Information About Alora

Common uses
Alora is a female hormone usually given to women who no longer produce the proper amount. It is used to reduce menopause symptoms such as hot flashes or vaginal dryness/discomfort or to prevent bone loss (osteoporosis) in those at high risk. Alora may be use to treat other conditions as determined by your physician.

Prior to Use
Estrogens have been reported to increase the chance of womb (endometrial) cancer, especially in women who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen used alone or in combination with another hormone (progestin) can increase the risk for heart disease (including heart attacks), stroke, serious blood clots in the lung (pulmonary embolism) or leg (deep venous thrombosis), cancer of the breast, or dementia. These risks appear to depend on the length of time Alora is used and the amount of estrogen per dose. Therefore, Alora should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. For details, contact your physician or pharmacist. 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. If you are taking any of the following, your dose or condition may need regular supervision: corticosteroids (such as prednisone), seizure medicines (such as phenytoin, carbamazepine, or phenobarbital), "blood thinners" (such as warfarin), certain antifungal medicines (such as ketoconazole or itraconazole), macrolide antibiotics (such as clarithromycin or erythromycin), cimetidine, rifampin, ritonavir, tacrine, or St. John's wort. Do not start or stop any medicine without physician or pharmacist approval. Inform your physician of any other medical conditions including any personal or family history of cancer, breast lumps, clotting problems, womb problems (such as uterine fibroids or endometriosis), heart disease (such as high blood pressure, heart attacks, or congestive heart failure), stroke, diabetes, cholesterol/lipid problems, gallbladder problems, low thyroid hormone (hypothyroidism), high blood pressure during pregnancy (toxemia), yellowing of the eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, depression, asthma, seizures, migraine headaches, kidney problems, abnormal calcium level in the blood, lupus, growths on the liver, history of tobacco use, excessive weight gain, allergies, pregnancy, or breast-feeding. You should not take Alora if you have a history of undiagnosed or abnormal vaginal bleeding, certain types of cancers (such as breast cancer), estrogen-dependent growths, history of blood clots or clotting problems, liver problems, certain blood disorders (porphyria), active/recent (within the past year) stroke or heart attack. If you have questions or concerns about Alora, be sure to let your physician or pharmacist know.

Instructions for Use
Follow your physician's instructions for taking Alora. Alora comes with a patient information leaflet. Read it carefully. Ask your physician, nurse, or pharmacist any questions you may have about Alora. The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your physician. Follow the dosing schedule carefully. Do not open the sealed pouch containing the patch until ready to use. Tear open the pouch (do not use scissors) and remove the patch from the protective liner. Apply the patch to a clean, dry, hairless area of the body as described in the patient information leaflet or on the package. Avoid applying to an area that is oily, irritated, or injured. Do not place the patch on the breast. Avoid applying to the waistline since tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. If you have any questions about where to apply the patch, contact your physician, nurse, or pharmacist for instructions. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. When it is time to change the patch, remove it slowly, fold in half (sticky sides together), and dispose of it properly. Apply a new patch to a different area to prevent skin irritation. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your physician promptly. Contact with water while bathing, showering, or swimming will not affect the patch. Store Alora at room temperature below 86 degrees F (30 degrees C), in the original sealed pouch, away from heat, moisture, and light. Use Alora regularly to receive the most benefit from it. Using Alora at the same times each week will help you to remember. Should you skip or forget a dose of Alora, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do NOT use 2 doses at once.

Warnings
Do not use Alora 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 Alora for longer than prescribed without checking with your physician. Laboratory and/or medical tests, including blood pressure measurements, triglyceride blood levels, breast and pelvic examinations, pap tests (for cervical cancer), or mammogram may be performed to monitor your progress or to check for side effects. Follow your physician's instructions for performing monthly breast self-examinations and report any lumps immediately. Keep all physician and laboratory appointments while you are taking Alora. If you take Alora for an extended period of time, you should be evaluated regularly by your physician to determine if you need to continue taking Alora. Alora may affect certain lab test results. Make sure laboratory personnel and your physicians know you take Alora. Before you have any medical or dental treatments, emergency care, or surgery, tell the physician or dentist that you are taking Alora. 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 physician beforehand. Alora may cause dizziness do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alora. Using Alora alone, with other medicines, or with alcohol may lessen your ability to drive, or to perform other potentially dangerous tasks. Alora 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. Alora may cause hyperglycemia (high blood sugar). Symptoms of hyperglycemia include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your physician immediately. smoking while using Alora may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels. Before you begin taking any new medicine, either prescription or over-the-counter, consult your pharmacist or physician . Caution is advised when using Alora in the elderly or in children because they may be more sensitive to the effects of Alora. Growth patterns in children should be monitored as Alora may affect their growth. Women, do not use Alora if you are pregnant. Be sure to consult your physician if you think you might be pregnant immediately. Alora is excreted in breast milk if you will be breast-feeding while you are taking Alora, consult your pharmacist or physician to discuss the risks to your baby. If you have diabetes, Alora 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 may go away during treatment, include dizziness, headache, breast pain or tenderness, or skin redness/irritation at the application site. Consult your physician if they do not go away or if they bring you difficulties. Consult your physician immediately if you experience stomach upset, pain, or bloating; persistent nausea; vomiting; unexplained weight changes; unusual vaginal discharge/itching/odor; increased/decreased interest in sex; or hair loss. Contact your physician immediately if you experience mental/mood changes (such as severe depression, memory loss, or confusion); severe dizziness or fainting; sudden severe headache; one-sided weakness; slurred speech; vision changes (such as a change in contact lens fit, loss of vision, or double vision); chest pain; shortness of breath; pain or swelling of the hands, legs, or feet; calf pain, swelling, or tenderness; breast lumps; nipple discharge; changes in vaginal bleeding (such as spotting, breakthrough bleeding, or prolonged bleeding); seizures; yellowing of eyes or skin; irregular heartbeat; or muscle cramps. An allergic reaction to Alora is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. 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
It is important that you and your physician regularly re-evaluate your need for Alora. 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 physician or pharmacist for more details. Do not let anyone else use Alora. Do not take Alora to treat health conditions other than what it was prescribed for. Store this and all medication away from the reach of children and pets. After removing the used patch, fold over with the sticky side together. Discard the patch out of reach of children and pets. If using Alora for an extended period of time, obtain refills before your supply runs out.