DIAMICRON MR TABLET 60mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

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Active ingredient:

gliclazide

Available from:

SERVIER (S) PTE LTD

ATC code:

A10BB09

Dosage:

60mg

Pharmaceutical form:

TABLET, FILM COATED, EXTENDED RELEASE

Composition:

gliclazide 60mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

2010-09-22

Patient Information leaflet

                                PRODUCT INFORMATION 
DIAMICRON® MR 
MODIFIED RELEASE TABLETS 
GLICLAZIDE 
NAME OF THE DRUG  
 
_DIAMICRON_® _MR 30 MG: _gliclazide 30mg modified
release tablet blister pack  
_DIAMICRON_® _MR 60MG: _gliclazide 60 mg modified release
tablet blister pack  
 
DESCRIPTION  
_DIAMICRON_® _MR _30 mg and _DIAMICRON_® _MR _60mg are modified
release formulations.  
 
Active Ingredient  
Gliclazide is a
white or almost white powder, practically insoluble in
water, freely soluble in 
dichloromethane, sparingly soluble in acetone and
slightly soluble in ethanol 96%. The melting point of 
gliclazide is approximately 168°C.  
 
_Chemical Name
: _1-(3-azabicyclo[3.3.0]oct-3-yl)-3-_p_-tolylsulfonylurea  
 
_Molecular Formula _: C
15
H
21
N
3
O
3
S  
 
_Chemical Structure _: 
 
 
Excipients  
_DIAMICRON®_ _MR 30MG: _Calcium hydrogen phosphate, maltodextrin, hypromellose, magnesium 
stearate and silica–colloidal anhydrous.  
 
_DIAMICRON_® _MR 60MG: _Lactose
monohydrate, maltodextrin, hypromellose, magnesium stearate 
and silica–colloidal anhydrous. 
PHARMACOLOGY  
 
Gliclazide is an oral hypoglycaemic sulfonylurea which differs from other related
compounds. It has an 
N-containing heterocyclic ring with an endocyclic bond.  
 
Gliclazide reduces blood glucose levels by stimulating insulin
secretion from the 
β-cells of the islets of 
Langerhans. Gliclazide shows high affinity, strong selectivity and
reversible binding to the 
β-cell K
ATP
 
channels with a low affinity for cardiac and vascular K
ATP
 channels. Increased postprandial insulin and 
C-peptide secretion
persists after two years of treatment. Gliclazide also
has extra-pancreatic effects 
and haemovascular properties. 
Effects on insulin release  
In type II diabetes, gliclazide restores the
first peak of insulin secretion in response to glucose and 
increases the s
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                PRODUCT INFORMATION
DIAMICRON® MR
MODIFIED RELEASE TABLETS
GLICLAZIDE
NAME OF THE DRUG
_DIAMICRON_® _MR 30MG: _gliclazide 30mg modified release tablet
blister pack
_DIAMICRON_® _MR 60MG: _gliclazide 60mg modified release tablet
blister pack
DESCRIPTION
_ _
_DIAMICRON_® _MR 30MG_ and _DIAMICRON_® _MR 60MG_ are modified
release formulations.
Active Ingredient
Gliclazide is a white or almost white powder, practically insoluble in
water, freely soluble in
dichloromethane, sparingly soluble in acetone and slightly soluble in
ethanol 96%. The melting point of
gliclazide is approximately 168°C.
_Chemical Name :
_1-(3-azabicyclo[3.3.0]oct-3-yl)-3-_p_-tolylsulfonylurea
_Molecular Formula _: C
15
H
21
N
3
O
3
S
_Chemical Structure _:
Excipients
_DIAMICRON®_ _MR 30MG: _Calcium hydrogen phosphate, maltodextrin,
hypromellose, magnesium
stearate and silica–colloidal anhydrous.
_DIAMICRON_® _MR 60MG: _Lactose monohydrate, maltodextrin,
hypromellose, magnesium stearate
and silica–colloidal anhydrous.
PHARMACOLOGY
Gliclazide is an oral hypoglycaemic sulfonylurea which differs from
other related compounds. It has an
N-containing heterocyclic ring with an endocyclic bond.
Gliclazide reduces blood glucose levels by stimulating insulin
secretion from the β-cells of the islets of
Langerhans. Gliclazide shows high affinity, strong selectivity and
reversible binding to the β-cell K
ATP
channels with a low affinity for cardiac and vascular K
ATP
channels. Increased postprandial insulin and
C-peptide secretion persists after two years of treatment. Gliclazide
also has extra-pancreatic effects
and haemovascular properties.
Effects on insulin release
In type II diabetes, gliclazide restores the first peak of insulin
secretion in response to glucose and
increases the second phase of insulin secretion. A significant
increase in insulin release is seen in
response to stimulation induced by a meal or glucose.
Extra-pancreatic effects
Gliclazide has been shown to increase peripheral insulin sensitivity:
•
In muscle, euglycaemic h
                                
                                Read the complete document
                                
                            

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