Angeliq contains a combination of drospirenone and estradiol. Drospirenone is a female hormone that helps regulate ovulation and menstruation. Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

Angeliq is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Angeliq is for use only if you have a uterus (if you have not had a hysterectomy).

You should not use Angeliq if you have: undiagnosed vaginal bleeding, coronary artery disease, a bleeding disorder, kidney disease, liver disease, an adrenal gland disorder, if you will have major surgery, if you have had a hysterectomy, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use Angeliq if you are pregnant.

Angeliq may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Taking this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Angeliq should not be used to prevent heart disease, stroke, or dementia.

Take Angeliq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not crush, chew, break, or dissolve a Angeliq tablet. Swallow it whole.

Take this medicine at the same time each day.

Angeliq may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Angeliq.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using this medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Postmenopausal Symptoms:

Vasomotor symptoms:
One 0.25 mg drospirenone/0.5 mg estradiol tablet orally once a day
OR
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day

Vulvar and vaginal atrophy:
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day


Comments:
-Treatment is continuous.
-Women not on estrogens, or those on a continuous combination product may start treatment anytime.
-Women switching from continuous sequential or cyclic hormone therapy should complete their current cycle before switching.
-When used solely for vulvar and vaginal atrophy, consider using topical vaginal products.

Uses: Treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause

You should not use Angeliq if you are allergic to drospirenone or estradiol, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• a bleeding disorder;

• coronary artery disease;

• a history of heart attack, stroke, or blood clot;

• kidney disease;

• liver disease;

• an adrenal gland disorder;

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina; or

• if you have had your uterus removed (hysterectomy).

Do not use Angeliq if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Angeliq should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a thyroid disorder;

• gallbladder disease;

• jaundice caused by pregnancy or taking hormones;

• high triglycerides (a type of fat in the blood);

• asthma;

• epilepsy or other seizure disorder;

• migraine headaches;

• lupus;

• endometriosis or uterine fibroid tumors;

• high levels of calcium or potassium in your blood, or low sodium levels;

• hereditary angioedema (an immune system disorder); or

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Using Angeliq may increase your risk of breast cancer. Talk with your doctor about your risk before using this medicine long term.

This medicine lowers the hormone needed to produce breast milk and can slow breast milk production. You should not breast-feed while taking Angeliq.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using this medicine.

Grapefruit may interact with drospirenone and estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction to Angeliq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• sudden vision loss;

• swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes);

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding;

• a lump in your breast; or

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor.

Common Angeliq side effects may include:

• headache, mood changes;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• breast pain;

• nausea, diarrhea, stomach pain; or

• fluid retention (swelling, rapid weight gain).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with drospirenone and estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.