Drospirenone, Estradiol Oral tablet

What is this medicine?

DROSPIRENONE; ESTRADIOL (dro SPY re nown; es tra DYE ole) is used as hormone replacement in menopausal women who still have their uterus. This medicine is used to treat some of the symptoms of menopause like hot flashes and vaginal dryness.

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 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

• stroke

• systemic lupus erythematosus (SLE)

• tobacco smoker

• vaginal bleeding

• 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?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine at the same time each day. Do not take your medicine 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.

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

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?

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone, vorozole

This medicine may also interact with the following medications:

• antibiotics like clarithromycin, erythromycin

• carbamazepine

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• grapefruit juice

• griseofulvin

• itraconazole

• ketoconazole

• medicines that treat or prevent blood clots like warfarin

• other medicines or supplements for menopause or female problems

• phenobarbital

• rifampin

• ritonavir

• St. John's Wort

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 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.

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 like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast tissue changes or discharge

• breathing problems

• changes in vision

• chest pain

• feeling faint or lightheaded, falls

• high blood pressure

• leg, arm or groin pain

• migraine

• problems with balance, talking, walking

• stomach pain

• vaginal bleeding

• vomiting

• 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

• changes in sexual desire

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

• nausea, stomach upset

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

• vaginal itching, irritation or discharge

• weight gain

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