of contraception
if used correctly.
-
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in
the first year or when restarting a combined hormonal contraceptive
following a break of 4 or
more weeks.
-
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”)
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before you use [nationally completed name]
3. How to take[nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
_ _
•
[Nationally completed name]is a contraceptive tablet and is used to
prevent pregnancy.
•
Each tablet contains a small amount of two different female hormones,
namely ethinylestradiol
and gestodene.
•
Contraceptive tablets as [nationally completed name] that contain two
hormones are called
“combination” contraceptives.
[NATIONALLY COMPLETED NAME] NEEDS TO BE TAKEN AS DIRECTED

Toote omadused

Sandoz B.V.
Kosidina 0,075 mg/0,020 mg 21+7, tabletten
Page 1/23
RVG 116280
1311-v8
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
1.
NAAM VAN HET GENEESMIDDEL
Kosidina 0,075 mg/0,020 mg 21+7, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active white tablet contains 0.075 mg (equivalent to 75
micrograms) gestodene and 0.020 mg
(equivalent to 20 micrograms) ethinylestradiol
Each placebo green tablet does not contain active substances.
Excipient(s) with known effect
Each active white tablet contains 59.12 mg lactose monohydrate.
Each placebo green tablet contains 55.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Active tablets: Round, white tablet, with a diameter of 5.7 mm
approximately. The tablet is debossed
with a ‘
_C’ _
on one side and ‘
_34’ _
on the other side.
Placebo tablets: Round, green film-coated tablets, with a diameter of
5 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe [nationally completed name] should take into
consideration the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and how the risk
of VTE with [nationally completed name] compares with other CHCs (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE [NATIONALLY COMPLETED NAME]
Sandoz B.V.
Kosidina 0,075 mg/0,020 mg 21+7, tabletten
Page 2/23
RVG 116280
1311-v8
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
The tablets must be taken every day at approximately the same time, if
necessary with a little liquid, in
the order indicated on the blister pack. One white active tablet per
day should be taken for 21 days and
then a green placebo tablet for the last 7 days. You must then start a
new pack straightaway (21 white
and then 7 green tablets). There is therefore no gap between packs. A
withdrawal bleeding will occur
usually on the 2
nd
or 3
rd
day taking the placebo green tablets, and may not sto