In the U.S.—

• Contraceptive (vaginal)

The etonogestrel and ethinyl estradiol vaginal ring ( ee-tone-oh-JESS-trel and ETH-in-ill-ess-tra-DYE-ole) is a flexible combination contraceptive vaginal ring. Ethinyl estradiol is a kind of estrogen (ES-troh-jen) and etonogestrel is a kind of progesterone (proe-JES-ter-one). These are both female hormones used for contraception. The etonogestrel and ethinyl estradiol vaginal ring releases these hormones and is used to prevent pregnancy.

Etonogestrel and ethinyl estradiol vaginal ring will not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) . The use of latex (rubber) condoms or abstinence (not having intercourse) is recommended for protection from these diseases.

Etonogestrel and ethinyl estradiol vaginal ring is available only from your doctor or other authorized health care professional in the following form:

Intravaginal
• Etonogestrel and ethinyl estradiol vaginal ring (U.S.)

In deciding whether to use the combined contraceptive vaginal ring as a method of birth control, you need to consider the risks of using it as well as the good it can do. This is a decision you, your sexual partner, and your health care professional will make. For etonogestrel and ethinyl estradiol vaginal ring the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to etonogestrel, ethinyl estradiol, estrogens or progesterones. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Etonogestrel and ethinyl estradiol vaginal ring use is not recommended during pregnancy or if you think you are pregnant. Before using this contraceptive ring be sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—The hormones contained in this contraceptive ring have been shown to cause unwanted effects in the nursing baby when they were administered orally to the nursing mother. It may be necessary for you to use another form of contraception or to stop breast-feeding while you are using this contraceptive ring. Be sure you have discussed the risks and benefits of using this contraceptive ring with your doctor.

Children—Studies with this contraceptive ring have been done only in adult patients, and it is not expected to cause different side effects in children than it does in adults. The etonogestrel and ethinyl estradiol vaginal ring is not intended for use in children or adolescents who have not yet started menstruating.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known if this works the same way in younger adults as it does in older adults. There is no specific information comparing the use of etonogestrel and ethinyl estradiol vaginal ring in the elderly with use in other age groups. The etonogestrel and ethinyl estradiol vaginal ring is not intended for use in women older than child-bearing age.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Be sure to tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. When you are using the etonogestrel and ethinyl estradiol vaginal ring, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antibiotics (medicines to treat infections) such as:
• Ampicillin or
• Rifampin (e.g., Rifadin, Rifadin IV. Rimactane) or
• Tetracyclines (e.g., Declomycin, Doxycycline, Minocycline, Monodox, Vibra-Tabs)—Taking these medicines while using the contraceptive ring can cause the ring to fail and cause unintended pregnancy.

• Anticonvulsants (medicine for seizures) such as:
• Carbamazepine (e.g., Epitol, Tegretol) or
• Felbamate (e.g., Felbatol) or
• Oxcarbazepine (e.g., Trileptal) or
• Phenytoin (e.g., Dilantin, Phenytek) or
• Topiramate (e.g.,Topamax)—These medicines may prevent the contraceptive ring from working properly and may result in an unplanned pregnancy. While taking these medicines you may need to use a back up form of contraception.

• Antifungals (medicine for fungus infections) such as:
• Griseofulvin (e.g., Fulvicin, Grifulvin, Gris-Peg)—These medicines may prevent the contraceptive ring from working properly and may result in an unplanned pregnancy. While taking these medicines you may need to use a back up form of contraception.

• Barbiturates (e.g., Mebaral, Nembutal, Phenobarbital, Seconal)—This medicine may prevent the contraceptive ring from working properly and may result in an unplanned pregnancy. While taking this medicine you may need to use a back up form of contraception.

• Cyclosporine (e.g., Neoral, Sandimmune) or
• Prednisolone (e.g., Prelone) or
• Theophylline— The hormones in your contraceptive ring can prevent these medicines being removed from your body and this can cause problems from having too much of these medicines in your body.

• Protease inhibitors (medicine used to treat HIV infections)—This medicine may prevent the contraceptive ring from working properly or increase hormone levels in your body leading to unwanted side effects. Tell your doctor which protease inhibitors you are taking.

• Smoking, cigarette— Smoking increases the risk for very serious side effects. If you are using etonogestrel and ethinyl estradiol vaginal ring it is strongly advised that you do not smoke.
• St. Johns's Wort—This herbal medicine may prevent the contraceptive ring from working properly and result in unplanned pregnancy.

• Abnormal or unusual vaginal bleeding (nonmenstrual)— The use of etonogestrel and ethinyl estradiol vaginal ring may delay diagnosis or worsen this condition. The reason for the bleeding should be determined before etonogestrel and ethinyl estradiol vaginal ring is used.

• Breast cancer (now or in the past or if suspected) or
• Cancer of the lining of the uterus, cervix or vagina (now or in the past) or
• Cancer that worsens when estrogen is present (now or in the past) or
• Confined to bed or inability to move for long period of time or
• Coronary artery disease (now or in the past) or
• Diabetes mellitus with blood vessel problems or
• Headache (severe) with changes in vision, loss of coordination, inability to move, numbness in arms or legs, or fainting or
• High blood pressure, severe or
• Jaundice while using birth control pills or
• Jaundice during pregnancy or
• Liver disease (active) or
• Liver tumors or
• Surgery (major) or
• Problems with circulation or blood clots, now or in the past, such as:
• Blood clots in your brain or
• Blood clots in your legs or
• Blood clots in your lungs or
• Blood clots in your eyes
• Problems with heart valves— these conditions may increase your chance of serious side effects.

• Coronary artery disease risk factors such as:
• Diabetes (sugar diabetes) or
• High blood pressure or
• High cholesterol or
• Obesity—These conditions may increase your chance of serious side effects when using etonogestrel and ethinyl estradiol vaginal ring.

• Depression or
• Diabetes mellitus (sugar diabetes) or
• Headache of type not experience before or
• High blood pressure or
• Kidney disease or
• Migraine headache or
• Problems with too much insulin in your blood or
• Problems with too much sugar in your blood—This medication may make this condition worse.

• Menstrual vaginal bleeding (lack of or heavy)—This problem may occur when contraceptive medicine is stopped, especially if it has happened in the past.

• Smoking cigarettes—Smoking may increase your chance of serious side effects, especially if you are over 35 years of age or smoke 15 cigarettes or more a day.

• Swollen ankles, feet, or hands—This medication may make this condition worse. This medicine may also make other medical problems worse when your body keeps too much water or fluid.

Dosing—

This etonogestrel and ethinyl estradiol vaginal ring comes with patient information. You must understand this information. You should keep a copy for reference. Be sure you understand possible problems with the etonogestrel and ethinyl estradiol vaginal ring , especially side effects, risks, and signs of a serious problem.

It is important to know how and when to insert, remove, or replace etonogestrel and ethinyl estradiol vaginal ring. If you have any questions about this ask your doctor. It is very important to follow the instructions on when to insert and remove your etonogestrel and ethinyl estradiol vaginal ring.

Pregnancy must be ruled out if there is a problem or change in your regimen. It is important to use additional methods of contraception if there was a problem or change in the regimen. Back-up contraception must be used until the ring has been in place for seven days.

• For vaginal dosage form
  • For preventing pregnancy:
    • Adults—One ring inserted into the vagina for three weeks. The ring is removed for a one week break and the old ring is disposed of. A new ring is inserted one week after the last ring was removed and left in place for three weeks.

      Note:

      The ring must be inserted on the appropriate day and left in place for three weeks. This means that the ring is removed three weeks later on the same day of the week it was inserted and at about the same time.

Missed dose—

If the etonogestrel and ethinyl estradiol vaginal ring has slipped out of the vagina and it has been out less than three hours, you should still be protected from pregnancy. If the etonogestrel and ethinyl estradiol vaginal ring has been out of the vagina for more than three hours you may not adequately be protected from pregnancy, and you must use an extra method of birth control until the etonogestrel and ethinyl estradiol vaginal ring has been in place for seven days in a row.

For additional information changes or problems with your regimen consult your patient information leaflet or ask your doctor.

Storage—

To store this medicine:

• Store at room temperature 25°C (77°F). Temperatures can be from 59 to 86°F (15 to 39°C)
• Do not store in direct sunlight.
• Do not store in places with a temperature higher than 86°F (30°C)

It is very important that your doctor check you at regular annual visits. Your doctor may want to see you more often than once a year.

It is very important that you tell your doctor if you think that you might be pregnant or if you miss a period.

This product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

The risk of serious adverse effects is unlikely for most women using the etonogestrel and ethinyl estradiol vaginal ring.. However, oral combination hormonal contraceptives have been associated with unwanted effects which may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Incidence not determined
  • abdominal fullness;  abdominal pain or tenderness usually after eating a meal;  blurred vision ;  changes in skin color;  chest pain or discomfort;  confusion;  constipation;  diarrhea;  dizziness;  gaseous abdominal pain;  headache;  inability to speak;  nausea;  nervousness;  numbness of hands;  pain or discomfort in arms, jaw, back or neck;  pain;  pains in chest, groin, or legs, especially calves of legs;  pounding in the ears;  prominent superficial veins over affected area with tenderness and warmth;  recurrent fever;  seizures;  severe headaches of sudden onset;  shortness of breath;  slow or fast heartbeat;  sudden loss of coordination;  sudden onset of slurred speech;  sudden vision changes;  sudden and severe weakness in arm and/or leg on one side ;  sweating ;  swelling;  swelling of foot or leg on one side of the body;  temporary blindness ;  vomiting or vomiting of blood;  yellow eyes or skin 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Menstrual changes;  nausea;  vaginal bleeding;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Cough;  fever;  headache;  itching of the vagina or genital area;  pain during sexual intercourse;  pain or tenderness around eyes and cheekbones;  sore throat ;  stuffy or runny nose;  thick, white vaginal discharge with no odor or with a mild odor;  tightness of chest or wheezing;  weight gain 
  
  

• Less common
  • 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 
  
  

• Incidence not determined
  • absent, missed, or irregular menstrual periods;  bloody vaginal discharge;  brown, blotchy spots on exposed skin;  chills;  clay-colored stools;  contact lenses intolerance;  dark urine;  decreased amount or quality of milk;  dry mouth;  dry skin;  fatigue;  flushed;  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 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.