BRAND NAME: SB-Metlina

GENERIC NAME WITH SPECIFICATION: Metformin Hydrochloride BP and Linagliptin INN

STRENGTH: 500/2.5 mg & 850/2.5 mg

COMPOSITION

SB-Metilna 500/2.5 Tablet : Each Film Coated Tablet contains Metformin Hydrochloride BP 500 mg and Linagliptin INN 2.5 mg. SB-Metlina 850/2.5 Tablet : Each Film Coated Tablet contains Metformin Hydrochloride BP 850 mg and Linagliptin INN 2.5 mg. SB-Metlina 1000/2.5 Tablet : Each Film Coated Tablet contains Metformin Hydrochloride BP 1000 mg and Linagliptin INN 2.5 mg.

INDICATION:

SB-Metlina Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate. Important Limitations of Use: . Not for treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

• Has not been studied in patients with a history of pancreatitis.

DOSAGE AND ADMINISTRATION:

The dosage of SB-Metlina should be individualized on the basis of both effectiveness and tolerability. Dose escalation should be gradual to reduce the gastrointestinal side effects associated with Metformin Hydrochloride use. The maximum recommended dose is 1000 mg Metformin Hydrochloride/2.5 mg Linagliptin twice daily with meals.

RECOMMENDED STARTING DOSE: . In patients currently not treated with Metformin Hydrochloride, initiate treatment with SB-Metlina 500/2.5 twice daily . In patients already treated with Metformin Hydrochloride, If patient is taking Metformin Hydrochloride 500 mg tablet twice daily, then give him/her SB-Metlina 500/2.5 tablet twice daily.

• If patient is taking Metformin Hydrochloride 850 mg tablet twice daily, then give him/her SB-Metlina 850/2.5 tablet twice daily with meal.
• If patient on Metformin Hydrochloride 1000 mg twice daily would be started on SB-Metlina 1000/2.5 twice daily with meals. . Patients already treated with Metformin Hydrochloride and Linagliptin individual components may be switched to Metformin Hydrochloride and Linagliptin combination containing the same doses of each component. Concomitant use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulln:
• When Metformin Hydrochloride and Linagliptin combination is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

SIDE EFFECTS

Adverse reactions reported in 5% of patients treated with Metformin Hydrochloride & Linagliptin combination more commonly than in patients treated with placebo are nasopharyngitis and diarrhea.

• Hypoglycemia was more commonly reported in patients treated with the combination of Metformin Hydrochloride & Linagliptin along with sulfonylurea (SU) compared with those treated with the combination of sulfonylurea (SU) and Metformin Hydrochloride.

CONTRAINDICATION:

Metformin Hydrochloride and Linagliptin combination is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients.
• Patients with Renal Impairment: (e.g., serum creatinine 21.5 mg/dL for men, 21.4 mg/dL for women, or abnormal creatinine clearance).
• Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Patients with type 1 diabetes.

USE IN PREGNANCY & LACTATION

Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Metformin Hydrochloride and Linagliptin combination tablets should be used during pregnancy only if clearly needed. Nursing Mothers: Caution should be exercised when Metformin Hydrochloride and Linagliptin combination is administered to a nursing woman. Pedlatric Use: Safety and effectiveness of Metformin Hydrochloride and Linagliptin combination in pediatric patients under 18 years of age have not been established. Geriatric Use: Linagliptin is minimally excreted by the kidney; however, Metformin Hydrochloride is substantially excreted by the kidney. Considering that aging can be associated with reduced renal function, Metformin Hydrochloride and Linagliptin combination should be used with caution as age increases. OVERDOSE: In the event of an overdose with Metformin Hydrochloride and Linagliptin combination, employ the usual supportive measures (e.g., remove unabsorbed

strointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Therefore, hemodialysis may be useful partly for removal of accumulated Metformin Hydrochloride from patients in whom Metformin Hydrochloride and Linagliptin combination overdosage is suspected. STORAGE: Store in a cool and dry place (below 30° C), protected from light and moisture. Keep out of the reach of children.

AVAILABLE PACKAGING:

SB-Metlina 500/2.5 : Each box contains 30 Flim Coated Tablets in Alu-Alu blister pack.

SB-Metlina 850/2.5 : Each box contains 30 Flim Coated Tablets in Alu-Alu blister pack.

SB-Metlina 1000/2.5 : Each box contains 20 Flim Coated Tablets in Alu-Alu blister pack.