Ethinyl Estradiol; Norethindrone Acetate (estrogen replacement)

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (ETh in il es tra DYE ole; nor eth IN drone AS e tate) is used as hormone replacement in menopausal women who still have their uterus. This product helps to treat hot flashes and prevent osteoporosis (weak bones).

How should I use this medicine?

Take this medicine by mouth with a drink of water. You may take this medicine with food. Follow the directions on the prescription label. You will take one tablet daily at roughly the same time each day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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:

• breakthrough bleeding and spotting

• breast enlargement, tenderness, or discharge

• chest pain

• leg, arm, or groin pain

• severe headaches

• stomach or abdominal pain (severe)

• sudden shortness of breath

• swelling of the hands, feet or ankles, or rapid weight gain

• vaginal yeast infection (irritation and white discharge)

• vision or speech problems

• 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):

• change in appetite

• change in sexual desire

• mild stomach upset

• mood changes, anxiety, depression, frustration, anger, or emotional outbursts

• nausea

• skin rash, acne, or brown spots on the face

• tiredness

• weight gain

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

• barbiturates, such as phenobarbital

• benzodiazepines

• bosentan

• bromocriptine

• carbamazepine

• caffeine

• clofibrate

• cimetidine

• cyclosporine

• dantrolene

• doxercalciferol

• grapefruit juice

• felbamate

• hydrocortisone, cortisone

• isoniazid (INH)

• medications for diabetes, including pioglitazone

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• methotrexate

• mineral oil

• modafinil

• mycophenolate

• nefazodone

• oxcarbazepine

• phenytoin

• prednisolone

• raloxifene

• ritonavir or other medicines for HIV infection or AIDS

• rosuvastatin

• selegiline

• soy isoflavones supplements

• St. John's wort

• tamoxifen

• theophylline

• thyroid hormones

• topiramate

• tricyclic antidepressants

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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 any of these conditions:

• blood vessel disease or blood clots

• breast, cervical, endometrial, or uterine cancer

• diabetes

• endometriosis

• fibroids

• gallbladder disease

• heart disease or recent heart attack

• high blood cholesterol

• high blood pressure

• high level of calcium in the blood

• hysterectomy

• kidney disease

• liver disease

• mental depression

• migraine headaches

• porphyria

• systemic lupus erythematosus (SLE)

• tobacco smoker

• stroke

• vaginal bleeding

• 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 health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines.

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 have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke, especially if you are more than 35 years old. You are strongly advised not to smoke.

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

If you are going to have elective surgery, you may need to stop taking this medicine beforehand. Consult your health care professional for advice prior to scheduling the surgery.