|||Hypersensitivity to metformin hydrochloride or any of the excipients.|
|||Diabetic ketoacidosis, diabetic pre-coma, or the history thereof.|
|||Renal failure or impaired renal function.|
|||Chronic liver disease.|
|||History of or states associated with lactic acidosis such as shock or pulmonary insufficiency.|
|||Cardiac failure and recent myocardial infarction.|
|||Conditions associated with hypoxia.|
|||Hepatic insufficiency, acute alcohol intoxication, alcoholism.|
|||Safety in pregnancy and lactation has not been established.|
|||Children, as safety and efficacy have not been established.|
|||At least annually in patients with normal renal function.|
|||At least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects.|
|||All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.|
|||The usual laboratory tests for diabetes monitoring should be performed regularly.|
|||Although METORED alone never causes hypoglycaemia, caution is advised when it is used in combination with insulin or sulphonylureas.|
|||fasting or malnutrition,|
|Lactic acidosis associated with the use of METORED. In patients with a metabolic acidosis and not having evidence of ketoacidosis (ketonuria and ketonaemia), lactic acidosis should be suspected and METORED therapy stopped. Lactic acidosis is a medical emergency, which must be treated in hospital.|
METORED is excreted by the kidney and regular monitoring of renal function is advised in all diabetics.
METORED therapy should be stopped 2 to 3 days before surgery and before clinical investigations such as intravenous urography and intravenous angiography, and reinstated only after control of renal function has been regained.
The use of METORED is not advised in conditions which may cause dehydration, or in patients suffering from serious infections, trauma or on low calorie intake.
Patients on long-term treatment with METORED should have an annual estimation of Vitamin B12levels, since METORED may cause malabsorption of Vitamin B12, which may result in megaloblastic anaemia.
During concomitant treatment with a sulphonylurea, blood glucose should be monitored because combined therapy may cause hypoglycaemia. Stabilisation of diabetic patients with METORED and insulin should be carried out in hospital because of the possibility of hypoglycaemia until the ratio of the two drugs has been obtained. Contra-indications should be carefully observed.