Ethinylestradiol/Desogestrel 0,03 mg/0,15 mg Teva, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DESOGESTREL 150 µg/stuk ; ETHINYLESTRADIOL 30 µg/stuk

Beschikbaar vanaf:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

G03AA09

INN (Algemene Internationale Benaming):

DESOGESTREL 150 µg/stuk ; ETHINYLESTRADIOL 30 µg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

AARDAPPELZETMEEL ; LACTOSE 0-WATER ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TOCOFEROL, DL-ALFA (E 307),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Desogestrel And Ethinylestradiol

Product samenvatting:

Hulpstoffen: AARDAPPELZETMEEL; LACTOSE 0-WATER; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TOCOFEROL, DL-ALFA (E 307);

Autorisatie datum:

2013-06-06

Bijsluiter

Desogestrel/Ethinylestradiol, NL/H/2673/002, 03.04.2023
rvg 112201 EU PIL II/025 met NL info-clean
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
Ethinylestradiol/Desogestrel 0,03 mg/0,15 mg Teva, tabletten
desogestrel/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
__
is and what it is used for
2.
What you need to know before you take
__
3.
How to take
__
4.
Possible side effects
5.
How to store
__
6.
Contents of the pack and other information
1.
WHAT __ IS AND WHAT IT IS USED FOR
COMPOSITION AND TYPE OF PILL
__
tablet is a combined oral contraceptive pill, also called the combined
pill. Each
tablet contains a small amount of two types of female hormones,
namely, a progestogen,
desogestrel and an oestrogen, ethinylestradiol. Because of the small
amount of hormones,
__
is considered a low-dose contraceptive. Because both hormones are
combined
in the same quantity in all tablets in the strip, it

Productkenmerken

Desogestrel/Ethinylestradiol, tablets, NL/H/2673/002, 03.04.2023
rvg 112201 EU SPC II-025 met NL info-clean
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Ethinylestradiol/Desogestrel 0,03 mg/0,15 mg Teva, tabletten
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 micrograms desogestrel and 30 micrograms
ethinylestradiol.
Excipients with known effect:
Each tablet contains 58 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Each tablet is round, white to off-white, 5.00 mm, uncoated, biconvex,
debossed with ‘142’ on
one side and other side plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe

should take into consideration the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and how the
risk of VTE with

compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE
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. One tablet is to be taken daily for
21 consecutive days. Each
subsequent pack is started after a 7-day tablet-free interval; during
which time a withdrawal
bleeding usually occurs. This usually starts on day 2-3 after the last
tablet and may not have
finished before the next pack is started.
HOW TO START
_ _
•
_No preceding hormonal contraceptive use (in the past month) _
_ _
Desogestrel/Ethinylestradiol, tablets, NL/H/2673/002, 03.04.2023
rvg 112201 EU SPC II-025 met NL info-clean
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual
bleeding). Tablet intake is also allowed to start on day 2-5, but
during the first cycle concurrent
use of a barrier method for the first 7 days of tablet intake is
advisable.
•
_Changing from a combined hormonal contraceptive (combined oral
co