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|Premphase

Premphase

Premphase is used for:

Treating menopausal symptoms (eg, hot flashes, vaginal dryness). If you are only being treated for vaginal menopause symptoms, products applied locally, such as vaginal creams, tablets, or rings, should be considered before products taken by mouth or absorbed through the skin. This medicine is also used to prevent bone loss (osteoporosis) in women at high risk.

Premphase is a combination of hormones (estrogen and progestin). It works by replacing hormones that the body makes less of.

Do NOT use Premphase if:

• you are allergic to any ingredient in Premphase
• you are pregnant or think you may be pregnant
• you have abnormal vaginal bleeding, an estrogen-dependent tumor, a history of blood clots, circulation problems, active/recent stroke or heart attack, or liver disease
• you have or have had breast, uterine, ovarian, or vaginal cancer; or have had a hysterectomy (removal of the uterus)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Premphase :

Some medical conditions may interact with Premphase . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a family history of breast cancer or have had an abnormal breast mammogram or x-ray, a noncancerous lump on the breast, or bone cancer
• if you have asthma, diabetes, seizures, dementia, migraine headaches, heart disease (eg, high blood pressure, heart attacks, heart failure), kidney disease, an underactive thyroid, lupus, pancreatitis, or abnormal calcium levels in the blood
• if you have depression, uterus problems (eg, uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, a blood disorder (eg, porphyria), or are significantly overweight
• if you have had high blood pressure during pregnancy or yellowing of the skin or eyes during pregnancy or with past estrogen use
• if you are scheduled for surgery or will be on bed rest
• if you smoke cigarettes or use tobacco

Some MEDICINES MAY INTERACT with Premphase . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminogluthethimide, hydantoins (eg, phenytoin), or rifampin because they may decrease Premphase "s effectiveness
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or their risk of side effects may be increased by Premphase
• Corticosteroids (eg, prednisone) or succinylcholine because the risk of their side effects may be increased by Premphase

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premphase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Premphase :

Use Premphase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Premphase by mouth with food or right after a meal to prevent stomach upset.
• An extra patient leaflet is available with Premphase . Talk to your pharmacist if you have questions about this information.
• Premphase works best if it is taken at the same time each day.
• Continue to take Premphase even if you feel well. Do not miss any doses.
• If you miss a dose of Premphase , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Premphase .

Important safety information:

• Premphase may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Premphase with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Premphase may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. If patches develop, consult your doctor about the use of sunscreen or protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.
• Premphase may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years of age).
• You should talk to your doctor about instructions for examining your own breasts, and report any lumps to your doctor immediately.
• Before you have surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), talk to your doctor about your use of Premphase .
• Tell your doctor or dentist that you take Premphase before you receive any medical or dental care, emergency care, or surgery.
• Premphase may interfere with certain lab tests. Be sure your doctors and lab personnel know that you are using Premphase .
• Diabetes patients - Premphase may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including blood pressure monitoring and Pap smears, may be performed while you use Premphase . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Premphase with caution in the ELDERLY; they may be more sensitive to its effects.
• Premphase should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Premphase if you are pregnant. If you think you may be pregnant, contact your doctor right away. Premphase is found in breast milk. Do not breast-feed while using Premphase .

Possible side effects of Premphase :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal hair growth; bloating; breast tenderness or pain; changes in sleep patterns; darkening of the skin; dizziness; fatigue; hair loss; headache; irritability; lightheadedness; increased or decreased sex drive; nausea; stomach cramps; stomach upset; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or swelling; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); chest pain; faintness; leg pain; mental or mood changes (eg, severe depression, memory loss); one-sided weakness; shortness of breath; slurred speech; sudden severe headache; swelling of hands or feet; unusual vaginal discharge, itching, or odor; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea and vomiting.

Store Premphase at room temperature, between 68 and 77 degrees F (20 and 20 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Premphase out of the reach of children and away from pets.

General information:

• If you have any questions about Premphase , please talk with your doctor, pharmacist, or other health care provider.
• Premphase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Premphase . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.