Estradiol (es-tra-DYE-ol), Progesterone (proe-JES-ter-one)

Treats moderate to severe symptoms of menopause (including hot flashes) in women with a uterus.

Brand Name(s):

Bijuva

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is more than 2 hours until your next dose, take the missed dose as soon as possible with food, then go back to your regular time. If you miss a dose and it is within 2 hours of your next evening dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how estradiol/progesterone works. Tell your doctor if you are using carbamazepine, clarithromycin, erythromycin, itraconazole, ketoconazole, phenobarbital, rifampin, ritonavir, St John's wort, or thyroid medicines.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, high blood pressure, diabetes, high cholesterol, obesity, lupus, migraine headaches, thyroid problems, edema (swelling), endometriosis, hereditary angioedema, asthma, seizures, porphyria, or a history of cancer. Tell your doctor if you have had your uterus (womb) removed (hysterectomy). Tell your doctor if you smoke or if you are having surgery that will require inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of endometrial, breast, or ovarian cancer
  • Possible risk of dementia (especially in women 65 years of age or older)
  • Gallbladder problem
  • Eye or vision problems
  • High blood pressure
  • High cholesterol or fats in the blood
  • Thyroid problems
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blurred or other changes in vision
• Breast lumps or tenderness
• Chest pain that may spread, coughing up blood, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, diarrhea, muscle pain, dizziness, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with memory, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Redness, pain, burning, or itching in or near your vagina
• Unusual vaginal bleeding, spotting, discharge, or itching

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