📌 COMPOSITION

• Each F/C tablet of Glucolow XR 500 contains: Metformin hydrochloride 500 mg prolonged release.
• Each F/C tablet of Glucolow XR 750 contains: Metformin hydrochloride 750 mg prolonged release.
• Each F/C tablet of Glucolow XR 1000 contains: Metformin hydrochloride 1000 mg prolonged release.

📌 DESCRIPTION

Glucolow XR (Metformin) is a biguanide antidiabetic agent, lowering both basal and postprandial plasma glucose. Glucolow XR does not stimulate insulin secretion and therefore does not produce hypoglycaemia; it acts by reducing hepatic glucose production, increasing insulin sensitivity in muscles, hence improving peripheral tissue glucose uptake, and delaying intestinal glucose absorption. After an oral dose of Glucolow XR, the absorption is not affected by meals. The maximum plasma concentration is reached in approximately 7 hours. Plasma protein binding is negligible. It is excreted unchanged in the urine, with an elimination half‑life of approximately 6.5 hours.

📌 INDICATIONS

• Glucolow XR is used for the treatment of type 2 diabetes mellitus (insulin‑independent), particularly in overweight patients, when dietary management and exercise alone do not result in adequate glycaemic control.
• In adults: Metformin can be used as monotherapy, in combination with insulin, or with other oral antidiabetic agents.

📌 DOSAGE & ADMINISTRATION

• Adults: The usual starting dose is one tablet of Glucolow XR 500 with the evening meal once daily. After 10-15 days, the dose should be adjusted on the basis of blood glucose tests, then every 10-15 days. The maximum recommended dose is 4 tablets of Glucolow XR 500 daily.
• Glucolow XR 750 and Glucolow XR 1000: These are intended for patients who are already being treated with metformin tablets (prolonged or immediate release). The dose should be equivalent to the daily dose of metformin tablets (prolonged or immediate release), up to a maximum recommended dose of 2 tablets daily given with the evening meal.
• Elderly patients: The dose should be adjusted on the basis of renal function tests.
• Combination with insulin: Given at the usual starting dose (one tablet of Glucolow XR 500 once daily), while the insulin dosage must be adjusted on the basis of blood glucose measurements.
• Children: Glucolow XR should not be used.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to metformin.
• Diabetic ketoacidosis (symptoms include abdominal pain, fast and deep breathing, sleepiness or unusual mouth odour) and diabetic pre‑coma.
• Renal failure or renal dysfunction (creatinine clearance rate less than 60 ml/min), hepatic insufficiency, excessive consumption of alcohol.
• Conditions that may be accompanied by renal function changes such as dehydration, severe infection such as respiratory or urinary tract infections, and shock.
• Diseases that cause hypoxia in tissues such as cardiorespiratory failure, recent myocardial infarction or shock.

Precautions

• Treatment with metformin should be stopped immediately and the doctor consulted if symptoms of lactic acidosis appear, which include vomiting, abdominal pain with muscle cramps, fatigue and difficulty in breathing. This condition occurs due to metformin accumulation, especially in patients with renal impairment.
• Metformin should be stopped before an X‑ray examination involving injection of iodinated contrast media (iodinated radiographic dye used to show organs and vessels in X‑ray images), and treatment should not be resumed until 48 hours after the test, after ensuring that kidney function is normal.
• Regular tests should be performed to monitor blood glucose levels and kidney function before initiation and during treatment with metformin. Metformin is excreted by the kidneys. Caution should be taken when starting antihypertensive drugs, diuretics or NSAIDs, due to the possibility of alteration of renal function.
• In the case of major surgery, metformin should be stopped 48 hours before the surgery and 48 hours after the surgery. Treatment should not be resumed unless kidney function is confirmed to be normal.
• The patient should inform the doctor of any other drug being taken or any infection.
• It is recommended to monitor the effect of metformin on growth and puberty in children, especially in pre‑pubescent children.

Use in Pregnancy and Lactation

Glucolow XR should not be taken by women who are pregnant or planning to become pregnant for the treatment of type 2 diabetes, and they should consult the doctor for replacement of Glucolow XR with insulin. Glucolow XR is not recommended during breast‑feeding.

Effects on ability to drive vehicles and use machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or use machines. Hypoglycaemia may occur when metformin is used at the same time as other antidiabetic agents; hence, mental concentration may be impaired.

📌 DRUG INTERACTIONS

Caution should be taken when co‑administering metformin with: corticosteroids, NSAIDs, antihypertensive agents of the ACE inhibitor class, diuretics, beta‑2 agonists such as salbutamol, and alcohol‑containing medicaments.

📌 ADVERSE EFFECTS

• The most common: Nausea, vomiting, diarrhoea, abdominal pain and loss of appetite may occur, especially at the beginning of treatment.
• Common effects: Taste disturbances.
• Very rare: Lactic acidosis, itching, red skin, decrease in vitamin B12 levels in the blood.

📌 OVERDOSAGE

• Symptoms: Overdose of metformin may lead to lactic acidosis.
• Treatment: Lactate and metformin can be removed by haemodialysis.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Glucolow XR 500 Tablets: Pack of 30 tablets.
• Glucolow XR 750 Tablets: Pack of 30 tablets.
• Glucolow XR 1000 Tablets: Pack of 30 tablets.