NuvaRing vaginal ring

Do not smoke while using the vaginal ring, especially if you are older than 35 years of age.

Grapefruit and grapefruit juice may interact with ethinyl estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

This medicine will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of ethinyl estradiol, especially:

• acetaminophen (Tylenol), ascorbic acid (vitamin C), diltiazem;

• an antibiotic--clarithromycin, erythromycin;

• antifungal medicine--fluconazole, itraconazole, ketoconazole, voriconazole;

• cholesterol medication--atorvastatin (Zocor, Vytorin) or rosuvastatin (Crestor); or

• HIV/AIDS medication--atazanavir, etravirine, indinavir, ritonavir.

Some drugs can make birth control less effective, which may result in pregnancy. Use a barrier form of birth control (a male condom with spermicide, but not a diaphragm or female condom) with the vaginal ring if you also use any of the following medicines:

• aprepitant, bosentan, griseofulvin, St. John's wort;

• antiviral medicine to treat hepatitis C or HIV/AIDS--boceprevir, darunavir, efavirenz, fosamprenavir, lopinavir, nevirapine, ritonavir, telaprevir, tipranavir;

• tuberculosis medicine--rifabutin, rifampin; or

• seizure medicine--carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate.

Keep using the barrier birth control for at least 28 days after your last dose of any of these medicines.

These lists are not complete and many other drugs can interact with ethinyl estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using.

You should not use NuvaRing if you have: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use NuvaRing if you smoke and are older than 35 years of age.

Using NuvaRing can increase your risk of blood clots, stroke, or heart attack, You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using the vaginal ring, or when you insert a new ring after not wearing one for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use the vaginal ring if you smoke and are older than 35 years of age.

Do not use a NuvaRing vaginal ring if you have had a baby within the past 4 weeks. Stop using NuvaRing and call your doctor if you become pregnant, or if you miss two menstrual periods in a row.

You should not use the NuvaRing vaginal ring if you have:

• untreated or uncontrolled high blood pressure;

• a heart valve disorder or history of a heart attack, stroke, or blood clot;

• bleeding or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• severe migraine headaches (with aura, numbness, weakness, or vision changes);

• liver disease or liver cancer; or

• if you smoke and are over 35 years old.

To make sure the NuvaRing vaginal ring is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol or triglycerides;

• liver or kidney disease;

• depression;

• diabetes, underactive thyroid, gallbladder disease;

• a seizure or migraine headaches;

• irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation;

• jaundice caused by pregnancy or birth control pills;

• a family history of breast cancer;

• fibrocystic breast disease, or an abnormal mammogram; or

• if you have recently had a miscarriage or abortion.

The hormones in NuvaRing can slow breast milk production. Do not use if you are breast feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Applies to ethinyl estradiol / etonogestrel: vaginal insert extended release

Along with its needed effects, ethinyl estradiol / etonogestrel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / etonogestrel:

• Blurred vision
• changes in skin color
• chest pain or discomfort
• confusion
• constipation
• diarrhea
• dizziness
• gaseous stomach pain
• headache
• inability to speak
• nausea
• nervousness
• numbness of the hands
• pain or discomfort in the arms, jaw, back, or neck
• pain in the chest, groin, or legs, especially calves of the legs
• pounding in the ears
• prominent superficial veins over the affected area with tenderness and warmth
• recurrent fever
• seizures
• severe headache of sudden onset
• slow or fast heartbeat
• stomach fullness
• stomach pain or tenderness usually after eating a meal
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sudden and severe weakness in the arm or leg on one side
• sweating
• swelling of the foot or leg on one side of the body
• temporary blindness
• vomiting with or without blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / etonogestrel:

• Menstrual changes
• nausea
• vaginal bleeding

Some side effects of ethinyl estradiol / etonogestrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• fever
• itching of the vagina or genital area
• pain during sexual intercourse
• pain or tenderness around the eyes and cheekbones
• sore throat
• stuffy or runny nose
• thick, white vaginal discharge with or without a mild odor
• tightness of the chest
• weight gain

• Crying
• depersonalization
• false or unusual sense of well-being
• hoarseness
• mental depression
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods, mild feeling of sadness or discouragement that come and go

• Absent, missed, or irregular menstrual periods
• bloody vaginal discharge
• brown, blotchy spots on exposed skin
• chills
• clay-colored stools
• contact lens intolerance
• dark urine
• decreased amount or quality of milk
• dry mouth
• dry skin
• fruit-like or unpleasant breath odor
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• rash
• soreness, swelling, or discharge from the breast or breasts
• trouble getting pregnant
• unexplained weight loss
• unusual tiredness or weakness