Drospirenone/estradiol (By mouth)

Introduction

Drospirenone (droe-SPYE-re-none), Estradiol (es-tra-DYE-ol)

Treats hot flashes and other symptoms of menopause in women who still have a uterus. Also treats dryness, itching, and burning in and around the vagina in women who still have a uterus. This medicine contains estrogen and progestin (female hormones).

Brand Name(s)

Angeliq

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to drospirenone or estradiol. You should not use this medicine if you have an adrenal gland problem, kidney disease, liver disease, or cancer of the breast or uterus. Do not use this medicine if you have a history of heart attack, stroke, or blood clotting problems. Do not use this medicine if you may be pregnant, are breastfeeding, or have unusual vaginal bleeding that has not been checked by a doctor. This medicine should not be used to prevent heart disease, heart attack, stroke, or dementia.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Take this medicine at the same time every day.
• Begin a new blister pack the next day after the old pack is empty.
• Swallow the tablet whole with liquids. Do not break, crush, or chew it.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.If you forget to take the tablets for several days, bleeding may occur.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using St. John's wort, carbamazepine (Tegretol®), clarithromycin (Biaxin®), erythromycin (Ery-Tab®), heparin, itraconazole (Sporanox®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), certain blood pressure medicines (such as captopril, enalapril, lisinopril, losartan, olmesartan, valsartan, Accupril®, Atacand®, Avapro®, Cozaar®, Diovan® Lotrel®, Mavik®, Monopril®, Prinivil®, Zestoretic®, or Zestril®), or pain or arthritis medicine called NSAIDs (such as celecoxib, ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, Ecotrin®, or Motrin®).
• Tell your doctor if you are also using a diuretic or water pill (such as eplerenone, spironolactone, triamterene, Aldactone®, or Inspra®) or potassium supplements.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have endometriosis or a history of cancer. Tell your doctor if you have asthma, diabetes, epilepsy, inherited angioedema (swelling of the face, lips, tongue, or throat), lupus, migraine headache, porphyria, or a thyroid problem. Your doctor should know if you have edema (body swelling), heart disease, high blood pressure, high cholesterol, high potassium in the blood, high or low calcium in the blood, or low sodium in the blood. Tell your doctor if you have ever had liver problems caused by pregnancy or estrogen.
• Using this medicine may increase your risk for blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol, or diabetes. Your risk is also greater if you are overweight or smoke cigarettes. Talk to your doctor about your personal risks compared with the benefits of this medicine.
• Using this medicine may increase your risk of some kinds of cancer, including cancer of the uterus. Check with your doctor right away if you have unusual vaginal bleeding.
• Tell your doctor if you have a severe headache or vision changes. Your doctor may want you to have your eyes checked by an eye doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for a long time. This medicine may affect the results of certain medical tests.
• This medicine may increase the risk for dementia (loss of some mental abilities, such as memory or judgment), especially in women over 65 years of age. Talk with your doctor about this risk.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. You should have regular pelvic exams, breast exams, and mammograms.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lumps
• Chest pain, shortness of breath, or coughing up blood
• Confusion, body weakness, uneven heartbeat, shortness of breath, or numbness or tingling in your hands, feet, or lips
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Problems with vision, speech, or walking
• Rapid weight gain
• Sudden and severe stomach pain, with or without nausea, vomiting, fever, and lightheadedness
• Sudden or severe headache
• Swelling in your hands, ankles, or feet
• Unusual vaginal bleeding or discharge

If you notice these less serious side effects, talk with your doctor:

• Abdominal pain or tenderness
• Back pain or body aches
• Breast pain, swelling, or tenderness
• Headache