Conjugated Estrogens (KON-joo-gay-ted ES-troe-jenz), Medroxyprogesterone Acetate (me-drox-ee-proe-JES-ter-one AS-e-tate)

Treats hot flashes and vaginal dryness from menopause. Prevents osteoporosis after menopause. This medicine is a combination of 2 hormones.

Brand Name(s):

Premphase, Prempro, Prempro Low Dose

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.
• 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 and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  • Carbamazepine, phenobarbital
  • Clarithromycin, erythromycin
  • Itraconazole, ketoconazole
  • Rifampin
  • Ritonavir
  • St John's wort
  • Thyroid medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding or if you have endometriosis, asthma, diabetes, epilepsy, heart failure, high blood pressure, high cholesterol, kidney disease, lupus, migraine headaches, porphyria, or thyroid problems. Tell your doctor if you have a history of cancer or serious allergic reactions (such as hereditary angioedema).
• This medicine may increase your risk for the following:
  • Cancer, including breast cancer, especially with long-term use of large doses
  • Heart attack or dementia
  • Stroke or blood clots, especially if you smoke, you have high blood pressure, high cholesterol, or diabetes, or you are overweight
• Tell your doctor if you have a sudden, severe headache or vision changes while you are taking this medicine. He may want you to have your eyes checked by an eye doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Tell any doctor or dentist who treats you that you are taking this medicine. You may need to stop taking it before you have surgery or if you need to be on bedrest.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• Breast lumps
• Chest pain, shortness of breath, or coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your calf
• Severe or unusual vaginal bleeding
• Sudden and severe stomach pain, with or without nausea, vomiting, fever, and lightheadedness
• Swelling in your face, hands, ankles, or feet
• Yellowing of your skin or the whites of your eyes

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

• Breast pain
• Depression
• Light vaginal bleeding or spotting
• Mild stomach pain or cramps

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