drospirenone and estradiol

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Pronunciation: droe SPYE re none and ES tra DYE ole

Brand: Angeliq

What is the most important information I should know about drospirenone and estradiol?

You should not take this medicine if you have: a bleeding or blood-clotting disorder, circulation problems, unusual vaginal bleeding, kidney disease, liver disease, an adrenal gland disorder, if you have had a hysterectomy, if you have had a heart attack or stroke, or if you have ever had breast or uterine cancer, or a blood clot (especially in your lung or your lower body).

Do not use if you are pregnant.

This medicine should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

What is 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.

Drospirenone and estradiol is a combination medicine used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medicine is for use only if you have a uterus (if you have not had a hysterectomy).

Drospirenone and estradiol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking drospirenone and estradiol?

You should not take this medicine if you are allergic to drospirenone or estradiol, or if you have:

  • a bleeding or blood-clotting disorder, or circulation problems;
  • unusual vaginal bleeding that a doctor has not checked;
  • kidney disease;
  • liver disease;
  • an adrenal gland disorder;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • if you have had your uterus removed (hysterectomy);
  • if you are pregnant or plan to become pregnant;
  • if you have had a heart attack or stroke; or
  • if you have ever had a blood clot (especially in your lung or your lower body).

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

To make sure this medicine is safe for you, tell your doctor if you have:

  • heart disease;
  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);
  • a thyroid disorder;
  • endometriosis;
  • high levels of calcium, sodium, or potassium in your blood;
  • hereditary angioedema (an immune system disorder);
  • gallbladder disease;
  • asthma;
  • migraine headaches;
  • a history of jaundice caused by pregnancy or taking hormones;
  • epilepsy or other seizure disorder;
  • a history of breast lump or abnormal mammogram; or
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Taking the combination of drospirenone and estradiol may reduce this risk. Talk with your doctor about your individual risk, and report any unusual vaginal bleeding right away.

Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant. Tell your doctor right away if you become pregnant during treatment.

The hormones in drospirenone and estradiol can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding a baby.

How should I take drospirenone and estradiol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break a drospirenone and estradiol tablet. Swallow it whole.

Try to take drospirenone and estradiol at the same time each day.

If you need surgery or medical tests or if you will be on 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 taking drospirenone and estradiol.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Have regular physical exams and mammograms, and self-examine your breasts for lumps every month.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 24 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking drospirenone and estradiol?

Avoid drinking alcohol while you are taking this medication.

Grapefruit and grapefruit juice may interact with drospirenone and estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of drospirenone and estradiol?

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

Stop using this medicine and call your doctor at once if you have:

  • abnormal vaginal bleeding;
  • a breast lump;
  • confusion, unusual thoughts or behavior;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
  • high potassium --nausea, slow or unusual heart rate, weakness, loss of movement;
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • 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 in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • light vaginal bleeding or spotting;
  • breast pain or tenderness;
  • headache, mood changes;
  • nausea, stomach pain, diarrhea;
  • swelling, weight gain; or
  • vaginal itching or discharge.

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.

What other drugs will affect drospirenone and estradiol?

Other drugs may interact with drospirenone and estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about drospirenone and estradiol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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