Ethinyl Estradiol, Etonogestrel Vaginal insert

What is this medicine?

ETHINYL ESTRADIOL; ETONOGESTREL (ETH in il es tra DYE ole; et oh noe JES trel) vaginal ring is a flexible, vaginal ring used as a contraceptive (birth control method). This medicine combines two types of female hormones, an estrogen and a progestin. This ring is used to prevent ovulation and pregnancy. Each ring is effective for one month.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have or ever had any of these conditions:

• abnormal vaginal bleeding
• blood vessel disease or blood clots
• breast, cervical, endometrial, ovarian, liver, or uterine cancer
• diabetes
• gallbladder disease
• heart disease or recent heart attack
• high blood pressure
• high cholesterol
• kidney disease
• liver disease
• migraine headaches
• stroke
• systemic lupus erythematosus (SLE)
• tobacco smoker
• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Insert the ring into your vagina as directed. Follow the directions on the prescription label. The ring will remain place for 3 weeks and is then removed for a 1-week break. A new ring is inserted 1 week after the last ring was removed, on the same day of the week. Do not use more often than directed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

You will need to replace your vaginal ring once a month as directed. If the ring should slip out, or if you leave it in longer or shorter than you should, contact your health care professional for advice.

What may interact with this medicine?

• acetaminophen
• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• aprepitant
• ascorbic acid (vitamin C)
• atorvastatin
• barbiturate medicines, such as phenobarbital
• bosentan
• carbamazepine
• caffeine
• clofibrate
• cyclosporine
• dantrolene
• doxercalciferol
• felbamate
• grapefruit juice
• hydrocortisone
• medicines for anxiety or sleeping problems, such as diazepam or temazepam
• medicines for diabetes, including pioglitazone
• modafinil
• mycophenolate
• nefazodone
• oxcarbazepine
• phenytoin
• prednisolone
• ritonavir or other medicines for HIV infection or AIDS
• rosuvastatin
• selegiline
• soy isoflavones supplements
• St. John's wort
• tamoxifen or raloxifene
• theophylline
• thyroid hormones
• topiramate
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.

Use an additional method of contraception during the first cycle that you use this ring.

If you have any reason to think you are pregnant, stop using this medicine right away and contact your doctor or health care professional.

If you are using this medicine for hormone related problems, it may take several cycles of use to see improvement in your condition.

Smoking increases the risk of getting a blood clot or having a stroke while you are using hormonal birth control, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

If you are going to have elective surgery, you may need to stop using this medicine before the surgery. Consult your health care professional for advice.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breast tissue changes or discharge
• changes in vaginal bleeding during your period or between your periods
• chest pain
• coughing up blood
• dizziness or fainting spells
• headaches or migraines
• leg, arm or groin pain
• severe or sudden headaches
• stomach pain (severe)
• sudden shortness of breath
• sudden loss of coordination, especially on one side of the body
• speech problems
• symptoms of vaginal infection like itching, irritation or unusual discharge
• tenderness in the upper abdomen
• vomiting
• weakness or numbness in the arms or legs, especially on one side of the body
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills
• breast tenderness
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• increased sensitivity to sun or ultraviolet light
• nausea
• skin rash, acne, or brown spots on the skin
• weight gain (slight)

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) for up to 4 months. The product will expire after 4 months. Protect from light. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.