NuvaRing, 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETHINYLESTRADIOL, ETONOGESTREL

Available from:

N.V. Organon Kloosterstraat 6, NL-5349 AB Oss, Netherlands

ATC code:

G02BB01

INN (International Name):

ETHINYLESTRADIOL 2.7 mg ETONOGESTREL 11.7 mg

Pharmaceutical form:

VAGINAL DELIVERY SYSTEM

Composition:

ETHINYLESTRADIOL 2.7 mg ETONOGESTREL 11.7 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2020-01-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUVARING, 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 NUVARING
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 NuvaRing is and what it is used for
2.
What you need to know before you use NuvaRing
3.
How to use NuvaRing
4.
Possible side effects
5.
How to store NuvaRing
6.
Contents of the pack and other information
1.
WHAT NUVARING IS AND WHAT IT IS USED FOR
NuvaRing 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,
NuvaRing is considered a low-dose hormonal contraceptive. Since
NuvaRing releases two different
types of hormones it is a so-called combined hormonal contraceptive.
NuvaRing 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. NuvaRing releases two
female sex horm

Summary of Product characteristics

Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
Page 2 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
Page 3 of 25
1.
NAME OF THE MEDICINAL PRODUCT
NuvaRing, 0.120 mg/0.015 mg per 24 hours, Vaginal delivery system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NuvaRing contains 11.7 mg etonogestrel and 2.7 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.
NuvaRing 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.
NuvaRing 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 NuvaRing should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
NuvaRing 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, NuvaRing must be used as
directed (see ‘How to use
NuvaRing’ and ‘How to start NuvaRing’).
_Paediatric population _
The safety and efficacy of NuvaRing in adolescents under the age of 18
have not been studied.
_ _
Method of administration
H
OW TO USE
N
UVA
R
ING
The woman herself can insert NuvaRing in the vagina. The physician
should advise the woman how to
insert and remove NuvaRing. 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. NuvaRing should be
compressed and inserted into the vagina until it feels comfortable. An
optional alternative is to insert
the ring using the NuvaRing Applicator which is distributed separ