Perlinring 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 ; ETONOGESTREL

Beschikbaar vanaf:

Actavis Group PTC ehf

ATC-code:

G02BB01

INN (Algemene Internationale Benaming):

ETHINYL ESTRADIOL ; ETONOGESTREL

farmaceutische vorm:

Hulpmiddel voor vaginaal gebruik

Samenstelling:

COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat) ; COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (9 pCt. vinylacetaat) ; MAGNESIUMSTEARAAT (E 470b)

Toedieningsweg:

Vaginaal gebruik

Therapeutisch gebied:

Vaginal Ring With Progestogen And Estrogen

Autorisatie datum:

2019-04-02

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Perlinring 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal
gebruik

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 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. 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 use /…/
3.
How to use /…/
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
/.../ is a contraceptive vaginal ring used to prevent pregnancy. Each
ring contains a small amount of
two female sex hormones – etonogestrel and ethinylestradiol. The
ring slowly releases these hormones
into the blood circulation. Because of the low amount of hormones that
is released, /.../ is considered a
low-dose hormonal contraceptive. Since /.../ releases two different
types of hormones it is a so-called
combined hormonal contraceptive.
/.../ works just like a combined contraceptive pill (the Pill) but
instead of taking a pill every day, the ring
is used for 3 weeks in a row. /.../ releases two female sex hormones
that prevent the release

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perlinring 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal
gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
/.../ contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. The
ring releases etonogestrel and
ethinylestradiol at an average amount of 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.
/.../ 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.
/.../ 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 /.../ 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
To achieve contraceptive effectiveness, /.../ must be used as directed
(see 'How to use /.../' and 'How
to start /.../').
_Paediatric population _
The safety and efficacy of /.../ in adolescents under the age of 18
years have not been established.
Method of administration
HOW TO USE /.../
The woman herself can insert /.../ in the vagina. The physician should
advise the woman how to insert
and remove /.../. 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. /.../ should
be compressed and inserted into the
2
vagina until it feels comfortable. The exact position of /.../ in the
vagina is not critical for the
contraceptive effect of the ring (see Figures 1-4).
Once /.../ has been inserted (see 'How to start /.../') it is left in
the vagina continuously for 3 weeks.
Advise women to regularly check for the p