metformin hydrochloride tablet
Indications：
Treatment of type 2 diabetes mellitus, particularly in over weight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
Dosage and Administration:
1.Monotherapy and combination with other oral antidiabetic agents:
The usual starting dose is 500 mg or 500mg metformin hydrochloride 2 or 3 times daily given during or after meals.
2.Combination with insulin:Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500mg or 850mg metformin hydrochloride 2or3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
3.Elderly:Regular assessment of renal function
4.Paediatric population:Monotherapy and combination with; Metformin hydrochloride film-coated tablets can be used in children from 10 years of age and adolescents;The usual starting dose is 500 mg or 500mg metformin hydrochloride once daily, given during or after meals.
Contraindications
1.Hypersensitivity to metformin hydrochloride or the excipients
2. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
3. Diabetic pre-coma.
4. Severe renal failure (GFR <30 mL/min)
5.Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
6.Disease which may cause tissue hypoxia such as: (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
7.Hepatic insufficiency, acute alcohol intoxication, alcoholism
Precautions & Warning:
1.Lactic acidosis:Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
2.Changes In Renal function
3.cardiac insufficiency
4.Administration of iodinated contrast agents
5.Surgery
Adverse Reactions
1.During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite
2.Nervous system disorders:Taste disturbance
3.Gastrointestinal disorders: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
4.Hepatobiliary disorders:Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
5.Skin and subcutaneous tissue disorders:erythema, pruritus, urticaria
Paediatric population
Adverse event reporting was similar in nature and severity to that reported in adults.
Metabolism and nutrition disorders: Lactic acidosis ；Decrease of vitamin B12 absorption
Storage instructions:
This medicinal product does not require any special storage conditions.