NuvaRing

Italy
Brand name NuvaRing
Form vaginal ring
Active substance / Dosage
ETONOGESTREL
ETHINYLESTRADIOL
Prescription type Prescription only
ATC code
G02BB01
Registration number 035584
Manufacturer ORGANON ITALIA S.R.L.
NuvaRing vaginal ring

Table of Contents

Package leaflet: Information for the user

NuvaRing, 0.120 mg/0.015 mg per 24 hours, vaginal ring

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

  • They are one of the most reliable reversible contraceptive methods, if used correctly.
  • They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
  • Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before using NuvaRing as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, as it may be harmful to them.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What NuvaRing is and what it is used for
  2. What you need to know before using NuvaRing
        2.1 Do not use NuvaRing
        2.2 Warnings and precautions
            Blood clots
            Tumours
        2.3 Children and adolescents
        2.4 Other medicines and NuvaRing
            Laboratory tests
        2.5 Pregnancy and breastfeeding
        2.6 Driving and using machines
  3. How to use NuvaRing
        3.1 How to insert and remove NuvaRing
        3.2 Three weeks with the ring in place, one week without
        3.3 When to start with the first ring
        3.4 What to do if…
            The ring is accidentally expelled from the vagina
            The ring remains temporarily outside the vagina
            The ring breaks
            More than one ring has been inserted
            You forget to insert a new ring after a ring-free interval
            You forget to remove the ring
            You miss a menstrual period
            You experience unexpected bleeding
            You wish to change the first day of your menstrual cycle
            You wish 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
        Description of the appearance of NuvaRing and contents of the pack
        Marketing Authorisation Holder and Manufacturer

1. What NuvaRing is and what it is used for

NuvaRing is a vaginal contraceptive 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 bloodstream. Because the amounts of hormones released are
low, 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 in the same way as a combined oral contraceptive pill (the Pill), but instead of taking a pill every day, the ring is used continuously for 3 weeks. NuvaRing releases two
female sex hormones that prevent the release of an egg from the ovaries. If no egg is released, pregnancy cannot occur.

2. What you should know before using NuvaRing

General notes
Before starting to use NuvaRing, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot – see section 2 “Blood clots”.
This patient leaflet describes various situations in which you must stop using NuvaRing or in which NuvaRing may be less effective. In such situations, you must not have sexual intercourse or you must use additional non-hormonal contraceptive precautions – such as using a male condom or another barrier method. Do not use rhythm or basal body temperature methods, which may be unreliable, since NuvaRing alters the monthly variations in body temperature and cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

2.1 Do not use NuvaRing
Do not use NuvaRing if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

  • if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in another organ;
  • if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
  • if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section “Blood clots”);
  • if you have ever had a heart attack or stroke;
  • if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
  • if you have any of the following conditions, which could increase the risk of clots forming in the arteries:
    • severe diabetes with blood vessel damage
    • very high blood pressure
    • very high levels of fats (cholesterol or triglycerides) in the blood
    • a condition known as hyperhomocysteinaemia
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have had) inflammation of the pancreas (pancreatitis) associated with high levels of fats in the blood;
  • if you have (or have had) a serious liver disease and liver function has not yet returned to normal;
  • if you have (or have had) a benign or malignant liver tumour;
  • if you have (or have had), or may have, a tumour of the breast or genital organs;
  • if you have vaginal bleeding of unknown origin;
  • if you are allergic to ethinylestradiol or etonogestrel, or to any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occurs for the first time while using NuvaRing, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Do not use NuvaRing if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4 “Other medicines and NuvaRing”).

2.2 Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

  • if you notice possible signs of a blood clot which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are using NuvaRing, you must inform your doctor.

  • if a close family member has or has ever had breast cancer;
  • if you have epilepsy (see section 2.4: “Other medicines and NuvaRing”);
  • if you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones);
  • if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
  • if you have systemic lupus erythematosus (SLE – a disease affecting the body’s natural defence system);
  • if you have haemolytic uraemic syndrome (HUS – a blood clotting disorder causing kidney failure);
  • if you have sickle cell anaemia (an inherited red blood cell disorder);
  • if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
  • if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section 2 “Blood clots”);
  • if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start using NuvaRing;
  • if you have inflammation of the veins just 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 during a previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [skin rash with blisters during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden body movements], hereditary angioedema [you must seek immediate medical attention if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulties]);
  • if you have (or have ever had) chloasma (brown-yellowish pigmented patches, so-called “pregnancy mask”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
  • if you have a medical condition that makes it difficult to use NuvaRing – for example, constipation, uterine cervical prolapse, or pain during sexual intercourse;
  • if you have a sudden need to urinate, frequent urination, burning and/or pain, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of NuvaRing into the bladder.

BLOOD CLOTS
Using a combined hormonal contraceptive such as NuvaRing increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

  • in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
  • in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with NuvaRing is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have one of these signs? What might you have?

  • swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
    • pain or tenderness in the leg, felt only when standing or walking
    • increased warmth in the affected leg
    • change in skin colour of the leg, such as paleness, reddish or bluish discolouration
  • sudden and unexplained shortness of breath or rapid breathing
  • sudden cough without an obvious cause, possibly with coughing up of blood
  • sharp chest pain that may worsen when breathing deeply
  • severe dizziness or lightheadedness
  • rapid or irregular heartbeat
  • severe stomach pain

If you are unsure, inform your doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g., a “common cold”).

Symptoms occurring more frequently in an eye: Retinal vein thrombosis (blood clot in the eye)

  • sudden loss of vision
  • painless blurring of vision that may progress to loss of vision

Do you have one of these signs? What might you have?

  • chest pain, discomfort, pressure, or heaviness
  • crushing sensation or fullness in the chest, arm, or under the breastbone
  • feeling of fullness, indigestion, or suffocation
  • discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach
  • sweating, nausea, vomiting, or dizziness
  • extreme weakness, anxiety, or shortness of breath
  • rapid or irregular heartbeat
  • sudden numbness or weakness of the face, arm, or leg, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding
  • sudden difficulty seeing with one or both eyes
  • sudden difficulty walking, dizziness, loss of balance or coordination
  • sudden severe or prolonged headache with no known cause
  • loss of consciousness or fainting, with or without seizures

Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still contact a doctor urgently as you may be at risk of another stroke.

  • swelling and pale blue colouration of a limb
  • severe stomach (abdominal) pain

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 associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. Most cases occur during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
  • If a blood clot moves from the leg and lodges in the lung, it may cause a pulmonary embolism.
  • Very rarely, the clot may form 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 when you first start using a combined hormonal contraceptive. The risk may also be higher if you restart using a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop using NuvaRing, the risk of developing a blood clot returns to normal levels 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 using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with NuvaRing is low.

  • Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etonogestrel, such as NuvaRing, about 6–12 will develop a blood clot in one year.
  • The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).
Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnantAbout 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimateAbout 5-7 women out of 10,000
Women who use NuvaRingAbout 6-12 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with NuvaRing is low, but certain conditions can increase it. Your risk is higher:

  • if you are very overweight (body mass index or BMI above 30 kg/m²);
  • if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
  • if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop using NuvaRing several weeks before surgery or during periods of reduced mobility. If you need to stop using NuvaRing, ask your doctor when you can start using it again;
  • as you get older (especially over 35 years of age);
  • if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have any of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop using NuvaRing.
If any of the above conditions change while you are using NuvaRing—for example, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
As with blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of NuvaRing is very low, but it may increase:

  • with increasing age (over 35 years);
  • if you smoke. When using a combined hormonal contraceptive such as NuvaRing, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may recommend using a different type of contraceptive;
  • if you are overweight;
  • if you have high blood pressure;
  • if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
  • if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
  • if you suffer from migraine, especially migraine with aura;
  • if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
  • if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, your risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using NuvaRing—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Tumors
The information below comes from studies on combined oral contraceptives and may also apply to NuvaRing. There is no specific information available on the vaginal administration of contraceptive hormones (such as NuvaRing).
Breast cancer diagnoses are slightly more frequent in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, tumors may be detected more often in women taking the pill because they undergo more frequent medical check-ups. The increased occurrence of breast cancer gradually decreases after stopping the combined oral contraceptive.
It is important to regularly examine your breasts and contact your doctor as soon as you feel a lump.
Also, inform your doctor if a close relative has or has had breast cancer (see section 2.2 “Warnings and precautions”).
Benign liver tumors have been rarely reported in women taking oral contraceptives, and malignant liver tumors even more rarely. Consult your doctor if you experience unusual, severe abdominal pain.
In women using combined oral contraceptives, endometrial cancer (cancer of the inner lining of the uterus) and ovarian cancer have been reported to occur less frequently. This may also be the case with NuvaRing, but it has not been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

2.3 Children and adolescents
The safety and efficacy of NuvaRing in adolescents under 18 years of age have not been studied.

2.4 Other medicines and NuvaRing
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors, dentists, or pharmacists prescribing other medicines that you are using NuvaRing. They may advise whether you need to use additional contraceptive methods (e.g., male condom), for how long, or whether you need to adjust the use of another medicine you are taking.

Some medicines:

  • may affect blood levels of NuvaRing;
  • may cause a reduction in contraceptive effectiveness;
  • may cause unexpected bleeding. These include medicines used to treat:
    • 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 infections (e.g., griseofulvin);
    • high blood pressure in the lung blood vessels (bosentan);
    • depression (St. John’s wort herbal remedy).

If you are taking medicines or herbal products that may reduce the effectiveness of NuvaRing, you must also use a barrier contraceptive method (e.g., male condom). Because the effect of other medicines on NuvaRing may last up to 28 days after stopping them, you must continue using an additional barrier contraceptive method throughout this period.
Note: Do not use NuvaRing together with a diaphragm, cervical cap, or female condom.

NuvaRing may affect the action of other medicines, for example:

  • medicines containing cyclosporine;
  • the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Do not use NuvaRing if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause increases in blood tests indicating liver function (elevated liver enzymes ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
NuvaRing may be resumed approximately 2 weeks after completion of such treatment. See section 2.1 “Do not use NuvaRing”.
Ask your doctor or pharmacist for advice before taking any medicine.

You may use sanitary tampons while using NuvaRing. Insert NuvaRing before inserting the tampon. Take particular care when removing the tampon to ensure the ring is not accidentally expelled. If this happens, simply rinse the ring with cool or lukewarm water and reinsert it immediately.
Ring breakage has occurred when using a vaginal product such as a lubricant or anti-infective treatment (see section 3.4 “What to do if…The ring breaks”).
The use of spermicidal products or vaginal yeast-based treatments does not reduce the contraceptive effectiveness of NuvaRing.

Laboratory tests
If you undergo blood or urine tests, inform the healthcare professional that you are using NuvaRing, as it may affect the results of certain tests.

2.5 Pregnancy and breastfeeding
NuvaRing must not be used if you are pregnant or suspect you may be pregnant. If you become pregnant while using NuvaRing, remove the ring and contact your doctor.
If you wish to stop using NuvaRing because you want to become pregnant, see section 3.5 “When you want to stop using NuvaRing”.
NuvaRing is generally not recommended during breastfeeding. If you wish to use NuvaRing while breastfeeding, consult your doctor.

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

3. How to use NuvaRing

You can insert and remove NuvaRing yourself. Your doctor will give you instructions on when to start using NuvaRing for the first time. The vaginal ring must be inserted on the appropriate day of the menstrual cycle (see section 3.3 “When to start with the first ring”) and left in the vagina for three consecutive weeks. Regularly check that NuvaRing is in place in the vagina (for example, before and after sexual intercourse) to ensure protection against pregnancy. After the third week, remove NuvaRing and take a one-week break. Your menstrual period will usually occur during this ring-free interval.

While using NuvaRing, do not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap, or female condom. These barrier contraceptive methods should not be used as an additional method of birth control, as NuvaRing may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove NuvaRing

  1. Before inserting the ring, check that it has not expired (see section 5 “How to store NuvaRing”).
  2. Wash your hands before inserting or removing the ring.
  3. Choose the position most comfortable for you to insert the ring, such as standing with one leg raised, squatting, or lying down.
  4. Remove NuvaRing from its pouch.
  5. Hold the ring between your thumb and index finger, compressing opposite sides, and insert it 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. Once NuvaRing is inserted and in place, you should not feel any discomfort. If you do experience discomfort, gently adjust the position of NuvaRing (e.g., push the ring a little deeper into the vagina) until you feel it is comfortably placed. The exact position of the ring within the vagina is not important.
  6. After three weeks, remove NuvaRing from the vagina. NuvaRing can be removed by hooking your index finger under the front edge of the ring or by grasping the edge of the ring and pulling outward (see Figure 5). If you have inserted the ring into the vagina but have difficulty removing it, you must contact your doctor.
  7. The used ring should be disposed of with ordinary household waste, preferably inside the resealable pouch. Do not flush NuvaRing down the toilet.
Figure 1 Remove NuvaRing from the pouch
A hand holds between the thumb and the
Figure 3 Choose a comfortable position for inserting the ring
Two stylized female figures show a woman lifting one leg onto a step and a crouching woman on a faded blue background
Drawing of a person with bent knees lying on one side, head resting on a white pillow

Figure 2 Compress the ring
A hand holds between the thumb and the
Figure 4A Figure 4B Figure 4C Insert the ring into the vagina with one hand (Figure 4A); if necessary, the labia may be parted with the other hand. Push the ring into the vagina until you feel it is comfortably in place (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).
Three anatomical diagrams showing the
Female anatomical diagram showing a hand inserting a medical device into theFigure 5 NuvaRing can be removed by hooking the index finger under the ring or by grasping the ring between the index finger and middle finger and pulling outward.

3.2 Three weeks with the ring in place, one week without

  1. Starting from the day it is inserted, the vaginal ring must remain in the vagina without interruption for 3 weeks.
  2. After 3 weeks, remove the ring on the same day of the week it was inserted, approximately at the same time. For example, if you insert NuvaRing on a Wednesday around 10 p.m., you should remove the ring on the Wednesday of the third following week, approximately at 10 p.m.
  3. After removal, do not use the ring for 1 week. During this week, vaginal bleeding is expected to occur. This usually begins 2–3 days after removal of NuvaRing.
  4. Start with a new ring exactly after the 1-week interval (again on the same day of the week and approximately at the same time), even if vaginal bleeding has not yet stopped. If insertion of the new ring is delayed by more than 3 hours, contraceptive protection may be reduced. In this case, follow the instructions provided in section 3.4 “What to do if… You forget to insert a new ring after a ring-free interval”. If you use NuvaRing as described above, vaginal bleeding will typically occur every month around the same days.

3.3 When to start with the first ring

  • If you have not used a hormonal contraceptive during the last month Insert the first NuvaRing on day 1 of your natural cycle (i.e., the first day of your menstrual period). NuvaRing becomes effective immediately. No additional contraceptive measures are necessary. You may also start NuvaRing between day 2 and day 5, but if you have sexual intercourse during the first 7 days of using NuvaRing, make sure to use an additional contraceptive method (such as a male condom). You need to follow this advice only when using NuvaRing for the first time.
  • If you have used a combined oral contraceptive pill during the last month Start using NuvaRing no later than the day after the pill-free interval of your current pill pack. If your pack also contains inactive tablets, start using NuvaRing no later than the day after the last inactive tablet. If you are unsure, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond its recommended duration. If you have taken the pill consistently and correctly and are sure you are not pregnant, you may also stop taking the pill on any day of the current pack and start using NuvaRing immediately.
  • If you have used a transdermal patch during the last month Start using NuvaRing no later than the day after the usual patch-free interval. Never extend the patch-free interval beyond the recommended period.

If you have used the patch consistently and correctly and are sure you are not pregnant, you may also
stop using the patch on any day and start using NuvaRing immediately.

  • If you have used a progestogen-only pill (minipill) during the last month You may stop the minipill on any day and start using NuvaRing the next day at the same time you would normally have taken the pill. Make sure to also use an additional contraceptive method (such as a male condom) during the first 7 days of ring use.
  • If you have used a progestogen-releasing injection, implant, or intrauterine device (IUD) during the last month Start using NuvaRing on the day the next injection is due, or on the day of removal of the implant or progestogen-releasing IUD. Make sure to also use an additional contraceptive method (such as a male condom) during the first 7 days of ring use.
  • After childbirth If you have recently given birth, your doctor will advise you to wait for your first natural cycle before starting to use NuvaRing. In some cases, earlier initiation may be possible. Consult your doctor. If you wish to use NuvaRing during breastfeeding, you must consult your doctor first.
  • After a spontaneous or surgical abortion Consult your doctor.

3.4 What to do if…
The ring is accidentally expelled from the vagina
NuvaRing may accidentally come out of the vagina – for example, if it was not inserted correctly, during tampon removal, during sexual intercourse, or in association with constipation or uterine prolapse. Therefore, you should regularly check whether the ring is still in place (e.g., before and after sexual intercourse).
The ring remains temporarily outside the vagina
NuvaRing may still continue to protect you from pregnancy, but this depends on how long it remained outside the vagina.
If the ring remains outside the vagina for:

  • a period less than 3 hours, it may still protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it as soon as possible, but only if it has been outside the vagina for less than 3 hours.

  • a period more than 3 hours during week 1 or 2, it may not protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it as soon as you remember, and leave the ring in the vagina continuously for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in week 1 and have had sexual intercourse in the previous 7 days, there is a possibility that pregnancy may have occurred. In this case, contact your doctor.

  • a period more than 3 hours during week 3, it may not protect you from pregnancy. Discard that ring and choose one of the following two options:
    1 – Insert a new ring immediately. This will start the next three-week use period. Menstrual bleeding may not occur, but breakthrough bleeding or spotting may occur.
    2 – Do not reinsert the ring. Wait until you have your menstrual period and insert a new ring no later than 7 days after the previous ring was removed or expelled.
    You should choose this option only if you have used NuvaRing continuously for the previous 7 days.

  • an unknown duration, you may not be protected from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, NuvaRing may break. Vaginal injury associated with ring rupture has been reported. If you notice that NuvaRing has broken, discard that ring and start with a new ring as soon as possible. Use additional contraceptive precautions (e.g., a male condom) for the next 7 days. If you had sexual intercourse before noticing the breakage, consult your doctor.
More than one ring has been inserted
No serious adverse effects due to overdose of NuvaRing hormones have been reported. If you accidentally inserted more than one ring, you may experience nausea, vomiting, or vaginal bleeding. Remove the extra rings and consult your doctor if symptoms persist.
You forget to insert a new ring after a ring-free interval
If the ring-free interval is longer than 7 days, insert a new ring as soon as you remember. Use an additional contraceptive method (such as a male condom) if you have sexual intercourse, for the next 7 days. If you had sexual intercourse during the ring-free interval, the possibility of pregnancy must be considered. Discuss this immediately with your doctor. The longer the ring-free interval, the higher the risk of pregnancy.
You forget to remove the ring

  • If the ring has remained in place for more than 3 but not more than 4 weeks, it may still protect you from pregnancy. Take the regular one-week ring-free interval and then insert a new ring.
  • If the ring has remained in place for more than 4 weeks, there is a possibility that pregnancy may have occurred. Contact your doctor before inserting a new ring.

You miss a menstrual period

  • NuvaRing has been used according to instructions If you miss a period but have used NuvaRing as directed and have not taken other medications, it is very unlikely that you are pregnant. Continue using NuvaRing as usual. However, if you miss two consecutive periods, pregnancy may have occurred. Consult your doctor immediately. Do not start a new NuvaRing until your doctor has ruled out pregnancy.
  • NuvaRing has not been used according to instructions If you miss a period and have not followed the instructions, and you did not have your expected period during the first normal ring-free interval, pregnancy may have occurred. Contact your doctor before starting a new NuvaRing.

You experience unexpected bleeding
While using NuvaRing, some women may experience unexpected vaginal bleeding between periods. You may need to use sanitary protection. In any case, leave the ring in the vagina and continue using it normally. Consult your doctor if irregular bleeding persists, becomes heavy, or recurs.
You wish to change the first day of your menstrual cycle
If you use NuvaRing as directed, your menstrual period (withdrawal bleeding) will begin during the ring-free interval. If you wish to change the day your period starts, you may shorten the ring-free interval (never extend this interval!).
For example, if your period usually starts on Friday, you may change it to Tuesday (3 days earlier) starting next month. Simply insert the next ring 3 days earlier than usual.
If the ring-free interval is very short (e.g., 3 days or less), you may not have the usual bleeding, but you may experience spotting (small drops or stains of blood) or breakthrough bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for clarification.
You wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking a ring-free interval. The new ring may remain in place for a maximum of 3 weeks. During use of the new ring, you may experience spotting (small drops or stains of blood) or breakthrough bleeding. Remove the ring when you decide to have your period. Then observe the regular one-week ring-free interval before inserting a new ring.
You may consult your doctor before deciding to delay your menstrual period.
3.5 When you wish to stop using NuvaRing
You may stop using NuvaRing at any time.
If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you stop using NuvaRing because you wish to become pregnant, wait for your natural cycle before trying to conceive. This will help you calculate the expected date of delivery.

4. Possible side effects

Like all medicines, NuvaRing can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to NuvaRing, tell your doctor.

There is an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE) in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, "What you need to know before using NuvaRing".

If you are allergic to any of the components of NuvaRing (hypersensitivity), you may experience the following symptoms (frequency not known): angioedema and/or anaphylaxis [swelling of the face, lips, tongue and/or throat and/or difficulty swallowing] or urticaria associated with breathing difficulties. If this occurs, remove NuvaRing and consult your doctor immediately.

The following side effects have been reported during use of NuvaRing.

Common: may affect up to 1 in 10 women

  • abdominal pain; feeling unwell (nausea)
  • vaginal fungal infection (e.g., "Candida"); vaginal discomfort due to the ring; genital itching; vaginal discharge
  • headache or migraine; depressed mood; decreased libido
  • breast pain; pelvic pain; painful menstruation
  • acne
  • weight gain
  • expulsion of the ring

Uncommon: may affect up to 1 in 100 women

  • visual disturbances; dizziness
  • bloated abdomen; vomiting, diarrhoea or constipation
  • feeling tired, unwell or irritable; mood changes; mood swings
  • fluid retention (oedema)
  • urinary tract or bladder infection
  • difficulty or pain when urinating; strong urge or need to urinate; increased frequency of urination
  • problems during sexual intercourse, including pain, bleeding or partner awareness of the ring
  • increased blood pressure
  • increased appetite
  • back pain; muscle spasms; leg or arm pain
  • reduced skin sensitivity
  • tender or enlarged breasts; fibrocystic mastopathy (breast cysts that may swell or cause pain)
  • inflammation of the cervix; cervical polyps (growths in the cervix); cervical ectropion (outward displacement of the cervical lining)
  • changes in menstrual cycle (e.g., periods may be heavy, prolonged, irregular or may stop completely); pelvic discomfort; premenstrual syndrome; uterine cramps
  • vaginal infections (fungal and bacterial); burning, bad odour, pain, discomfort or dryness of the vagina or vulva
  • hair loss, eczema, itching, rash or hot flushes
  • urticaria

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 (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk. (See section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot.)
  • breast secretion

Not known (frequency cannot be estimated from the available data)

  • chloasma (brown-yellowish pigmented skin patches, particularly on the face)
  • penile discomfort in partner (such as irritation, rash, itching)
  • inability to remove the ring without medical assistance (e.g., due to adhesion to the vaginal wall)
  • vaginal injury associated with ring rupture

Cancer of the breast and liver tumours have been reported in association with the use of combined hormonal contraceptives. For further information, see section 2.2 Warnings and precautions, Tumours.

Very rarely, the NuvaRing may break. For further information, see section 3.4 What to do if... The ring breaks.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NuvaRing

Keep NuvaRing out of the sight and reach of children.
If you find out that a child has been exposed to the hormones in NuvaRing, consult your doctor.
Store below 30°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not use NuvaRing if it was dispensed more than 4 months ago. The dispensing date is indicated on the box and on the pouch.
Do not use NuvaRing after the expiry date stated on the box and on the pouch.
Do not use NuvaRing if you notice any colour changes in the ring or any other visible signs of deterioration.
Dispose of the used ring with normal household waste, preferably placed in the resealable pouch. Do not flush NuvaRing down the toilet. As with other medicines, do not dispose of unused or expired rings via wastewater or household waste. Ask your pharmacist how to properly discard unused rings that you no longer need. This will help protect the environment.

6. Package contents and other information

What NuvaRing contains

  • The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg)
  • The other components are: ethylene vinylacetate copolymers (28% and 9% vinylacetate) (a type of plastic that does not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the ring at daily doses of 0.120 mg/day and 0.015 mg/day, respectively, over a period of 3 weeks.

Description of the appearance of NuvaRing and package contents
NuvaRing is a flexible, transparent, colourless or almost colourless ring with a diameter of 54 mm.
Each ring is packaged in a resealable aluminium pouch. The pouch is contained in a cardboard box together with this package leaflet. Each box contains either 1 or 3 rings.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

This medicinal product is authorised in the European Economic Area countries under the
following name:
NuvaRing
0.120 mg/0.015 mg per 24 hours, vaginal ring
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Romania, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).

These stickers, when applied on the correct date in the calendar, can help you remember when to insert and remove NuvaRing.

Three rows of logos composed of a stylized female silhouette within the

Insert the ring Remove the ring

Package leaflet: Information for the user

NuvaRing, 0.120 mg/0.015 mg every 24 hours, vaginal ring

Etonogestrel/Ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

  • They are among the most reliable reversible methods of contraception when used correctly.
  • They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
  • Be alert and contact your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Please read this leaflet carefully before using NuvaRing as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What NuvaRing is and what it is used for
  2. What you need to know before using NuvaRing
    2.1 Do not use NuvaRing
    2.2 Warnings and precautions
    Blood clots
    Tumours
    2.3 Children and adolescents
    2.4 Other medicines and NuvaRing
    Laboratory tests
    2.5 Pregnancy and breastfeeding
    2.6 Driving and use of machines
  3. How to use NuvaRing
    3.1 How to insert and remove NuvaRing
    3.2 Three weeks with the ring in place, one week without
    3.3 When to start with the first ring
    3.4 What to do if…
    The ring is accidentally expelled from the vagina
    The ring remains temporarily outside the vagina
    The ring breaks
    More than one ring is inserted
    You forget to insert a new ring after a ring-free interval
    You forget to remove the ring
    You miss a menstrual period
    You experience unexpected bleeding
    You want to change the first day of your menstrual cycle
    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 and the NuvaRing Applicator
  6. Contents of the pack and other information
    What NuvaRing contains
    Description of the appearance of NuvaRing and the NuvaRing Applicator and contents of the pack

Marketing Authorisation Holder and Manufacturer

1. What NuvaRing is and what it is used for

NuvaRing is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. The ring releases these hormones slowly into the bloodstream. Because the amounts of hormones released are low, 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 oral contraceptive pill (the Pill), but instead of taking a pill every day, the ring is used continuously for 3 weeks. NuvaRing releases two female sex hormones that prevent the release of an egg from the ovaries. If no egg is released, pregnancy cannot occur.

2. What you should know before using NuvaRing

General information
Before starting to use NuvaRing, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot – see section 2
“Blood clots”.
This patient leaflet describes various situations in which you must stop using
NuvaRing or in which NuvaRing may be less reliable. In such cases, you must not have
sexual intercourse or you must use additional non-hormonal contraceptive precautions – such as the
male condom or another barrier method. Do not use rhythm or basal body temperature methods,
which may be unreliable, as NuvaRing alters the monthly variations in body temperature and cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

2.1 Do not use NuvaRing
Do not use NuvaRing if you have any of the conditions listed below. If you have any of the
conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

  • if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
  • if you know you have a disorder affecting blood clotting – such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
  • if you are about to undergo surgery or if you will be bedridden for a long period (see section “Blood clots”);
  • if you have ever had a heart attack or stroke;
  • if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
  • if you have any of the following diseases, which could increase the risk of clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
  • if you have (or have had) severe liver disease and liver function has not yet returned to normal;
  • if you have (or have had) a benign or malignant liver tumour;
  • if you have (or have had), or may have, a tumour of the breast or genital organs;
  • if you have vaginal bleeding of unknown origin;
  • if you are allergic to ethinylestradiol or etonogestrel or to any of the other ingredients of this medicine (listed in section 6). If any of these conditions occurs for the first time while using NuvaRing, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use NuvaRing if you have hepatitis C and are taking
medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4
“Other medicines and NuvaRing”).

2.2 Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

  • if you notice possible signs of a blood clot that may indicate you are suffering from a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are using NuvaRing, you must inform your doctor.
if a close relative has, or has ever had, breast cancer;
if you suffer from epilepsy (see section 2.4: “Other medicines and NuvaRing”);
if you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones);
if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (SLE – a disease affecting the natural defence system);
if you have haemolytic uraemic syndrome (HUS – a blood clotting disorder causing kidney failure);
if you have sickle cell anaemia (a hereditary red blood cell disorder);
if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
if you are about to undergo surgery or if you will be bedridden for a long period (see section 2 “Blood clots”);
if you have recently given birth, your risk of developing blood clots is higher. Ask your
doctor how long after delivery you can start using NuvaRing;
if you have inflammation of 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 during a previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden body movements], hereditary angioedema [you must see a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulty]);
if you have (or have ever had) chloasma (brownish-yellow pigmented patches, so-called “pregnancy mask”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
if you have a medical condition that makes the use of NuvaRing difficult – e.g., constipation, uterine prolapse or pain during sexual intercourse;
if you have a sudden need to urinate, frequent urination, burning and/or pain, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of NuvaRing into the bladder.

BLOOD CLOTS
Using a combined hormonal contraceptive such as NuvaRing increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).
Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, or very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with NuvaRing is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have one of these signs? What are you likely suffering from?

  • swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

    • pain or tenderness in the leg, felt only when standing or walking
    • increased warmth in the affected leg
    • change in skin colour of the leg, such as paleness, redness or bluish discolouration
      → Deep vein thrombosis

  • sudden and unexplained shortness of breath or rapid breathing

  • sudden cough without an obvious cause, possibly with coughing up blood

  • sharp chest pain that may worsen when breathing deeply

  • severe dizziness or lightheadedness

  • rapid or irregular heartbeat

  • severe stomach pain
    → Pulmonary embolism

Symptoms occurring more frequently in one eye:

  • sudden loss of vision or painless blurring of vision that may progress to loss of vision
    → Retinal vein thrombosis (blood clot in the eye)

  • chest pain, discomfort, pressure or heaviness

  • squeezing or fullness sensation in the chest, arm or under the breastbone

  • fullness, indigestion or choking sensation

  • discomfort in the upper body, radiating to back, jaw, throat, arms and stomach

  • sweating, nausea, vomiting or dizziness

  • extreme weakness, anxiety or shortness of breath

  • rapid or irregular heartbeat
    → Heart attack

  • sudden numbness or weakness of the face, arm or leg, especially on one side of the body

  • sudden confusion, difficulty speaking or understanding

  • sudden difficulty seeing with one or both eyes

  • sudden difficulty walking, dizziness, loss of balance or coordination

  • sudden severe or prolonged headache with no known cause

  • loss of consciousness or fainting, with or without seizures
    → Stroke

Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still contact a doctor urgently as you may be at risk of another stroke.

  • swelling and pale blue discolouration of a limb
  • severe abdominal pain (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 associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
  • If a blood clot moves from the leg and lodges in the lung, it may cause a pulmonary embolism.
  • Very rarely, the clot may form 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 when first starting to use a combined hormonal contraceptive. The risk may also be higher if you restart using a combined hormonal contraceptive (the same or a different drug) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop using NuvaRing, the risk of developing a blood clot returns to normal levels 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 using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with NuvaRing is low.

  • Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
  • Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone or norgestimate, about 5–7 will develop a blood clot in a year.
  • Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etonogestrel, such as NuvaRing, about 6–12 will develop a blood clot in a year.
  • The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).
Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnantAbout 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimateAbout 5-7 women out of 10,000
Women who use NuvaRingAbout 6-12 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with NuvaRing is low, but certain conditions can increase it. Your risk is higher:

  • if you are very overweight (body mass index or BMI above 30 kg/m²);
  • if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
  • if you need to undergo surgery or must remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop using NuvaRing several weeks before surgery or during periods of reduced mobility. If you need to stop using NuvaRing, ask your doctor when you can start using it again;
  • as you get older (especially over 35 years of age);
  • if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop using NuvaRing.
If any of the above conditions change while you are using NuvaRing—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of NuvaRing is very low, but it may increase:

  • with increasing age (over 35 years);
  • if you smoke. When using a combined hormonal contraceptive such as NuvaRing, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
  • if you are overweight;
  • if you have high blood pressure;
  • if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
  • if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
  • if you suffer from migraine, especially migraine with aura;
  • if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
  • if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using NuvaRing—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Tumors
The information below comes from studies on combined oral contraceptives and may also apply to NuvaRing. There is no available information specifically on the vaginal administration of contraceptive hormones (such as NuvaRing).

Diagnoses of breast cancer are slightly more frequent in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, tumors may be detected more often in women taking the combined pill because they see their doctor more frequently. The increased occurrence of breast cancer gradually decreases after stopping the combined pill.
It is important to regularly examine your breasts and contact your doctor as soon as you feel a lump.
Also, inform your doctor if a close relative has or has had breast cancer (see section 2.2 “Warnings and precautions”).

Benign liver tumors have been rarely reported in women taking the pill, and malignant liver tumors even more rarely. Consult your doctor if you experience unusual, severe abdominal pain.

In women using the combined pill, endometrial cancer (cancer of the inner lining of the uterus) and ovarian cancer have been reported to occur less frequently. This may also be the case with NuvaRing, but this has not been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.

2.3 Children and adolescents
The safety and efficacy of NuvaRing in adolescents under 18 years of age have not been studied.

2.4 Other medicines and NuvaRing
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctors, dentists, or pharmacists who prescribe other medicines that you are using NuvaRing. They can advise you whether you need to use additional contraceptive methods (e.g., male condom), for how long, or whether adjustments to other medications you are taking are necessary.

Some medicines:

  • may affect blood levels of NuvaRing;
  • may cause a reduction in contraceptive effectiveness;
  • may cause unexpected bleeding.

These include medicines used to treat:

  • 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 lung vessels (pulmonary hypertension) (bosentan);
  • depression (St. John’s wort herbal remedy).

If you are taking medicines or herbal products that may reduce the effectiveness of NuvaRing, you must also use a barrier contraceptive method (e.g., male condom). Since the effect of other medicines on NuvaRing may last up to 28 days after stopping them, you must continue using an additional barrier contraceptive method throughout this period.
Note: Do not use NuvaRing together with a diaphragm, cervical cap, or female condom.

NuvaRing may affect the action of other medicines, for example:

  • medicines containing cyclosporine;
  • the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Do not use NuvaRing if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause increases in liver function blood tests (elevated liver enzymes ALT).

Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
NuvaRing can be resumed approximately 2 weeks after completion of such treatment. See section 2.1 “Do not use NuvaRing”.
Ask your doctor or pharmacist for advice before taking any medicine.

You may use sanitary tampons while using NuvaRing. Insert NuvaRing before inserting the tampon. Special care should be taken when removing the tampon to ensure that the ring is not accidentally expelled. If this happens, simply rinse the ring with cool or lukewarm water and reinsert it immediately.

Ring breakage has occurred when also using a vaginal product such as a lubricant or anti-infective treatment (see section 3.4 “What to do if…The ring breaks”).

The use of spermicidal or vaginal yeast-based products does not reduce the contraceptive effectiveness of NuvaRing.

Laboratory tests
If you undergo blood or urine tests, inform the healthcare professional that you are using NuvaRing, as it may affect the results of certain tests.

2.5 Pregnancy and breastfeeding
NuvaRing must not be used if you are pregnant or suspect you may be pregnant. If pregnancy occurs while you are using NuvaRing, you must remove the ring and contact your doctor.
If you wish to stop using NuvaRing because you want to become pregnant, see section 3.5 “When you want to stop using NuvaRing”.
NuvaRing is generally not recommended during breastfeeding. If you wish to use NuvaRing while breastfeeding, consult your doctor.

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

3. How to use NuvaRing

You can insert and remove NuvaRing yourself. Your doctor will provide instructions on when to start using NuvaRing for the first time. The vaginal ring must be inserted on the appropriate day of the menstrual cycle (see section 3.3 "When to start with the first ring") and left in the vagina for 3 consecutive weeks. Regularly check that NuvaRing is in place in the vagina (for example, before and after sexual intercourse) to ensure pregnancy protection. After the third week, remove NuvaRing and take a one-week break. Your menstrual period usually begins 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 barrier methods should not be used as an additional method of birth control, as NuvaRing may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove NuvaRing

  1. Before inserting the ring, check that it has not expired (see section 5 "How to store NuvaRing and the NuvaRing Applicator").
  2. Wash your hands before inserting or removing the ring.
  3. Choose the most comfortable position for inserting the ring, such as standing with one leg raised, squatting, or lying down.
  4. Remove NuvaRing from its pouch.
  5. Hold the ring between your thumb and index finger, compressing opposite sides, and insert it into the vagina (see Figures 1–4). Alternatively, you may choose to use the NuvaRing Applicator to help insert the ring (see below Instructions for use). Once inserted, NuvaRing should not cause any discomfort. If you experience discomfort, gently adjust the position of NuvaRing (e.g., push the ring slightly deeper into the vagina) until it feels comfortable. The exact position of the ring within the vagina is not important.
  6. After 3 weeks, remove NuvaRing from the vagina. NuvaRing can be removed by hooking your index finger under the front edge of the ring or by grasping the edge of the ring and pulling outward (see Figure 5). If you have inserted the ring into the vagina but have difficulty removing it, you must contact your doctor.
  7. The used ring should be disposed of with ordinary household waste, preferably inside the resealable pouch. Do not flush NuvaRing down the toilet.

How to insert NuvaRing using fingers only:

Figure 1 Remove NuvaRing from the pouch
A hand holds a small circle or thin ring with a distinct edge between thumb and index finger against a light background
Figure 3 Choose a comfortable position for inserting the ring
Stylized drawing of a woman stepping up onto a stair and a crouching woman on either side of a vertical dividing line
Stylized drawing of a person lying on one side with knees bent and head resting on a white pillow

Figure 2 Compress the ring
A hand holds a small ring or thin circular elastic between thumb and index finger against a light gray background
Figure 4A Figure 4B Figure 4C Insert the ring into the vagina with one hand (Figure 4A); if necessary, the labia may be separated with the other hand. Push the ring into the vagina until you feel it is comfortably in place (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).
Three lateral section diagrams showing the
Anatomical diagram of the female pelvis showing theFigure 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 outward.

Important information for the NuvaRing Applicator:

  1. Optional use to help insert NuvaRing.
  2. DO NOT reuse the applicator; it is designed for single use only.
  3. DO NOT share the applicator with others.
  4. If the applicator accidentally falls, wash it with cold or lukewarm water (NOT hot).
  5. Dispose of the applicator in a regular waste container immediately after use.
  6. Do not flush the applicator down the toilet.

How to insert NuvaRing using the applicator:
1: Preparation

Black and white drawing showing a person washing hands under a stream of waterWash your hands before opening the package. Open ONLY immediately before use. DO NOT use if the contents or packaging are visibly damaged.
A hand holds between the thumb and theThe applicator must be used ONLY with NuvaRing vaginal ring, not with other products.
Technical diagram with labels A, B, C, D, and circle E indicating different component parts of a syringe-shaped medical deviceExamine the illustration of the applicator to become familiar with its components. A.Plunger B.Grip C.Cannula D.Cannula Opening E.NuvaRing

2: Loading and Positioning

Two hands hold a cylindrical container while a black arrow indicates a pulling motion to the left to separate componentsPull back the plunger gently until it stops.
Two hands grip a cylindrical medical device to prepare or use it with a rotational or pulling movement on the terminal partSqueeze the opposite sides of the ring together and insert the ring into the cannula opening.
Two hands hold a horizontal syringe while a finger presses the tip to expel the contentsGently push the ring into the cannula. The tip of the ring should protrude slightly from the cannula opening.
Three stylized female figures in black and white showing different body positions: one lying down, one crouching, and one standing with one leg raisedChoose the position that is most comfortable for you to insert the ring, for example lying down, squatting, or standing with one leg raised.

3: Insertion and Disposal

A hand vertically holds a graduated pipette with thumb andPlace your thumb and middle finger on the handle.
Medical diagram showing a hand inserting an applicator into theGently insert the cannula into the vagina until your fingers (on the handle) touch the body. Then use your index finger to gently push the plunger into the cannula. Some women have experienced a brief, mild stinging sensation when using the applicator.
Medical diagram showing a hand inserting an applicator into theThe ring is pushed out of the applicator. Gently remove the applicator.
A hand holds a cylindrical container and is about to dispose of it into a wire mesh trash bin placed in a cornerMake sure the ring is NOT in the applicator. Dispose of the used applicator in a regular waste container. DO NOT flush the applicator down the toilet. DO NOT reuse the applicator.

3.2 Three weeks with the ring in place, one week without

  1. Starting from the day of insertion, the vaginal ring must be kept in the vagina without interruption for 3 weeks.
  2. After 3 weeks, remove the ring on the same day of the week and approximately at the same time as when it was inserted. For example, if you insert NuvaRing on a Wednesday around 10 p.m., you should remove the ring on the Wednesday of the third following week, approximately at 10 p.m.
  3. After removal, do not use the ring for 1 week. During this week, vaginal bleeding is expected. This usually starts 2–3 days after removal of NuvaRing.
  4. Insert a new ring exactly after the 1-week interval (again on the same day of the week and approximately at the same time), even if vaginal bleeding has not yet stopped. If the new ring is inserted more than 3 hours late, contraceptive protection may be reduced. In this case, follow the instructions provided in section 3.4 “What to do if… You forget to insert a new ring after a ring-free interval”. If you use NuvaRing as described above, vaginal bleeding will occur every month approximately on the same days.

3.3 When to start with the first ring

  • If you have not used a hormonal contraceptive during the last month Insert the first NuvaRing on day 1 of your natural cycle (i.e. the first day of your menstrual period). NuvaRing starts to work immediately. No additional contraceptive measures are necessary. You may also start NuvaRing between day 2 and day 5, but if you have sexual intercourse during the first 7 days of NuvaRing use, make sure to use an additional contraceptive method (such as a male condom). You need to follow this advice only when using NuvaRing for the first time.
  • If you have used a combined oral contraceptive pill during the last month Start using NuvaRing no later than the day after the pill-free interval of your current pill. If the pack also contains inactive tablets, start using NuvaRing no later than the day after the last inactive tablet. If you are unsure, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond the recommended duration. If you have used the pill consistently and correctly and are sure you are not pregnant, you may also stop taking the pill at any time during the current pack and start using NuvaRing immediately.
  • If you have used a transdermal patch during the last month Start using NuvaRing no later than the day after the usual patch-free interval. Never extend the patch-free interval beyond the recommended duration. If you have used the patch consistently and correctly and are sure you are not pregnant, you may also stop using the patch at any time and start using NuvaRing immediately.
  • If you have used a progestogen-only pill (mini-pill) during the last month You may stop taking the mini-pill at any time and start using NuvaRing the next day at the same time you would normally have taken the pill. Make sure to use an additional contraceptive method (such as a male condom) during the first 7 days of ring use.
  • If you have used an injection, implant, or intrauterine device (IUD) releasing progestogen during the last month Start using NuvaRing on the day the next injection is due, or on the day of removal of the implant or progestogen-releasing IUD. Make sure to use an additional contraceptive method (such as a male condom) during the first 7 days of ring use.
  • After childbirth If you have recently given birth, your doctor will advise you to wait for your first natural cycle before starting to use NuvaRing. In some cases, earlier initiation may be possible. Consult your doctor. If you wish to use NuvaRing during breastfeeding, you must consult your doctor first.
  • After spontaneous or surgical abortion Consult your doctor.

3.4 What to do if…
The ring is accidentally expelled from the vagina
NuvaRing may accidentally come out of the vagina – for example, if it was not inserted correctly, during tampon removal, during sexual intercourse, or in association with constipation or uterine prolapse. Therefore, you should regularly check whether the ring is still in the vagina (e.g. before and after sexual intercourse).
The ring remains temporarily outside the vagina
NuvaRing may still continue to protect you from pregnancy, but this depends on how long it remains outside the vagina.
If the ring remains outside the vagina for:

  • a period less than 3 hours, it may still protect you from pregnancy. Wash the ring with cool or lukewarm water (do not use hot water) and reinsert it as soon as possible, but only if it has been out of the vagina for less than 3 hours.
  • a period more than 3 hours during week 1 or 2, it may not protect you from pregnancy. Wash the ring with cool or lukewarm water (do not use hot water) and reinsert it as soon as you remember, and leave the ring in the vagina continuously for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in week 1 and have had sexual intercourse in the previous 7 days, there is a possibility that pregnancy may have occurred. In this case, contact your doctor.
  • a period more than 3 hours during week 3, it may not protect you from pregnancy. Discard that ring and choose one of the following two options: 1 - Insert a new ring immediately. This will start the next three-week use period. Your menstrual period may not occur, but breakthrough bleeding or spotting may occur. 2 - Do not reinsert the ring. Wait for your menstrual period and insert a new ring no later than 7 days after the previous ring was removed or expelled. Choose this option only if you have used NuvaRing continuously for the previous 7 days.
  • an unknown duration, you may not be protected from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Very rarely, NuvaRing may break. Vaginal injury associated with ring breakage has been reported. If you notice that NuvaRing has broken, discard that ring and start with a new ring as soon as possible. Use additional contraceptive precautions (e.g. a male condom) for the next 7 days. If you had sexual intercourse before noticing the breakage, consult your doctor.
More than one ring has been inserted
No serious adverse effects due to overdose of NuvaRing hormones have been reported. If you have accidentally inserted more than one ring, you may experience nausea, vomiting, or vaginal bleeding. Remove the extra rings and consult your doctor if symptoms persist.
You forget to insert a new ring after a ring-free interval
If the ring-free interval is longer than 7 days, insert a new ring as soon as you remember. Use an additional contraceptive method (such as a male condom) if you have sexual intercourse, for the next 7 days. If you had sexual intercourse during the ring-free interval, the possibility of pregnancy must be considered. Discuss this immediately with your doctor. The longer the ring-free interval, the higher the risk of pregnancy.
You forget to remove the ring

  • If the ring has been left in for more than 3 but not more than 4 weeks, it may still protect you from pregnancy. Proceed with the regular one-week ring-free interval and then insert a new ring.
  • If the ring has been left in for more than 4 weeks, there is a possibility that pregnancy may have occurred. Contact your doctor before inserting a new ring.

You miss a menstrual period

  • NuvaRing has been used according to instructions If you miss a period but have used NuvaRing according to instructions and have not taken other medications, it is very unlikely that you are pregnant. Continue using NuvaRing as usual. However, if you miss two consecutive periods, pregnancy may have occurred. Consult your doctor immediately. Do not start a new NuvaRing until pregnancy has been ruled out by your doctor.
  • NuvaRing has not been used according to instructions If you miss a period and have not followed the instructions, and you did not have the expected period during the first normal ring-free interval, pregnancy may have occurred. Contact your doctor before starting to use a new NuvaRing.

You have unexpected bleeding
During use of NuvaRing, some women may experience unexpected vaginal bleeding between periods. You may need to use sanitary protection. In any case, leave the ring in the vagina and continue using it normally. Consult your doctor if irregular bleeding persists, becomes heavy, or recurs.
You wish to change the first day of your menstrual cycle
If you use NuvaRing according to instructions, your menstrual period (withdrawal bleeding) will start during the ring-free interval. If you wish to change the day your period starts, you may shorten the ring-free interval (never extend it!).
For example, if your period usually starts on Friday, you can change it to Tuesday (3 days earlier) starting next month. Simply insert the next ring 3 days earlier than usual.
If the ring-free interval is very short (e.g. 3 days or less), you may not have the usual bleeding, but may experience spotting (drops or small stains of blood) or breakthrough bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for clarification.
You wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking a ring-free interval. The new ring may be left in place for up to 3 weeks. During use of the new ring, you may experience spotting (drops or small stains of blood) or breakthrough bleeding. Remove the ring when you decide to have your period. Then observe the regular one-week ring-free interval before inserting a new ring.
You may consult your doctor before deciding to delay your menstrual period.
3.5 When you wish to stop using NuvaRing
You may stop using NuvaRing at any time.
If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you stop using NuvaRing because you wish to become pregnant, wait for your natural cycle before trying to conceive. This will help you calculate the expected due date.

4. Possible side effects

Like all medicines, NuvaRing can cause side effects, although not everyone gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to NuvaRing, inform your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you need to know before using NuvaRing".

If you are allergic to any of the components of NuvaRing (hypersensitivity), you may experience the following symptoms (frequency not known): angioedema and/or anaphylaxis [swelling of the face, lips, tongue and/or throat and/or difficulty swallowing] or urticaria associated with breathing difficulties. If this occurs, remove NuvaRing and consult your doctor immediately.

The following side effects have been reported during use of NuvaRing.

Common: may affect up to 1 in 10 women

  • abdominal pain; feeling unwell (nausea)
  • vaginal fungal infection (e.g., "Candida"); vaginal discomfort due to the ring; genital itching; vaginal discharge
  • headache or migraine; depressed mood; decreased libido
  • breast pain; pelvic pain; painful menstruation
  • acne
  • weight gain
  • expulsion of the ring

Uncommon: may affect up to 1 in 100 women

  • visual disturbances; dizziness
  • bloated abdomen; vomiting, diarrhoea or constipation
  • feeling tired, unwell or irritable; mood changes; mood swings
  • fluid retention in tissues (oedema)
  • urinary tract or bladder infection
  • difficulty or pain when urinating; strong urge or need to urinate; increased frequency of urination
  • problems during sexual intercourse, including pain, bleeding or partner sensation of the ring
  • increased blood pressure
  • increased appetite
  • back pain; muscle spasms; leg or arm pain
  • reduced skin sensitivity
  • tender or enlarged breasts; fibrocystic mastopathy (breast cysts that may swell or cause pain)
  • inflammation of the cervix; cervical polyps (growths in the cervix); cervical ectropion (outward displacement of the cervical lining)
  • menstrual cycle disturbances (e.g., periods may be heavy, prolonged, irregular or may stop completely); pelvic discomfort; premenstrual syndrome; uterine spasms
  • vaginal infections (fungal and bacterial); burning, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
  • hair loss, eczema, itching, skin rash or hot flushes
  • urticaria

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 (DVT), in a lung (PE), heart attack, stroke, mini-stroke or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk. (See section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot.)
  • breast milk secretion

Not known (frequency cannot be estimated from the available data)

  • chloasma (brown-yellowish pigmented skin patches, particularly on the face)
  • penile discomfort in partner (such as irritation, rash, itching)
  • inability to remove the ring without medical assistance (e.g., due to adhesion to the vaginal wall)
  • vaginal injury associated with ring rupture

Breast cancer and liver tumours have been reported in association with the use of combined hormonal contraceptives. For further information, see section 2.2 Warnings and precautions, Tumours.

Very rarely, the NuvaRing may break. For further information, see section 3.4 What to do if... the ring breaks.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NuvaRing and the NuvaRing Applicator

Keep NuvaRing out of the sight and reach of children.
If you find out that a child has been exposed to the hormones in NuvaRing, consult your doctor.
Store below 30°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not use NuvaRing if it was dispensed more than 4 months ago. The date of dispensing is indicated on the box and on the ring pouch.
Do not use NuvaRing after the expiry date stated on the box and on the pouch.
Do not use NuvaRing if you notice any colour changes in the ring or any other visible signs of deterioration.
Dispose of the used ring with ordinary household waste, preferably placed in the resealable pouch.
Dispose of the used applicator in a regular waste container. Do not flush NuvaRing or the applicator down the toilet.
As with other medicines, do not dispose of unused or expired rings via wastewater or household waste.
Ask your pharmacist how to dispose of unused rings that you no longer require. This will help protect the environment.

6. Package contents and other information

What NuvaRing contains

  • The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg)
  • The other components are: ethylene vinylacetate copolymers (28% and 9% vinylacetate) (a type of plastic that does not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the ring at daily doses of 0.120 mg/day and 0.015 mg/day, respectively, for a period of 3 weeks.

Description of the appearance of NuvaRing and NuvaRing Applicator and contents of the pack
NuvaRing is a flexible, transparent, colourless or almost colourless ring with a diameter of 54 mm.
Each ring is individually packaged in a resealable aluminium pouch.
The applicator is a single-use, non-sterile plastic device (i.e., disposable). Each applicator is individually packaged. The applicator bears a CE mark in relief on the device.
The pouch(es) containing the ring(s) and the applicator(s) are packed together with this patient information leaflet in a cardboard box.
Each box contains either 1 or 3 rings and matching applicators.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, the Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following name:
NuvaRing
0.120 mg/0.015 mg per 24 hours, vaginal ring
Austria, Belgium, Bulgaria, 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 (Northern Ireland).

These stickers, when applied to the correct date on the calendar, can help you remember when to insert and remove NuvaRing.

Three rows of circular icons with stylized female silhouettes, alternating blue circles with white figures and white circles with blue figures

Insert the ring Remove the ring