Indications: Treatment of type 2 diabetes mellitus in adults when dietary management and exercise do not result in adequate glycaemic control, as a monotherapy or in combination with other antidiabetic agents or insulin. 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 and method of Administration: Adults with normal renal function (GFR ≥90mL/min): Starting dose of one 500mg SR tablet once daily with evening meal. Adjust dose based on blood glucose measurements every 10 to 15 days in increments of 500mg, to a maximum dose of 2000mg once daily, until glycaemic control achieved. A slow increase of dose may improve gastro-intestinal tolerability. Reduction in the risk or delay onset of type 2 diabetes: Regularly monitor (every 3-6 months) glycaemic status and risk factors to evaluate treatment. Re-evaluate therapy if patient implements diet and/or exercise improvements. Monotherapy in type 2 diabetes and combination with other oral antidiabetic agents: 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). In patients treated with metformin dose above 2000mg daily, switching to metformin prolonged release tablets is not recommended. 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. Paediatric population: Sukkarto SR should not be used in children. Contraindications: Hypersensitivity to metformin or any excipients; 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 (decompensated, acute or 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. Medicinal products that can acutely impair renal function (e.g. antihypertensives, NSAIDs, diuretics) should be initiated with caution. Renal function: GFR should be assessed before initiation and regularly thereafter. Discontinue temporarily in the presence of conditions that alter renal function. Cardiac function: monitor cardiac and renal function regularly in patients with stable chronic heart failure. Elderly patients: metformin initiation not recommended. Discontinue Sukkarto SR prior to using iodinated contrast agents, do not reinstitute until 48 hours afterwards and renal function has been re-evaluated as 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 diet with regular carbohydrate intake during the day. Usual laboratory tests for diabetes monitoring should be performed regularly. Metformin may reduce vitamin B12 serum levels, in case of suspicion of deficiency or in patients with risk factors for B12 deficiency, monitor serum levels. Caution advised when used in combination with insulin or other oral antidiabetics (e.g., sulphonylureas or meglitinides) due to possible hypoglycaemia. Interactions: Concomitant use not recommended with alcohol or iodinated contrast agents. Closely monitor renal function when using NSAIDs, including selective cyclooxygenase II inhibitors, ACE-inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. More frequent blood glucose monitoring required, and dose adjustments may be necessary when using medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local) and sympathomimetics). Caution is advised and dose adjustment may be required during co-administration of organic cation transporters Pregnancy & Lactation: Maintain blood glucose levels as close to normal throughout pregnancy. If clinically needed, the use of metformin can be considered during pregnancy and in the periconceptional phase as an addition or an alternative to insulin. Metformin is excreted into breast milk. A decision should be made whether to discontinue nursing, taking into account the benefit of breast-feeding and the potential risk to adverse effects on the child. 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: Please refer to the SmPC for full list of adverse events. Very common (≥1/10): gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain, loss of appetite). Common (≥1/100 to <1/10): taste disturbances, vitamin B12 decrease/insufficiency. Very rare (<1/10,000): lactic acidosis, isolated reports of liver function test abnormalities, hepatitis, skin reactions such as erythema, pruritus, urticaria. 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. The most effective method to remove lactate and metformin is haemodialysis. 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: March 2025 Version number: 10103111834 v 3.0.
