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Frequency not reported . Hepatitis.alanine aminotransferase increased.abnormal liver function tests.

Hepatitis and hepatic enzyme elevations to >3 XUL.including very rare incidences of hepatic failure with and without fatal outcome.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

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In controlled clinical trials of metformin of 29 weeks’ order actoplus metformin.a decrease to subnormal levels of previously normal serum vitamin B 12 levels.without clinical manifestations.was observed in approximately 7% of patients. Such decrease.possibly due to interference with B 12 absorption from the B 12 -intrinsic factor rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B 12 supplementation. Measurement of hematologic parameters on order actoplus metformin annual basis is advised in patients on ACTOPLUS MET and any apparent abnormalities should be appropriately investigated and managed. Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels. In these patients.routine serum vitamin B 12 measurements at two-to three-year intervals may be useful.

New onset or worsening diabetic macular edema with decreased visual acuity [see WARNINGS AND PRECAUTIONS ]. Fatal and nonfatal hepatic failure [see WARNINGS AND PRECAUTIONS ].

ACTOPLUS MET should be taken with meals to reduce the gastrointestinal side effects associated with metformin.

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