Premarin Tablets

GENERIC NAME: CONJUGATED ESTROGENS (KON-joo-gay-ted ES-troe-jenz)

COMMON USES: This medicine is a female hormone and is usually given to women who do not produce the proper amount. It is used to reduce menopause symptoms (such as hot flashes or vaginal dryness), to prevent bone loss (osteoporosis) in some post-menopausal women, to treat certain cancers in men and women (such as certain types of metastatic breast cancer or androgen-dependent prostate cancer), or to treat low estrogen levels caused by certain conditions. It may be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Laboratory and/or medical tests, including physical exams, blood pressure, cholesterol levels, breast and pelvic examinations, PAP tests, or mammogram may be performed to monitor your progress or to check for side effects. Follow your doctor's instructions for performing monthly breast self-examinations and report any lumps immediately. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. If you take this medicine for an extended period of time, you should be evaluated regularly by your doctor to determine if you need to continue taking this medicine. THIS MEDICINE MAY AFFECT certain lab test results. Make sure laboratory personnel and your doctors know you take this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking this medicine. If you will be having surgery or will be confined to a chair (such as a long plane flight) or bed for a long period of time, notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking this medicine or take other special precautions for a period of time. THIS MEDICINE MAY CAUSE dark skin patches on your face (melasma). Exposure to the sun, sunlamps, or tanning booths may make these patches darker. Use a sunscreen or protective clothing if you must be outside for a prolonged period. IF YOU WEAR CONTACT LENSES and you develop problems with them, contact your doctor. 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. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options. SMOKING WHILE USING THIS MEDICINE may increase your risk of blood clots (especially in women over 35 years old). BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of this medicine. Growth patterns in children should be monitored as this medicine may affect their growth and/or development. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include breast pain or tenderness; fluid retention; gas; headache; hair loss; mild nausea or vomiting; nervousness; spotting or breakthrough bleeding; stomach cramps or bloating. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal vaginal bleeding; breast lumps or pain; calf pain, swelling, or tenderness; chest pain; confusion; coughing up blood; dizziness; fainting; mental or mood changes; new or worsening memory problems; severe headache; severe or persistent stomach pain or tenderness; slurred speech; shortness of breath; sudden, severe, or persistent vomiting; swelling of the hands or feet; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); unusual vaginal discharge/itching/odor; vision loss or other vision changes; weakness or numbness of an arm or leg; or yellowing of the skin or eyes. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: This medicine should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use this medicine. Talk with your doctor if you have questions about the benefits and risks of using this medicine. THIS MEDICINE SHOULD BE USED FOR THE SHORTEST POSSIBLE TIME AT THE LOWEST EFFECTIVE DOSE to minimize the risk of these side effects. Talk with your doctor regularly about your need to use this medicine. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking hydantoins (eg, phenytoin) or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of asthma, depression, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, porphyria, kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, thyroid problems, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer; if you have a vaginal infection or a history of uterus problems (eg fibroids, endometriosis, abnormal vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy); or if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time. Tell your doctor if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant or suspect you may be pregnant; if you have suspected breast cancer or a history of breast cancer, unless your doctor tells you otherwise; if you have other cancers that are estrogen-dependent; if you have liver problems or abnormal vaginal bleeding of unknown cause; if you have active blood clots (eg, of the legs or lungs), or a history of blood clots; or if you have recently (within the last year) had a stroke or heart attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include abnormal vaginal bleeding; breast tenderness; drowsiness or fatigue; nausea and vomiting; or stomach pain.

ADDITIONAL INFORMATION: It is important that you and your physician regularly re-evaluate your need for this medicine. Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.