Information About Activella



Chemical Name: ESTRADIOL (es-tra-DYE-ole) and NORETHINDRONE (nor-eth-IN-drone) ACETATE

Common uses
Activella is an estrogen and progestin combination used to reduce menopausal symptoms. It is also used to prevent osteoporosis. Activella may also be used to treat other conditions as determined by your physician. There are several medications (e.g. raloxifene or bisphosphonates) that are safe and effective to prevent or treat bone loss. These medicines should be considered for use before estrogen/progestin HRT for osteoporosis. If you have other medical conditions as well and are prescribed estrogen/progestin HRT for more than one condition, consult your physician about your treatment plan and its options.

Prior to Use
Two-drug combination hormone replacement therapy (estrogen and progestin menopause HRT) can infrequently cause breast cancer, heart disease (CHD/MI), stroke, dementia, or blood clots in the lung (PE) if used for a long period of time (greater than one year). Therefore, the risks of use of HRT for a long period of time (more than one year) must be discussed with your physician. Use of two-drug HRT for short periods of time (less than one year) to relieve menopause symptoms may be considered. Discuss the risks and benefits with your physician. Blood clots may be more likely to form during very long periods of sitting or if you are bedridden, as well as with certain types of surgery. If this applies to you, ask your physician whether you should temporarily stop your medication. Be aware that pre-existing medical conditions, or taking additional medications could interfere with the effectiveness of this one. Let your physician or pharmacist know about any other medications -- prescription or over-the-counter -- that you are using. Inform your physician of any other medical conditions including heart disease or circulation problems (e.g., stroke or heart attack), asthma, migraine headaches, any previous cancers, blood disorders (e.g., blood clots), gallbladder disease, history of depression, diabetes, seizure disorders, undiagnosed abnormal vaginal bleeding, any allergies, pregnancy, or breast-feeding. If you are taking any of the following, your dose or condition may need regular supervision: carvedilol, corticosteroids, metoprolol, rifampin, theophylline, troleandomycin, or medicine for seizures. You should not take Activella if you have had a hysterectomy, liver disease, or a history of pulmonary embolism. If you have questions or concerns about Activella, be sure to let your physician or pharmacist know.

Instructions for Use
Follow your physician's instructions for taking Activella. Activella comes with a patient information leaflet. Read it carefully. Ask your physician, nurse, or pharmacist any questions that you may have before using Activella. Activella should be used for the shortest possible length of time so you obtain the benefits and minimize the chance of serious side effects from long-term therapy. Consult your physician for more details. Try to take Activella at the same time every day. Store Activella at room temperature between 59 and 86 degrees F (15 and 30 degrees C), away from heat and light. Should you skip or forget a dose of Activella, begin using it immediately. If it is almost time for your next dose, omit the skipped dose and continue to follow your original dosing schedule. Never take more than one dose at the same time.

Warnings
Keep all physician and laboratory appointments while you are using Activella. Before you have any medical or dental treatments, emergency care, or surgery, tell the physician or dentist that you are using Activella. You should perform regular self-examinations of your breasts. If you have any questions about how to do this, ask your physician, nurse, or pharmacist. Smoking while using Activella may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Activella. Using Activella alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. If you wear contact lenses and you develop problems with them, contact your physician. Activella may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. Do not use Activella if you are pregnant. Be sure to consult your physician if you think you might be pregnant immediately. Activella is excreted in breast milk if you are or will be breast-feeding while you are using Activella, consult your pharmacist or physician to discuss the risks to your baby. If you have diabetes, Activella may affect your blood sugar. Check blood sugar levels closely and ask your physician before adjusting the dose of your diabetes medicine.

Potential Side Effects
Side effects that could disappear while taking Activella, include dizziness, lightheadedness, nausea, stomach upset, or bloating. Consult your physician if they do not go away or if they bring you difficulties. Consult your physician immediately if you experience mental/mood changes (e.g., severe depression); breast tenderness; weight change; or swelling of your fingers or ankles. Contact your physician immediately if you experience calf/leg pain or swelling; trouble breathing or shortness of breath; chest pain; one-sided weakness; slurred speech; lumps in the breast; sudden severe headache, dizziness, or fainting; yellowing of the skin or eyes; dark urine; abnormal vaginal bleeding; or abdominal pain, swelling, or tenderness; vomiting; vision problems; or coughing up blood. Let your physician, pharmacist, or nurse know if you experience any side-effects not listed here.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job.

In Case of Overdose
Contact a poison control center or visit an emergency room immediately, if you think you have overdosed. Indications of an overdose are severe nausea and vomiting, and excessive vaginal bleeding.

Additional information
If you are taking Activella to prevent osteoporosis, it is important to have enough calcium and vitamin D in your diet. Ask your physician, nurse, or pharmacist if you have questions about your diet or about taking dietary supplements such as calcium or vitamin d. do not share Activella with others for whom it was not prescribed. Do not take Activella to treat health conditions other than what it was prescribed for. Store this and all medication away from the reach of children. If using Activella for an extended period of time, obtain refills before your supply runs out.





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Activella