Nuvaring

• Vaginal ring
• Reliable method of contraception
• Insert new ring once a month

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.

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.

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 and left in place for three weeks in a row. Regularly check that NuvaRing is in your vagina 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.

How to insert and remove NuvaRing:

• Wash your hands before inserting or removing the ring.
• Choose the position for inserting that is most comfortable to you, like standing with one leg up, squatting, or lying down.
• Hold the ring between your thumb and index finger, press the opposite sides together and insert the ring into the vagina (see figures in the package leaflet). 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.
• After three 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. If you are unable to remove it, you should contact your doctor.
• Dispose of the used ring with the normal household waste, preferably inside the reclosable
• sachet. Do not flush NuvaRing down the toilet.
• Start a new ring exactly after the one-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 three hours too late, your ring has temporarily been out of the vagina or has been broken, the protection from pregnancy may be reduced. Refer to the package leaflet for instructions or consult a doctor.
• If you want to change the first day of your menstrual period, follow the instructions in the package leaflet.

See the package leaflet for more information on how to use NuvaRing.

NuvaRing is not suitable for everyone. You should not use this vaginal ring in the following situations:

• You have, or have had, a blood clot in a blood vessel of your legs (deep vein thrombosis), your lungs (pulmonary embolus) or other organs.
• You have, or have had, a condition that is linked to an increased risk of heart attack (e.g., angina pectoris or chest pain) or mini-stroke (also known as TIA or transient ischaemic attack).
• One or more factors that increase your risk of a blood clot apply to you.
• You know you have a disorder affecting your blood clotting, for instance, protein C deficiency.
• You have, or have had, a type of migraine associated with focal neurological symptoms (migraine with aura).
• You have diabetes with blood vessel damage.
• You have or have had inflammation of the pancreas (pancreatitis) associated with high levels of fat in your blood.
• You have, or have had, severe liver disease and your liver is not yet working normally.
• You have, or have had, a benign or malignant tumour in the liver.
• You have, have had, or may have, cancer of the breast or the genital organs.
• You have any unexplained vaginal bleeding.
• You are allergic to ethinylestradiol or etonogestrel, or any of the other ingredients of NuvaRing.

When should NuvaRing be used with caution?

Tell your doctor if any of the following situations apply to you. If the condition develops or gets worse while you are using NuvaRing, you should also tell your doctor.

• Anyone in your immediate family has or has had breast cancer.
• You have epilepsy.
• You have liver disease (e.g., jaundice) or gall bladder disease (e.g., gallstones).
• You have Crohn’s disease or ulcerative colitis.
• You have systemic lupus erythematosus (SLE).
• You have haemolytic uraemic syndrome (HUS).
• You have a condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea, or hereditary angio-oedema). If you experience symptoms of angio-oedema, such as swollen face, tongue and/or throat and/or difficulty swallowing, or hives together with difficulty in breathing, contact a doctor immediately.
• You have, or have had, chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face). If so, avoid too much exposure to the sun or ultraviolet radiation.
• You have a medical condition that makes it difficult to use NuvaRing – for example, if you are
• constipated, have a prolapse of the uterine cervix or have pain during intercourse.
• You have had surgery or are bedridden for a long period of time.

Pregnancy and breastfeeding

Do not use NuvaRing if you are pregnant or think you may be pregnant. If you get pregnant while using NuvaRing you should remove the ring and contact your doctor.

NuvaRing is not usually recommended for use during breastfeeding. If you wish to use NuvaRing while breastfeeding, please seek the advice of your doctor.

Other medicines and NuvaRing

NuvaRing may interact with other medicines.

The following medicines can make it less effective in preventing pregnancy or cause unexpected bleeding:

• Certain medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates).
• Certain medicines for tuberculosis (e.g., rifampicin).
• Certain HIV inhibitors (e.g., ritonavir).
• Certain antibiotics, with the exception of doxycycline and amoxicillin.
• St John's Wort.

NuvaRing may influence the effect of other medicines. These include:

• Ciclosporin.
• Lamotrigine.

Always tell your doctor which medicines or herbal products you are already using, including medicines obtained without a prescription.

See the package leaflet for more information on how to use NuvaRing,

The following side effects have been reported by users of NuvaRing.

Common:

• Stomach ache, nausea.
• Discomfort in the vagina due to the ring (thrush, itching, vaginal discharge).
• Headache/ migraine.
• Depression.
• Breast pain.
• Painful menstruation.
• Acne.
• Weight gain.
• The ring falling out.

Uncommon:

• Dizziness.
• Disturbed vision.
• Problems affecting the stomach and intestines.
• Tiredness.
• Feeling unwell.
• Fluid retention (oedema).
• Urinary tract infection.
• Problems during intercourse, including pain and bleeding.
• Increased blood pressure.
• Increased appetite.

For a complete list of all possible side effects, see the package leaflet.

Note: the use of hormonal contraceptives has been associated with a higher risk of thrombosis and certain types of cancer. For more detailed information, see the package leaflet.

If any of the side effects are severe or persistent, talk to your doctor. This includes any possible side effects not listed in this leaflet.

The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).

The other ingredients are: ethylene vinyl acetate copolymers (a type of plastic that will not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the ring at a rate of 0.120 mg/day and 0.015 mg/day, each for three weeks.

The manufacturers of NuvaRing are:

NV Organon Kloosterstraat 6
Oss
The Netherlands

And:

Organon Ireland Ltd. Drynam Road Swords
Co. Dublin
Ireland

Read the package leaflet before use. The official package leaflet of NuvaRing is available for download here.