Indications: Type 2 diabetes mellitus. Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or impaired fasting glucose and/or increased HbA1C who are at risk and progressing towards type 2 diabetes mellitus despite lifestyle modifications for 3–6 months. Posology: Adults. Dosage and Administration: Monotherapy and combination with other oral antidiabetic agents: Starting dose of one 500mg SR tablet once daily with evening meals. Adjust dose based on blood glucose measurements every 10 to 15 days in increments of 500mg, to a maximum dose of 2000mg, until glycaemic control achieved. A slow increase of dose may improve gastro-intestinal tolerability. If glycaemic control is not achieved, consider Sukkarto SR 1000mg twice daily with food; then consider standard metformin tablets to a maximum of 3000mg daily. If transferring from another oral antidiabetic agent: discontinue and initiate Sukkarto SR at the dose indicated above. For patients already treated with metformin, the dose of Sukkarto SR should be equivalent to the daily dose of metformin in tablets (prolonged or immediate release). Combination with insulin: Usual starting dose of Sukkarto SR is one 500mg tablet once daily or the equivalent daily dose of metformin in tablets (prolonged or immediate release) up to a maximum of 1500mg or 2000mg for patients on 750mg or 1000mg tablets, respectively, with the evening meal; adjust insulin dose according to blood glucose measurements. Elderly: Adjust metformin dosage based on renal function; regular assessment of renal function is necessary. Children: Sukkarto SR should not be used in children. Contraindications: Hypersensitivity; acute metabolic acidosis (including lactic acidosis or diabetic ketoacidosis); diabetic pre-coma; severe renal failure (glomerular filtration rate [GFR] < 30mL/min); acute conditions with potential to alter renal function (including dehydration, severe infection or shock); acute or chronic disease which may cause tissue hypoxia (including acute and unstable heart failure, respiratory failure, recent myocardial infarction or shock); hepatic insufficiency; acute alcohol intoxication; alcoholism. Precautions and warnings: Lactic acidosis: metformin should be discontinued and contact with a healthcare professional recommended if dehydrated. Patients/caregivers should be informed of risk of lactic acidosis and if suspected metformin should be discontinued and immediate medical attention sought. Renal function: GFR should be assessed before initiation and at least annual thereafter, elderly patients and those with creatinine levels at the upper limit of normal should be checked two to four times a year. Special caution should be exercised in situations where renal function may become impaired. Regularly monitor cardiac and renal function in patients with stable chronic heart failure. Discontinue Sukkarto SR prior to using iodinated contrast agents, do not reinstitute until 48 hours afterwards and renal function is stable. Discontinue at the time of surgery with general, spinal or epidural anaesthesia and do not reinstate until 48 hours afterwards when renal function has been re-evaluated as stable. Patients should continue their prescribed diet. Usual diabetes monitoring should be performed regularly. Caution advised when used in combination with insulin or other oral antidiabetics (e.g., sulphonylureas or meglitinides) due to possible hypoglycaemia. Interactions: Avoid alcohol and alcohol containing medications. Closely monitor renal function when using selective cyclooxygenase II inhibitors, ACE-inhibitors, angiotensin II receptor antagonists and diuretics. More frequent blood glucose monitoring required, and dose adjustments may be necessary when using glucocorticoids (systemic and local) and sympathomimetics. Dose adjustment may be required during co-administration of organic cation transporters. Pregnancy & Lactation: During and prior to pregnancy, patients should not be treated with metformin, but insulin is recommended to maintain glucose levels and lower the risk of foetal malformations. Metformin is excreted into breast milk. No adverse effects were observed in breast-fed newborns/infants; a decision should be made whether to discontinue nursing. Effects on ability to drive and use machines: Metformin alone does not affect the ability to drive or operate machinery. However, there is a risk of hypoglycaemia when used in combination with other anti-diabetic agents. Undesirable effects: Very common (≥1/10): nausea, vomiting, diarrhoea, abdominal pain, loss of appetite (most frequent during therapy initiation and majority resolve spontaneously). Common (≥1/100 to <1/10): taste disturbances. Very rare (<1/10,000): decrease of vitamin B12 absorption, lactic acidosis, isolated reports of liver function test abnormalities, hepatitis resolving upon discontinuation, skin reactions (erythema, pruritus, urticaria). Please refer to relevant SmPC for full information on adverse events. Overdose: Hypoglycaemia has not been seen with metformin doses of up to 85g although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks may lead to lactic acidosis which is a medical emergency and must be treated in hospital. Legal category: POM. Marketing Authorisation Numbers: Sukkarto SR 500mg: PL 20117/0110; 750mg: PL 20117/0277; 1000mg: PL 20117/0111. Price: 56 tablets Sukkarto SR 500mg: £3.46; 750mg: £2.87; 1000mg: £5.24. 28 tablets Sukkarto SR 500mg: £1.73, 1000mg: £2.77. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date Reviewed: May 2024 Version number: 10103111834 v 2.0.
