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ANGELIQ® TABLETS
(drospirenone and estradiol)

Read this PATIENT INFORMATION before you start taking ANGELIQ (drospirenone and estradiol) and read what you get each time you refill ANGELIQ (drospirenone and estradiol) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is ANGELIQ (drospirenone and estradiol) ?

ANGELIQ (drospirenone and estradiol) is a medicine that contains two kinds of hormones, estrogen and progestin.

What is ANGELIQ (drospirenone and estradiol) used for?

ANGELIQ (drospirenone and estradiol) is used after menopause to:

• reduce moderate to severe hot flashes.Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
  When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes”or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ (drospirenone and estradiol) .
• treat moderate to severe dryness, itching, and burning in or around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ (drospirenone and estradiol) to control these problems. If you use ANGELIQ (drospirenone and estradiol) only to treat dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who should not use ANGELIQ (drospirenone and estradiol) ?

Do not use ANGELIQ (drospirenone and estradiol) if you have had your uterus removed (hysterectomy).

ANGELIQ (drospirenone and estradiol) contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use ANGELIQ (drospirenone and estradiol) .

Do not start taking ANGELIQ (drospirenone and estradiol) if you:

• have unusual vaginal bleeding.
• currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take ANGELIQ (drospirenone and estradiol) .
• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• have kidney disease, liver disease, or disease of your adrenal glands.
• are allergic to ANGELIQ (drospirenone and estradiol) or any of its ingredients. See the end of this leaflet for a list of ingredients in ANGELIQ (drospirenone and estradiol) .
• think you may be pregnant.

Tell your healthcare provider:

• if you are breastfeeding. The hormone in ANGELIQ (drospirenone and estradiol) can pass into your milk.
• about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, hypertension (high blood pressure) or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ANGELIQ (drospirenone and estradiol) works. ANGELIQ (drospirenone and estradiol) may also affect how your other medicines work.
• if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How should I take ANGELIQ (drospirenone and estradiol) ?

1. Take one tablet every day.
2. Estrogens should be used only as long as needed. The lowest effective dose of ANGELIQ (drospirenone and estradiol) has not been determined. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with ANGELIQ (drospirenone and estradiol) .

What are the possible side effects of ANGELIQ (drospirenone and estradiol) ?

ANGELIQ (drospirenone and estradiol) is different from other hormonal medicines for menopausal symptoms because it contains drospirenone, and drospirenone may increase the potassium or lower the sodium in your blood.

You should not take ANGELIQ (drospirenone and estradiol) if you have kidney, liver or adrenal disease because these conditions may also increase the potassium in your blood. Some other medicines also increase potassium. If you regularly take another medicine that increases potassium levels, talk with your healthcare provider about whether ANGELIQ (drospirenone and estradiol) is right for you. In some situations, your healthcare provider may recommend testing your blood for potassium.

Less common but serious side effects include the following and should be discussed with your healthcare provider to assess your personal risks:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer

These are some of the warning signs of serious side effects:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargement of benign tumors of the uterus (“fibroids”)
• Vaginal yeast infection

These are not all the possible side effects of ANGELIQ (drospirenone and estradiol) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with ANGELIQ (drospirenone and estradiol) ?

Talk with your healthcare provider regularly about whether you should continue taking ANGELIQ (drospirenone and estradiol) .

See your healthcare provider right away if you get vaginal bleeding while taking ANGELIQ (drospirenone and estradiol) .

Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.

If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of ANGELIQ (drospirenone and estradiol) .

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ANGELIQ (drospirenone and estradiol) for conditions for which it was not prescribed. Do not give ANGELIQ (drospirenone and estradiol) to other people, even if they have the same symptoms you have. It may harm them.

Keep ANGELIQ (drospirenone and estradiol) out of the reach of children

This leaflet summarizes the most important information about ANGELIQ (drospirenone and estradiol) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ANGELIQ (drospirenone and estradiol) that is written for health professionals. You can get more information by calling our toll free number (1-888-237-5394) or visit www.angeliq (drospirenone and estradiol) -us.com

What are the ingredients in ANGELIQ (drospirenone and estradiol) ?

The active ingredients in ANGELIQ (drospirenone and estradiol) are drospirenone (a progestin) and estradiol. ANGELIQ (drospirenone and estradiol) also contains lactose monohydrate NF, corn starch NF, modified starch NF, povidone USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

Do not store above 86°F (30°C).

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.