Label: information for the user
NuvaRing 0.120 mg/0.015 mg every 24 hours, vaginal delivery system
etonogestrel/ethinyl estradiol
Important things you should know about combined hormonal contraceptives (CHCs):
Read this label carefully before starting to use NuvaRing, because it contains important information for you.
1.What is NuvaRing and how it is used
2.What you need to know before starting to use NuvaRing
3.How to use NuvaRing
4.Possible adverse effects
5.Storage of NuvaRing and the NuvaRing Applicator
6.Contents of the package and additional information
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. Given the small amount of hormones released, NuvaRing is a low-dose hormonal contraceptive. As NuvaRing releases two different types of hormones, it is a combined hormonal contraceptive.
NuvaRing acts like the combined oral contraceptive pill (the “Pill”), but instead of taking a pill every day, the ring is used for 3 consecutive weeks. NuvaRing releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, you cannot become pregnant.
Before starting to use NuvaRing, read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).
This leaflet describes various situations in which you should stop using NuvaRing, or in which NuvaRing may be less reliable. In these situations, you should not have sexual intercourse, or you should take additional non-hormonal contraceptive measures, such as a male condom.Do not use the rhythm or basal body temperature method. These methods may not be reliable because NuvaRing alters the monthly body temperature changes and cervical mucus.Do not use NuvaRing with the rhythm or basal body temperature method.
NuvaRing, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
2.1 When not to use NuvaRing
You should not use NuvaRing if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.
− Severe diabetes with vascular damage.
If any of these circumstances occur for the first time while using NuvaRing, remove the ring immediately and consult your doctor. Meanwhile, use non-hormonal contraceptive measures.
Do not use NuvaRing if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4 “Other Medications and NuvaRing”).
2.2 Warnings and Precautions
When to consult your doctor? Seek urgent medical attention
For a description of the symptoms of these serious adverse effects, see “How to Recognize a Blood Clot”. |
Inform your doctor if you suffer from any of the following conditions.
Inform your doctor if the condition develops or worsens while you are using NuvaRing.
BLOOD CLOTS
The use of a combined hormonal contraceptive like NuvaRing increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can form:
The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.
It is essential to remember that the overall risk of a blood clot that can cause harm due to NuvaRing is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek urgent medical attentionif you notice any of the following signs or symptoms.
Do you experience any of these signs? | What could you be suffering from? |
| Deep vein thrombosis |
If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a less severe condition like a common cold. | Pulmonary embolism |
Symptoms that occur more frequently in one eye:
| Retinal vein thrombosis (blood clot in the eye). |
| Heart attack |
Sometimes, the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention because you may be at risk of another stroke. | Stroke |
| Blood clots that block other blood vessels. |
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
When is the risk of a blood clot in a vein higher?
The risk of a blood clot in a vein is higher during the first year you use a combined hormonal contraceptive for the first time. The risk may be higher if you restart using a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.
After the first year, the risk decreases, but it 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 in a few weeks.
What is the risk of 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 a blood clot in your leg or lung (DVT or PE) with NuvaRing is small.
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot is higher:
The risk of a blood clot increases the more conditions you have.
Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.
It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using NuvaRing.
If any of the conditions listed above change while you are using NuvaRing, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform 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 blood 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 essential to note that the risk of a heart attack or stroke due to NuvaRing is very small, but it may increase:
If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.
If any of the conditions listed above change while you are using NuvaRing, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.
CANCER
The following information has been obtained from studies with combined oral contraceptives and may be applicable to NuvaRing. There is no information available on the vaginal administration of hormone contraceptives (such as NuvaRing).
Cases of breast cancer have been observed with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to treatment. For example, it may be that more tumors are found in women using oral contraceptives because they attend medical check-ups more frequently. This increased frequency decreases gradually after stopping treatment.
It is essential to examine your breasts regularly and inform your doctor if you notice any lump. Inform your doctor if any of your close relatives have had or have breast cancer (see section 2.2 “Warnings and Precautions”).
Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using oral contraceptives. Contact your doctor if you have severe and unusual abdominal pain.
Combined oral contraceptives have been associated with a lower incidence of endometrial cancer (the lining of the uterus) or ovarian cancer. This may also be the case with NuvaRing, but it has not been confirmed.
PSYCHIATRIC DISORDERS
Some women who use hormonal contraceptives like NuvaRing have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.
The safety and efficacy of NuvaRing have not been established in adolescents under 18 years old.
Always inform your doctor about any medications or herbal remedies you are taking. Also, inform any doctor, dentist, or pharmacist (or pharmacist) who prescribes another medication that you are using NuvaRing. They can inform you if you need to take additional contraceptive measures (for example, use a male condom) and, if necessary, for how long, or if you need to modify the use of the other medication.
Some medications
These include medications used to treat:
If you are taking medications or herbal remedies that may make NuvaRing less effective, you should also use a barrier contraceptive method (for example, a male condom). Since the effect of another medication on NuvaRing may last for up to 28 days after stopping the medication, you will need to use an additional barrier contraceptive method during that time. Note: Do not use NuvaRing with a diaphragm, cervical cap, or female condom.
NuvaRing mayinfluence the effectof other medications, for example:
-medications containing ciclosporin
-the antiepileptic lamotrigine (this could lead to an increase in seizure frequency).
Do not useNuvaRingif you have Hepatitis C and are taking medications that contain
ombitasvir/paritaprevir/ritonavir and dasabuviror glecaprevir/pibrentasvir, increased liver enzyme levels (ALT) may occur.
Your doctor will prescribe another type of contraceptive before starting treatment with these
medications.
NuvaRing can be used again approximately 2 weeks after the end of this treatment. See section2.1“When not to use NuvaRing”.
Consult your doctor or pharmacist before taking any medication.
You can use tampons while using NuvaRing. First, insert NuvaRing, and then the tampon. Be especially careful when removing the tampon to avoid accidentally expelling the ring. If the ring is expelled, simply wash it with cold or lukewarm water and reinsert it immediately.
The ringcan be openedwhenyou are alsousing a vaginal product such as a lubricant or a treatment for an infection (see section 3.4“What to do if… The ring is open”).The use of spermicides or vaginal antifungal products does not reduce the effectiveness of NuvaRing as a contraceptive.
Laboratory Tests
If you have blood or urine tests, inform your doctor that you are using NuvaRing, as it may affect the results of some tests.
Women who are pregnant or suspect they may be pregnant should not use NuvaRing. If you become pregnant while using NuvaRing, remove the ring and consult your doctor.
If you want to stop using NuvaRing because you want to become pregnant, see section 3.5 “Stopping NuvaRing”.
Generally, it is not recommended to use NuvaRing while breastfeeding. If you want to use NuvaRing while breastfeeding, consult your doctor.
NuvaRing is unlikely to affect your ability to drive or operate machinery.
You can put and take NuvaRing yourself. Your doctor will tell you when to start using it for the first time. The vaginal ring must be inserted on the correct day of your menstrual cycle (see section 3.3 “When to start with the first ring”) and remain in the vagina for 3 consecutive weeks. Check regularly that NuvaRing is in your vagina (for example, before and after sexual intercourse) to ensure that you are protected against pregnancy. After the third week, remove NuvaRing and leave a week of rest. You will usually have your menstrual period or bleeding during this pause without a ring.
While using NuvaRing, you should not use some barrier female contraceptives, such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptives should not be used as a backup method of birth control since NuvaRing may interfere with the correct placement and position of the diaphragm, cervical cap, or female condom. However, you can use a male condom as an additional barrier contraceptive method.
3.1 How to put on and take off NuvaRing
Insertion of NuvaRing only with your fingers:
Figure 1 Remove NuvaRing from its package Figure 2 Press the ring | Figure 3 Choose a comfortable position to put on the ring |
Figure 4AFigure 4BFigure 4C
Put the ring in the vagina with one hand (Figure 4A), if necessary, separate the vaginal lips with the other. Push the ring into the vagina until you feel comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).
Figure 5 NuvaRing can be removed by hooking the ring with your index finger or holding it with your index and middle fingers and pulling it out. |
Important information about the NuvaRing Applicator:
Insertion of NuvaRing with the applicator:
1: Preparation
Wash your hands before opening the package. Always open immediately before use. DO NOT use if the contents or package are visibly damaged. |
The applicator is designed to be used ONLY with the NuvaRing ring, not with other products. |
Examine the applicator image to familiarize yourself with its parts. A. Plunger E. NuvaRing ring |
2: Loading and placement
Pull the plunger back gently until it stops. |
Press the opposite sides of the ring and insert the ring into the tube opening of the applicator. |
Push the ring gently into the tube. The ring end should protrude slightly from the tube opening of the applicator. |
Choose a comfortable position to insert the ring, for example, lying down, squatting, or standing with one leg raised. |
3: Insertion and removal
Place your thumb and index finger on the holding area. |
Insert the applicator tube gently into the vagina until your fingers (the holding area of the applicator) come into contact with your body. Some women have reported a brief sensation of mild pinching when using the applicator. |
The ring is pushed out of the applicator. Remove the applicator gently. |
Make sure the ring is no longer inside the applicator. Dispose of the used applicator in the trash. DO NOT flush the applicator down the toilet. DO NOT reuse the applicator. |
3.2 Three weeks in, one week out
If you use NuvaRing as described above, your bleeding will occur approximately on the same days each month.
3.3 When to start with the first ring
Put on NuvaRing on the first day of your natural cycle (i.e., the first day of your menstruation). NuvaRing starts working immediately. You do not need to take any other contraceptive measures.
You can also start with NuvaRing between days 2 and 5 of your cycle, 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 should only follow this recommendation when using NuvaRing for the first time.
Start using NuvaRing as late as the day after your current pill pause. If your pill package also contains inactive pills, start NuvaRing as late as the day after the last inactive pill. If you are unsure which pill is which, consult your doctor or pharmacist. Do not extend your pill pause beyond what is recommended.
If you have taken your current pill correctly and continuously and are sure you are not pregnant, you can stop taking the pill on any day of your cycle and start with NuvaRing immediately.
Start using NuvaRing as late as the day after your patch-free pause. Do not extend your patch-free pause beyond what is recommended.
If you have used the patch correctly and continuously and are sure you are not pregnant, you can stop using the patch on any day and start with NuvaRing immediately.
You can stop taking your progestin-only pill on any day and start NuvaRing the next day at the same time. However, make sure to use an additional contraceptive method (such as a male condom) during the first 7 days of using the ring.
Start using NuvaRing at the time you should receive your next injection or the day your implant or IUS is removed. However, make sure to use an additional contraceptive method (such as a male condom) during the first 7 days of using the ring.
If you have just given birth, your doctor may advise you to wait until your first normal menstrual period before starting with NuvaRing. Sometimes, it is possible to start earlier; your doctor will advise you on how to do it. If you are breastfeeding and want to use NuvaRing, consult your doctor first.
Consult your doctor.
3.4 What to do if...
Your ring is expelled accidentally from the vagina
NuvaRing can be expelled accidentally from the vagina, for example, if it was not inserted correctly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse (uterine descent). Therefore, you should check regularly if the ring is in your vagina (for example, before and after sexual intercourse).
Your ring has been out of the vagina temporarily
NuvaRing may still protect you from pregnancy, but this will depend on how long it has been out of your vagina.
If the ring has been out of the vagina for:
When you put on a new ring, you will start a new 3-week cycle of use. You may not experience your period. However, you may experience spotting (bloody discharge) or irregular bleeding during that cycle.
Choose this option only if you have used NuvaRing consecutively for the previous 7 days.
Your ring has opened
In rare cases, the NuvaRing ring may open. Vaginal injury associated with ring rupture has been reported. If you notice that NuvaRing has opened, remove the ring and put on a new one as soon as possible. Take additional contraceptive precautions (such as a male condom) for the next 7 days. If you had sexual intercourse before noticing that the ring had opened, consult your doctor.
You have put on more than one ring
No serious injuries have been reported due to NuvaRing overdose. If you accidentally put on more than one ring, you may feel unwell (nausea), vomit, or experience vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not subside. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.
If you forget to put on a new ring after the pause without a ring
Yourpause without a ringhas lastedmore than 7 days. Put a new ring in the vagina as soon as you remember. Take additional contraceptive precautions (such as a male condom) if you have sexual intercourse during the next 7 days.If you have had sexual intercourse during this pause without a ring, there is a possibility that you may be pregnant. In that case, inform your doctor immediately. The longer the pause without a ring, the higher the risk of pregnancy.
If you have forgotten to remove the ring
If you do not experience your period or menstrual bleeding
If you do not experience your period, but have used NuvaRing as instructed and have not taken any other medications, it is highly unlikely that you are pregnant. Continue using NuvaRing as usual. However, if you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not put on the next NuvaRing until your doctor has confirmed that you are not pregnant.
If you do not experience your menstrual bleeding during the pause without a ring and have deviated from the recommended regimen, there is a possibility that you may be pregnant, so contact your doctor before putting on a new ring.
If you experience unexpected vaginal bleeding
During the use of NuvaRing, some women may experience unexpected vaginal bleeding between their menstrual periods. You may need sanitary protection. However, continue using the ring as usual, do not remove it. If the bleeding continues, becomes heavier, or starts again, consult your doctor.
If you want to change the day when your period or menstrual bleeding starts
If you use NuvaRing as instructed, your menstrual period (withdrawal bleeding) will start during the pause without a ring. If you want to change the day when your period starts, you must shorten (never extend!) the pause without a ring.
For example, if your period usually starts on a Friday, you can change it to a Tuesday, i.e., 3 days earlier from the next month. Simply put on the next ring 3 days earlier than usual.
If the pause is made very short (e.g., 3 days or less), you may not experience your usual menstrual bleeding. You may experience spotting (bloody discharge) or irregular bleeding during the use of the next ring.
If you are unsure how to do it, consult your doctor.
If you want to delay your period or menstrual bleeding
Although this is not the recommended regimen, you can delay your menstrual bleeding by putting on a new ring immediately after removing the current ring, without leaving the pause between rings. You can leave the new ring in for a maximum of 3 weeks. During the use of the new ring, you may experience spotting (bloody discharge) or irregular bleeding. When you want your period to start, simply remove the ring. Leave the usual pause without a ring and put on a new ring.
You can consult your doctor before deciding to delay your menstrual bleeding.
3.5 If you want to stop using NuvaRing
You can stop using NuvaRing at any time you want. If you do not want to become pregnant, consult your doctor about other contraceptive methods.
If you stop using NuvaRing because you want to become pregnant, it is recommended to wait until you have had your first natural menstrual period before trying to conceive. This will help you calculate the due date.
Like all medications, NuvaRing may cause side effects, although not all women will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to NuvaRing, consult your doctor.
All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use 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, possibly with difficulty breathing. If this occurs, remove NuvaRing and contact your doctor immediately (see also section 2.2 “Warnings and precautions”).
Users of NuvaRing have reported the following side effects:
Frequent:may affect up to 1 in 10 women.
Infrequent:may affect up to 1 in 100 women.
Rare:may affect up to 1 in 1,000 women.
The risk of having 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).
Frequency not known:(cannot be estimated from available data).
Cases of breast cancer and liver tumors have been reported in women using combined hormonal contraceptives. For more information, see section 2.2 “Warnings and precautions, Cancer”.
In very rare cases, the NuvaRing ring may open. For more information, see section 3.4 “What to do if… The ring opens.”
Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
If you discover that a child has been exposed to the hormones of NuvaRing, ask your doctor for advice.
Store below 86°F. Store in the original packaging to protect it from light and moisture.
Do not use NuvaRing if it was dispensed more than 4 months ago. The dispensing date is shown on the box and on each ring package.
Do not use NuvaRing after the expiration date that appears on the box and on each ring package.
Do not use NuvaRing if you observe changes in the color of the ring or any visible sign of deterioration.
Dispose of the used ring with household waste, preferably in its package with a closure.Dispose of the used applicatorwith regular household waste. NeitherNuvaRingnor the applicatorshould be thrown into the toilet.
Like other medications, do not throw away unused or expired rings through the drains or in the trash.
Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.
Composition of NuvaRing
Etonogestrel and ethinylestradiol are released from the ring at a ratio of 0.120 mg/day and 0.015 mg/day respectively, over three weeks.
Appearance of NuvaRing andof the NuvaRing Applicator andcontents of the packaging
NuvaRing is a flexible, transparent, and almost colorless ring, measuring 54 mm in width.
Each ring is packaged in a laminated aluminum foil pouch that can be resealed.
The applicator is a non-sterile plastic device, designed for single use (i.e., disposable). Each applicator is individually packaged. The applicator has the CE mark engraved on it.
The ring or rings and applicator or applicators are presented in a cardboard box along with this leaflet. Each box contains 1 or 3 rings and the corresponding applicator or applicators.
Only some packaging sizes may be marketed.
Marketing Authorization Holder and Responsible Manufacturer
Marketing Authorization Holder:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Phone: 915911279
Responsible Manufacturer:
N.V. Organon
Kloosterstraat 6,
5349 ABOss
Netherlands
This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following name:
NuvaRing
0.120 mg/0.015 mg every 24 hours, vaginal delivery system
Germany, Austria, Belgium, Czech Republic, Denmark, Spain, Slovakia, Slovenia, Estonia, Finland, France, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway,Netherlands,Poland, Portugal, United Kingdom(Northern Ireland), Romania, Sweden.
Date of the last review of this leaflet:09/2022.
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.