Etonogestrel/Ethinylestradiol 0.120 mg/0.015 mg per 24 hours vaginal delivery system

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etonogestrel; Ethinylestradiol ph.eur.

Available from:

Laboratorios Leon Farma, S.A.

ATC code:

G02BB; G02BB01

INN (International Name):

Etonogestrel; Ethinylestradiol ph.eur.

Dosage:

0.120/0.015 milligram(s)

Pharmaceutical form:

Vaginal delivery system

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Intravaginal contraceptives; vaginal ring with progestogen and estrogen

Authorization status:

Not marketed

Authorization date:

2017-06-23

Patient Information leaflet

1
LF-ETOEE-IE-NL.H.3723.001.IA.034-D0
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETONOGESTREL/ETHINYLESTRADIOL 0.120 MG/0.015 MG PER 24 HOURS, VAGINAL
DELIVERY SYSTEM
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
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 throughout this leaflet
WHAT IS IN THIS LEAFLET
1. WHAT ETONOGESTREL/ETHINYLESTRADIOL IS AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETONOGESTREL/ETHINYLESTRADIOL
2.1 When you should not use Etonogestrel/Ethinylestradiol
2.2 Warnings and precautions
Blood clots
Cancer
2.3 Children and adolescents
2.4 Other medicines and Etonogestrel/Ethinylestradiol
Laboratory tests
2.5 Pregnancy and breast-feeding
2.6 Driving and using machines
3. HOW TO USE ETONOGESTREL/ETHINYLESTRADIOL
3.1 How to insert and remove Etonogestrel/Ethinylestradiol
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

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2023
CRN00D7K0
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etonogestrel/Ethinylestradiol 0.120 mg/0.015 mg per 24 hours vaginal
delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Etonogestrel/Ethinylestradiol 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 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 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 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
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
must be used as directed (see 'How to use
Etonogestrel/Ethinylestradiol' and 'How to start
Etonogestrel/Ethinylestradiol').
Paediatric Population
The safety and efficacy of Etonogestrel/Ethinylestradiol in
adolescents under the age of 18 have not been studied.
Method of administration
HOW TO USE Etonogestrel/Ethinylestradiol
The woman herself can insert Etonogestrel/Ethinylestradiol in the
vagina. The physician should advise the woman how to insert
and remove Etonogestrel/Ethinylestradiol. For insertion the woman
should choose a position that is most comfortable for her,
e.g. standing with one l