Etonogestrel and ethinyl estradiol (patient information)

# IMPORTANT WARNING
Cigarette smoking increases the risk of serious side effects from etonogestrel and ethinyl estradiol vaginal ring, including heart attacks, blood clots, and strokes. This risk is higher for women over 35 years old and heavy smokers (15 or more cigarettes per day). If you use etonogestrel and ethinyl estradiol ring, you should not smoke.

# Why this medication is prescribed
Etonogestrel and ethinyl estradiol vaginal ring is used to prevent pregnancy. Etonogestrel and ethinyl estradiol vaginal ring is in a class of medications called combination hormonal contraceptives (birth control medications). Etonogestrel is a progestin and ethinyl estradiol is an estrogen. Etonogestrel and ethinyl estradiol vaginal ring works by preventing ovulation (the release of an egg from the ovaries). It also changes the lining of the uterus (womb) to prevent pregnancy from developing and changes the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. The contraceptive ring is a very effective method of birth control but does not prevent the spread of human immunodeficiency virus  or other sexually transmitted diseases.

# How this medication should be used
Etonogestrel and ethinyl estradiol combination comes as a flexible ring to place in the vagina. It is usually placed in the vagina and left in place for 3 weeks. After 3 weeks, it is removed for a 1-week break; then a new ring is inserted. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use the contraceptive ring exactly as directed. Never use more than one contraceptive ring at a time and always insert and remove the ring according to the schedule your doctor gives you.
You should always insert and remove the contraceptive ring on the same day of the week and at about the same time of day. Your menstrual period will probably start 2-3 days after you remove the contraceptive ring and may continue through that week. Be sure to insert your new ring at the end of the week on the same day and at the same time that you usually insert or remove the ring even if you have not stopped bleeding.
Your doctor will tell you when you should insert your first contraceptive ring. This depends on whether you were using a different type of birth control in the past month, were not using birth control, or have recently given birth or had an abortion or miscarriage. In some cases, you may need to use an additional method of birth control for the first seven days that you use the contraceptive ring. Your doctor will tell you whether you need to use backup birth control and will help you choose a method, such as male condoms and/or spermicides. You should not use a diaphragm when a contraceptive ring is in place.
You do not need to position the contraceptive ring a certain way inside your vagina. The ring will work no matter how it is positioned, but will be more comfortable and less likely to fall out when it is placed as far back in your vagina as possible. The ring cannot get past the cervix, so it will not go too far into the vagina or get lost when you push it in.
The contraceptive ring will usually stay in your vagina until you remove it. It may sometimes slip out when you are removing a tampon or having a bowel movement, or if you are very constipated or have not placed it properly in your vagina. Call your doctor if your contraceptive ring slips out often.
If your contraceptive ring slips out, you should rinse it with cool or lukewarm (not hot) water and replace it in your vagina as soon as possible. If your ring falls out and gets lost, you should replace it with a new ring and remove the new ring at the same time you were scheduled to remove the ring that was lost. Try to replace your ring within 3 hours after it falls out. If you do not replace your ring within 3 hours, you must use a backup method of birth control until you have had the ring in place for 7 days in a row.
To use the contraceptive ring, follow these steps:
- Wash and dry your hands.
- Remove one contraceptive ring from its foil pouch, but do not throw away the pouch. Put the pouch in a safe place so you can use it to properly throw away the contraceptive ring after you remove it.
- Lie down on your back with your knees bent, squat, or stand with one leg up on a chair, step, or other object. Choose the position that is most comfortable for you.
- Hold the contraceptive ring between your thumb and index finger and press the opposite sides of the ring together.
- Gently push the folded ring into your vagina.
- If you feel discomfort, push the ring further back into your vagina with your index finger.
- Wash your hands again.
- When it is time to remove the contraceptive ring, hook your index finger under the front rim or hold the rim between your index and middle fingers and pull it out.
- Put the used ring into the foil pouch and throw it away in a trash can that is out of the reach of children and pets. Do not throw the used ring in the toilet.
- Wash your hands.
- Wait one week, then insert a new ring following the directions above.

# Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

# Special precautions
Before using etonogestrel and ethinyl estradiol vaginal ring:
- tell your doctor and pharmacist if you are allergic to etonogestrel, ethinyl estradiol or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking. Be sure to mention any of the following: acetaminophen (Tylenol, others); antibiotics such as ampicillin (Omnipen, Principen others), clarithromycin (Biaxin), demeclocycline (Declomycin), doxycycline (Vibramycin, Doryx, others), erythromycin (E.E.S., E-Mycin, Erythrocin), minocycline (Vectrin, Minocin), rifampin (Rifadin, Rimactane), rifabutin (Mycobutin); tetracycline (Sumycin), and troleandomycin (TAO); antifungals such as fluconazole (Diflucan), griseofulvin (Grifulvin V, Fulvicin, others), itraconazole (Sporanox), and ketoconazole (Nizoral); ascorbic acid (Vitamin C); atorvastatin (Lipitor); cimetidine (Tagamet); clofibrate (Abitrate, Atromid-S); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); ethosuxamide (Zarontin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); isoniazid (INH, Nydrazid); medications for HIV or AIDS such as delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), Saquinavir (Fortovase, Invirase), and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and topiramate (Topamax); metronidazole (Flagyl); morphine (MSIR, Oramorph, others); nefazodone; prednisolone (Prelone); primidone; theophylline (TheoDur, others); temazepam (Restoril); verapamil (Calan, Covera, Isoptin, Verelan); zafirlukast (Accolate) and any medication that is placed in the vagina. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. You may need to use an extra method of birth control if you take some of these medications while you are using the contraceptive ring.
- tell your doctor what herbal products you are taking, especially products containing St. John's wort.
- tell your doctor if you have or have ever had, or anyone in your family has or has ever had, breast cancer, if you have ever had yellowing of the skin or eyes during pregnancy or while you were using another type of hormonal contraceptive (birth control pills, patches, rings, or injections), if you are on bed rest or are unable to walk around for any reason, or if you have or have ever had breast lumps; an abnormal mammogram (breast x-ray); fibrocystic breast disease (swollen, tender breasts and/or breast lumps that are not cancer); any type of cancer, especially cancer of the endometrium (lining of the uterus), cervix, or vagina; blood clots in your legs, lungs, or eyes; stroke or mini-stroke; coronary artery disease (clogged blood vessels leading to the heart); chest pain; a heart attack; any condition that affects your heart valves (flaps of tissue that open and close to control blood flow in the heart); high cholesterol or triglycerides; high blood pressure; diabetes; headaches; seizures; depression; unexplained vaginal bleeding; any condition that makes your vagina more likely to become irritated; bladder, uterus or rectum that has dropped or bulged into the vagina; constipation; or liver, kidney, thyroid, or gallbladder disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using etonogestrel and ethinyl estradiol vaginal ring, call your doctor immediately.You should suspect that you are pregnant and call your doctor if you have used the contraceptive ring correctly and you miss two periods in a row, or if you have not used the contraceptive ring according to the directions and you miss one period. You should not breastfeed while you are using the contraceptive ring.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using etonogestrel and ethinyl estradiol vaginal ring.
- tell your doctor if you wear contact lenses. If you notice changes in your vision or your ability to wear your lenses while using etonogestrel and ethinyl estradiol vaginal ring, see an eye doctor.

# Special dietary instructions
Talk to your doctor about drinking grapefruit juice while using this medication.

# What to do if you forget a dose
If you forget to insert a new contraceptive ring 1 week after you removed the old ring, you may not be protected from pregnancy.Check to be sure that you are not pregnant. If you are not pregnant, insert a new ring as soon as you remember and use a backup method of birth control until the new ring has been in place for 7 days in a row.
If you forget to remove the contraceptive ring on time but remember before 1 week has passed, remove the ring as soon as you remember. Wait 1 week and then insert a new ring. If you forget to remove the contraceptive ring and remember after more than 1 week has passed, you may not be protected from pregnancy. Check to be sure that you are not pregnant. If you are not pregnant, remove the ring as soon as you remember, wait 1 week and insert a new ring. Use a backup method of birth control until the new ring has been in place for 7 days in a row.

# Side effects

## Minor side effects
Etonogestrel and ethinyl estradiol vaginal ring may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- swelling, redness, irritation, burning, itching, or infection of the vagina
- white or yellow vaginal discharge
- vaginal bleeding or spotting when it is not time for your period. (Call your doctor if the *bleeding lasts longer than a few days or happens in more than one cycle.)
- headache
- runny nose
- upset stomach
- vomiting
- changes in appetite
- weight gain or loss
- stomach cramps or bloating
- nervousness
- breasts that are large, tender, or produce a liquid
- growth of hair on face
- loss of hair on scalp
- acne
- changes in sexual desire

## Severe side effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them call your doctor immediately:
- pain in the back of the lower leg
- sharp, sudden, or crushing chest pain
- heaviness in chest
- coughing up blood
- sudden shortness of breath
- sudden severe headache, vomiting, dizziness, or fainting
- sudden problems with speech
- weakness or numbness of an arm or leg
- sudden loss of vision
- double vision, blurred vision, or other changes in vision
- bulging eyes
- yellowing of the skin or eyes, especially if you also have fever, tiredness, loss of appetite, *dark urine, and/or light-colored bowel movements
- depression, especially if you also have trouble sleeping, tiredness, loss of energy, or other *mood changes
- pain, tenderness, or swelling of the abdomen (area between the chest and the waist)
- stomach pain that worsens after eating
- swelling of the hands, feet, ankles, or lower legs
- diarrhea
- painful, difficult, or frequent urination
- brown patches on the skin, especially the face
- rash
Etonogestrel and ethinyl estradiol vaginal ring may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. The contraceptive ring may also increase the chance that you will develop breast or liver cancer, or have a heart attack, a stroke, or a serious blood clot. Talk to your doctor about the risks of using the contraceptive ring.
Etonogestrel and ethinyl estradiol vaginal ring may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online  or by phone .

# Storage conditions needed for this medication
Keep this medication in the packet it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Etonogestrel and ethinyl estradiol vaginal ring is unlikely to cause an overdose. You will not receive too much medication if the ring breaks inside your vagina or if it is left in your vagina for too long.
Symptoms of overdose may include:
- upset stomach
- vomiting
- vaginal bleeding
- irregular period

# Other information
Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using etonogestrel and ethinyl estradiol vaginal ring.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

# Brand names
- NuvaRing

# Other names
- contraceptive ring