NUVARING 0.120 MG / 0.015 MG PER 24 HOURS VAGINAL DELIVERY SYSTEM - patient leaflet, side effects, dosage

3. how to use nuvaring

Your ring is accidentally expelled from the vagina

Your ring has temporarily been out of the vagina

Your ring breaks

You have inserted more than one ring

You have forgotten to insert a new ring after the ring-free interval

You have forgotten to remove the ring

You have missed a menstrual period

You have unexpected bleeding

You want to change the first day of your menstrual period

You want to delay your menstrual period

• 3.5 When you want to stop using NuvaRing

• 4. Possible side effects

• 5. How to store NuvaRing

• 6. Contents of the pack and other information

What NuvaRing contains

What NuvaRing looks like and contents of the pack Marketing Authorisation Holder and Manufacturer

1. what nuvaring is and what it is used for

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.

2. what you need to know before you use nuvaring

3. how to use nuvaring

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.

• 3.1 How to insert and remove NuvaRing

• 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 Figures 1– 4). Alternatively, you may choose to use the NuvaRing Applicator (not included with NuvaRing) to help you insert the ring. The NuvaRing Applicator may not be available in all countries. 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 farther into the vagina) until it is comfortable. The exact position of the ring inside the vagina is not important.

• 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 (see Figure 5). 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.

  Figure 1

  Take NuvaRing out of the sachet

  
  

  Figure 2 Compress the ring

  
  

  Figure 3

  Choose a comfortable position to insert the ring

  
  
  
  
  
  

  Figure 4A

  
  

  Figure 4B

  
  

  Figure 4C

  
  
  
  

Insert the ring into the vagina with one hand (Figure 4A), if necessary the labia may be spread with the other. Push the ring into the vagina until the ring feels comfortable (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).

• Figure 5

NuvaRing can be removed by hooking the index finger under the ring or by grasping the ring between the index and middle finger and pulling it out.

• 3.2 Three weeks in, one week out

• 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.

• 3.3 When to start with the first ring

• You have not used a hormonal contraceptive during the last month Insert the first NuvaRing on the first day of your natural cycle (i.e. the first day of your menstrual period). NuvaRing starts working straight away. You don’t need to take any other contraceptive precautions. You can also start NuvaRing between day 2 and day 5 of your cycle, but if you have sexual intercourse during the first 7 days of NuvaRing use make sure that you also use an additional contraceptive method (such as a male condom). You only have to follow this advice when you use NuvaRing for the first time.
• You have used a combined Pill during the last month

Start using NuvaRing at the latest the day following the tablet-free period of your present Pill. If your Pill pack also contains inactive tablets, start NuvaRing at the latest on the day after the last inactive tablet. If you are not sure which tablet this is, ask your doctor or pharmacist. Never extend the hormone-free interval of your current Pill pack beyond its recommended length.

If you have used the Pill consistently and correctly and if you are sure that you are not pregnant, you can also stop taking the Pill on any day of your current Pill pack and start using NuvaRing immediately.

• You have used a transdermal patch during the last month Start using NuvaRing at the latest the day following your usual patch-free break. Never extend the patch-free break beyond its recommended length.

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

• You have used a minipill (progestagen-only pill) during the last month. You can stop taking the minipill any day and start NuvaRing the next day, at the same time you would normally have taken your pill. But make sure you also use an additional contraceptive method (such as a male condom) for the first 7 days of ring use.
• You have used an injectable or implant or a progestagen-releasing intrauterine device (IUD) during the last month.

Start using NuvaRing when your next injection is due or on the day that your implant or your progestagen-releasing IUD is removed. But make sure you also use an additional contraceptive method (such as a male condom) for the first 7 days of ring use.

• After having, a baby.

If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start using NuvaRing. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to use NuvaRing, you should discuss this first with your doctor.

• After a miscarriage or an abortion.

Your doctor will advise you.

• 3.4 What to do if…
  
  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:

• less than 3 hours, it will still protect you from pregnancy. You should rinse the ring with cold to lukewarm water (do not use hot water) and put the ring back in 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 and 2nd week, it may not protect you from pregnancy. You should rinse the ring with cold to lukewarm water (do not use hot water) and put the ring back in the vagina as soon as you remember, and leave the ring in place without interruption for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in your 1st week, and you had sexual intercourse during the past 7 days, there is a possibility you may be pregnant. In that case contact your doctor.
• more than 3 hours in the 3rd week it may not protect you from pregnancy. You should discard that ring and choose between one of the following two options:

• 1 – Insert a new ring immediately

This will start the next three-week use period. You may not have your period, but breakthrough bleeding and spotting may occur.

• 2 – Do not insert the ring again. Have your period first and insert a new ring no later than 7 days from the time the previous ring was removed or fell out.

You should only choose this option if you have used NuvaRing continuously during the previous 7 days.

• unknown amount of time, you may not be protected from pregnancy. Perform a pregnancy test and consult your doctor prior to inserting a new ring.

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

• If your ring has been left in place for between 3 and 4 weeks, it will still protect you from pregnancy. Have your regular ring-free interval of one week and subsequently insert a new ring.
• If your ring has been left in place for more than 4 weeks there is a possibility of becoming pregnant. Contact your doctor before you start with a new ring.

You have missed a menstrual period

• You have followed the instructions for NuvaRing

If you have missed a menstrual period but you followed the instructions for NuvaRing, and have not used other medicines, it is very unlikely that you are pregnant. Continue to use NuvaRing as usual. If you miss your menstrual period twice in a row, however, you may be pregnant. Tell your doctor immediately. Do not start the next NuvaRing until your doctor has

checked you are not pregnant.

• If you have not followed the instructions for NuvaRing

If you have missed a menstrual period and you did not follow the instructions, and you do not have your expected period in the first normal ring-free interval, you may be pregnant. Contact your doctor before you start with a new NuvaRing.

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. 30

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.

• 3.5 When you want to stop using NuvaRing

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.

4. possible side effects

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 together with difficulty breathing. If this happens, remove NuvaRing and contact your doctor immediately.

Users of NuvaRing have reported the following side effects.

Common: may affect up to 1 in 10 women

• abdominal pain, feeling sick (nausea)
• yeast infection of the vagina (such as ‘thrush’); discomfort in the vagina due to the ring; genital itching; secretion from the vagina
• headache or migraine; depressive moods; lower sex drive
• breast pain; pelvic pain; painful menstrual periods
• acne
• weight gain
• the ring falling out

Uncommon: may affect up to 1 in 100 women

• disturbed vision; dizziness
• swollen abdomen; vomiting, diarrhoea or constipation
• feeling tired, unwell or irritable; mood changes; mood swings
• extra fluid in the body (oedema)
• bladder or urinary tract infection
• difficulty or pain when passing urine; strong desire or need to pass urine; passing urine more often
• problems during intercourse, including pain, bleeding or partner feeling the ring
• increased blood pressure
• increased appetite
• back pain; muscle spasms; pain in legs or arms
• less sensitive skin
• sore or larger breasts; fibrocystic breast disease (cysts in the breasts which may become swollen or painful)
• inflammation of the cervix; cervical polyps (growths in the cervix); rolling outward of the margin of the cervix (ectropion)
• changes to menstrual periods (e.g. periods can be heavy, long, irregular or stop altogether); pelvic discomfort; premenstrual syndrome; spasm of the uterus
• vaginal infection (fungal and bacterial); burning feeling, smell, pain, discomfort or dryness in the vagina or vulva
• hair loss, eczema, itching, rash or hot flushes
• hives

Rare: may affect up to 1 in 1,000 women

• harmful blood clots in a vein or artery, for example:

o in a leg or foot (i.e. DVT)

o in a lung (i.e. PE)

h heart attack

o stroke

o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)

o blood clots in the liver, stomach/intestine, kidneys or eye.

• 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.) breast discharge

Not known (cannot be estimated from the available data)

• chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face)
• penis discomfort of the partner (such as irritation, rash, itching)
• inability to remove ring without medical assistance (e.g., because of adherence to vaginal wall)
• vaginal injury associated with ring breakage

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.

Reporting of side effects

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: 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.

5. how to store nuvaring

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.

6. contents of the pack and other information

What NuvaRing contains

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

What NuvaRing looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder :

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

Manufacturer:

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.

This medicinal product is authorised in the Member States of the EEA under the following name:

NuvaRing

0.120 mg/0.015 mg per 24 hours, Vaginal delivery system

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Romania, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).

This leaflet was last revised in October 2021.

© Organon Pharma (UK) Limited, 2021. All rights reserved.

PIL.NVRNG.21.UK­.7771.WS-538.RCN000121

These stickers, when applied to the appropriate date in your calendar, can help you to remember when to insert and remove NuvaRing

Insert Remove

Ring Ring