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. 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. 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 What may interact with this medicine? Do not take this medicine with any of the following medications: amprenavir, fosamprenavir aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone atazanavir; cobicistat bosentan metyrapone This medicine may also interact with the following medications: acetaminophen antiviral medicines for HIV or AIDS aprepitant barbiturates certain antibiotics like clarithromycin, erythromycin, rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines certain diuretics like amiloride, spironolactone, triamterene certain medicines for fungal infections like griseofulvin, ketoconazole, itraconazole certain medications for high blood pressure or heart conditions like ACE-inhibitors, Angiotensin-II receptor blockers, eplerenone certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin cholestyramine cobicistat corticosteroid like hydrocortisone and prednisolone cyclosporine dantrolene felbamate grapefruit juice heparin lamotrigine medicines for diabetes, including pioglitazone modafinil NSAIDs potassium supplements pyrimethamine raloxifene St. John's wort sulfasalazine tamoxifen topiramate thyroid hormones 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 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 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.

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.

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.

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

What may interact with this medicine?

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

amprenavir, fosamprenavir
aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
atazanavir; cobicistat
bosentan
metyrapone

This medicine may also interact with the following medications:

acetaminophen
antiviral medicines for HIV or AIDS
aprepitant
barbiturates
certain antibiotics like clarithromycin, erythromycin, rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines
certain diuretics like amiloride, spironolactone, triamterene
certain medicines for fungal infections like griseofulvin, ketoconazole, itraconazole
certain medications for high blood pressure or heart conditions like ACE-inhibitors, Angiotensin-II receptor blockers, eplerenone
certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
cholestyramine
cobicistat
corticosteroid like hydrocortisone and prednisolone
cyclosporine
dantrolene
felbamate
grapefruit juice
heparin
lamotrigine
medicines for diabetes, including pioglitazone
modafinil
NSAIDs
potassium supplements
pyrimethamine
raloxifene
St. John's wort
sulfasalazine
tamoxifen
topiramate
thyroid hormones
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
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

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.