Estradiol-Drospirenone

Warning

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 can rarely cause heart disease (such as heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), 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.

Precautions

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.

Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk. Consult your doctor before breastfeeding.

Side Effects

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 deep vein thrombosis, pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, trouble speaking, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very 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.

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