0.120mg / 0.015mg per 24 hours, vaginal insert
etonogestrel / ethinylestradiol
What NuvaRing is and what it is used for
NuvaRing is a contraceptive in the form of a vaginal ring that is used to prevent pregnancy. Each ring contains a small amount of two female sex hormones, etonogestrel, and Ethinyl estradiol. The ring slowly releases these hormones into the bloodstream. Due to the small amounts of hormones that are released, NuvaRing is considered a low-dose hormonal contraceptive. Because NuvaRing releases two different types of hormones, it is a so-called combined hormonal contraceptive.
NuvaRing works just like a combined pill, but instead of taking one pill every day, the ring is used for 3 weeks in a row. NuvaRing releases two female sex hormones that prevent an egg from detaching from the ovaries. If no egg is released, you can not get pregnant.
What you need to know before using NuvaRing
General information
Before using NuvaRing, read the information on blood clots in section 2. It is especially important to read about the symptoms of blood clots – see section 2, “BLOOD CLOTS”).
This leaflet describes several situations when you should stop using NuvaRing, or when NuvaRing may be less reliable. In such situations, you should not have intercourse or protect yourself with a non-hormonal contraceptive – such as a male condom or any other barrier method. Do not use safe periods or temperature methods. These methods may be unsafe because NuvaRing affects the monthly changes in body temperature and secretions in the cervix.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or any other sexually transmitted disease.
2.1 When not to use NuvaRing
Do not use NuvaRing if you have any of the conditions listed below. If you have any of these conditions, you must inform your doctor/midwife. Your doctor/midwife will discuss which other type of contraception may be more appropriate.
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis , DVT), in your lungs ( pulmonary embolism , PE) or in any other organ.
- if you know you have a disease that affects blood coagulation – eg protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies.
- if you need to have an operation or if you stay in bed for a long time (see section “BLOOD CLOTS”).
- if you have (or have had) a heart attack or a stroke .
- if you have (or have had) angina (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms).
- if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with vascular damage
- very high blood pressure
- very high levels of blood fats ( cholesterol and triglycerides )
- a condition called hyperhomocysteinemia.
- if you have or have had a type of migraine called “migraine with aura”.
- if you have (have had) inflammation of the pancreas ( pancreatitis ) in combination with high levels of blood fats.
- if you have (have had) severe liver disease and your liver is not yet functioning normally.
- if you have (have had) benign or malignant tumors in your liver.
- if you have (have had) or if you suspect you may have breast or genital cancer.
- if you have genital bleeding for no known reason.
- if you are allergic to ethinyl estradiol or etonogestrel, or any of the other ingredients of this medicine (listed in section 6).
Should any of these conditions occur for the first time when using NuvaRing, remove the ring immediately and contact your doctor. In the meantime, use a non-hormonal contraceptive.
Do not use NuvaRing if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir / ritonavir and dasabuvir or glekaprevir / pibrentasvir (see also section 2.4 “Other medicines and NuvaRing”).
Warnings and Precautions
| When should you contact a doctor? Seek medical attention immediately if you notice any signs of a blood clot that may mean you have a blood clot in your leg (so-called deep vein thrombosis ), a blood clot in your lung (so-called pulmonary embolism ), a heart attack or stroke (see section “BLOOD CLOTHS” below). For a description of the symptoms of these serious side effects, see the section “HOW TO FEEL A BLOOD CLOTH AGAIN”. |
Tell your doctor/midwife if any of the following conditions apply to you.
If the condition occurs or worsens when you use NuvaRing, you should also contact your doctor/midwife.
- if a close relative has or has ever had breast cancer.
- if you have epilepsy (see section 2.4 “Other medicines and NuvaRing”).
- if you have liver disease (eg jaundice) or gallbladder disease (eg gallstones ).
- if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease).
- if you have systemic lupus erythematosus ( SLE – a disease that affects your natural immune system).
- if you have hemolytic uremic syndrome (HUS – a disease that affects the blood’s ability to coagulate and leads to kidney failure ).
- if you have sickle cell anemia (a hereditary disease that affects the red blood cells ).
- if you have elevated levels of blood fats ( hypertriglyceridemia ) or heredity for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis ( inflammation of the pancreas).
- if you need to have an operation or if you stay in bed for a long time (see section “BLOOD CLOTS”).
- if you have just given birth, you are at increased risk of blood clots. Ask your doctor how soon after giving birth you can start using NuvaRing.
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis ).
- if you have varicose veins.
- if you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones (eg hearing loss, porphyria (a blood disease), herpes gestationis (skin redness with fluid blisters during pregnancy), Sydenhams korea (a nerve disease where sudden movements of the body occur ), hereditary angioedema (you should contact your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and / or throat and / or difficulty swallowing or rash along with difficulty breathing)).
- if you have (or have ever had) chloasma (yellow-brown pigment spots, so-called pregnancy spots, especially on the face); if so, avoid excessive sunlight or ultraviolet rays.
- if you have a medical condition that makes it difficult to use NuvaRing – for example if you have constipation, uterine prolapse or pain during intercourse.
- if you have an urgent, frequent, burning and / or painful urination and can not locate the ring in the vagina. These symptoms may indicate accidental placement of NuvaRing in the bladder.
BLOOD CLOTS
If you use combined hormonal contraceptives such as NuvaRing, the risk of blood clots increases compared to if you do not use these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- in veins (so-called venous thrombosis , venous thromboembolism or VTE)
- in arteries (so-called arterial thrombosis , arterial thromboembolism or ATE).
Recovery from blood clots is not always complete. In rare cases, they can cause serious lasting effects and, in very rare cases, be fatal.
It is important to remember that the overall risk of damaging a blood clot due to NuvaRing is small.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms.
| Do you experience any of these signs? | What can you possibly suffer from? |
|---|---|
| swelling of a leg or along a blood vessel in the leg or foot, especially if you also get: pain or tenderness in the leg that is only felt when you stand or walk increased heat in the affected leg color change of the skin on the leg eg pale, red or blue. | Deep vein thrombosis |
| sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathing severe instability or dizziness fast or irregular heartbeat severe pain in the abdomen. If you are unsure, consult a doctor as some of these symptoms such as cough and shortness of breath can be misinterpreted as a milder condition such as a respiratory infection (such as a common cold). | Pulmonary embolism |
| Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can develop into vision loss. | Retinal venous thrombosis(blood clot in the eye) |
| chest pain, discomfort, pressure, heaviness feeling of pressure or fullness in the chest, arm or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breath fast or irregular heartbeat. | Myocardial infarction |
| sudden weakness or numbness in the face, arms or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding suddenly difficult to see with one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination sudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures. Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke. | Stroke |
| swelling and slight blue discoloration of an arm or leg severe abdominal pain ( acute abdomen). | Blood clots that block other blood vessels |
BLOOD CLOTS IN A FRIEND
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 in a vein (venous thrombosis ). However, these side effects are rare. They usually 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 can cause deep vein thrombosis (DVT).
- If a blood clot travels from the bone and gets stuck in the lung, it can cause a pulmonary embolism .
- In very rare cases, a blood clot can form in a vein in another organ, such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk may also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you do not use a combined hormonal contraceptive.
When you stop using NuvaRing, the risk of a blood clot returns to normal within a few weeks.
How big 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 total risk of a blood clot in the leg or lung with NuvaRing is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot in a year.
- Of 10,000 women who use a combined hormonal contraceptive that contains norelgestromin or etonogestrel such as NuvaRing, about 6-12 develop a blood clot in a year.
- The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
| Risk of developing a blood clot during a year | |
|---|---|
| Women who do not use a combined hormonal pill/patch / ring and who are not pregnant | About 2 out of 10,000 women |
| Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate | About 5-7 out of 10,000 women |
| Women using NuvaRing | About 6-12 out of 10,000 women |
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot with NuvaRing is small, but certain conditions increase the risk. The risk is higher:
- if you are very overweight (body mass index or BMI over 30 kg / m 2 )
- if a close relative has had a blood clot in the leg, lung or other organs at a young age (eg younger than about 50 years). In that case, you may have a hereditary blood clotting disease.
- if you need to have surgery or stay in bed for a long time due to an injury or illness, or if you have a plastered leg. The use of NuvaRing may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using NuvaRing, ask your doctor when you can start using it again.
- with increasing age (especially if you are over about 35 years old)
- if you gave birth a few weeks ago.
The more conditions you have, the greater the risk of developing a blood clot.
Air travel (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other listed factors.
You must tell your doctor if you have any of these conditions, even if you are unsure. Your doctor may decide that you must stop using NuvaRing.
If any of the above conditions change while you are using NuvaRing, such as close relative suffering from a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a blood clot in an artery can lead to serious problems. It can, for example, cause a heart attack or stroke.
Factors that may increase the risk of a blood clot in an artery
It is important to know that the risk of a heart attack or stroke due to the use of NuvaRing is very small but may increase:
- with increasing age (after about 35 years of age)
- if you smoke. If you use a combined hormonal contraceptive such as NuvaRing, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another 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 (younger than about 50 years). In that case, you may also be at greater risk for a heart attack or stroke .
- if you or a close relative have high blood fats ( cholesterol or triglycerides )
- if you get migraines , especially migraines with aura
- if you have heart problems (flap, heart rhythm disorder called atrial fibrillation )
- if you have diabetes .
If you have more than one of these conditions or if any of them are particularly serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change while you are using NuvaRing, such as if you start smoking, a close relative suffers from a blood clot for no known reason, or if you gain a lot of weight, talk to your doctor.
Cancer
The information below is taken from studies with combined oral contraceptives and it may also apply to NuvaRing. Information on vaginally administered hormonal contraceptives (such as NuvaRing) is lacking.
Breast cancer has been detected slightly more often in women using combined contraceptive pills, but it is not known if this is due to the treatment. It may, for example, be that tumors are detected more often in women who use combined contraceptive pills, as they go for more check-ups with a doctor. The increased risk of breast cancer gradually decreases when you stop taking combined birth control pills. It is important that you check your breasts regularly and that you contact your doctor/midwife if you feel any lumps. You should also tell your doctor/midwife if a close relative has or has previously had breast cancer (see section 2.2 “Warnings and precautions”).
In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in women using birth control pills. Contact your doctor/midwife if you experience unusual severe abdominal pain.
In women using combined contraceptive pills, it has been reported that cancer of the endometrium (uterine lining) and cancer of the ovaries are less common. This may also apply to NuvaRing, but it has not been confirmed.
Mental disorders
Some women who use hormonal contraceptives, including NuvaRing, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
2.3 Children and young people
The safety and efficacy of NuvaRing in adolescents below 18 years have not been studied.
2.4 Other medicines and NuvaRing
Always tell your doctor/midwife which medicines or (traditional) herbal medicines you are already using. Also, tell other doctors and dentists who prescribe medicines and the relevant pharmacy staff that you are using NuvaRing. They can tell you if you need to use supplemental protection (eg male condoms) and if so for how long or if the use of any other medicine you need needs to be changed.
Some medicines
- may have an effect on the blood levels of NuvaRing
- may make it less effective in preventing pregnancy
- may cause unexpected bleeding.
This applies to medicines used to treat:
- epilepsy (eg primidone, phenytoin , barbiturate , carbamazepine, oxcarbazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin)
- HIV infection (eg ritonavir, nelfinavir , nevirapine, efavirenz)
- hepatitis C virus infections (eg boceprevir, telaprevir)
- other infectious diseases (eg griseofulvin)
- high blood pressure in the blood vessels of the lungs ( bosentan )
- depression ((traditional) herbal medicines containing St. John’s wort ).
If you are using medicines or (traditional) herbal medicines that may make NuvaRing less effective, a barrier method should also be used (eg male condoms). As the effect of another drug on NuvaRing may persist for up to 28 days after stopping treatment with the drug, it is necessary to use a barrier method throughout this time. Note: Do not use NuvaRing with pessaries or female condoms.
NuvaRing may affect the effectiveness of other medicines, e.g.
- medicines containing ciclosporin
- the epilepsy drug lamotrigine (this may lead to an increased seizure frequency)
Do not use NuvaRing if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir / ritonavir and dasabuvir or glekaprevir / pibrentasvir as it may lead to elevated liver function levels in the blood (an increase in the liver enzyme ALT ).
Your doctor/midwife will prescribe another type of contraceptive before you start treatment with these medicines.
NuvaRing can be used approximately 2 weeks after the end of this treatment. See section 2.1 “When not to use NuvaRing”.
Ask your doctor or pharmacist for advice before taking any medicine.
You can use tampons while using NuvaRing. Insert NuvaRing before inserting the tampon. Be careful when removing the tampon, so that NuvaRing does not accidentally come out. Should this occur, wash the ring in cool or lukewarm water and insert it again immediately.
It has happened that the ring has ruptured when using vaginal products as a lubricant or when treating an infection (see section 3.4 “What to do if… Your ring breaks”). Concomitant use with spermicides or antifungals given in the vagina does not affect the effect of NuvaRing.
Laboratory tests
If you take blood or urine samples, tell your healthcare provider that you are using NuvaRing as it may affect the results of some tests.
2.5 Pregnancy and lactation
NuvaRing should not be used by women who are pregnant or think they may be pregnant.
Should you become pregnant while using NuvaRing, remove the ring and contact your doctor/midwife.
If you want to stop using NuvaRing before you become pregnant, see the section “If you stop using NuvaRing”.
The use of NuvaRing is generally not recommended during breastfeeding. If you want to use NuvaRing while breastfeeding, contact your doctor/midwife for advice.
2.6 Driving and using machines
There is no reason to believe that NuvaRing would affect your ability to drive.
How to use NuvaRing
You can insert and remove NuvaRing yourself. Your doctor/midwife will tell you when to start using NuvaRing for the first time. Vaginal ring one must be inserted on the correct day in your menstrual cycle (see section 3.3: “Inserting the first ring”) and should remain in place for 3 consecutive weeks. Check regularly that NuvaRing remains in the vagina (eg before and after intercourse) to ensure that you are protected against pregnancy. After the third week, you take out NuvaRing and have a one-week break. Usually, you will get your period during the ring-free interval.
While using NuvaRing, do not use certain female barrier methods, such as pessaries or female condoms. These preventive barrier methods should not be used as complementary barrier methods as NuvaRing may affect the correct placement and position of the diaphragm or female condom. However, you can use a male condom as an extra barrier method.
3.1 How to insert and remove NuvaRing
- Check that the expiration date has not passed (see section 5 “How to store the NuvaRing”) before inserting the ring.
- Wash your hands before inserting or removing the ring.
- You can choose the position that feels most comfortable for you, such as standing with one leg lifted, squatting or lying down.
- Take NuvaRing out of the sachet.
- Hold the ring between your thumb and forefinger, press the sides together and insert the ring into the vagina (see picture 1-4). Alternatively, you can choose to use the NuvaRing Applicator (not included with the NuvaRing) which can be helpful when inserting the ring. NuvaRing Applicator may not be available in all countries. When NuvaRing is in place, you should not feel anything. If it feels uncomfortable, gently change the position of the NuvaRing, (eg by gently pushing the ring further into the vagina) until it feels comfortable. The exact position of the ring in the vagina does not matter.
- NuvaRing should be removed after 3 weeks. You can do this by hooking your index finger to the bottom edge of the ring or by grasping the edge and pulling it out (see picture 5). If you feel NuvaRing in your vagina but cannot remove it yourself, contact your doctor / midwife.
- Discard the used ring together with your other household waste, preferably in the resealable bag. Do not flush NuvaRing down the toilet.
Picture 5
NuvaRing can be removed by hooking the index finger to the lower edge of the ring or by grasping the edge with the index and middle fingers and pulling it out.
3.2 Three weeks inserted, one week removed
- From the day when the vaginal ring is inserted, it must be in place without interruption for 3 whole weeks.
- After 3 weeks, the vaginal ring is removed on the same day of the week and at approximately the same time as it was inserted. For example, if you have deposited NuvaRing on a Wednesday around 10 pm, you must remove the ring 3 weeks later on Wednesday around 10 pm.
- After removing the ring, do not use the ring for 1 week. During this week, you should have a genital bleeding. It usually starts 2-3 days after NuvaRing is removed.
- Insert a new ring exactly after one week (again on the same day of the week and at about the same time), even if the bleeding has not stopped.
- If the ring is inserted more than 3 hours late, the contraceptive effect may be reduced. Follow the instructions in section “3.4 What to do if … You forgot to insert a new ring after the ring-free interval”
If you follow the advice given above, your vaginal bleeding will come every month at about the same time.
3.3 Inserting the first ring
- You have not used any hormonal contraceptives in the last month
Insert your first NuvaRing on the first day of your natural menstrual cycle (ie on your first day of bleeding). NuvaRing works immediately. You do not need to use any other preventive protection.
It is also possible to start with NuvaRing day 2 to day 5 of the menstrual cycle, but then during the first cycle you must use extra protection, such as a male condom, if you have intercourse during the first 7 days with NuvaRing. You only need to follow these instructions the first time you use NuvaRing. - You have used a combined oral contraceptive pill during the last month
Start with NuvaRing no later than the day after the tablet-free period of your current oral contraceptive pill . If your pill also contains hormone-free tablets, start taking NuvaRing no later than the day after the last hormone-free tablet. If you are not sure which tablet it is, ask your doctor / midwife or pharmacist. Never allow the hormone-free period for your current birth control pills to be longer than the recommended time. If you have used your birth control pills correctly and without interruption and if you are sure that you are not pregnant, you can stop taking the tablets at any time and start using NuvaRing immediately. - You have used a contraceptive patch during the last month
Start using NuvaRing no later than the day after the patch-free period. Never allow the patch-free period to last longer than the recommended time.If you have used the hormone patch correctly and without interruption and if you are sure that you are not pregnant, you can stop using the hormone patch at any time and start using NuvaRing immediately. - You have used a mini-pill (containing only progestogens ) in the last month
You can stop taking your mini -pill any day and start taking NuvaRing the next day, at the same time as you would normally take your pill . Be sure to use extra protection (eg male condom) for the first 7 days with NuvaRing. - You have been using an injection or implant or an IUD for the past month
Start using NuvaRing when you should have your next injection or the day your implant or hormone-releasing IUD is removed. Be sure to use extra protection (eg male condom) for the first 7 days with NuvaRing. - After you have given birth
If you have just given birth, your doctor / midwife may tell you to wait for your first spontaneous period before starting NuvaRing. Sometimes it is possible to start earlier. Your doctor / midwife will give you advice. If you are breast-feeding and want to use NuvaRing, you should first discuss this with your doctor / midwife. - After a miscarriage or abortion
Your doctor / midwife will give you advice.
3.4 What to do about…
Your ring has been accidentally pushed out of the vagina
NuvaRing can be accidentally pushed out of the vagina – for example, if it has not been inserted correctly, when you take out a tampon, during intercourse, during constipation or if you have a prolapse. It is therefore important that you regularly check that the ring is in place in the vagina (eg before and after intercourse).
Your ring has been temporarily out of the vagina
NuvaRing can still protect you against pregnancy, but it depends on how long it has been out of the vagina.
If the ring has been out of the vagina:
- less than 3 hours you are still protected against pregnancy. Rinse the ring with cold to lukewarm water (do not use hot water) and replace the ring as soon as possible but only if the ring has been out of the vagina for less than 3 hours.
- more than 3 hours during the 1st or 2nd week of use, the protection against pregnancy may have been affected. Rinse the ring with cold to lukewarm water (do not use hot water) and replace the ring as soon as you remember and leave the ring in place without a socket for at least 7 days. Use a male condom if you have intercourse for the next 7 days. If it occurs during the first week of use and you have had intercourse during the last 7 days, there is a risk that you are pregnant. In this case, contact your doctor / midwife.
- more than 3 hours during the 3rd week , the protection against pregnancy may have been affected. Discard the ring and then select one of the following options:
- Insert a new ring immediately.
By inserting a new ring, the next 3-week period begins. It is possible that you do not get a period, however, breakthrough bleeding or splashing may occur. - Do not insert a new ring. Wait for your period and then insert a new ring no later than 7 days after the previous ring was removed or pushed out.
You should only select this option if you have used the ring continuously for the previous 7 days.
- Insert a new ring immediately.
- for an unknown period of time you may not be protected against pregnancy. Take a pregnancy test and talk to your doctor / midwife before inserting a new ring.
Your ring breaks
In very rare cases, NuvaRing can break. Vaginal injuries have been reported in connection with the ring breaking. If you find that your ring has broken, remove the ring and insert a new ring as soon as possible. Use extra protection, such as a male condom, for the next 7 days. Contact your doctor/midwife if you had intercourse before you discovered that the ring had broken.
You have inserted more than one ring
There are no reports of serious adverse effects after overdose with the hormones included in NuvaRing. If you have accidentally inserted more than one ring, you may feel nauseous, vomit or have genital bleeding.
Remove the extra ring and contact your doctor, hospital, or the Poison Information Center (tel. 112) if symptoms persist.
You forgot to insert a new ring after the ring-free interval
If your ring-free interval was longer than 7 days, insert a new ring as soon as you remember. Use extra protection (eg male condom) if you have intercourse for the next 7 days. If you have had intercourse during the ring-free interval, there is a risk that you have become pregnant. If this is the case, contact your doctor/midwife immediately. The longer the ring-free interval lasts, the greater the risk that you will become pregnant.
You forgot to take out the ring
- If your ring has been inserted between 3 and 4 weeks , it still protects against pregnancy. Start with your ring-free interval for a week and then insert a new ring.
- If your ring has been inserted for more than 4 weeks , there is a risk that you have become pregnant. Contact your doctor / midwife before inserting a new ring.
Your period has not been missed
- You have used NuvaRing according to the instructions.
If you have not had your period but you have used NuvaRing according to the instructions and if you have not used other medicines, it is very unlikely that you are pregnant. Continue with NuvaRing as usual. However, if you miss your period twice in a row, you may be pregnant. Contact your doctor / midwife immediately. Do not start the next NuvaRing until your doctor / midwife has checked that you are not pregnant. - If you have deviated from the instructions for NuvaRing. If you have not had your period and you have deviated from the instructions for NuvaRing and you do not get your expected loss of bleeding during the ring-free period, you may be pregnant. Contact your doctor / midwife before inserting a new NuvaRing.
You get an unexpected bleeding
While using NuvaRing, some women may experience unexpected abdominal bleeding between menstrual periods. You may need to use menstrual pads. You should always leave the ring in the vagina and continue to use the ring as usual. If the irregular bleeding continues, becomes heavier, or recurs, contact a doctor/midwife.
You want to change the first day of your period
If you use NuvaRing according to the instructions, you will have your period (dropout bleeding) during the ring-free interval. If you want to change the day it starts, you can shorten (but never extend!) The ring-free interval.
For example, if your period usually starts on a Friday, you can change it to a Tuesday (3 days earlier) from next month onwards. Only insert your next ring 3 days earlier than usual. If you make the ring-free interval very short (eg 3 days or less) you may not get your usual bleeding. You may have spotting (drops or blood stains) or breakthrough bleeding while using the next ring.
If you have any further questions on the use of this product, ask your doctor/midwife for advice.
You want to postpone your period
Even if it is not the recommended regimen, it is possible to postpone the period (dropout bleeding) by inserting a new ring directly after the current one, ie without a ring-free interval between the rings. You can leave the second ring for up to 3 weeks. While using the new ring, you may experience spotting (drops or stains of blood) or breakthrough bleeding. When you want your period to come, just take out the ring. Have your regular ring-free interval of one week and then insert a new ring.
You can ask your doctor/midwife for advice before you decide to postpone your period.
3.5 If you stop using NuvaRing
You can stop using NuvaRing whenever you want. If you do not want to get pregnant, contact your doctor/midwife regarding other contraceptives. If you stop taking NuvaRing because you want to get pregnant, it is generally recommended that you wait until you have had a natural period. This will help you calculate the time of delivery.
Possible side effects
Like all medicines, NuvaRing can cause side effects, although not everybody gets them.
If you get any side effects, especially if they are serious or persistent, or if your health changes and you think it may be due to NuvaRing, talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries ( arterial thromboembolism (ATE)) is present in all women who use combined hormonal contraceptives. For more detailed information on the different risks of using combined hormonal contraceptives, see section 2, “What you need to know before using NuvaRing”.
If you are allergic to any of the ingredients of NuvaRing (hypersensitivity) you may experience the following symptoms (no known frequency): swollen face, lips, tongue, and/or throat and/or difficulty swallowing or rash along with difficulty breathing ( angioedema and/or anaphylaxis ). If you experience this, remove NuvaRing and contact your doctor immediately.
The following side effects have been reported by NuvaRing users.
Common: may affect up to 1 in 10 women
- abdominal pain, nausea
- vaginal fungal infection (such as “cod”), ring-related vaginal discomfort, abdominal itching, vaginal discharge
- headache or migraine , depression, decreased sex drive
- sore breasts, pelvic pain, painful menstruation
- acne
- weight gain
- ring ejection.
Uncommon: may affect up to 1 in 100 women
- visual disturbance, dizziness
- swollen abdomen, vomiting, diarrhea or constipation
- fatigue, discomfort or irritation, mood swings, mood swings
- fluid retention in the body ( edema )
- Cystitis (urinary tract infection)
- difficulty or pain in emptying the bladder, strong desire and need to empty the bladder, frequent urges
- problems during intercourse such as pain, bleeding or that the partner feels the ring
- high blood pressure
- increased appetite
- back pain, muscle cramps, pain in legs and arms
- decreased skin sensitivity
- tender or enlarged breasts, fibrocystic breast disease (cysts in the breasts that may swell or become painful)
- inflammation of the cervix, cervical polyp (growth in the cervix), outgrowth on the border of the cervix (ectopy)
- changes in the bleeding pattern (eg the bleeding may be heavier, longer, irregular or completely absent), pelvic discomfort, premenstrual tension syndrome (PMS), spasm in the uterus
- vaginal infection (fungal and bacterial), burning sensation, foul-smelling, pain, discomfort or dryness in the vagina or vulva
- hair loss, eczema , itching , rash or hot flashes
- hives.
Rare: may affect up to 1 in 1,000 women
- harmful blood clots in a vein or artery , such as:
- in one leg or foot (so-called DVT)
- in a lung (so-called PE)
- myocardial infarction
- stroke
- mini – stroke or transient stroke-like symptoms called transient ischemic attack ( TIA )
- blood clots in the liver, stomach / intestine, kidneys or eyes
The risk of developing 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 the risk of blood clots and symptoms of a blood clot .)
- secretion from the breasts
Has been reported: occurs an unknown number of users
- chloasma (yellow-brown spots on the skin, especially on the face)
- problems with the penis of the partner (such as irritation, rash, itching ).
- inability to remove the ring without medical help (eg due to it sticking to the vaginal wall)
- vaginal injury in connection with the rupture of the ring.
Breast cancer and liver tumors have been reported in users of combined hormonal contraceptives. For more information, see section 2.2 Warnings and Precautions, Cancer.
In very rare cases, NuvaRing may rupture. For more information, see section 3.4 What to do about… Your ring is missing.
How to store NuvaRing
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C. Store in the original package. Sensitive to light. Moisture sensitive.
You should not deposit NuvaRing if it was sent to you more than 4 months ago. The date of delivery is indicated 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 any color change on the ring or signs of poor quality.
Discard used rings as follows:
Dispose of the used ring with your other household waste, preferably in the resealable sachet. Do not flush NuvaRing down the toilet.
As with other medicines, do not throw away unused rings or rings that have passed the expiration date in the drain or among the household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are: etonogestrel (11.7 mg) and ethinyl estradiol (2.7 mg).
- The other ingredients are: ethylene vinyl acetate copolymer ( 28% and 9% vinyl acetate, respectively) (a type of plastic that cannot be dissolved in the body) and magnesium stearate.
Etonogestrel and Ethinyl estradiol are released from the ring in an amount corresponding to 0.120 mg/day and 0.015 mg/day each for 3 weeks.
What the medicine looks like and contents of the pack
NuvaRing is a soft, transparent, colorless to almost colorless ring, 54 mm wide.
Each ring is packaged in a resealable foil sachet bag. The sachet is packed in a cardboard box together with this leaflet. Each pack contains 1 or 3 rings.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
This medicinal product is authorized under the European Economic Area under the name:
NuvaRing 0.120 mg / 0.015 mg per 24 hours, vaginal insert
Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland), Sweden, Czech Republic, Germany, Hungary, Austria.