Synthetic conjugated estrogens, B (By mouth)

Introduction

Conjugated Estrogens Synthetic B (KON-joo-gay-ted ES-troe-jenz sin-THET-ik B)

Treats symptoms of menopause, such as hot flashes (warmth or redness in your face, neck, arms, or upper chest) and vaginal dryness, which may cause pain with sex.

Brand Name(s)

Enjuvia

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to estrogen, or if you are pregnant. Do not use this medicine if you have liver disease or certain kinds of cancer, such as cancer of the breast or uterus. You should not use this medicine if you have had a heart attack, stroke, or a problem with blood clots, such as a deep vein thrombosis (DVT) or a lung embolism, in the past year. Do not use this medicine if you have unusual vaginal bleeding that has not been checked by a doctor.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also using medicine for thyroid problems (such as levothyroxine or Synthroid®) or a blood thinner (such as warfarin or Coumadin®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are breastfeeding, or if you have heart disease, kidney disease, thyroid disease, gallbladder problems, high or low levels of calcium in your blood, or a history of cancer. Make sure your doctor knows if you have ever had liver problems caused by estrogen use or during pregnancy. Tell your doctor if you have endometriosis (uterus problem), asthma, epilepsy, migraine headaches, lupus, or porphyria (an enzyme problem).
• Taking large amounts of this medicine over long periods of time may increase your risk for having some kinds of cancer. This risk may continue even after you stop using the medicine. Talk to your doctor about your personal risks compared with the benefits of this medicine.
• Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, or diabetes. Your risk is also greater if you are overweight or smoke cigarettes. Talk to your doctor about your personal risks compared with the benefits of this medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• This medicine may increase the risk for having dementia (loss of some mental abilities, such as memory or judgment) in women over 65 years old. Talk with your doctor about this risk.

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 lump.
• Chest pain, shortness of breath, or coughing up blood.
• Confusion or memory problems.
• Dizziness or fainting.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Trouble seeing or double vision.
• Unusual vaginal bleeding or discharge.
• Yellowing of your skin or the whites of your eyes.

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

• Breast pain.
• Hair loss.
• Nausea, vomiting, bloating, or stomach pain or cramps.
• Spotty or irregular vaginal bleeding.

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