Lumivela 0,150 mg/0,03 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DESOGESTREL 0,15 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Beschikbaar vanaf:

Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)

ATC-code:

G03AA09

INN (Algemene Internationale Benaming):

DESOGESTREL 0,15 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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 ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, D-ALFA (E 307)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Desogestrel And Ethinylestradiol

Autorisatie datum:

2018-09-04

Bijsluiter

_ _
1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
150 MICROGRAMS/30 MICROGRAMS 28 FILM-COATED TABLETS
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.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet.
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 IS USED FOR
are a combined oral contraceptive, also called the
pill.
•
Each of the 21 white tablets contains a small amount of two types of
female hormones,
namely, a progestogen, desogestrel and an oestrogen, ethinylestradiol.
•
The 7 green tablets contain no active substances and are also called
placebo tablets.
These help to stop you from getting pregnant, just as your natural
hormones would stop you
conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant
in three ways. These
hormones
_ _
2
_ _
1.
stop the ovary from releasin

Productkenmerken

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lumivela 0,150/0,03 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 WHITE FILM-COATED TABLETS (ACTIVE TABLETS):
Each
film-coated
tablet
contains
150
micrograms
of
desogestrel
and
30
micrograms
of
ethinylestradiol
Excipients with known effect: Lactose monohydrate 55 mg, soybean oil
(maximum 0.026 mg).
7 GREEN PLACEBO (INACTIVE) FILM-COATED TABLETS:
The tablet does not contain active substances
Excipient with known effect: Lactose monohydrate 55 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: White, round film-coated tablets of 5.00 mm diameter.
They are coded on one side
“C” and on the reverse side “7”.
Placebo tablets: Green, round film-coated tablets of 5.00 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Lumivela should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Lumivela compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
HOW TO TAKE LUMIVELA
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 subsequent pack is started the day after the
last tablet of the previous pack.
2
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.
_Paedriatic population _
The safety and efficacy of desogestrel and ethinylestradiol in
adolescents below 18 years has not yet
been established. No data are available.
HOW TO START LUMIVELA
•
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural c