Active Ingredients

Micronized Glyburide

Every tablet contains

5mg Micronized Glyburide

Metformin HCL

Every tablet contains

1000mg Metformin HCL

Mechanism of Action

Controlling blood glucose level, through two anti-diabetic agents with complementary mechanisms

Micronized Glyburide:

Stimulation of insulin secretion from the pancreas (Beta cells).

Metformin:

- Improves insulin sensitivity

- Increases insulin peripheral

  uptake

- Decreases hepatic glucose

  production (Gluconeogenesis)

- Decreases absorption of

  glucose from GIT

Indications

Glybofen® is indicated in patients with type 2 diabetes:

- As Initial therapy, in addition to diet and exercise to improve glycemic control in

  patients whose hyperglycemia cannot be controlled with diet and exercise alone

- As a second-line therapy when diet, exercise, and mono-therapy do not result in

  an adequate glycemic control

Precautions & Side Effects

Gastritis

Headache

Nausea/vomiting

Abdominal pain

Hypoglycemia

Mild Weight-gain

ContraIndications

Glybofen® is contraindicated in patients with:

1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels 1.5mg/dL (males}, 1.4mg/dL (females) or abnormal creatinine

    clearance ) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia

2. Congestive heart failure requiring pharmacologic treatment

3. Known hypersensitivity to metformin hydrochloride or glyburide

4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with Insulin. Glybofen

    should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials,

    because use of such products may result in acute alteration of renal function

Dose

Glybofen® must be prescribed under supervision of physician while not exceeding the maximum recommended daily dose of 12.5mg glyburide and 2000mg metformin, should be given with meals and should be initiated at low dose.

Package:

A Carton box of 3 strips each one contains 10 film coated scored tablets & insert leaflet.

Storage:

-Store below 30°C, in a dry place

-Keep all medicines out of reach of children

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