Gliclazide Tablets

Description

Gliclazide Tablets BP 80 mg

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Gliclazide Tablets in India. Gliclazide is a second-generation sulfonylurea prescribed for adults with type 2 diabetes when diet, exercise and other measures alone do not provide adequate glycaemic control. The supplied confirmed composition is an immediate-release, uncoated Gliclazide BP 80 mg tablet. Modified-release 30 mg and 60 mg products are mentioned in the description but have not been confirmed by a supplied composition.

2. Product Specifications

3. Manufacturing Technology

Low-solubility active ingredients require appropriate particle-size, blend-uniformity, compression and dissolution controls. Immediate-release and modified-release formulations have different performance requirements and cannot be treated as interchangeable. Specific micronization, HPMC matrix technology and bioequivalence claims require product-specific validation and are not asserted for this 80 mg tablet.

4. Quality Assurance

Quality controls may include identity, assay, content uniformity, dissolution, impurities and stability according to the registered BP specifications. Numerical release limits and expiry periods should be based on approved batch records and stability studies.

5. Pharmacology and Clinical Use

Gliclazide binds to sulfonylurea receptors on pancreatic beta cells and stimulates insulin secretion, helping reduce blood glucose in type 2 diabetes. It is not indicated for type 1 diabetes or diabetic ketoacidosis. Hypoglycaemia remains an important risk, particularly with missed meals, frailty, kidney or liver impairment and interacting medicines. Claims of unique vascular protection should not be inferred from this product description.

6. Export and Regulatory Support

Market-specific dossiers, certificates of analysis, product labels and other regulatory documents may be provided where available and applicable. Regulatory approvals and bioequivalence must be verified separately for each formulation and destination market.

7. Frequently Asked Questions

Who manufactures Gliclazide Tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is this the same as Diamicron MR?
No. The confirmed product here is Gliclazide BP 80 mg immediate release. Modified-release brands and strengths have different release characteristics and are not directly interchangeable.

Can gliclazide cause low blood sugar?
Yes. Sweating, shaking, hunger, confusion or dizziness may be signs of hypoglycaemia; follow the individual diabetes care plan.

Can MR tablets be crushed?
Modified-release tablets generally should not be crushed. Any permitted splitting depends on the specific approved product label.

8. Dosage and Administration

The dose is individualized by the prescriber according to blood glucose, meal pattern, kidney and liver function and other medicines. Take the confirmed 80 mg immediate-release formulation as instructed with meals. Do not substitute an 80 mg immediate-release tablet for a 30 mg or 60 mg modified-release tablet without medical review.

9. Side Effects and Precautions

• Hypoglycaemia: May be severe or prolonged; avoid skipping meals and seek urgent help for severe symptoms.
• Other effects: Gastrointestinal upset, weight gain and rare skin or blood disorders.
• Organ impairment: Severe kidney or liver impairment may require alternative therapy; use only with clinician assessment.
• Interactions: Other glucose-lowering medicines, alcohol and some anti-infectives can increase hypoglycaemia risk.

10. Storage Instructions

Store according to the approved label, protected from moisture and excessive heat. Keep securely out of reach of children.