Ethinyl Estradiol; Etonogestrel vaginal ring

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 2 types of female hormones, an estrogen and a progestin. This ring is used to prevent ovulation and pregnancy. Each ring is effective for 1 month.

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. Check often to make sure the ring is still in place. If the ring was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. Perform a pregnancy test and call your doctor. Do not use more often than directed.

A patient package insert for the product 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.

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:

• allergic reactions such as skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• depression

• high blood pressure

• migraines or severe, sudden headaches

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of infection like fever or chills with dizziness and a sunburn-like rash, or pain or trouble passing urine

• stomach pain

• symptoms of vaginal infection like itching, irritation or unusual discharge

• yellowing of the eyes or skin

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

• acne

• breast pain, tenderness

• irregular vaginal bleeding or spotting, particularly during the first month of use

• mild headache

• nausea

• painful periods

• vomiting

What may interact with this medicine?

Do not take this medicine with the following medications:

• dasabuvir; ombitasvir; paritaprevir; ritonavir

• ombitasvir; paritaprevir; ritonavir

• vaginal lubricants or other vaginal products that are oil-based or silicone-based

This medicine may also interact with the following medications:

• acetaminophen

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines

• aprepitant or fosaprepitant

• armodafinil

• ascorbic acid (vitamin C)

• barbiturate medicines, such as phenobarbital or primidone

• bosentan

• certain antiviral medicines for hepatitis, HIV or AIDS

• certain medicines for cancer treatment

• certain medicines for seizures like carbamazepine, clobazam, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate

• certain medicines for treating high cholesterol

• cyclosporine

• dantrolene

• elagolix

• flibanserin

• grapefruit juice

• lesinurad

• medicines for diabetes

• medicines to treat fungal infections, such as griseofulvin, miconazole, fluconazole, ketoconazole, itraconazole, posaconazole or voriconazole

• mifepristone

• mitotane

• modafinil

• morphine

• mycophenolate

• St. John's wort

• tamoxifen

• temazepam

• theophylline or aminophylline

• thyroid hormones

• tizanidine

• tranexamic acid

• ulipristal

• warfarin

What if I miss a dose?

You will need to use the ring exactly as directed. It is very important to follow the schedule every cycle. If you do not use the ring as directed, you may not be protected from pregnancy. If the ring should slip out, is lost, or if you leave it in longer or shorter than you should, contact your health care professional for advice.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened medicine for up to 4 months at room temperature at 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Do not store above 30 degrees C (86 degrees F). Throw away any unused medicine 4 months after the dispense date or the expiration date, whichever comes first. A ring may only be used for 1 cycle (1 month). After the 3-week cycle, a used ring is removed and should be placed in the re-closable foil pouch and discarded in the trash out of reach of children and pets. Do NOT flush down the toilet.

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

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

• abnormal vaginal bleeding

• blood vessel disease or blood clots

• breast, cervical, endometrial, ovarian, liver, or uterine cancer

• diabetes

• gallbladder disease

• having surgery

• heart disease or recent heart attack

• high blood pressure

• high cholesterol or triglycerides

• history of irregular heartbeat or heart valve problems

• kidney disease

• liver disease

• migraine headaches

• protein C deficiency

• protein S deficiency

• recently had a baby, miscarriage, or abortion

• stroke

• systemic lupus erythematosus (SLE)

• tobacco smoker

• your age is more than 35 years old

• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

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.

Check with your doctor or health care professional to see if you need an additional method of contraception during the first cycle that you use this ring. Male condoms (made with natural rubber latex, polyisoprene, and polyurethane) and spermicides may be used. Do not use a diaphragm, cervical cap, or a female condom, as the ring can interfere with these birth control methods and their proper placement.

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.

Some women are prone to getting dark patches on the skin of the face (cholasma). Your risk of getting chloasma with this medicine is higher if you had chloasma during a pregnancy. 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.

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.

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.