DONGARING 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:

Laboratorios Leon Farma, S.A. C/ La Vallina s/n. P.I Navatejera 24008 NAVATEJERA (LEON) (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.3743.001.IA.023-D0
PACKAGE LEAFLET: INFORMATION FOR THE USER
GESTIGENRING 0,120 MG/0,015 MG PER 24 UUR, HULPMIDDEL VOOR VAGINAAL
GEBRUIK
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 GESTIGENRING
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 GESTIGENRING
throughout this leaflet
WHAT IS IN THIS LEAFLET
1. WHAT GESTIGENRING IS AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GESTIGENRING
2.1 When you should not use GESTIGENRING
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and GESTIGENRING
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE GESTIGENRING
3.1 How to insert and remove GESTIGENRING
3.2 Three weeks in, one week out
3.3 When to start with the first ring
3.4 What to do if…
_Your ring is accidentally expelled from the vagina _
_Your ring has temporarily been out of the vagina _
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LF-ETOEE-NL-NL.H.3743.001.IA.023-D0
_Your ring breaks _
_ _
_You have inserted more than one ring _
_You have forgotten to insert

Productkenmerken

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SPC-ETOEE-NL-NL.H. 3743.001.IA.023-D0
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DONGARING 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal
gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DONGARING 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, 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.
DONGARING 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.
DONGARING 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 DONGARING should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of
VTE with DONGARING 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, DONGARING must be used as
directed (see ‘How to
use DONGARING’ and ‘How to start DONGARING’).
Paediatric Population
The safety and efficacy of DONGARING in adolescents under the age of
18 have not been
studied.
Method of administration
HOW TO USE DONGARING
The woman herself can insert DONGARING in the vagina. The physician
should advise the
woman how to insert and remove DONGARING. For insertion the woman
should choose a
position that is most comfortable for her, e.g. standing with one leg
up, squatting, or lying down.
DONGARING should be compressed and inserted into the vagina until it
feels comfortable. The
exact position of DONGARING in the vagina is not critical for the
contraceptive effect of the ring
(see Figures 1-4).
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SPC-ETOEE-NL-NL.H. 3743.001.IA.