Serious Warnings and Precautions

Cigarette smoking increases the risk of cardiovascular side effects (heart and blood vessel problems) associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, NuvaRing should not be used by women who are over 35 years of age and smoke.

NuvaRing (as with other hormonal contraceptives) DOES NOT PROTECT against HIV infection (AIDS) and other Sexually Transmitted Infections (STIs). For protection against STIs, it is advisable to use latex or polyurethane condoms while using NuvaRing.

BEFORE you use NuvaRing talk to your doctor or pharmacist if:

• you are taking any other prescription or nonprescription drugs as these may interfere with the actions of NuvaRing
• you are or will be having major surgery
• you have breast conditions
• you have a family history of breast cancer
• you have breast disorders including pain, discharge from the nipples, thickenings, or lumps
• you have a family history of circulatory disorders including blood clots, heart attacks or strokes
• you have diabetes
• you are overweight
• you have high blood pressure
• you have abnormal levels of fats in the bloodstream (high cholesterol or triglycerides)
• you are a cigarette smoker
• you have migraine headaches
• you have heart or kidney disease
• you have a history of seizures or epilepsy
• you have a history of mental depression
• you have fibroid tumors of the uterus
• you have gallbladder or pancreatic disease
• you have plans for forthcoming surgery
• you have a history of jaundice or other liver disease

Your doctor can advise you if you have any conditions that would pose a risk to you. The use of combination hormonal contraceptives (including NuvaRing) should always be supervised by your doctor, with regular follow up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use NuvaRing only on the advice of your doctor and carefully follow all directions given to you. Use NuvaRing exactly as prescribed or you could become pregnant.

If you see another doctor, inform him or her that you are using NuvaRing.

NuvaRing may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. In some cases, vaginal (fibrous) tissue may grow over the ring, necessitating removal by a doctor.

Pregnancy is almost always more risky than using combination hormonal contraceptives. However, this risk with hormonal contraceptives can be higher if you are over 35 and you smoke.

Side Effects

Combination hormonal contraceptives (including NuvaRing) are not suitable for every woman.

In a small number of women, serious side effects may occur. The most serious side effects of combined hormonal contraceptives include:

• circulatory disorders (including blood clots in legs, lungs, heart, eyes, or brain)
• breast cancer
• gall bladder disease or liver tumors

Contact your doctor as soon as possible if you notice any changes in your own health. Do not forget about the items related to your immediate family.

Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:

• sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.
• pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
• crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.
• sudden severe or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.
• sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.
• severe pain or lump in the abdomen. These symptoms could indicate a possible tumor of the liver.
• severe depression.
• yellowing of the skin (jaundice).
• unusual swelling of the extremities.
• breast lumps.

With all hormonal contraceptives, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to use NuvaRing as normal. Irregular vaginal bleeding usually stops once your body has adjusted (usually after about 3 cycles). If it continues, becomes heavy or starts again, tell your doctor.

Users of NuvaRing have reported the following side effects:

• headache;
• vaginal discomfort (e.g. vaginal secretion, infection of the vagina);
• weight increase;
• nausea;
• breast pain;
• mood changes (e.g. depressive moods and emotional lability);
• painful menstruation;
• acne;
• decreased libido;
• abdominal pain;
• migraine;
• expulsion of the ring, problems during intercourse and feeling of the ring.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In rare cases the following undesirable effects were reported during use of NuvaRing: itching in the genital area, rash, allergic reaction, inflammation of the cervix, urinary tract infection, bladder infection, dizziness, anxiety, diarrhea and vomiting, breast tumor formation, breast discharge, back pain, enlarged abdomen, fatigue and penis discomfort of the partner (such as irritation, rash, itching).