📌 COMPOSITION

• Each F/C tablet of Glucolow 500 contains: Metformin hydrochloride 500 mg.
• Each F/C tablet of Glucolow 850 contains: Metformin hydrochloride 850 mg.
• Each F/C tablet of Glucolow 1000 contains: Metformin hydrochloride 1000 mg.

📌 DESCRIPTION

Glucolow (Metformin) is a biguanide antidiabetic agent, lowering both basal and postprandial plasma glucose. It 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. Glucolow also reduces cholesterol levels. After an oral dose of metformin, the maximum plasma concentration is reached in approximately 2.5 hours. Plasma protein binding is negligible. Metformin is excreted unchanged in the urine, with an elimination half‑life of approximately 6.5 hours.

📌 INDICATIONS

• Glucolow 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 or in combination with insulin or with other oral antidiabetic agents.
• In children from 10 years of age and adolescents, metformin can be used as monotherapy or in combination with insulin only.

📌 DOSAGE & ADMINISTRATION

The tablet should be swallowed with a glass of water without chewing, during or after meals, daily without cessation. In case of a missed dose, do not take two tablets; take the next dose as usual.

• Children from 10 years of age and adolescents: One tablet of Glucolow 500 mg or 850 mg once daily as the usual starting dose. The dose can be increased gradually after 10-15 days according to blood sugar levels. The maximum dose is 2 g daily, taken as 2 or 3 divided doses.
• Adults: One tablet of Glucolow 500 mg or 850 mg two or three times daily as the usual starting dose. The dose can be increased gradually after 10-15 days according to blood sugar levels. The maximum dose is 3 g daily, taken as 3 divided doses.
• Combination of Glucolow with insulin: In combination therapy, take Glucolow at the usual starting dose for either children or adults, and adjust the insulin dose according to blood sugar levels.
• Patients with renal impairment and elderly patients: The dose should be adjusted on the basis of renal function.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to metformin.
• Diabetic ketoacidosis (symptoms include abdominal pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath) and diabetic pre‑coma.
• Renal failure or renal dysfunction (creatinine clearance 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, X‑ray examination involving the injection of iodinated contrast media, shock.
• Diseases that cause hypoxia such as cardiorespiratory failure, recent myocardial infarction or shock.
• Lactation.

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, and the treatment should not be resumed until 48 hours after the test, after ensuring that kidney function is normal.
• Regular tests should be done to assess blood glucose levels and kidney function before treatment initiation with metformin and regularly thereafter, since metformin is excreted by the kidneys. Caution should be taken when initiating antihypertensive treatment, 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. The treatment should not be resumed unless kidney function is confirmed to be normal.
• The patient should inform the doctor of any other treatment 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 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 with insulin. Glucolow is contraindicated 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. These effects can be reduced by taking the treatment with meals.
• Common effects: Taste disturbances.
• Very rare: Lactic acidosis, itching, red skin, decrease in vitamin B12 level.

📌 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 500 mg: Blisters of 30 tablets and hospital packs of different sizes.
• Glucolow 850 mg: Blisters of 30 tablets and hospital packs of different sizes.
• Glucolow 1000 mg: Blisters of 30 tablets and hospital packs of different sizes.