DIABREZIDE Tablet Ref.[50283] Active ingredients: Gliclazide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: L. Molteni & C. dei F.lli Alitti, Strada Statale 67, Localita Granatieri, Scandicci, Firenze, Italy

Product name and form

Diabrezide 80 mg tablets.

Pharmaceutical Form

Tablet.

White, round tablets with a breakline on one side.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains: gliclazide 80 mg.

Excipient(s): each tablet contains lactose monohydrate 33 mg.

For a 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
Microcrystalline cellulose PH101
Povidone K30
Sodium starch glycollate type A
Magnesium stearate

Pack sizes and marketing

AI/PVC+PE+PVDC strip (aluminium foil: thickness 20 ± 1.6 μm; plastic sheet: PVC, thickness 200 ± 10 μm – PE, thickness 30 ± 3 μm; spreading of PVDC: 90 g/m²± 5%).

Pack sizes:

  • Carton box with 28 tablets (2 × 14).
  • Carton box with 30 tablets (2 × 15).
  • Carton box with 60 tablets (3 × 20).
  • Carton box with 100 tablets (5 × 20).
  • Carton box with 120 tablets (6 × 20).
  • Carton box with 180 tablets (9 × 20).

Not all pack sizes may be marketed.

Marketing authorization holder

L. Molteni & C. dei F.lli Alitti, Strada Statale 67, Localita Granatieri, Scandicci, Firenze, Italy

Marketing authorization dates and numbers

PA0925/001/001

Date of first authorisation: 30 April 1999
Date of last renewal: 09 March 2008

Drugs

Drug Countries
DIABREZIDE Ireland, Italy, Poland
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈