Kosidina 0,060 mg/0,015 mg, filmomhulde tabletten

Nchi: Uholanzi

Lugha: Kiholanzi

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

Viambatanisho vya kazi:

ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk

Inapatikana kutoka:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC kanuni:

G03AA10

INN (Jina la Kimataifa):

ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk

Dawa fomu:

Filmomhulde tablet

Tungo:

ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLACRILINE KALIUM ; POLYVINYLALCOHOL (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415),

Njia ya uendeshaji:

Oraal gebruik

Eneo la matibabu:

Gestodene And Ethinylestradiol

Bidhaa muhtasari:

Hulpstoffen: ALUMINIUMOXIDE 0-WATER; CELLULOSE, MICROKRISTALLIJN (E 460); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLACRILINE KALIUM; POLYVINYLALCOHOL (E1203); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); XANTHAANGOM (E 415);

Idhini ya tarehe:

2015-12-22

Taarifa za kipeperushi

Sandoz B.V.
Kosidina 0,060 mg/0,015 mg, filmomhulde tabletten
Page
1/20
RVG 116167
1313-v10
1.3.1.3 Bijsluiter
Oktober 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
KOSIDINA 0,060 MG/0,015 MG, FILMOMHULDE 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 TAKING 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 or pharmacist.
-
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 or pharmacist .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 take [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 an oral contraceptive pill and is used
to prevent pregnancy.
•
Each yellow tablet contains a small amount of two different female
hormones, namely gestodene and
ethinylestradiol.
•
Each white tablet contains no active substances and are called placebo
tablets.
•
Contraceptive pills that contain two hormones are called
“combination” pill

Tabia za bidhaa

Sandoz B.V.
Kosidina 0,060 mg/0,015 mg, filmomhulde tabletten
Page 1/22
RVG 116167
1313-v10
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
1.
NAAM VAN HET GENEESMIDDEL
Kosidina 0,060 mg/0,015 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each yellow tablet contains 0.060 mg of gestodene and 0.015 mg of
ethinylestradiol.
Each white tablet does not contain active ingredients.
_ _
Excipients with known effect
The yellow tablets contains 57.61 mg of lactose monohydrate and 0,042
mg of lecithin (soya)
The white tablets contains 70.897 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[nationally completed name] yellow tablet
Round, plain film-coated tablet of 5.5 mm diameter.
[nationally completed name] white tablet (placebo)
Round and biconvex tablet of 5.5 mm diameter.
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 Combined Hormonal
Contraceptives (CHCs) (see sections
4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order shown
on the blister pack. Tablet taking is continuous. One tablet is to be
taken daily for 28 consecutive days. Each
Sandoz B.V.
Kosidina 0,060 mg/0,015 mg, filmomhulde tabletten
Page 2/22
RVG 116167
1313-v10
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
subsequent pack is started the day after the last tablet of the
previous pack. Withdrawal bleeding usually starts
on day 2-3 after starting the placebo tablets (last row) and may not
have finished before the next pack is started.
HOW TO START [NATIONALLY COMPLETED NAME]
•
No preceding hormonal contraceptive use [in the past month]
Tablet-taki