The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00025/0565.
NuvaRing® 0.120 mg/0.015 mg per 24 hours, Vaginal delivery system
1. What NuvaRing is and what it is used for
2. What you need to know before you use NuvaRing
3. How to use NuvaRing
4. Possible side effects
5. How to store NuvaRing
6. Contents of the pack and other information
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.
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.
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 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 or glecaprevir/pibrentasvir (see also section 2.4 ‘Other medicines and NuvaRing’).
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using NuvaRing, you should also tell your doctor.
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
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?
Deep vein thrombosis
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’).
Retinal vein thrombosis (blood clot in the eye)
Symptoms most commonly occur in one eye:
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.
Blood clots blocking other blood vessels
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
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.
Risk of developing a blood clot in a year
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:
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:
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.
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.
Some women using hormonal contraceptives including NuvaRing have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
The safety and efficacy of NuvaRing in adolescents under the age of 18 have not been studied.
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.
These include medicines used for the treatment of:
If you are taking medicines or herbal products that might make NuvaRing less effective, a barrier contraceptive method should also be used (for example, a male condom). 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.
Do not use NuvaRing if you have Hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir 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.
Ring breakage has occurred when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 ‘What to do if…Your ring breaks’). Using spermicides or vaginal yeast products will not reduce the contraceptive efficacy of NuvaRing.
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.
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.
NuvaRing is unlikely to affect your ability to drive or use machines.
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. You can however use a male condom as an extra barrier contraceptive method.
1. Before inserting the ring, check that it is not out of date (see section 5 ‘How to store NuvaRing’).
2. Wash your hands before inserting or removing the ring.
3. Choose the position for inserting that is most comfortable to you, like standing with one leg up, squatting, or lying down.
4. Remove NuvaRing from its sachet.
5. Hold the ring between your thumb and index finger, press the opposite sides together and insert the ring into the vagina (see 5a-5d below). 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 change the position of NuvaRing (e.g., push the ring a bit further into the vagina) until it is comfortable. The exact position of the ring inside the vagina is not important.
5a. Insert the ring into the vagina with one hand.
5b. If necessary the labia may be spread with the other.
5c. Push the ring into the vagina until the ring feels comfortable.
5d. Leave the ring in place for3 weeks.
6. After 3 weeks you remove NuvaRing from the vagina. You can do this by hooking your index finger under the front rim of the ring or by grasping the rim and pulling it out (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 out ). If you locate the ring in your vagina, but are unable to remove it, you should contact your doctor.
7. Dispose of the used ring with the normal household waste, preferably inside the reclosable sachet. Do not flush NuvaRing down the toilet.
1. Starting with the day you put it in, the vaginal ring must be left in place without interruption for 3 weeks.
2. After 3 weeks you remove the ring on the same day of the week and at approximately the same time as it was put in. For example, if you put NuvaRing in on a Wednesday at about 22.00 h, you should remove the ring 3 weeks later, on Wednesday, at about 22.00 h.
3. After you have removed the ring, you do not use a ring for 1 week. During this week a vaginal bleed should occur. Usually this starts 2–3 days after removal of NuvaRing.
4. Start a new ring exactly after the 1 week interval (again on the same day of the week and approximately the same time), even if you have not stopped bleeding.
If the new ring is inserted more than 3 hours too late, the protection from pregnancy may be reduced. Follow the instructions in section 3.4 ‘What to do if…You have forgotten to insert a new ring after the ring-free interval’.
If you use NuvaRing as described above, your vaginal bleed will take place every month on roughly the same days.
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).
Your ring has temporarily been out of the vagina
NuvaRing might still protect you from getting pregnant, but this depends on how long it has been out of your vagina.
If the ring has been out of the vagina for:
Your ring breaks
Very rarely NuvaRing may break. Vaginal injury associated with ring breakage has been reported. 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 was 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
You have missed a menstrual period
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.
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.
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 and/or anaphylaxis [swollen face, lips, tongue and/or throat and/or difficulty swallowing] or hives potentially with difficulty breathing. If this happens, remove NuvaRing and contact your doctor immediately (see also section 2.2 ‘Warnings and precautions’).
Users of NuvaRing have reported the following side effects.
Common: may affect up to 1 in 10 women
Uncommon: may affect up to 1 in 100 women
Rare: may affect up to 1 in 1,000 women
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.)
Not known (cannot be estimated from the available data)
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.
Very rarely NuvaRing may break. For more information, see section 3.4 What to do if…Your ring breaks.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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.
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:
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:
0.120 mg/0.015 mg per 24 hours, Vaginal delivery system
Austria, Belgium, 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).
This leaflet was last revised in May 2022.
© 2022 Organon group of companies. All rights reserved.
These stickers, when applied to the appropriate date in your calendar, can help you to remember when to insert and remove NuvaRing