PATIENT INFORMATION

Angioedema: Angioedema, including laryngeal edema, can occur with ACE inhibitor therapy, especially following the first dose. Patients should be told to report immediately signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, hoarseness or difficulty in swallowing or breathing) and to take no more drug before consulting a physician.

Symptomatic Hypotension: As with any antihypertensive therapy, patients should be cautioned that lightheadedness can occur, especially during the first few days of therapy and that it should be reported promptly. Patients should be told that if fainting occurs, ACEON® Tablets should be discontinued and a physician consulted.

All patients should be cautioned that inadequate fluid intake or excessive perspiration, diarrhea or vomiting can lead to an excessive fall in blood pressure in association with ACE inhibitor therapy.

Hyperkalemia: Patients should be advised not to use potassium supplements or salt substitutes containing potassium without a physician’s advice.

Neutropenia: Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) which could be a sign of neutropenia.

Pregnancy: Female patients of childbearing age should be told about the consequences of second and third trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

Please also see WARNINGS and PRECAUTIONS.