NuvaRing

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETHINYLESTRADIOL, ETONOGESTREL

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

G02BB01

INN (International Name):

ETHINYLESTRADIOL, ETONOGESTREL

Pharmaceutical form:

VAGINAL DELIVERY SYSTEM

Composition:

ETHINYLESTRADIOL 2.7 milligram(s) ; ETONOGESTREL 11.7 milligram(s)

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2007-08-28

Patient Information leaflet

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PACKAGE LEAFLET
Page 2 of 18
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
2.1
When you should not use NuvaRing
2.2
Warnings and precautions
Blood clots_ _
Cancer
2.3
Children and adolescents
2.4
Other medicines and NuvaRing
Laboratory tests
2.5
Pregnancy and breast-feeding
2.6
Driving and using machines
3.
How to use NuvaRing
3.1
How to insert and remove NuvaRing
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
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 forgotten to remove the ring
You have missed a menstrual period
You have unexpected bleeding
You want to change the first day of your menstrual pe

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 22
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 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
Page 3 of 22
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
separately. The NuvaRing
Applicator may not be available in all countries. The exact position
of NuvaRing i