Nillho 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, Pol. Ind. 24008 NAVATEJERA (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.3723.001.IA.034-D0
PACKAGE LEAFLET: INFORMATION FOR THE USER
NILLHO 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 NILLHO
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 Nillho throughout this
leaflet
WHAT IS IN THIS LEAFLET
1. WHAT NILLHO IS AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NILLHO
2.1 When you should not use Nillho
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and Nillho
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE NILLHO
3.1 How to insert and remove Nillho
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 _
2
LF-ETOEE-NL-NL.H.3723.001.IA.034-D0
_Your ring breaks _
_ _
_You have inserted more than one ring _
_You have forgotten to insert a new ring after the ring-free interval
_
_You have fo

Productkenmerken

1
SPC-ETOEE- NL-NL.H. 3723.001 .IA.031-D0
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nillho 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Nillho 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.
Nillho 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.
Nillho 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 Nillho should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Nillho 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, Nillho must be used as
directed (see ‘How to use Nillho’
and ‘How to start Nillho’).
Paediatric Population
The safety and efficacy of Nillho in adolescents under the age of 18
have not been studied.
Method of administration
HOW TO USE Nillho
The woman herself can insert Nillho in the vagina. The physician
should advise the woman how
to insert and remove Nillho. 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. Nillho should be
compressed and inserted into the vagina until it feels comfortable.
The exact position of Nillho 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. 3723.001 .IA.031-D0
Once Nillho has been inserted (see