Diaglyaran 60mg modified-release tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

gliclazide.

Available from:

Ranbaxy (UK) Limited

ATC code:

A10BB09

INN (International Name):

gliclazide.

Dosage:

60mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral use

Units in package:

packs of 30, 60 or 90 modified-release tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Ranbaxy Ireland Ltd

Therapeutic group:

Drugs used in diabetes; sulphonamides, urea derivatives

Therapeutic indications:

Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

Authorization status:

Authorised

Authorization date:

2015-03-06

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Diaglyaran 60 mg modified-release tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each modified-release tablet contains 60 mg gliclazide.  

Excipient(s) with known effect: 
Each tablet contains 127 mg of lactose (in the form of
lactose monohydrate) 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Modified-release tablet. 

White to off white oval-shaped tablets, scored on both sides,
engraved with ‘Z’ and 
‘I’ on one side and plain on the other side, with dimensions
15.0 x 7.0 mm. 

The score line is not intended for
breaking the tablet to provide a 30 mg dose. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Non insulin-dependent diabetes (type
2) in adults when dietary measures, physical 
exercise and weight loss alone are not sufficient to control
blood glucose. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

The daily dose of Diaglyaran 60 mg modified-release tablets
may vary from 30 to 120 
mg taken orally in a single intake at breakfast time. 

The tablets should be swallowed whole and not crushed or chewed.
A 30 mg dose 
cannot be obtained by dividing the tablet. 

If a dose is forgotten, there must be no increase in the dose
taken the next day. 

As with any hypoglycaemic agent, the dose should
be adjusted according to the 
individual patient's metabolic response (blood glucose, HbAlc) 

•

Initial dose 
The recommended starting dose is 30 mg daily. 
If blood glucose is effectively controlled, this dose may be
used for maintenance 
treatment. 

If blood glucose is not adequately controlled, the dose may be
increased to 60, 90 or 
120 mg daily, in successive steps. The interval between
each dose increment should 
be at least 1 month except in patients whose bl