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

Land: Holland

Tungumál: hollenska

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

Virkt innihaldsefni:

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

Fáanlegur frá:

Laboratorios Leon Farma, S.A. C/La Vallina s/n, Pol. Ind. 24008 NAVATEJERA (SPANJE)

ATC númer:

G02BB01

INN (Alþjóðlegt nafn):

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

Lyfjaform:

Hulpmiddel voor vaginaal gebruik

Samsetning:

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

Stjórnsýsluleið:

Vaginaal gebruik

Lækningarsvæði:

Vaginal Ring With Progestogen And Estrogen

Vörulýsing:

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

Leyfisdagur:

2017-09-11

Upplýsingar fylgiseðill

1
LF-ETOEE-NL-NLH.3722.001.IA.032-D0
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETONOGESTREL/ETHINYLESTRADIOL LEON FARMA 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
ETONOGESTREL/ ETHINYLESTRADIOL LEON
FARMA 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 Leon Farma throughout this leaflet
WHAT IS IN THIS LEAFLET
1. WHAT ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA IS AND WHAT IS IT
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETONOGESTREL/ ETHINYLESTRADIOL
LEON FARMA
2.1 When you should not use Etonogestrel/ Ethinylestradiol Leon Farma
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and Etonogestrel/ Ethinylestradiol Leon Farma
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA
3.1 How to insert and remove Etonogestrel/ Ethinylestradiol Leon Farma
3.2 Three weeks in, one week out
3.3 When to start with the first ring

Vara einkenni

1
SPC-ETOEE-CC-NL.H. 3722.001.IB.028-D0
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Etonogestrel/Ethinylestradiol Leon Farma 0,120 mg/0,015 mg per 24 uur,
hulpmiddel voor
vaginaal gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Etonogestrel/ Ethinylestradiol Leon Farma 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.
Etonogestrel/ Ethinylestradiol Leon Farma 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 Leon Farma 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
Leon
Farma
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 Leon
Farma 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
Leon Farma must be
used as directed (see ‘How to use Etonogestrel/ Ethinylestradiol
Leon Farma’ and ‘How to
start Etonogestrel/ Ethinylestradiol Leon Farma’).
Paediatric Population
The safety and efficacy of Etonogestrel/ Ethinylestradiol Leon Farma
in adolescents under the
age of 18 have not been studied.
Method of administration
HOW TO USE Etonogestrel/ Ethinylestradiol Leon Farma
2
SPC-ETOEE-CC-NL.H. 3722.001.IB.028-D0
The woman herself can insert Etonogestrel/ Ethinylestradiol Leon Farma
in the vagina. The
physician should advise the wo