BRAND NAME: SB-Metvilda

GENERIC NAME: Metformin Hydrochloride BP and Vildagliptin INN

STRENGTH: 500/50 mg & 850/50 mg

COMPOSITION

SB-Metvilda 500/50 Tablet:  Each Film Coated Tablet contains Metformin Hydrochloride BP 500 mg and Vildagliptin INN 50 mg.

SB-Metvilda 850/50 Tablet:  Each Film Coated Tablet contains Metformin Hydrochloride BP 850 mg and Vildagliptin INN 50 mg.

INDICATIONS

SB-Metvilda is indicated in patients with type 2 diabetes who are unable to achieve sufficient glycemic control at their maximally tolerated dose of oral Metformin Hydrochloride alone or who are already treated with the combination of Metformin Hydrochloride and Vildagliptin as separate tablets.

DOSAGE AND ADMINISTRATION

Adults: Based on the patient’s current dose of Metformin Hydrochloride, Combination of Metformin Hydrochloride and Vildagliptin may be initiated at either 500/50 mg or 850/50 mg twice daily, 1 tab in the morning and the other in the evening. The recommended daily dose is 2000 mg Metformin Hydrochloride plus 100 mg Vildagliptin. Patients receiving Metformin Hydrochloride and Vildagliptin from separate tablets may be switched to Combination of Metformin Hydrochloride and Vildagliptin containing the same doses of each component. Doses higher than 100 mg of Vildagliptin are not recommended. There is no clinical experience of Metformin Hydrochloride and Vildagliptin in triple combination with other antidiabetic agents. Taking Combination of Metformin Hydrochloride and Vildagliptin with or just after food may reduce gastrointestinal symptoms associated with Metformin Hydrochloride.

SIDE EFFECTS

The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. Lactic acidosis can occur due to Metformin Hydrochloride. Rare  cases of hepatic dysfunction. Some common side effects like tremor, headache, dizziness, nausea, hypoglycaemia, fatigue are seen. Clinical trials of up to and more than 2 years’ duration did not show any additional safety signals or unforeseen risks when use this combination.

CONTRAINDICATIONS

Combination (Metformin Hydrochloride and Vildagliptin) is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients
• Patients with Renal Impairment: Creatinine clearance <60 mL/min.
• Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or       without coma. Diabetic ketoacidosis should be treated with insulin
• Patients with type 1 diabetes

USE IN PREGNANCY & LACTATION

PREGNANCY: There are no adequate data on the use of Metformin Hydrochloride and Vildagliptin in pregnant women; hence the potential risk for human is unknown.

NURSING MOTHERS: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Metformin Hydrochloride and Vildagliptin should not be used during lactation.

Pregnancy Category: C

PACKAGING

SB-Metvilda 500/50 Tablet:  Each box contains 20 film coated Tablets in Alu-Alu blister pack.

SB-Metvilda 850/50 Tablet:  Each box contains 20 film coated Tablets in Alu-Alu blister pack.