Synthetic Conjugated Estrogens (B) oral tablet

What is this medication?

SYNTHETIC CONJUGATED ESTROGENS (B) (sin THET ic CON ju gate ed ESS troe jenz B) is an estrogen. It is mostly used as hormone replacement in menopausal women to treat hot flashes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Enjuvia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

•abnormal vaginal bleeding

•blood vessel disease or blood clots

•breast, cervical, endometrial, ovarian, liver, or uterine cancer

•dementia

•diabetes

•endometriosis

•fibroids

•gallbladder disease

•heart disease or recent heart attack

•high blood pressure

•high cholesterol

•high level of calcium in the blood

•kidney disease

•liver disease

•mental depression

•migraine headaches

•stroke

•tobacco smoker

•an unusual or allergic reaction to estrogens, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals, at the same time each day. Do not take your medicine more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

•aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

•metyrapone

This medicine may also interact with the following medications:

•barbiturates, such as phenobarbital

•carbamazepine

•clarithromycin

•erythromycin

•grapefruit juice

•medicines for fungal infections like ketoconazole and itraconazole

•phenytoin

•ritonavir

•St. John's Wort

•thyroid hormones

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow their guidelines for these tests.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

If you have any reason to think you are pregnant, stop taking this medication at once and contact your care team.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. The risk is higher if you are over the age of 35.

This medication can cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

This medication can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone medication, with this medication lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your care team may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your care team to determine the benefits and risks for you.

If you are going to have surgery, you may need to stop taking this medication. Consult your care team for advice before you schedule the surgery.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•breast tissue changes or discharge

•changes in vision

•chest pain

•confusion, trouble speaking or understanding

•dark urine

•general ill feeling or flu-like symptoms

•light-colored stools

•nausea, vomiting

•pain, swelling, warmth in the leg

•right upper belly pain

•severe headaches

•shortness of breath

•sudden numbness or weakness of the face, arm or leg

•trouble walking, dizziness, loss of balance or coordination

•unusual vaginal bleeding

•yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•hair loss

•increased hunger or thirst

•increased urination

•symptoms of vaginal infection like itching, irritation or unusual discharge

•unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.