METFORMIN-PCOR XR

What it is

METFORMIN-PCOR XR is available as extended release tablets in two strengths: 500 mg and 1000 mg, each containing metformin hydrochloride. The medicine is presented as extended release tablets. Both tablet strengths are gluten free.

Approved indications

— Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. METFORMIN-PCOR XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Dosing overview

For patients new to metformin, the usual starting dose is one tablet of METFORMIN-PCOR XR 500 once daily given with the evening meal. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. Dosage increases should be made in increments of 500 mg or 750 mg every 10–15 days. The maximum recommended dose is either 4 tablets of METFORMIN-PCOR XR 500, or 2 tablets of METFORMIN-PCOR XR 1000 once daily with the evening meal. Only one strength should be used at a time in order to avoid accidentally exceeding the recommended upper daily dose limit of 2000 mg. When used in combination with insulin, the usual starting dose of METFORMIN-PCOR XR is 500 mg once daily with the evening meal, and after titration, switch to METFORMIN-PCOR XR 1000 should be considered.

Key safety warnings

Life threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is renal impairment; other risk factors include old age associated with reduced renal function. Lactic acidosis is a rare, but serious metabolic complication that can occur due to metformin accumulation, with reported cases occurring primarily in diabetic patients with significant renal failure. It is recommended that creatinine clearance and/or serum creatinine levels be determined before initiating treatment and regularly thereafter: at least annually in patients with normal renal function, and at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects. The intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure, which may induce metformin accumulation and expose the patient to lactic acidosis. Metformin must be discontinued either 48 hours before the test when renal function is known to be impaired or from the time of the test when renal function is known to be normal; and may not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal. Metformin hydrochloride must be discontinued 48 hours before elective surgery. Therapy may be restarted no earlier than 48 hours following surgery and only after renal function has been re-evaluated and found to be normal. Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur very commonly. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. It is recommended that vitamin B12 serum levels are monitored annually. The risk of low vitamin B12 levels increases with increasing metformin dose, treatment duration, and/or in patients with risk factors known to cause vitamin B12 deficiency.

Contraindications

Hypersensitivity to metformin hydrochloride or to any of the excipients. Any type of metabolic acidosis such as lactic acidosis or diabetic ketoacidosis, and diabetic pre-coma. Renal failure or renal dysfunction with creatinine clearance less than 60 mL/min. Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents. Acute or chronic disease which may cause tissue hypoxia such as cardiac failure, recent myocardial infarction, respiratory failure, pulmonary embolism, shock, acute significant blood loss, sepsis, gangrene, pancreatitis, or major surgery. Severe hepatic insufficiency, acute alcohol intoxication, alcoholism. Lactation.

Regulatory history

METFORMIN-PCOR XR 500 and METFORMIN-PCOR XR 1000 were first registered on the ARTG on 8 January 2026.