Abbreviated Prescribing Information: Metformin Hydrochloride 500mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: Clear brown liquid. An oral solution each 5ml containing 500mg of metformin hydrochloride. Therapeutic Indications: Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Posology and Method of Administration: In adults, Metformin Hydrochloride Oral Solution may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. The usual starting dose is one 5ml spoonful (500mg) 2 or 3 times daily given during or after meals. The maximum recommended dose of metformin hydrochloride is 3g (six 5ml spoonfuls) daily, taken as 3 divided doses. 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 one 5ml spoonful (500mg) 2-3 times daily, while insulin dosage is adjusted based on blood glucose measurements. Due to the potential for decreased renal function in elderly subjects, the metformin hydrochloride dosage should be adjusted based on renal function. Paediatric population: In children metformin can be used as monotherapy and combination with insulin. Metformin Hydrochloride Oral Solution can be used in children from 10 years of age and adolescents. The usual starting dose is one 5ml spoonful (500mg) once daily, given during meals or after meals. After 10 to 15 days the dose should be adjusted based on blood glucose measurements. The maximum recommended dose of metformin hydrochloride is 2g (four 5ml spoonfuls) daily, taken as 2 or 3 divided doses. Contra-indications: Hypersensitivity to metformin hydrochloride or any of the excipients. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). Diabetic, diabetic pre-coma. Severe renal failure (GFR < 30 mL/min). Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock and hepatic insufficiency, acute alcohol intoxication, alcoholism. Special Warnings and Precautions for use: Metformin may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). Metformin should be discontinued if the patient has conditions associated with dehydration such as severe vomiting, diarrhoea, fever. Metformin is not recommended for patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD) due to potential lactic acidosis exacerbation and neurologic complications. If symptoms suggest MELAS syndrome or MIDD, metformin should be withdrawn immediately. Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function. For patients with acute and unstable heart failure, metformin is contraindicated. Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable. Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable. In children and adolescents, the diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin hydrochloride is initiated. Metformin may reduce vitamin B12 serum levels. In case of suspicion of vitamin B12 deficiency (such as anaemia or neuropathy), vitamin B12 serum levels should be monitored. Periodic vitamin B12 monitoring could be necessary in patients with risk factors for vitamin B12 deficiency. Metformin hydrochloride alone never causes hypoglycaemia, although caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides). Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM.
A list of very common, common, and serious adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite, Vitamin B12 decrease/deficiency, taste disturbance, lactic acidosis, liver function tests abnormalities or hepatitis, erythema, pruritus, urticarial. Refer to the SmPC for full details of other adverse reactions. Pack Size and NHS Price: 100ml – £30.00  and 150ml – £30.00. Marketing Authorisation Number: PL 00427/0139 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [March-2025]