Estradiol (es-tra-DYE-ol), Norethindrone (nor-ETH-in-drone)

Treats symptoms of menopause (including hot flashes, night sweats, and vaginal problems). Also prevents osteoporosis after menopause.

Brand Name(s):

Activella, Amabelz, Mimvey, Mimvey Lo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine comes in a dispenser pack with a calendar reminder dial.
  • To use this dispenser, first turn the inner disc so the current day of the week is lined up with the plastic tab. Pull the plastic tab up and break if off. Remove the first tablet.
  • To get the next tablet out (on the next day), turn the dial one space clockwise as shown by the arrow.
  • The dial can be turned only after the tablet in the opening has been removed. This will help you remember to take 1 tablet every day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• 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/norethindrone 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, heart disease, asthma, diabetes, endometriosis, epilepsy, migraine headaches, porphyria, lupus, thyroid problems, edema (swelling), hereditary angioedema, high blood pressure, seizures, high cholesterol, or a history of cancer. Tell you doctor if you have had your uterus (womb) removed (hysterectomy). Tell your doctor if you have had liver problems caused by pregnancy or estrogen, 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
  • Increased 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, trouble breathing, coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• 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 these less serious side effects, talk with your doctor:

• Back, arm, or leg pain
• Diarrhea, stomach upset

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