Bijuva capsules contains a combination of estradiol (a form of estrogen) and progesterone. Both are female hormones.

Bijuva is used to reduce moderate to severe hot flashes caused by menopause.

Bijuva is for use only in a woman who has not had her uterus removed.

You should not use Bijuva if your uterus has been removed, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor if you have any vaginal bleeding.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Bijuva should not be used to prevent heart disease, stroke, or dementia.

Before taking this medicine

You should not take Bijuva if your uterus has been removed, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;

• a history of heart attack, stroke, or blood clot; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

To make sure Bijuva is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• gallbladder disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• diabetes;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• hereditary angioedema;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a thyroid disorder; or

• high levels of calcium in your blood.

Bijuva should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Estrogens can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estrogens may also increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Bijuva is not for use in a woman who is pregnant or breast-feeding.

Take Bijuva exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Bijuva capsules with food.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Bijuva.

Call your doctor if you have any unusual vaginal bleeding.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using Bijuva.

Store Bijuva capsules at room temperature away from moisture and heat.

Usual Adult Dose for Postmenopausal Symptoms:

1 capsule (estradiol 1 mg/progesterone 100 mg) orally once a day in the evening with food

Comments:
-Hormone replacement therapy should be limited to the shortest duration consistent with treatment goals and risks for the individual women.
-Reevaluate periodically to determine if treatment is still necessary.

Use: Treatment of moderate to severe vasomotor symptoms due to menopause.

You should not take Bijuva if your uterus has been removed, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;

• a history of heart attack, stroke, or blood clot; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

To make sure Bijuva is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• gallbladder disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• diabetes;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• hereditary angioedema;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a thyroid disorder; or

• high levels of calcium in your blood.

Bijuva should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Estrogens can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estrogens may also increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Bijuva is not for use in a woman who is pregnant or breast-feeding.

Take the medicine (with food) as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using this medicine.

Grapefruit may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction to Bijuva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision;

• signs of a blood clot - sudden vision loss, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; or

• high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common Bijuva side effects may include:

• pelvic pain;

• vaginal bleeding or discharge;

• breast tenderness; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with estradiol and progesterone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.