Kosidina 0,075 mg/0,030 mg, tabletten

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

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

Δραστική ουσία:

ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk

Διαθέσιμο από:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Φαρμακολογική κατηγορία (ATC):

G03AA10

INN (Διεθνής Όνομα):

ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk

Φαρμακοτεχνική μορφή:

Tablet

Σύνθεση:

CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201),

Οδός χορήγησης:

Oraal gebruik

Θεραπευτική περιοχή:

Gestodene And Ethinylestradiol

Περίληψη προϊόντος:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLACRILINE KALIUM; POVIDON K 30 (E 1201);

Ημερομηνία της άδειας:

2015-12-28

Φύλλο οδηγιών χρήσης

Sandoz B.V.
Kosidina 0,075 mg/0,030 mg, tabletten
Page 1/19
RVG 116278
1313-V8
1.3.1.3 Bijsluiter
Oktober 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
KOSIDINA 0,075 MG/0,030 MG, 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.
Sandoz B.V.
Kosidina 0,075 mg/0,030 mg, tabletten
Page 2/19
RVG 116278

Αρχείο Π.Χ.Π.

Sandoz B.V.
Kosidina 0,075 mg/0,030 mg, tabletten
Page 1/21
RVG 116278
1311-v8
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
1.
NAAM VAN HET GENEESMIDDEL
Kosidina 0,075 mg/0,030 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white tablet contains 0.075 mg (equivalent to 75 micrograms)
gestodene and 0.030 mg (equivalent to
30 micrograms) ethinylestradiol
Excipient(s) with known effects
Each tablet contains 59.12 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round, white tablets, with a diameter of 5.7 mm approximately. The
tablet is debossed with a ‘
_C’ _
on one
side and ‘
_33’ _
on the other side.
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] _
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 tablet per day should be
taken for 21 days. Each
subsequent pack should be started after a 7-day tablet-free interval
during which time a withdrawal
bleeding will occur. This bleeding usually starts on the 2nd or 3rd
day after taking the last tablet, and may
not stop until the next pack is started.
_How to start taking [nationally completed name] _
_If no preceding hormonal contraceptive was used in the past month_
Sandoz B.V.
Kosidina 0,075 mg/0,030 mg, tabletten
Page 2/21
RVG 116278
1311-v8
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
Taking of the tablets should begin on the first day of the woman’s
natural cycle (i.e. on the first day of the
woman’s menstrual bleeding). One may begin taking the pills on day
2-5,