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NUVARING 0.120MG/ 0.015MG PER 24HOURS VAGINAL DELIVERY SYSTEM

Active substance(s): ETHINYLESTRADIOL / ETONOGESTREL

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Package Leaflet: information for the User
®

NuvaRing 0.120mg/0.015mg per 24hours, 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’).
The name of your medicine is NuvaRing® 0.120mg/0.015mg per 24hours,
vaginal delivery system, but will be referred to as NuvaRing throughout
this leaflet.
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 is it 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 period
You want to delay your menstrual period
3.5 When you want to stop using NuvaRing
4. Possible side effects
5. How to store NuvaRing
6. Contents of the pack and other Information
What NuvaRing contains
What NuvaRing looks like and contents of the pack
Manufacturer

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 hormones that prevent the release of
an egg cell from the ovaries. If no egg cell is released you cannot become
pregnant.

if you know you have a disorder affecting your blood clotting – for
instance, protein C deficiency, protein S deficiency, antithrombin – III
deficiency, Factor V Leiden or antiphospholipid antibodies;
if you need an operation or if you are off your feet for a long time (see
section ‘Blood clots’);
if you have ever had a heart attack, or a stroke;
if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms);
if you have any of the following diseases that may increase your risk of
a clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
if you have (or have ever had) a type of migraine called ‘migraine with
aura’;
if you have (had) inflammation of the pancreas (pancreatitis) associated
with high levels of fat in your blood.
if you have (had) severe liver disease and your liver is not yet working
normally.
if you have (had) a benign or malignant tumour in the liver.
if you have (had), or if you may have, cancer of the breast or the genital
organs.
if you have any unexplained vaginal bleeding.
if you are allergic to ethinylestradiol or etonogestrel, or any of the other
ingredients of this medicine (listed in section 6).
If any of these conditions appear for the first time while using NuvaRing,
remove the ring immediately and contact your doctor. In the meantime,
use non-hormonal contraceptive measures.
2.2 Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are
suffering from a blood clot in the leg (i.e. deep vein thrombosis), a
blood clot in the lung (i.e. pulmonary embolism), a heart attack or a
stroke (see ‘Blood clots’ section below).
For a description of the symptoms of these serious side effects please
go to ‘How to recognise a blood clot’.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using NuvaRing,
you should also tell your doctor.
if a close relative has or has ever had breast cancer;
if you have epilepsy (see section 2.4:‘Other Medicines and NuvaRing’);
if you have liver disease (for instance jaundice) or gallbladder disease
(for instance gallstones);
if you have Crohn’s disease or ulcerative colitis (chronic inflammatory
bowel disease);
if you have systemic lupus erythematosus (SLE - a disease affecting
your natural defense system);
if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the kidneys);
if you have sickle cell anaemia (an inherited disease of the red blood
cells);
if you have elevated levels of fat in the blood (hypertriglyceridaemia) or
a positive family history for this condition. Hypertriglyceridaemia has
been associated with an increased risk of developing pancreatitis
(inflammation of the pancreas);
if you need an operation, or you are off your feet for a long time (see in
section 2 ‘Blood clots’);
if you have just given birth you are at an increased risk of blood clots.
You should ask your doctor how soon after delivery you can start using
NuvaRing;
if you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
if you have varicose veins;
if you have a condition that occurred for the first time or worsened
during pregnancy or previous use of sex hormones (e.g. hearing loss,
porphyria [a disease of the blood], herpes gestationis [skin rash with
vesicles during pregnancy], Sydenham’s chorea [a disease of the
nerves in which sudden movements of the body occur], hereditary
angioedema [you should see your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue and/or throat
and/or difficulty swallowing or hives together with difficulty breathing];
if you have (or have ever had) chloasma (yellowish-brown pigment
patches, so called ‘pregnancy patches’, particularly on the face). If so,
avoid too much exposure to the sun or ultraviolet light;
if you have a medical condition that makes it difficult to use
NuvaRing – for example, if you are constipated, have a prolapse of the
uterine cervix or have pain during intercourse.

BLOOD CLOTS
Using a combined hormonal contraceptive such as NuvaRing increases
2. What you need to know before you use
your risk of developing a blood clot compared with not using one. In rare
NuvaRing
cases a blood clot can block blood vessels and cause serious problems.
if you
you have a disorder affecting your blood clotting – for
Package Leaflet: information for the User
Blood clots
canknow
develop
instance,
protein
deficiency,
protein S ‘venous
deficiency, antithrombin – III
General notes
in veins (referred to as aC‘venous
thrombosis’,
®
0.120mg/0.015mg
perinformation
24hours,
vaginal thromboembolism’
deficiency, Factor
V Leiden or antiphospholipid antibodies;
Before NuvaRing
you start using NuvaRing
you should read the
on blood
or VTE)
if you need
an operation
if you are
off your feet
for a long time (see
clots in section 2. It is particularlydelivery
important tosystem
read the symptoms of a
in the arteries
(referred
to as anor‘arterial
thrombosis’,
‘arterial
section
‘Blood
clots’);
blood clot – see section
2
‘Blood
clots’.
thromboembolism’ or ATE).
(etonogestrel/ethinylestradiol)
you have
a heart
attack,
or a stroke;
In this leaflet, several situations are described where you should stop
Recoveryiffrom
bloodever
clotshad
is not
always
complete.
Rarely, there may be
if you have
(oror,have
ever
had)
angina
pectoris
using NuvaRing,
or
where
NuvaRing
may
be
less
reliable.
In
such
serious
lasting
effects
very
rarely,
they
may
be fatal. (a condition that causes
Important things to know about combined hormonal contraceptives
severe chest pain and may be a first sign of a heart attack) or transient
situations
you should not have intercourse or you should take extra nonIt is important to remember that the overall risk of a harmful blood
(CHCs):
ischaemic attack (TIA – temporary stroke symptoms);
hormonal contraceptive precautions – such as using a condom or another
clot
due
to NuvaRing is small.
They are one of the most reliable reversible methods of contraception if
if you have any of the following diseases that may increase your risk
barrier method. Do not use rhythm or temperature methods. These
used correctly.
HOW
TO
A BLOOD CLOT
ofRECOGNISE
a clot in the arteries:
methods can be unreliable because NuvaRing alters the monthly changes
They slightly increase the risk of having a blood clot in the veins and
Seek urgent
youblood
noticevessel
any ofdamage
the following signs or
- medical
severe attention
diabetes ifwith
of the body temperature and of the cervical mucus.
arteries, especially in the first year or when restarting a combined
symptoms.- very high blood pressure
hormonal contraceptive following a break of 4 or more weeks.
- a very high level of fat in the blood (cholesterol or triglycerides)
Please
alert
and see your
doctor if you does
think you
have
Are you experiencing
any known
of these
What are you possibly
- a condition
assigns?
hyperhomocysteinaemia
NuvaRing,
like be
other
hormonal
contraceptives,
not may
protect
symptoms
of a(AIDS)
blood clot
(seeother
section
2 ’Blood
clots’).
if you have (or have ever had) a type ofsuffering
migrainefrom?
called ‘migraine with
against HIV
infection
or any
sexually
transmitted
®
The name of your medicine is NuvaRing 0.120mg/0.015mg per 24hours,
aura’;
disease.
Deep vein thrombosis
swelling of one leg or along a vein in the
vaginal delivery system, but will be referred to as NuvaRing throughout
if youespecially
have (had)
inflammation
of the pancreas (pancreatitis) associated
leg or foot
when
accompanied
2.1 When
should not use NuvaRing
this you
leaflet.
by: with high levels of fat in your blood.
You should not use NuvaRing if you have any of the conditions listed
have (had)
severe
liver disease
below. IfRead
you do
any
of thecarefully
conditions
listed you
below,
you
mustNuvaRing
tell your
pain iforyou
tenderness
in the
leg which
may and your liver is not yet working
all have
of this
leaflet
before
start
using
normally.
doctor. because
Your doctor
will
discuss
with
you
what
other
form
of
birth
control
be
felt
only
when
standing
or
walking
it contains important information for you.
if youwarmth
have (had)
a benign
malignant tumour in the liver.
would be more appropriate.
increased
in the
affectedorleg
Keep this leaflet. You may need to read it again.
if you
have (had),
if you
mayleg
have, cancer of the breast or the genital
if you have (or have ever had) a blood clot in a blood vessel of your legs
change
in colour
of the or
skin
on the
If you have any further questions, ask your doctor or pharmacist.
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or
e.g. organs.
turning pale, red or blue
This medicine has been prescribed for you only. Do not pass it on to
if you have any unexplained vaginal bleeding.
other organs;
others. It may harm them.
if you are allergic to ethinylestradiol or etonogestrel, or any of the other
If you get any side effects, talk to your doctor or pharmacist.
ingredients of this medicine (listed in section 6).
This includes any possible side effects not listed in this leaflet. See
If any of these conditions appear for the first time while using NuvaRing,
section 4.
remove the ring immediately and contact your doctor. In the meantime,
What is in this leaflet:
use non-hormonal contraceptive measures.

sudden unexplained breathlessness or rapid
breathing;
sudden cough without an obvious cause,
which may bring up blood;
sharp chest pain which may increase with
deep breathing;
severe light headedness or dizziness;
rapid or irregular heart beat;
severe pain in your stomach;
If you are unsure, talk to a doctor as some of
these symptoms such as coughing or being
short of breath may be mistaken for a milder
condition such as a respiratory tract infection
(e.g. a ‘common cold’).
Symptoms most commonly occur in one eye:
immediate loss of vision or
painless blurring of vision which can progress
to loss of vision

Pulmonary
embolism

chest pain, discomfort, pressure, heaviness
sensation of squeezing or fullness in the
chest, arm or below the breastbone;
fullness, indigestion or choking feeling;
upper body discomfort radiating to the back,
jaw, throat, arm and stomach;
sweating, nausea, vomiting or dizziness;
extreme weakness, anxiety, or shortness of
breath;
rapid or irregular heart beats
sudden weakness or numbness of the face,
arm or leg, especially on one side of the body;
sudden confusion, trouble speaking or
understanding;
sudden trouble seeing in one or both eyes;
sudden trouble walking, dizziness, loss of
balance or coordination;
sudden, severe or prolonged headache with
no known cause;
loss of consciousness or fainting with or
without seizure.
Sometimes the symptoms of stroke can be brief
with an almost immediate and full recovery, but
you should still seek urgent medical attention as
you may be at risk of another stroke.
swelling and slight blue discolouration of an
extremity;
severe pain in your stomach (acute
abdomen).

Heart attack

Retinal vein
thrombosis
(blood clot in the
eye)

Stroke

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems.
For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using
NuvaRing is very small but can increase:
with increasing age (beyond about 35 years);
if you smoke. When using a combined hormonal contraceptive like
NuvaRing you are advised to stop smoking. If you are unable to stop
smoking and are older than 35 your doctor may advise you to use a
different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if a member of your immediate family has had a heart attack or stroke at
a young age (less than about 50). In this case you could also have a
higher risk of having a heart attack or stroke;
if you, or someone in your immediate family, have a high level of fat in
the blood (cholesterol or triglycerides);
if you get migraines, especially migraines with aura;
if you have a problem with your heart (valve disorder, disturbance of the
rhythm called atrial fibrillation)
if you have diabetes.
If you have more than one of these conditions or if any of them are
particularly severe, the risk of developing a blood clot may be increased
even more.
If any of the above conditions change while you are using NuvaRing, for
example, you start smoking, a close family member experiences a
thrombosis for no known reason, or you gain a lot of weight, tell your
doctor.

Blood clots blocking
other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
The use of combined hormonal contraceptives has been connected with
an increase in the risk of blood clots in the vein (venous thrombosis).
However, these side effects are rare. Most frequently, they occur in the
first year of use of a combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
Very rarely a clot may form in a vein in another organ such as the eye
(retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year
of taking a combined hormonal contraceptive for the first time. The risk
may also be higher if you restart taking a combined hormonal
contraceptive (the same product or a different product) after a break of 4
weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if
you were not using a combined hormonal contraceptive.
When you stop using NuvaRing your risk of a blood clot returns to normal
within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined
hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with
NuvaRing is small.
Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot in
a year.
Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone, or
norgestimate, about 5-7 will develop a blood clot in a year.
Out of 10,000 women who are using a combined hormonal
contraceptive that contains norelgestromin, or etonogestrel such as
NuvaRing, between about 6 and 12 women will develop a blood clot in a
year.
The risk of having a blood clot will vary according to your personal
medical history (see ‘Factors that increase your risk of a blood clot’
below).

Women who are not using a combined
hormonal pill/patch/ring and are not pregnant
Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate
Women using NuvaRing

The risk of developing a blood clot increases the more conditions you
have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot,
particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you,
even if you are unsure. Your doctor may decide that NuvaRing needs to
be stopped.
If any of the above conditions change while you are using NuvaRing, for
example a close family member experiences a thrombosis for no known
reason, or you gain a lot of weight, tell your doctor.

Risk of developing a
blood clot in a year
About 2 out of
10,000 women
About 5-7 out of
10,000 women
About 6-12 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with NuvaRing is small but some conditions will
increase the risk. Your risk is higher:
if you are very overweight (body mass index or BMI over 30 kg/m2);
if one of your immediate family has had a blood clot in the leg, lung or
other organ at a young age (e.g. below the age of about 50). In this case
you could have a hereditary blood clotting disorder;
if you need to have an operation, or if you are off your feet for a long
time because of an injury or illness, or you have your leg in a cast. The
use of NuvaRing may need to be stopped several weeks before surgery
or while you are less mobile. If you need to stop using NuvaRing ask
your doctor when you can start using it again.
as you get older (particularly above about 35 years);
if you gave birth less than a few weeks ago.

Cancer
The information given below was obtained in studies with combined oral
contraceptives and it may also apply to NuvaRing. Information about
vaginal administration of contraceptive hormones (as in NuvaRing) is not
available.
Breast cancer has been found slightly more often in women using
combined pills, but it is not known whether this is caused by the treatment.
For example, it may be that tumours are found more in women on
combined pills because they are examined by the doctor more often. The
increased occurrence of breast cancer becomes gradually less after
stopping the combined pill.
It is important to regularly check your breasts and you should contact your
doctor if you feel any lump. You should also tell your doctor if a close
relative has, or ever had breast cancer (see section 2.2 ‘Warnings and
precautions’).
In rare cases, benign liver tumours, and in even fewer cases malignant
liver tumours have been reported in pill users. Contact your doctor if you
have unusual severe abdominal pain.
For users of the combined Pill it has been reported that cancer of the
endometrium (the lining of the womb) and cancer of the ovaries occur less
frequently. This may also be the case for NuvaRing but this has not been
confirmed.
2.3 Children and adolescents
The safety and efficacy of NuvaRing in adolescents under the age of
18 have not been studied.
2.4 Other medicines and NuvaRing
Always tell the doctor who prescribes NuvaRing which medicines or
herbal products you are already using. Also tell any other doctor or dentist
who prescribes another medicine (or the dispensing pharmacist) that you
use NuvaRing. They can tell you if you need to take additional
contraceptive precautions and, if so, for how long.
Some medicines may cause particular problems when you are using
hormonal contraceptives, such as NuvaRing.
There are medicines that can make NuvaRing less effective in
preventing pregnancy, or can cause unexpected bleeding. These
include medicines used to treat:
o
epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine oxcarbazepine, topiramate, felbamate);
o
tuberculosis (e.g. rifampicin);
o
HIV infections (e.g. ritonavir);
o
other infectious diseases (e.g. griseofulvin and antibiotics with
the exception of amoxicillin and doxycycline, which have been
shown not to influence the hormone release from NuvaRing).
The herbal product St. John’s Wort may also stop NuvaRing from
working properly. If you want to use herbal products containing
St. John’s Wort while you are already using NuvaRing you should
consult your doctor first.
NuvaRing may also interfere with the working of other medicines – such
as ciclosporin and the antiepileptic lamotrigine.
You can use tampons while using NuvaRing. Insert NuvaRing before
inserting a tampon.
You should be careful when removing a tampon to be sure that the ring is
not accidentally pulled out. If the ring does come out, simply rinse the ring
in cool to lukewarm water and immediately reinsert it.
Using spermicides or vaginal yeast products will not reduce the
contraceptive efficacy of NuvaRing.
Laboratory tests
If you are having any blood or urinary test, tell your health care
professional that you are using NuvaRing as it may affect the results of
some tests.
2.5 Pregnancy and breast-feeding
NuvaRing must not be used by women who are pregnant, or who think
they may be pregnant. If you get pregnant while using NuvaRing you
should remove the ring and contact your doctor.
If you want to stop NuvaRing because you want to get pregnant, see
section 3.5 ‘When you want to stop using NuvaRing’.
NuvaRing is not usually recommended for use during breast-feeding.
If you wish to use NuvaRing while breast-feeding, please seek the advice
of your doctor.
2.6 Driving and using machines
NuvaRing is unlikely to affect your ability to drive or use machines.

3. How to use NuvaRing
You can insert and remove NuvaRing yourself. Your doctor will tell you
when to start using NuvaRing for the first time. The vaginal ring must be
put in on the correct day in your monthly cycle (see section 3.3 ‘When to
start with the first ring’) and left in place for 3 weeks in a row. It is a good
habit to regularly check whether the ring is still in your vagina. After the
third week, you take NuvaRing out and have a one week break. You will
usually have your monthly period during this ring-free interval.
3.1 How to insert and remove NuvaRing
1. Before inserting the ring, check it is not out of date (see section 5
‘How to store NuvaRing’).
2. Wash your hands before inserting or removing the ring.
3. Choose the position for inserting that is most comfortable to you, like
standing with one leg up, squatting, or lying down.
4. Remove NuvaRing from its sachet.
5. Hold the ring between your thumb and index finger, press the opposite
sides together and insert the ring into the vagina (see Figures 1– 4).
When NuvaRing is in place you should not feel anything. If you feel
uncomfortable, gently push NuvaRing a bit further into the vagina. The
exact position of the ring inside the vagina is not important.
6. After 3 weeks you remove NuvaRing from the vagina. You can do this
by hooking your index finger under the front rim of the ring or by
grasping the rim and pulling it out (see Figure 5). If you locate the ring
in your vagina, but are unable to remove it, you should contact your
doctor.
7. Dispose of the used ring with the normal household waste, preferably
inside the reclosable sachet. Do not flush NuvaRing down the toilet.

pregnant, you can also stop taking the Pill on any day of your current
Pill pack and start using NuvaRing immediately.
You have used a transdermal patch during the last month
Start using NuvaRing at the latest the day following your usual patchfree break. Never extend the patch-free break beyond its
recommended length.
If you have used the patch consistently and correctly and if you are
sure that you are not pregnant, you can also stop using the patch on
any day and start using NuvaRing immediately.
You have used a minipill (progestagen-only pill) during the last month.
You can stop taking the minipill any day and start NuvaRing the next
day, at the same time you would normally have taken your pill. But
make sure you also use an additional contraceptive method (such as
a condom) for the first 7 days of ring use.
You have used an injectable or implant or a progestagen-releasing
IUD during the last month.
Start using NuvaRing when your next injection is due or on the day
that your implant or your progestagen-releasing IUD is removed. But
make sure you also use an additional contraceptive method (such as
a condom) for the first 7 days of ring use.
After having a baby.
If you have just had a baby, your doctor may tell you to wait until after
your first normal period before you start using NuvaRing. Sometimes it
is possible to start sooner. Your doctor will advise you. If you are
breast-feeding and want to use NuvaRing, you should discuss this first
with your doctor.
After a miscarriage or an abortion.
Your doctor will advise you.
3.4 What to do if….
Your ring is accidentally expelled from the vagina
NuvaRing may accidentally be expelled from the vagina – for example, if it
has not been inserted properly, while removing a tampon, during sexual
intercourse, during constipation, or if you have a prolapse of the womb.
Therefore, you should regularly check whether the ring is still in your
vagina.
If the ring is out for less than 3 hours it will still protect you from
pregnancy. You can rinse the ring with cold to lukewarm water (do not use
hot water) and put it back in. If the ring is out for more than 3 hours, it may
not protect you from pregnancy, see the advice in section 3.4 ‘What to do
if… Your ring has temporarily been out of the vagina’.
Your ring has temporarily been out of the vagina
When it is in the vagina, NuvaRing slowly releases hormones into the
body to prevent pregnancy. If the ring has been out of the vagina for more
than 3 hours, it may not protect you from pregnancy. So, the ring must not
be outside the vagina for longer than 3 hours in every twenty-four hour
period.
If the ring has been out of the vagina for less than 3 hours, it will still
protect you from pregnancy. You should put the ring back in as soon
as possible but at the latest within 3 hours.
If the ring has been out of the vagina, or you suspect that the ring has
been out of the vagina, for more than 3 hours during the 1st and 2nd
week, it may not protect you from pregnancy. Put the ring back in the
vagina as soon as you remember, and leave the ring in place without
interruption for at least 7 days. Use a condom if you have sexual
intercourse during these 7 days. If you are in your 1st week, and you
had sexual intercourse during the past 7 days, there is a possibility
you may be pregnant. In that case contact your doctor.
If the ring has been out of the vagina, or you suspect that the ring has
been out of the vagina, for more than 3 hours in the 3rd week it may
not protect you from pregnancy. You should discard that ring and
choose between one of the following two options:
1 - Insert a new ring immediately
This will start the next three-week use period. You may not have your
period, but breakthrough bleeding and spotting may occur.
2 - Do not insert the ring again. Have your period first and insert a new
ring no later than 7 days from the time the previous ring was removed or
fell out. You should only chose this option if you have used NuvaRing
continuously during the previous 7 days.
Your ring breaks
Very rarely NuvaRing may break. If you notice that your NuvaRing has
broken, discard it and start with a new ring as soon as possible. Use extra
contraceptive precautions (e.g. a condom) during the next 7 days. If you
had sexual intercourse before you noticed the ring breakage, please
contact your doctor.
You have inserted more than one ring
There have been no reports of serious harmful effects due to an overdose
of the hormones in NuvaRing. If you have accidentally inserted more than
one ring, you may feel sick (nausea) or have vomiting or vaginal bleeding.
Remove excess rings and contact your doctor if these symptoms persist.

3.2 Three weeks in, one week out
1. Starting with the day you put it in, the vaginal ring must be left in place
without interruption for 3 weeks.
2. After 3 weeks you remove the ring on the same day of the week and
at approximately the same time as it was put in. For example, if you
put NuvaRing in on a Wednesday at about 22.00 h, you should
remove the ring 3 weeks later, on Wednesday, at about 22.00 h.
3. After you have removed the ring, you do not use a ring for 1 week.
During this week a vaginal bleed should occur. Usually this starts 2–3
days after removal of NuvaRing.
4. Start a new ring exactly after the 1 week interval (again on the same
day of the week and approximately the same time), even if you have
not stopped bleeding.
If the new ring is inserted more than 3 hours too late, the protection
from pregnancy may be reduced. Follow the instructions in section 3.4
‘What to do if…You have forgotten to insert a new ring after the ringfree interval’.
If you use NuvaRing as described above, your vaginal bleed will take
place every month on roughly the same days.
3.3 When to start with the first ring
You have not used a hormonal contraceptive during the last month
Insert the first NuvaRing on the first day of your natural cycle (i.e. the
first day of your menstrual period). NuvaRing starts working straight
away. You don’t need to take any other contraceptive precautions.
You can also start NuvaRing between day 2 and day 5 of your cycle,
but if you have sexual intercourse during the first 7 days of NuvaRing
use make sure that you also use an additional contraceptive method
(such as a condom). You only have to follow this advice when you use
NuvaRing for the first time.
You have used a combined Pill during the last month
Start using NuvaRing at the latest the day following the tablet-free
period of your present Pill. If your Pill pack also contains inactive
tablets, start NuvaRing at the latest on the day after the last inactive
tablet. If you are not sure which tablet this is, ask your doctor or
pharmacist. Never extend the hormone-free interval of your current
Pill pack beyond its recommended length. If you have used the Pill
consistently and correctly and if you are sure that you are not

You have forgotten to insert a new ring after the ring-free interval
If your ring-free interval was longer than 7 days, put a new ring as soon
as you remember. Use extra contraceptive precautions (such as a
condom) if you have sexual intercourse during the next 7 days. If you had
sexual intercourse in the ring-free interval, there is a possibility you
may be pregnant. In that case contact your doctor immediately. The
longer the ring-free interval, the higher the risk that you have become
pregnant.
You have forgotten to remove the ring
If your ring has been left in place for between 3 and 4 weeks, it will
still protect you from pregnancy. Have your regular ring-free interval of
one week and subsequently insert a new ring.
If your ring has been left in place for more than 4 weeks there is a
possibility of becoming pregnant. Contact your doctor before you start
with a new ring.
You have missed a menstrual period
You have followed the instructions for NuvaRing
If you have missed a menstrual period but you followed the
instructions for NuvaRing, and have not used other medicines, it is
very unlikely that you are pregnant. Continue to use NuvaRing as
usual. If you miss your menstrual period twice in a row, however, you
may be pregnant. Tell your doctor immediately. Do not start the next
NuvaRing until your doctor has checked you are not pregnant.
If you have not followed the instructions for NuvaRing
If you have missed a menstrual period and you did not follow the
instructions, and you do not have your expected period in the first
normal ring-free interval, you may be pregnant. Contact your doctor
before you start with a new NuvaRing.
You have unexpected bleeding
While using NuvaRing, some women have unexpected vaginal bleeding
between menstrual periods. You may need to use sanitary protection. In
any case, leave the ring in the vagina and continue to use the ring as
normal. If the irregular bleeding continues, becomes heavy or starts again,
tell your doctor.

You want to change the first day of your menstrual period.
If you follow the instructions for NuvaRing, your menstrual period
(withdrawal bleed) will begin in the ring-free interval. If you want to change
the day it starts, you can make the ring-free interval shorter (but never
longer!).
For example, if your period usually begins on a Friday, you can change
this to a Tuesday (3 days earlier) from next month onwards. Simply insert
your next ring 3 days earlier than usual.
If you make your ring-free interval very short (for example, 3 days or less),
you may not have your usual bleeding. You may have spotting (drops or
flecks of blood) or breakthrough bleeding while using the next ring.
If you are not sure how to proceed, contact your doctor for advice.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

You want to delay your menstrual period
Although it is not the recommended regimen, delay of your menstrual
period (withdrawal bleed) is possible by inserting a new ring immediately
after removing the current ring, with no ring-free interval between rings.
You can leave the new ring inserted for up to a maximum of 3 weeks.
You may experience spotting (drops or flecks of blood) or breakthrough
bleeding while using this new ring. When you want your period to begin,
just remove the ring. Have your regular ring free interval of one week and
subsequently insert a new ring.
You can ask your doctor for advice before deciding to delay your
menstrual period.

Keep out of the sight and reach of children.
Do not use ring after the expiry date which is stated on the carton and
sachet label after ‘Exp’. The expiry date refers to the last day of that
month.
If you discover that a child has been exposed to the hormones from
NuvaRing, ask your doctor for advice.
Prior to dispensing to the patient, store in a refrigerator (2 – 8°C).
After dispensing: Use within 4 months. Store in the original pack in order
to protect from light and moisture. Do not store above 30°C.
Mark the dispensing date on the carton and sachet label in the box
provided.
Do not use NuvaRing if you notice a colour change in the ring or any
visible signs of deterioration.
Dispose of the used ring with the normal household waste, preferably
inside the reclosable sachet. Do not flush NuvaRing down the toilet. As
with other medicines, do not throw away any unused or outdated rings via
wastewater or household waste. Ask your pharmacist how to throw away
any unused rings no longer required. These measures will help protect the
environment.

3.5 When you want to stop using NuvaRing
You can stop using NuvaRing any time you want.
If you do not want to become pregnant, ask your doctor about other
methods of birth control.
If you stop using NuvaRing because you want to get pregnant, you should
wait until you have had a natural period before trying to conceive. This
helps you calculate when the baby will be due.

4. Possible side effects
Like all medicines, NuvaRing can cause side effects, although not
everybody gets them. If you get any side effect, particularly if severe or
persistent, or have any change to your health that you think may be due to
NuvaRing, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
present for all women taking combined hormonal contraceptives. For more
detailed information on the different risks from taking combined hormonal
contraceptives, please see section 2,’ What you need to know before you
use NuvaRing’.
If you are allergic to one of the ingredients of Nuvaring (hypersensitivity)
you may experience the following symptoms (frequency unknown):
angioedema [swollen face, tongue and/or throat and/or difficulty
swallowing] or hives together with difficulty breathing. If this happens,
remove NuvaRing and contact your doctor immediately.
Users of NuvaRing have reported the following side effects.
Common: may affect up to 1 in 10 women
abdominal pain, feeling sick (nausea)
yeast infection of the vagina (such as ‘thrush’); discomfort in the
vagina due to the ring; genital itching; secretion from the vagina
headache or migraine; depressive moods; lower sex drive
breast pain; pelvic pain; painful menstrual periods
acne
weight gain
the ring falling out

Uncommon: may affect up to 1 in 100 women
disturbed vision; dizziness
swollen abdomen; vomiting, diarrhoea or constipation
feeling tired, unwell or irritable; mood changes; mood swings
extra fluid in the body (oedema)
bladder or urinary tract infection
difficulty or pain when passing urine; strong desire or need to pass
urine; passing urine more often
problems during intercourse, including pain, bleeding or partner
feeling the ring
increased blood pressure
increased appetite
back pain; muscle spasms; pain in legs or arms
less sensitive skin
sore or larger breasts; fibrocystic breast disease (cysts in the
breasts which may become swollen or painful)
inflammation of the cervix; cervical polyps (growths in the cervix);
rolling outward of the margin of the cervix (ectropion)
changes to menstrual periods (e.g. periods can be heavy, long,
irregular or stop altogether); pelvic discomfort; premenstrual
syndrome; spasm of the uterus
vaginal infection (fungal and bacterial); burning feeling, smell, pain,
discomfort or dryness in the vagina or vulva
hair loss, eczema, itching, rash or hot flushes.
ring breakage

Rare: may affect up to 1 in 1,000 women
harmful blood clots in a vein or artery, for example:
o in a leg or foot i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other
conditions that increase this risk. (See section 2 for more information on
the conditions that increase risk for blood clots and the symptoms of a
blood clot.)
breast discharge
Not known (cannot be estimated from the available data)
chloasma (yellowish-brown pigmentation patches on the skin,
particularly of the face)
penis discomfort of the partner (such as irritation, rash, itching)
Breast cancer and liver tumours have been reported in users of combined
hormonal contraceptives. For more information, see section 2.2 ‘Warnings
and precautions, Cancer’.

By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store NuvaRing

6. Contents of the pack and other information
What NuvaRing contains
Each ring contains 11.7mg etonogestrel and 2.7mg ethinylestradiol.
Daily release of etonogestrel and ethinyl estradiol: 0.120mg and 0.015mg
respectively (for 3 weeks).The other substances are: ethylene-vinyl
acetate copolymer 9% VA, ethylene-vinyl acetate copolymer 28% VA and
magnesium stearate.
What NuvaRing looks like and the contents of the pack
NuvaRing is a flexible, transparent, colourless to almost colourless ring,
54mm wide. Each ring is packed in a reclosable foil sachet.
Nuvaring is available in packs containing 3 vaginal rings, each enclosed
separately in sealed sachets.
Manufactured by: Organon Ireland Ltd., Drynam Road Swords,
Co. Dublin, Ireland.
and
NV Organon, PO Box 20, 5340 BH Oss, The Netherlands.
Procured from within the EU and repacked by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
NuvaRing® 0.120mg/0.015mg per 24hours, vaginal delivery system
PL No: 18799/2445
Leaflet date: 08.07.2015

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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