LAMZARIN Prolonged-release tablet Ref.[49890] Active ingredients: Gliclazide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Lexon Pharmaceuticals (Ireland) Limited, Block 3, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

Product name and form

Lamzarin 30 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release Tablet.

Lamzarin 30 mg Prolonged-release Tablets are white biconvex capsule shaped tablet with ‘GLI 30’ on one side and plain on other side having dimensions Length 10.00 mm ± 0.15 mm, Breadth 4.50 mm ± 0.15 mm and Thickness: 3.55 mm ± 0.15 mm.

Qualitative and quantitative composition

Lamzarin 30 mg Prolonged-release Tablets.

Each Prolonged-release Tablet contains 30 mg gliclazide.

Excipient with known effect: Each Prolonged-release Tablet contains 81.90 mg lactose (as the monohydrate) (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gliclazide

Gliclazide is a hypoglycaemic sulfonylurea antidiabetic active substance. Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans.

List of Excipients

Lactose monohydrate
Hypromellose
Magnesium stearate

Pack sizes and marketing

PVC/PVDC/Alu blisters.

PVC/Alu blister.

Pack sizes:

Blisters: 14, 28, 56 Prolonged-release Tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Lexon Pharmaceuticals (Ireland) Limited, Block 3, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

Marketing authorization dates and numbers

PA23176/004/001

Date of first authorisation: 5th April 2019

Drugs

Drug Countries
LAMZARIN Ireland, United Kingdom

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