Product image of Gliklazid Lek (Gliclazide) supplied by GNH India

Gliklazid Lek

Active Ingredient:
Gliclazide
Origin:
EU

Gliklazid Lek (Gliclazide)

Gliklazid Lek is a prescription medication that contains the active ingredient gliclazide, supplied as oral tablets. It belongs to the sulfonylurea class of antidiabetic agents and is marketed in the European Union. The product is intended for adult patients with type 2 diabetes mellitus to improve glycemic control. It works by stimulating insulin release from pancreatic beta cells and is provided under EU pharmaceutical standards.

Manufacturer / TM Owner

Lek Pharmaceuticals D.D. Ljubljana

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Indications & Clinical Uses

Gliklazid Lek is indicated for the management of type 2 diabetes mellitus in adults when diet, exercise, and other oral agents are insufficient to achieve target blood glucose levels.

  • Improves fasting and post‑prandial glucose concentrations.
  • Can be used as monotherapy or in combination with metformin, thiazolidinediones, or DPP‑4 inhibitors.
  • May be considered when patients require a sulfonylurea with a lower risk of hypoglycaemia compared with older agents.
  • Suitable for patients with preserved pancreatic beta‑cell function.
  • Administered once daily, typically with the first main meal.

Side Effects

The safety profile of Gliklazid Lek reflects the typical adverse events associated with sulfonylurea therapy, most of which are mild and reversible.

Common

  • Mild hypoglycaemia, usually occurring when a dose is taken without adequate carbohydrate intake.
  • Gastrointestinal discomfort such as nausea, abdominal pain, or dyspepsia.
  • Transient headache or dizziness, often resolving without intervention.
  • Skin reactions including rash, pruritus, or mild erythema.
  • Weight gain may occur due to increased insulin activity and improved glucose utilization.
  • Elevated liver enzymes have been reported occasionally, warranting periodic monitoring.

Serious

  • Severe hypoglycaemia that may cause confusion, loss of consciousness, or seizures.
  • Hematologic abnormalities such as agranulocytosis, leukopenia, or thrombocytopenia.
  • Allergic reactions such as angioedema or anaphylaxis, though rare, require immediate medical attention.

Precautions & Warnings

When prescribing Gliklazid Lek, clinicians should consider several precautionary measures to minimize risks and ensure appropriate use.

  • Assess renal and hepatic function before initiation and periodically during therapy.
  • Use caution in elderly patients due to increased susceptibility to hypoglycaemia.
  • Avoid use in patients with a history of sulfonylurea‑induced severe hypoglycaemia.
  • Adjust dose or discontinue if the patient experiences recurrent hypoglycaemic episodes.
  • Monitor blood glucose closely when initiating therapy or changing dose.
  • Counsel patients to take the medication with food to reduce gastrointestinal upset.

Avoid Interactions

Gliklazid Lek may interact with other medicines, altering its glucose‑lowering effect or increasing the risk of adverse events.

Avoid

  • Concomitant use with other sulfonylureas or insulin may cause severe hypoglycaemia.
  • Strong CYP2C9 inhibitors (e.g., fluconazole, amiodarone) can increase gliclazide plasma concentrations.
  • MAO‑B inhibitors may potentiate hypoglycaemic risk.
  • Thiazolidinediones combined with Gliklazid Lek can increase the risk of fluid retention and edema.

Use with caution

  • CYP2C9 inducers such as rifampicin may reduce gliclazide efficacy.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) can mask hypoglycaemia symptoms.
  • Beta‑blockers may blunt the adrenergic signs of low blood glucose.
  • Loop diuretics may affect electrolyte balance, potentially influencing insulin secretion.

Frequently Asked Questions

Gliklazid Lek contains gliclazide, which stimulates insulin release from pancreatic beta cells by closing ATP‑sensitive potassium channels, thereby enhancing glucose uptake.

Renal function should be evaluated before starting Gliklazid Lek, and dose adjustments may be needed in patients with significant renal impairment.

Yes, Gliklazid Lek can be combined with metformin to improve glycaemic control, but the combination should be prescribed and monitored by a healthcare professional.

Common signs include sweating, shakiness, dizziness, hunger, confusion, and in severe cases, loss of consciousness or seizures.

Blood glucose should be checked regularly, especially during the first weeks of therapy or after any dose change, to ensure appropriate glycaemic control.

The pregnancy category for Gliklazid Lek is unknown; it should only be used during pregnancy if the potential benefits outweigh the risks and after consulting a physician.

If a dose is missed, take it as soon as remembered with food, unless it is close to the time of the next scheduled dose. Do not double the dose.

Alcohol can increase the risk of hypoglycaemia when combined with sulfonylureas like gliclazide, so moderate intake and close monitoring are advised.

Patients should maintain a consistent carbohydrate intake and avoid skipping meals, as irregular eating patterns can predispose to hypoglycaemia.

Periodic monitoring of fasting blood glucose, HbA1c, renal and hepatic function, and liver enzymes is recommended to assess efficacy and safety.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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