Etonogestrel/Ethinylestradiol Exeltis 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

G02BB01

INN (Algemene Internationale Benaming):

ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk

farmaceutische vorm:

Hulpmiddel voor vaginaal gebruik

Samenstelling:

COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat) ; POLYURETAAN,

Toedieningsweg:

Vaginaal gebruik

Therapeutisch gebied:

Vaginal Ring With Progestogen And Estrogen

Product samenvatting:

Hulpstoffen: COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat); POLYURETAAN;

Autorisatie datum:

2017-09-11

Bijsluiter

1
LF-ETOEE-NL-NL.H.3719.IA.029-D0
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETONOGESTREL/ETHINYLESTRADIOL EXELTIS 0,120 MG/0,015 MG PER 24 UUR,
HULPMIDDEL
VOOR
VAGINAAL GEBRUIK
ETONOGESTREL/ETHINYLESTRADIOL EXELTIS
etonogestrel/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
ETONOGESTREL/ETHINYLESTRADIOL
EXELTIS 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. See section 4.
Your
medicine
is
available
as
the
above
name
but
will
be
referred
to
as
Etonogestrel/Ethinylestradiol Exeltis throughout this leaflet
WHAT IS IN THIS LEAFLET
1. WHAT ETONOGESTREL/ETHINYLESTRADIOL EXELTIS IS AND WHAT IS IT USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETONOGESTREL/ETHINYLESTRADIOL
EXELTIS
2.1 When you should not use Etonogestrel/Ethinylestradiol Exeltis
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and Etonogestrel/Ethinylestradiol Exeltis
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE ETONOGESTREL/ETHINYLESTRADIOL EXELTIS
3.1 How to insert and remove Etonogestrel/Ethinylestradiol Exeltis
3.2 Three weeks in, one week out
3.3 When to start with the first ring

Productkenmerken

SPC-ETOEE-NL-NL.H.3719.001.IA.29-D0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Etonogestrel/Ethinylestradiol Exeltis 0,120 mg/0,015 mg per 24 uur,
hulpmiddel voor vaginaal
gebruik
Etonogestrel/Ethinylestradiol Exeltis
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Etonogestrel/Ethinylestradiol Exeltis contains 11.0 mg etonogestrel
and 3.474 mg
ethinylestradiol. The ring releases etonogestrel and ethinylestradiol
at an average amount of
0.120 mg and 0.015 mg 120 micrograms and 15 micrograms, respectively
per 24 hours, over a
period of 3 weeks.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vaginal delivery system.
Etonogestrel/Ethinylestradiol Exeltis is flexible, transparent, and
colourless to almost colourless
ring, with an outer diameter of 54 mm and a cross-sectional diameter
of 4 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
Etonogestrel/Ethinylestradiol Exeltis is intended for women of fertile
age. The safety and efficacy
have been established in women aged 18 to 40 years.
The decision to prescribe Etonogestrel/Ethinylestradiol Exeltis should
take into consideration the
individual woman’s current risk factors, particularly those for
venous thromboembolism (VTE),
and how the risk of VTE with Etonogestrel/Ethinylestradiol Exeltis
compares with other combined
hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, Etonogestrel/Ethinylestradiol
Exeltis must be used as
directed (see ‘How to use Etonogestrel/Ethinylestradiol Exeltis’
and ‘How to start
Etonogestrel/Ethinylestradiol Exeltis’).
Paediatric Population
The safety and efficacy of Etonogestrel/Ethinylestradiol Exeltis in
adolescents under the age of
18 have not been studied.
Method of administration
HOW TO USE Etonogestrel/Ethinylestradiol Exeltis
SPC-ETOEE-NL-NL.H.3719.001.IA.29-D0
2
The woman herself can insert Etonogestrel/Ethinylestradiol Exeltis in
the vagina. The physician