GLITISOL Tablet Ref.[28295] Active ingredients: Glibenclamide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Remedica Ltd, Aharnon Str.,Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Glitisol 5 mg tablets.

Pharmaceutical Form

Tablet.

White, oblong, flat, scored tablets.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each Glitisol 5 mg tablet contains 5 mg glibenclamide.

Excipients with known effect:

Each Glitisol 5 mg tablet contains 93.3 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glibenclamide

Glibenclamide, a second-generation, short half-life sulphonylurea, is a hypoglycaemic agent that reduces blood-glucose by stimulating insulin release by the pancreas. Sulphonylureas act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels.

List of Excipients

Microcrystalline cellulose
Povidone
Lactose
Starch
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Talc

Pack sizes and marketing

PVC/Aluminium blisters. Pack-sizes of 40, 100, and 1000 tablets.

PP containers with PE closure. Pack sizes of 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str.,Limassol Industrial Estate, 3056 – Limassol, Cyprus

Marketing authorization dates and numbers

19878

Date of first authorization: 13 December 2005
Date of latest renewal: 01 December 2014

Drugs

Drug Countries
GLITISOL Cyprus, Hong Kong, Malta

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