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.