| Specifications | MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide Multaq medicaton guide MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide fda/cder |
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| Specifications | MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide Multaq medicaton guide MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide fda/cder |
| Business section |
| Specifications | MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide Multaq medicaton guide MULTAQ, SANOFI AVENTIS US LLC, Multaq medicaton guide fda/cder |
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| Content | Box of 10 blisters (10 tablets per blister) NDC 0024-4142-10 Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature]. 17 PATIENT COUNSELING INFORMATION 17.1 Information for Patients [See Medication Guide (17.2)] MULTAQ should be administered with a meal. Warn patients not to take MULTAQ with grapefruit juice. If a dose is missed, patients should take the next dose at the regularly scheduled time and should not double the dose. Advise patients to consult a physician if they develop signs or symptoms of heart failure such as acute weight gain, dependent edema, or increasing shortness of breath. Advise patients to immediately report any symptoms of potential liver injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant abdominal discomfort, jaundice, dark urine or itching) to their physician. Advise patients to inform their physician of any history of heart failure, rhythm disturbance other than atrial fibrillation or flutter or predisposing conditions such as uncorrected hypokalemia. MULTAQ may interact with some drugs; therefore, advise patients to report to their doctor the use of any other prescription, non-prescription medication or herbal products, particularly St. John’s wort. 17.2 Medication Guide Medication Guide MULTAQ (MUL-tak) (dronedarone) Tablets Read this Medication Guide before you start taking MULTAQ and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about MULTAQ? 1. MULTAQ is not for people with heart failure with symptoms which recently worsened or for people with severe heart failure. People with these conditions who take MULTAQ have an increased chance of dying. Heart failure means your heart does not pump blood through your body as well as it should. Reference ID: 3077191 23 |
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| Following Datasheets | UCM173430 (2 pages) UCM188476_1 (4 pages) UCM189544 (7 pages) UCM190609_1 (15 pages) UCM191474_1 (99 pages) UCM191985_1 (13 pages) UCM197252_1 (1 pages) UCM209068_1 (7 pages) UCM209196 (2 pages) UCM212937_1 (2 pages) |
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