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

Active substance(s): ETHINYLESTRADIOL / ETONOGESTREL

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XXXXXXX/XXXXXX-X

XXXXXXX/XXXXXX-X

UNITED KINGDOM USER PACKAGE LEAFLET OF NUVARING
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.

1

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
2

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
Marketing Authorisation Holder and Manufacturer

3

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.
4 mm

54 mm

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.
4

2. What you need to know before you
use NuvaRing
General notes
Before you start using NuvaRing you should read the information on
blood clots in section 2. It is particularly important to read the symptoms
of a blood clot – see section 2 “Blood clots”.
In this leaflet, several situations are described where you should stop
using NuvaRing, or where NuvaRing may be less reliable. In such
situations you should not have intercourse or you should take extra
non-hormonal contraceptive precautions – such as using a condom
or another barrier method. Do not use rhythm or temperature methods.
These methods can be unreliable because NuvaRing alters the monthly
changes of the body temperature and of the cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted
disease.

5

2.1 When you should not use NuvaRing
You should not use NuvaRing if you have any of the conditions listed
below. If you do have any of the conditions listed below, you must tell
your doctor. Your doctor will discuss with you what other form of birth
control would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your
legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE)
or other organs;
• 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’;
6

• 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”.
7

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 defence 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;
8

• 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
your risk of developing a blood clot compared with not using one. In rare
cases a blood clot can block blood vessels and cause serious problems.

9

Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may
be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood
clot due to NuvaRing is small.

10

HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs
or symptoms.
Are you experiencing any of these signs?

What are you possibly
suffering from?
• swelling of one leg or along a vein in the leg Deep vein thrombosis
or foot especially when accompanied by:
• pain or tenderness in the leg which
may be felt only when standing or
walking
• increased warmth in the affected leg
• change in colour of the skin on the
leg e.g. turning pale, red or blue

11

• 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 heartbeat;
• 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

12

Pulmonary embolism

Retinal vein
thrombosis
(blood clot in the eye)

• chest pain, discomfort, pressure, heaviness Heart attack
• 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 heartbeats

13

• sudden weakness or numbness of the face, Stroke
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 Blood clots blocking
other blood vessels
extremity;
• severe pain in your stomach (acute abdomen).
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,
14

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.

15

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).
Risk of developing a
blood clot in a year
Women who are not using a combined
About 2 out of
hormonal pill/patch/ring and are not pregnant 10,000 women
Women using a combined hormonal
About 5-7 out of 10,000
contraceptive pill containing levonorgestrel, women
norethisterone or norgestimate
Women using NuvaRing
About 6-12 out of
10,000 women
16

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.
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.
17

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.
18

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.
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.
19

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.
20

• NuvaRing may also interfere with the working of other medicines –
such as ciclosporin and the anti-epileptic 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.
21

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 that 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). Alternatively,
you may choose to use the NuvaRing Applicator (not included with
NuvaRing) to help you insert the ring. The NuvaRing Applicator may not
be available in all countries. When NuvaRing is in place you should not feel
anything. If you feel uncomfortable, gently push NuvaRing a bit farther 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
22 inside the reclosable sachet. Do not flush NuvaRing down the toilet.

Figure 1
Take NuvaRing out of the
sachet

Figure 2
Compress the ring

Figure 3
Choose a comfortable position to insert
the ring
23

Figure 4A

Figure 4B
Insert the ring into the vagina with
one hand (Figure 4A), if necessary
the labia may be spread with the
other. Push the ring into the vagina
until the ring feels comfortable
(Figure 4B). Leave the ring in place
for 3 weeks (Figure 4C).

Figure 4C
Figure 5
NuvaRing can be removed by
hooking the index finger under
the ring or by grasping the ring
between the index and middle
finger and pulling it out.
24

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 ring-free 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.
25

• 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 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
patch-free 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.
26

• 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.
27

• 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.
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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.
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.
29

• 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.
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.
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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.
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
31

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
32

• 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.
33

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of this
medicine.
United Kingdom: Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting at www.medicinesauthority.gov.mt/adrportal

34

5. How to store NuvaRing
Keep NuvaRing out of the sight and reach of children.
If you discover that a child has been exposed to the hormones from
NuvaRing, ask your doctor for advice.
Store below 30°C. Store in the original package in order to protect from
light and moisture.
Do not use a NuvaRing if it was dispensed to you more than 4 months
ago. The dispensing date is stated on the carton and sachet.
Do not use NuvaRing after the expiry date which is stated on the carton and
sachet.
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.

6. Contents of the pack and other information
What NuvaRing contains
• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg)
• The other ingredients are: ethylene vinylacetate copolymer (28% and
9% vinylacetate) (a type of plastic that will not dissolve in the body)
and magnesium stearate.
Etonogestrel and ethinylestradiol are released from the ring at a rate of
0.120 mg/day and 0.015 mg/day, each for 3 weeks.
35

What NuvaRing looks like and contents of the pack
NuvaRing is a flexible, transparent, colourless to almost colourless
ring, 54 mm wide.
Each ring is packed in a reclosable foil sachet. The sachet is packed in
a cardboard box together with this package leaflet. Each box contains
1 or 3 rings.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, United Kingdom
Manufacturers:
N.V. Organon, PO Box 20, 5340 BH Oss, The Netherlands.
This medicinal product is authorized in the Member States of the
EEA under the following name:
NuvaRing
0.120 mg/0.015 mg per 24 hours, vaginal delivery system
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Romania,
Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom.
This leaflet was last revised in March 2016.
© Merck Sharp & Dohme Limited 2016. All rights reserved.
PIL.NVRNG.15.UK.4707.IB-046

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These stickers, when applied to the appropriate date
in your calendar, can help you to remember when to
insert and remove NuvaRing

Insert
Ring

Remove
Ring

Expand view ⇕

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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