Glucovance

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Glibenclamide; Metformin hydrochloride

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

GLUCOVANCE
®

_contains the active ingredients metformin hydrochloride and
glibenclamide_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glucovance.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Glucovance
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT GLUCOVANCE IS
USED FOR
Glucovance is used to control blood
glucose levels (the amount of sugar
in the blood) in adults with type II
diabetes mellitus. This type of
diabetes is also known as non-insulin
dependent diabetes mellitus
(NIDDM) or maturity onset diabetes.
Glucovance is used:
•
when diet, exercise and treatment
with either metformin or a
sulfonylurea medicine are not
enough to control your blood
glucose
•
in people whose blood sugar
levels are already well controlled
by the combination of metformin
and a sulfonylurea medicine.
Glucovance is to replace these
two medicines.
Glucovance contains two active
ingredients, metformin hydrochloride
and glibenclamide.
Metformin belongs to a group of
medicines called biguanides.
Metformin lowers blood glucose by
helping your body make better use of
insulin.
Glibenclamide belongs to a group of
medicines called sulfonylureas.
Glibenclamide lowers blood glucose
by increasing the amount of insulin
produced by your pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
HYPOGLYCAEMIA
Hypoglycaemia (low blood glucose)
can occur suddenly. Signs may
include:
•
weakness, trembling or shaking
•
sweating
•
light headedness, dizziness,
headache or lack of concentration
•
irritability, tearfulness or crying
•
hunger
•
numbness around the lip

Summary of Product characteristics

GLUCOVANCE
®

_metformin hydrochloride and glibenclamide_

PRODUCT INFORMATION 
NAME OF THE MEDICINE 
_METFORMIN HYDROCHLORIDE _
Chemical name:  
1,1-dimethylbiguanide hydrochloride.  
Structural formula: 

Molecular formula: 
C
4
H
11
N
5
,HCl 

Molecular weight: 
165.6 

CAS Registry No:  
1115-70-4 
_GLIBENCLAMIDE _
Chemical name: 
1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzene-sulphonyl}-3-
cyclohexylurea.   
Structural formula: 
OMe
NH
S
N
H
N
H
O
O
O
Cl
O

Molecular formula: 
C
23
H
28
CIN
3
O
5
S  

Molecular weight: 
494   

CAS Registry No: 
10238-21-8 
DESCRIPTION 
Metformin  hydrochloride  is  a  white,  crystalline  powder,  which  is  odourless  or  almost  odourless  and 
hygroscopic.    It  is  freely  soluble  in  water,  slightly  soluble  in  ethanol  (96%),  and  practically  insoluble  in 
chloroform and in ether. 
Glibenclamide is a white or almost white, crystalline powder; odourless or almost odourless.  It is practically 
insoluble in water and in ether,

slightly soluble in ethanol and
methanol and sparingly soluble in chloroform. 
GLUCOVANCE 
– Product Information

2

Each  Glucovance  250/1.25  tablet  contains  250  mg  metformin  hydrochloride  and  1.25  mg  glibenclamide. 
Each Glucovance 500/2.5 tablet contains 500 mg metformin hydrochloride and 2.5 mg glibenclamide. Each 
Glucovance 500/5 tablet contains 500 mg metformin hydrochloride
and 5 mg glibenclamide. 
The 
tablets 
also 
contain 
croscarmellose 
sodium, 
povidone, 
magnesium 
stearate,  
cellulose  -  microcrystalline  and  Opadry  II  complete  film  coating  system  OY-L-22903  Yellow  (Glucovance 
250/1.25  tablets),  Opadry  II  complete  film  coating  system  OY-L-24808  Pink  (Glucovance  500/2