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

Active substance(s): ETHINYLESTRADIOL / ETONOGESTREL

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S0637-3-PL-PIL-28.02.2017 (PAGE 1 of 4)

PATIENT INFORMATION LEAFLET
NuvaRing® 0.120 mg/0.015 mg per 24 hours,
vaginal delivery system
(etonogestrel/ethinylestradiol)
Your medicine is available as the above name but will be referred to as
NuvaRing throughout this leaflet
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 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.

• 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 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;
• 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.

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.

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 nonhormonal 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.

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;

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.

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?
• swelling of one leg or along a
vein in the leg 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
• 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

What are you possibly suffering
from?
Deep vein thrombosis

Pulmonary embolism

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
• 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 heartbeats
• 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).

Retinal vein
thrombosis
(blood clot in the eye)

Heart attack

Stroke

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.
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.

Cancer
The information given below was obtained in studies with combined
oralcontraceptives and it may also apply to NuvaRing. Information about
vaginal administration of contraceptive hormones (as in NuvaRing) is not
available.
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).
Risk of developing a
blood clot in a year
Women who are not using a
About 2 out of 10,000 women
combined hormonal pill/patch/ring
and are not pregnant
Women using a combined
About 5-7 out of
hormonal contraceptive pill
10,000 women
containing levonorgestrel,
norethisterone or norgestimate
Women using NuvaRing
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/m 2);
• 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.
S0637-3-PL-PIL-28.02.2017 (PAGE 2 of 4)

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 your doctor which medicines or herbal products you are
already using. Also tell any other doctor or dentist (or pharmacist) who
prescribes another medicine that you use NuvaRing. They can tell you if
you need to take additional contraceptive precautions (for example,
condoms), and if so, for how long, or, whether the use of another
medicine you need must be changed.
Some medicines
• can have an influence on the blood levels of NuvaRing
• can make it less effective in preventing pregnancy
• can cause unexpected bleeding.
These include medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (the herbal remedy St. John’s wort
(Hypericum perforatum)).
If you are taking medicines or herbal products that might make NuvaRing
less effective, a barrier contraceptive method should also be used. Since
the effect of another medicine on NuvaRing may last up to 28 days after
stopping the medicine, it is necessary to use the additional barrier
contraceptive method for that long. Note: Do not use NuvaRing with a
female condom.
NuvaRing may influence the effect of other medicines, e.g.
• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency
of seizures)
Ask your doctor or pharmacist for advice before taking any medicine.
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.

3. How to use NuvaRing

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 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.

• 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.

3.1 How to insert and remove NuvaRing

• 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.

2.6 Driving and using machines
NuvaRing is unlikely to affect your ability to drive or use machines.

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
inside the reclosable sachet. Do not flush NuvaRing down the toilet.

• 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 twentyfour 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
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’.

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 you use NuvaRing as described above, your vaginal bleed will take
place every month on roughly the same days.

• 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.

3.3 When to start with the first ring

You have missed a menstrual period

• 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

• 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.
S0637-3-PL-PIL-28.02.2017 (PAGE 3 of 4)

You have unexpected bleeding

Reporting of side effects

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.

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

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!).

5. How to store NuvaRing

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.

 Do not use a NuvaRing if it was dispensed to you more than 4 months

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.
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
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:
• in a leg or foot (i.e. DVT)
• in a lung (i.e. PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)
• 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.

 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.
 Do not store above 30°C. Store in the original package in order to

protect from light and moisture.
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
• Daily release of 0.120mg etonogestrel and 0.015mg ethinylestradiol (for
3 weeks). One ring contains 11.7mg etonogestrel and 2.7mg
ethinylestradiol.
• The other ingredients are: Ethylene vinylacetate copolymer 28%
vinylacetate, Ethylene vinylacetate copolymer 9% vinylacetate (a type of
plastic that will not dissolve in the body) and magnesium stearate.

What NuvaRing looks like and contents of the pack
Vaginal delivery system. NuvaRing is flexible, transparent, and colourless
to almost colourless ring, with an outer diameter of 54 mm and a crosssectional diameter of 4 mm. Each ring is packed in a reclosable foil
sachet. Each box contains 3 rings.
Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.
Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL 33902/0637

This leaflet was last approved: 28/02/2017
NuvaRing® is a registered trademark of Merck Sharp & Dohme B.V.

Blind or partially sighted? Is this
leaflet hard to see or read? Call
02082033203 to obtain the leaflet in
a format suitable for you.
S0637-3-PL-PIL-28.02.2017 (PAGE 4 of 4)

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