Ethynodiol Diacetate; Ethinyl Estradiol Oral Tablets

What is this medicine?

ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL (e thye noe DYE ole dye AS e tate; ETH in il es tra DYE ole) is an oral contraceptive. The products combine two types of female hormones, an estrogen and a progestin. These products prevent ovulation and pregnancy.

How should I use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. Take this medicine at the same time each day and in the order directed on the package. Do not take your medicine more often than directed.

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.

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.

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

• breast tissue changes or discharge

• dark patches of skin on your forehead, cheeks, upper lip, and chin

• 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

• 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

• weight gain (slight)

What may interact with this medicine?

Do not take this medicine with the following medication:

• dasabuvir; ombitasvir; paritaprevir; ritonavir

• ombitasvir; paritaprevir; ritonavir

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

• 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

• mineral oil

• 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

What if I miss a dose?

If you miss a dose, refer to the patient information sheet you received with your medicine for direction. If you miss more than one pill, this medicine may not be as effective and you may need to use another form of birth control.

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). Throw away any unused medicine after the expiration date.

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

• 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

• 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.

Use an additional method of contraception during the first cycle that you take these tablets.

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

If you are taking 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 taking birth control pills, 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 taking 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.