drospirenone 0.5 mg-estradiol 1 mg tablet

Generic name:
Drospirenone/estradiol - oral

Pronunciation
(droh-SPYE-re-none/ess-truh-DYE-all)

Brand name(s)
Angeliq

Rarely, very serious side effects have occurred when estrogen-only and combination hormone replacement therapies (estrogen and progestin HRT) are used after menopause. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.

Combination HRT should not be used to prevent heart disease or dementia. Combination HRT may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs), dementia, and breast cancer. The risk for stroke and breast cancer increases with age, especially for women older than 75. Estrogens may also increase the risk of cancer of the ovaries. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. This medication should be used for the shortest possible length of time at the lowest effective dose, so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss the details with your doctor and check with him/her regularly (such as every 3-6 months) to see if you still need to take this medication.

If you use this drug for an extended time, you should have a complete physical exam at regular intervals (such as once a year) or as directed by your doctor. See Notes section.

This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of estrogen. This medication is a combination of 2 types of hormones: an estrogen (estradiol) and a progestin (drospirenone). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication.

If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Certain combination HRT products may also be prescribed for bone loss (osteoporosis) in people at high risk who cannot take other drugs that are safe and effective to prevent or treat bone loss (such as raloxifene, bisphosphonates such as alendronate). These medicines should be considered for use before estrogen/progestin HRT therapy for osteoporosis.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, memory loss)
• breast lumps
• nipple discharge
• swelling of the hands/feet
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/returning bleeding)
• yellowing eyes/skin
• stomach/abdominal pain
• worsening of a seizure condition
• muscle weakness
• signs of worsening diabetes control (such as increased thirst and urination)
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• pain/swelling/warmth in the groin/calf
• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• sudden dizziness/fainting
• confusion
• trouble speaking
• weakness on one side of the body
• sudden vision changes
• sudden/severe headaches

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone or estradiol; or to spironolactone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• vaginal bleeding of unknown cause
• certain types of cancer (breast, ovary, uterus)
• blood clotting disorders (such as protein C or protein S deficiency)
• current/history of blood clots (such as in the legs, eyes, lungs)
• stroke
• liver disease
• kidney disease
• adrenal gland problems
• family medical history (including blood clots, breast lumps/cancer)
• family or personal history of a certain swelling disorder (angioedema)
• asthma
• diabetes
• seizures
• migraine headaches
• heart disease (such as high blood pressure, heart failure, heart attack)
• underactive thyroid (hypothyroidism)
• a certain hormone problem (hypoparathyroidism)
• mineral imbalance (high or low calcium blood level, high potassium blood level, low sodium blood level)
• mental/mood disorders (such as depression, memory loss)
• high blood pressure during pregnancy (toxemia)
• yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use
• uterus problems (such as uterine fibroids, endometriosis)
• high blood cholesterol/fat (triglyceride) levels
• gallbladder disease
• obesity
• a certain metabolic disorder (porphyria)
• lupus

This drug may make you dizzy or lightheaded. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

Do not smoke cigarettes or use tobacco. Smoking/using tobacco while taking this medication further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.

If you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight), tell your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug because of the increased risk for blood clots.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication is not effective for preventing a miscarriage and should not be used for this purpose.

This medication passes into breast milk. Consult your doctor before breastfeeding.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aromatase inhibitors (such as anastrozole, exemestane)
• atazanavir/cobicistat
• corticosteroids (such as prednisone)
• fezolinetant
• ospemifene
• raloxifene
• tamoxifen
• tizanidine
• tranexamic acid
• warfarin

Drospirenone may raise your potassium blood level. Tell your doctor if you are regularly taking other drugs/products that can also raise your potassium level (including aliskiren, ACE inhibitors such as enalapril/lisinopril, angiotensin receptor blockers such as losartan/valsartan, heparin, NSAIDs such as ibuprofen/naproxen, potassium-sparing "water pills"/diuretics such as eplerenone/spironolactone/triamterene).

Other medications can affect the removal of estrogen from your body, which may affect how estrogen works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding in females.

Do not share this medication with others. Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Additional lifestyle changes (such as reducing stress, eating a low fat/low salt diet, losing weight if you are overweight) to control or prevent high blood pressure, high cholesterol, and diabetes help to prevent heart disease and strokes. Keep your mind active with mental exercises to help prevent dementia. Discuss with your doctor lifestyle changes that might benefit you.

You can also manage hot flashes by keeping a cool body temperature (such as by using a fan, drinking cool beverages, dressing lightly/in layers, avoiding hot/spicy foods). Limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.