NovoNorm

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Repaglinide

Dostupné z:

Novo Nordisk Pharmaceuticals Pty Ltd

Trieda:

Medicine Registered

Príbalový leták

 
NovoNorm
®

Page 1 of 5 
NovoNorm-cmi13.doc  

NOVONORM
®

_Repaglinide _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
WHAT NOVONORM
®
 IS USED FOR .. 1

BEFORE YOU TAKE NOVONORM
®
 ... 1

HOW TO TAKE NOVONORM
®
 ......... 2

WHILE YOU ARE TAKING NOVONORM
®
 .................................................... 3

SIDE EFFECTS ................................. 4

AFTER USING NOVONORM
®
 ........... 4

PRODUCT DESCRIPTION ................. 4

FURTHER INFORMATION ................. 5

This leaflet answers some common 
questions about NovoNorm
®
. It does 
not contain all the available 
information.  It does not take the 
place of talking to your doctor, 
pharmacist or diabetes educator. 
All medicines have risks and 
benefits. Your doctor has weighed 
the risks of you taking NovoNorm
®

against the benefits they expect it 
will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE 
MEDICINE.  You may need to read it 
again. 
WHAT NOVONORM
®
 IS 
USED FOR 
NovoNorm
®
 is used to control blood 
glucose levels in patients with type 2 
diabetes mellitus.  This type of 
diabetes is also known as non-
insulin-dependent diabetes 
mellitus (NIDDM) or maturity onset 
diabetes. 
NovoNorm
®
 is used when diet and 
exercise are not enough to control 
your blood glucose level. 
NovoNorm
®
 can be used alone, or 
together with insulin or other 
medicines for treating diabetes. 
NovoNorm
®
 lowers high blood 
glucose levels by helping your 
pancreas to produce more insulin. 
This medicine is only available with 
a doctor’s prescription. 
There is no evidence that 
NovoNorm
®
 is addictive.

BEFORE YOU TAKE 
NOVONORM
®

_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOVONORM
®
 IF: 
1.  You have an allergy to 
NovoNorm
®
 or any of the 
ingredients listed at the en

Súhrn charakteristických

Product Information 
NovoNorm-pi12.doc 

Page 1 of 13

PRODUCT INFORMATION  

NOVONORM

NAME OF THE MEDICINE 

Repaglinide. 

Repaglinide has one asymmetric centre.  Repaglinide is the pure
enantiomer named Benzoic 
acid, 2-ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl) phenyl] butyl]
amino] -2-oxoethyl] -, 
(S)(+) -. 

The CAS number for repaglinide is 135062-02-1.  

Structure: 

H
3
C
CH
CH
3
CH
2
CH
3
CH
2
C
N
H
N
H
C
O
O
CH
2
C
OH
O

DESCRIPTION 

Repaglinide is a white to off-white powder with needle shaped
crystals.  It is slightly soluble 
in aqueous acid, very slightly soluble in aqueous base and freely
soluble in methanol and 
ethanol.  The pKa values are pKa
1
 (acid) = 3.9; pKa
2
 (amine) = 6.0. 

Molecular formula: C
27
H
36
N
2
O
4
.  Molecular weight: 452.6 

NovoNorm tablets also contain poloxamer, povidone, meglumine, maize
starch, calcium 
hydrogen phosphate anhydrous, microcrystalline cellulose, glycerol,
water, polacrilin 
potassium and magnesium stearate as inactive ingredients.  The 1.0
mg tablets also contain 
iron oxide yellow and the 2.0 mg tablets contain iron oxide red as
colouring agents. 

PHARMACOLOGY 

PHARMACODYNAMICS 

Repaglinide is a novel short-acting oral hypoglycaemic agent
structurally unrelated to the 
sulphonylurea drugs.  It lowers blood glucose levels acutely by
stimulating the release of 
insulin from the pancreas, an effect which is dependent upon
functioning beta cells in the 
pancreatic islets.  
Product Information 
NovoNorm-pi12.doc 

Page 2 of 13

Repaglinide closes ATP-dependent potassium channels in the 
-cell membrane by binding to 
sites which are pharmacologically distinguishable from the
sulphonylurea binding sites.  This 
depolarises the 
-cell and leads to an opening of the calcium channels.  The
resulting 
increased calcium influx induces secretion from the 
-cell.  The pharmacology of repaglinide 
differs from other oral hypoglycae