NuvaRing 0.12mg0.015mg per day vaginal delivery system

Package leaflet: Information for the user

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

Etonogestrel/Ethinylestradiol

Important things to know about combined hormonal contraceptives (CHCs):

They are one of the most reliable reversible methods of contraception if used correctly.

They slightly increase the risk of having a blood clot in the veins and arteries, especially in the

first year or when restarting a combined hormonal contraceptive following a break of 4 or more

weeks.

Please be alert and see your doctor if you think you may have symptoms of a blood clot (see

section 2 “Blood clots”).

Read all of this leaflet carefully before you start using NuvaRing

because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What NuvaRing is and what it is used for

What you need to know before you use NuvaRing

When you should not use NuvaRing

Warnings and precautions

Blood clots

Cancer

Children and adolescents

Other medicines and NuvaRing

Laboratory tests

Pregnancy and breast-feeding

Driving and using machines

How to use NuvaRing

How to insert and remove NuvaRing

Three weeks in, one week out

When to start with the first ring

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

When you want to stop using NuvaRing

Possible side effects

How to store NuvaRing

Contents of the pack and other information

What NuvaRing contains

What NuvaRing looks like and contents of the pack

Marketing Authorisation Holder and 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.

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 male 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;

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.

Do not use NuvaRing if you have hepatitis C and are taking medicinal products containing

ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section 2.4 ‘

Other medicines and

NuvaRing

’).

2.2

Warnings and precautions

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 [y

ou 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;

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”.

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;

if you have an urgent, frequent, burning, and/or painful urination, and cannot locate the ring in

the vagina. These symptoms may indicate accidental placement of NuvaRing into the urinary

bladder.

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.

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?

What are you possibly

suffering from?

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

Deep vein thrombosis

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’).

Pulmonary embolism

Symptoms most commonly occur in one eye:

immediate loss of vision or

painless blurring of vision which can progress to loss of vision

Retinal vein thrombosis

(blood clot in the eye)

chest pain, discomfort, pressure, heaviness

sensation of squeezing or fullness in the chest, arm or below the

Heart attack

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.

Stroke

swelling and slight blue discolouration of an extremity;

severe pain in your stomach (acute abdomen).

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 combined hormonal pill/patch/ring

and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal contraceptive pill containing

levonorgestrel, norethisterone or

norgestimate

About 5-7 out of 10,000 women

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

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.

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 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 your doctor which medicines or herbal products you are already using. Also tell any other

doctor or dentist (or the pharmacist) who prescribes another medicine that you use NuvaRing. They

can tell you if you need to take additional contraceptive precautions (for example, male 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 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 diaphragm, cervical cap, or 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)

Do not use NuvaRing if you have Hepatitis C and are taking medicinal products containing

ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test

results (increase in ALT liver enzyme).

Your doctor will prescribe another type of contraceptive prior to the start of treatment with these

medicinal products.

NuvaRing can be restarted approximately 2 weeks after completion of this treatment. See section 2.1

When you should not use NuvaRing’

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.

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. Regularly

check that NuvaRing is in your vagina (for example, before and after intercourse) to ensure that you

are protected from pregnancy. 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.

While using NuvaRing, you should not use certain female barrier contraceptive methods, such as a

vaginal diaphragm, cervical cap, or female condom. These contraceptive barrier methods should not

be used as your back-up method of birth control because NuvaRing may interfere with the correct

placement and position of a diaphragm, cervical cap, or female condom.

3.1

How to insert and remove NuvaRing

Before inserting the ring, check that it is not out of date (see section 5 ‘

How to store

NuvaRing’

Wash your hands before inserting or removing the ring.

Choose the position for inserting that is most comfortable to you, like standing with one leg up,

squatting, or lying down.

Remove NuvaRing from its sachet.

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.

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.

Dispose of the used ring with the normal household waste, preferably 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

Figure 4A

Figure 4B

Figure 4C

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 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.

3.2

Three weeks in, one week out

Starting with the day you put it in, the vaginal ring must be left in place

without interruption

for 3 weeks.

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.

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.

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 ifYou 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 male 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 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 male 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 male 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

(for example, before and after intercourse).

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 2

nd

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 male condom if you have sexual intercourse during these

7 days. If you are in your 1

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 3

rd

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 choose this option if you have used NuvaRing continuously during the

previous 7 days.

If NuvaRing was out of the vagina for an unknown amount of time, you may not be protected

from pregnancy. Perform a pregnancy test and consult your doctor prior to inserting a new ring.

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 male 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.

You have forgotten to insert a new ring after the ring-free interval

If your

ring-free interval

longer than 7 days

, put a new ring as soon as you remember. Use

extra contraceptive precautions (such as a male 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.

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)

inability to remove ring without medical assistance (e.g., because of adherence to vaginal wall)

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, nurse 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 or search for MHRA

Yellow Card in the Google Play or Apple App Store

Ireland:

HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2 Tel: +353 1 6764971, Fax:

+353 1 6762517, Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

Malta:

ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

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 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 copolymers (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.

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 Holders

The Marketing Authorisation Holder

in the UK and Malta is Merck Sharp & Dohme Ltd, Hertford

Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

The Marketing Authorisation Holder

in Ireland is Merck Sharp & Dohme Ireland (Human Health)

Ltd, Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland.

Manufacturer:

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.

This medicinal product is authorised 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, 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 July 2017.

© Merck Sharp & Dohme Limited, 2017. All rights reserved.

PIL.NVRNG.17.UK.5034.WS 232