Please read the instructions carefully and use under the guidance of a physician.
[Drug name]
English name: Metformin Hydrochloride and Vildagliptin Tablets (II)

[Ingredients]This product is a fixed-dose combination containing metformin hydrochloride and vildagliptin.
Active ingredient: Metformin hydrochloride.

Chemical name: 1,1-dimethylbiguanide monohydrochloride.
Structural formula:
Molecular formula: C₄H₁₁N₅.HCI
Molecular weight: 165.63
Active ingredient: Vildagliptin.
Chemical name: (S)-1-[2-(3-hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile.
Structural formula:
Molecular formula: C₁₇H₂₅N₃O₂
Molecular weight: 303.40

[Description]
This product is a yellow film-coated tablet. After removal of the film coating, it appears white.

[Indications]
This product is indicated for adults with type 2 diabetes mellitus as an adjunct to diet and exercise in patients whose blood glucose is inadequately controlled on metformin monotherapy at the maximum tolerated dose, or who are already receiving treatment with the combination of vildagliptin and metformin, and may also be used in combination with insulin as an adjunct to diet and exercise to improve glycemic control when glycemic control remains inadequate on a stable dose of insulin in combination with metformin.

[Specification]
Each tablet contains metformin hydrochloride 850 mg and vildagliptin 50 mg.

[Dosage and Administration]

Adults

When used for glycemic control, the dosage of this product should be individualized based on the patient's current treatment regimen, therapeutic response, and tolerability; however, the maximum recommended daily dose of vildagliptin should not exceed 100 mg. The usual dosing schedule is one tablet twice daily, in the morning and evening. Taking this product with or after meals may reduce the gastrointestinal symptoms associated with metformin (see [Pharmacokinetics]). If a dose is missed, it should be taken as soon as remembered, but a double dose should not be taken on the same day.

For patients inadequately controlled on metformin monotherapy at the maximum tolerated dose:：

The starting dose of this product is equivalent to vildagliptin 50 mg twice daily (total daily dose 100 mg) and the corresponding dose of metformin.

For patients who are currently receiving concomitant treatment with vildagliptin and metformin and need to be switched to this product:：

The starting dose of this product should be selected based on the doses of vildagliptin and metformin that the patient is currently taking.

For patients receiving combination therapy with insulin:：

The starting dose of this product is equivalent to vildagliptin 50 mg twice daily (total daily dose 100 mg) and the corresponding dose of metformin.