Forbetes XR Patient Counseling Information

Patients should be informed of the potential risks and benefits of FORBETES 500 XR and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters.
The risk of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in PRECAUTIONS, should be explained to patients. Patients should be advised to discontinue FORBETES 500 XR immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of FORBETES 500 XR, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving FORBETES 500 XR.
FORBETES 500 XR alone does not usually cause hypoglycemia, although may occur when FORBETES 500 XR is used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment and conditions that predispose to its development should be explained to patients and responsible family members.