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Gluconorm SR 500 Tablets

NAFDAC Reg. No. A4-6949 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Gluconorm SR 500 Tablets
NAFDAC number
A4-6949
Active ingredient
Metformin Hydrochloride
Strength
500 mg
Form
Tablet
Pack size
10 x 10's
Manufacturer
Not listed
Applicant (holder)
Zolon Healthcare Limited
Approved
25 Feb 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
24 Feb 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Gluconorm SR 500 Tablets is on the NAFDAC register with an active registration (A4-6949). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Gluconorm SR 500 Tablets is used for

From the official U.S. FDA label for metformin hydrochloride, the active ingredient registered with NAFDAC.

Boxed warning: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. …
What it is used for

Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Possible side effects

Common adverse reactions are diarrhea, nausea/vomiting, abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC Toll-Free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Do not use if

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 ) Hypersensitivity to metformin ( 4 ) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. ( 4 ) Metformin hydrochloride extended-release tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1) ] . Hypersensitivity to metformin. …

Warnings

Lactic Acidosis: See boxed warning . ( 5.1 ) Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities. ( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. ( 5.3 ) 5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ] . …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Gluconorm SR 500 Tablets

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Gluconorm SR 500 Tablets

What is in Gluconorm SR 500 Tablets?

Gluconorm SR 500 Tablets contains Metformin Hydrochloride (500 mg), as tablet, according to its NAFDAC registration record.

Is Gluconorm SR 500 Tablets registered with NAFDAC?

Yes. Gluconorm SR 500 Tablets is listed on the NAFDAC register under registration number A4-6949, and its registration is active as of 6 November 2026.

Has Gluconorm SR 500 Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Gluconorm SR 500 Tablets in our automatically synced alert list.

How can I check that my pack of Gluconorm SR 500 Tablets is genuine?

Run a free authenticity scan with the NAFDAC number A4-6949, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Gluconorm SR 500 Tablets used for?

Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (Summarised from the official U.S. FDA label for metformin hydrochloride. Always follow your doctor or pharmacist.)

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