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GLUCOTROL® XL Patient Counseling Information (glipizide extended release tablets)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the potential adverse reactions of GLUCOTROL XL including hypoglycemia. Explain the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development to patients and responsible family members. Also inform patients about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of glycemic control.

Inform patients that GLUCOTROL XL should be swallowed whole. Inform patients that they should not chew, divide or crush tablets and they may occasionally notice in their stool something that looks like a tablet. In the GLUCOTROL XL tablet, the medication is contained within a non-dissolvable shell that has been specially designed to slowly release the drug so the body can absorb it.

Pregnancy

Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women taking GLUCOTROL XL to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, poor feeding, seizures) [see Use in Specific Populations (8.2)].

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