NuvaRing ® Vaginal Ring Etonogestrel 11,7 mg/2,7 mg

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. 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 like a combined orally taken 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.

General notes

In this leaflet, several situations are described where you should stop using NuvaRing, or where NuvaRing may be less reliable. In such situations you should not have intercourse, or you should take extra non-hormonal contraceptive precautions, such as using a male or female condom or other barrier methods. Do not use rhythm or temperature methods. These methods can be unreliable because NuvaRing alters the monthly changes of the body temperature and of the cervical mucus.

NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not use NuvaRing

Tell your doctor if any of the following conditions applies to you. Your doctor may then advise you to use a different (non-hormonal) method of birth control.

• If you are allergic to ethinylestradiol or etonogestrel, or any of the other inactive substances of NuvaRing.
• If you have (or have ever had) a blood clot (venous thrombosis) in a blood vessel of your legs, lungs (embolus) or other organs. For possible signs of a blood clot see “Blood Clots (Thrombosis)”.
• If you have ever had a heart attack, or a stroke, or if you have (or have ever had) a condition that may be a first sign of a heart attack (such as angina pectoris or severe chest pain) or stroke (such as a transient ischaemic attack [a TIA - a slight temporary stroke]).
• If you have a serious risk factor, or several risk factors, for developing a blood clot see also in section “Blood Clots (Thrombosis)”.
• If you have (or had) a disorder affecting your blood clotting, for instance protein C deficiency.
• If you have (or had) a type of migraine called “migraine with aura”.
• If you have diabetes with damaged blood vessels.
• You have (or had) an inflammation of the pancreas (pancreatitis) associated with high levels of fat in your blood.
• If you have (or had) severe liver disease and your liver is not yet working normally.
• If you have (or had) a benign or malignant tumour in the liver.
• If you have (or had), or if you may have cancer of the breast or the genital organs.
• If you have any unexplained vaginal bleeding.
• if you have major surgery (e.g., an operation) and your ability to move around is limited for a long period of time (see in section “Blood clots (Thrombosis)”.
• if you are pregnant or think you might be pregnant.

If any of these conditions appear for the first time while using NuvaRing, remove the ring immediately and contact your doctor. In the meantime, use non-hormonal contraceptive measures.

For possible signs of a blood clot see in section “Blood Clots (Thrombosis)”.

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 inserted on the correct day in your monthly cycle (see section “When to start with the first ring”) and left in place for 3 consecutive weeks. Regularly check that NuvaRing is in your vagina (for example, before and after intercourse) to ensure that you are protected from pregnancy. After the 3rd 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 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.

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 to 4). When NuvaRing is in place you should not feel anything. If you feel uncomfortable, gently change the position of the NuvaRing (e.g., push the ring a bit further into the vagina) until it is comfortable. The exact position of the ring inside the vagina is not important.
6. After 3 weeks 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).
7. Dispose of the used ring with the normal household waste, preferably inside the reclosable sachet. Do not flush NuvaRing down the toilet.

NuvaRing can cause side effects, although not everybody gets them. Serious reactions seen with NuvaRing, as well as the related symptoms, are described in “Blood Clots (Thrombosis)” and “Cancer”. Users of NuvaRing have reported the following side effects:

Common side effects

(affecting more than 1 in 100, but less than 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, painful menstrual periods
• acne
• weight gain
• the ring falling out.

Uncommon side effects

(affecting more than 1 in 1 000, but less than 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)
• genital secretion, 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
• ring breakage.

Rare side effects

(affecting more than 1 in 10 000, but less than 1 in 1 000 women)

• blood clot in a vein
• blood clot in an artery

The following rare side effects have been reported during market use of NuvaRing: allergic reactions (hypersensitivity), including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis); vaginal injury associated with ring breakage; breast discharge, penis discomfort of the partner (such as irritation, rash, itching).

Not all side effects reported for NuvaRing are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using NuvaRing, please consult your doctor, pharmacist or other healthcare professional for advice.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NuvaRing.

Store NuvaRing in the original package. Prior to dispensing: Refrigerate at 2 to 8 °C for up to 36 months. At the time of dispensing: The dispenser places a date of dispensing on the box. The product should not be inserted after the expiry date or 4 months from the date of dispensing, whichever comes first. After dispensing: Store at room temperature below 30 °C for up to 4 months. See “3. How to use NuvaRing”. The dispenser has to indicate on the box the date of dispensing and the date before which NuvaRing has to be used. After removal, NuvaRing should be stored in the reclosable sachet. NuvaRing should be disposed of with the normal household waste in a manner that avoids accidental contact with other people. NuvaRing should not be flushed down the toilet. Keep out of reach of children.