INDICATIONS AND USAGE Metformin Hydrochloride Extended-release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ADVERSE REACTIONS In a US double-blind clinical study of Metformin Hydrochloride Tablets in patients with type 2 diabetes, a total of 141patients received Metformin Hydrochloride Tablets therapy (up to 2550 mg per day) and 145 patients received placebo.Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Tablets patients, and that were more common in Metformin Hydrochloride Tablets - than placebo-treated patients, are listed in Table 11.

.

Table 11: Most Common Adverse Reactions (>5.0 Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Tablets Monotherapy Reactions that were more common in metformin Hydrochloride Extended-release Tablets - than placebo-treated patients.

Metformin Hydrochloride Extended-release Tablets Monotherapy n=141) Placebo (n=145) Adverse Reaction % of Patients Diarrhea 53.2 11.7 Nausea/Vomiting 25.5 8.3 Flatulance 12.1 5.5 Asthenia 9.2 5.5 Indigestion 7.1 4.1 Abdominal Discomfort 6.4 4.8 Headache 5.7 4.8 Diarrhea led to discontinuation of study medication in 6% of patients treated with Metformin Hydrochloride Tablets.

Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of Metformin Hydrochloride Tablets patients and were more commonly reported with Metformin Hydrochloride Tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder,chest discomfort, chills, flu syndrome, flushing, palpitation.

In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with Metformin Hydrochloride Extended-release Tablets in placebo- and active-controlled studies.

In placebo-controlled trials, 781 patients were administered Metformin Hydrochloride Extended-release Tablets and 195 patients received placebo.

Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Extended-release Tablets patients, and that were more common in Metformin Hydrochloride Extended-release Tablets - than placebo-treated patients, are listed in Table 12.

Table 12: Most Common Adverse Reactions (>5.0 Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Extended-release Tablets Reactions that were more common in metformin Hydrochloride Extended-release Tablets - than placebo-treated patients.

Metformin Hydrochloride Extended-release Tablets n=781) Placebo (n=195) Adverse Reaction % of Patients Diarrhea 9.6 2.6 Nausea/Vomiting 6.5 1.5 Diarrhea led to discontinuation of study medication in 0.6% of patients treated with Metformin Hydrochloride Extended-release Tablets.

Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of Metformin Hydrochloride Extended-release Tablets patients and were more commonly reported with Metformin Hydrochloride Extended-release Tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Liver function test abnormalities or hepatitis, resolving upon metformin discontinuation, have been reported very rarely.