Avandia

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Rosiglitazone maleate 1.33mg equivalent to 1 mg rosiglitazone

Dostępny od:

GlaxoSmithKline NZ Limited

INN (International Nazwa):

Rosiglitazone maleate 1.33 mg (equivalent to 1 mg rosiglitazone)

Dawkowanie:

1 mg

Forma farmaceutyczna:

Film coated tablet

Skład:

Active: Rosiglitazone maleate 1.33mg equivalent to 1 mg rosiglitazone Excipient: Hypromellose Lactose monohydrate Magnesium stearate Opadry yellow OY-L-22809 Powdered cellulose Sodium starch glycolate

Sztuk w opakowaniu:

Blister pack, White opaque PVC-Al x 56, 56 tablets

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

SmithKline Beecham (Cork) Ltd

Podsumowanie produktu:

Package - Contents - Shelf Life: Blister pack, White opaque PVC-Al x 56 - 56 tablets - 24 months from date of manufacture stored at or below 30°C

Data autoryzacji:

1999-01-12

Ulotka dla pacjenta

1
AVANDIA TABLETS
Rosiglitazone 4mg and 8mg tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET?
Please read this leaflet 
carefully before you take 
_Avandia _tablets.
This leaflet answers some 
common questions about 
_Avandia _tablets.  It does not 
contain all of the available 
information.
It does not take the place of 
talking to your doctor or 
pharmacist.
All medicines have risks and 
benefits.  Your doctor has 
weighed the risks of you 
taking _Avandia _tablets 
against the benefits this 
medicine is expected to 
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 _AVANDIA _IS USED FOR
_Avandia _tablets contain the 
active ingredient 
rosiglitazone.  
This medicine belongs to a 
group of drugs that lower 
high blood sugar levels 
(anti-diabetic) called 
_thiazolidinediones_.
It is used in the treatment of 
Type 2 diabetes (non-insulin 
dependent diabetes 
mellitus)_. _
It may be used in patients 
inadequately controlled by 
diet and exercise and in 
combination with 
sulphonylureas and 
metformin (other blood 
glucose lowering agents) or 
insulin to improve blood 
glucose levels. 
DIABETES is a condition in 
which the body does not 
produce enough insulin or 
else the body tissues are 
not able to use the insulin 
present. This leads to 
hyperglycaemia (too much 
sugar in the blood). 
Symptoms include 
excessive thirst, the passing 
of a greatly increased 
amount of urine, increase in 
appetite with a loss of 
weight, feeling tired, drowsy, 
weak, depressed, irritable 
and generally unwell.
BEFORE YOU TAKE YOUR 
_AVANDIA _TABLET
WHEN YOU MUST NOT TAKE 
AVANDIA
Do not take _Avandia _tablets 
if you have ever had an 
allergic reaction to 
rosiglitazone or any of the 
ingredients listed at the end 
of this leaflet.
Do not take _Avandia _tablets
if you have heart failure 
requiring tr

Charakterystyka produktu

1 
DATA SHEET 
AVANDIA
TM 
 FILM COATED TABLETS 
_ROSIGLITAZONE MALEATE _
_ _
PRESENTATION 
Film coated, pentagonal shaped Tiltab
TM
 tablets.  The tablet strengths are 
distinguished by colour: 4.0mg (orange) and 8.0mg (red-brown). 
Avandia  4.0mg  tablets,  orange  in  colour,  are  debossed  with  "GSK"  on  one 
side and "4" on the other.  Each tablet contains  5.3mg rosiglitazone maleate 
equivalent to 4mg rosiglitazone. 
Avandia 8.0mg tablets, red-brown in colour, are
debossed with "GSK" on one 
side and "8" on the other.  Each tablet contains
10.6mg rosiglitazone maleate 
equivalent to 8mg rosiglitazone. 
Each strength is provided in opaque blister packs
(PVC/aluminium). 
USES 
_ACTIONS _
AVANDIA, an antihyperglycaemic, is
a selective and potent agonist at the 
PPAR  (peroxisomal proliferator activated gamma) nuclear
receptor and is a 
member of the thiazolidinedione class of antidiabetic
agents.  It improves 
glycaemic control by improving insulin sensitivity at key sites
of insulin 
resistance namely adipose tissue, skeletal muscle and liver.
 Insulin 
resistance is known to play a major
role in the pathogenesis of type 2 
diabetes.  Thus, AVANDIA improves metabolic
control by lowering blood 
glucose, circulating insulin and free fatty acids. 
As
a consequence of different but complementary mechanisms of action, 
combination therapy of AVANDIA_ _with_ _a sulphonylurea or metformin resulted 
in synergistic improvements in glycaemic control
in type 2 diabetic patients. 
The antihyperglycaemic activity of AVANDIA has
been demonstrated in a 
number of animal models
of type 2 diabetes.  In addition, AVANDIA preserved 
ß-cell function as shown by increased pancreatic
islet mass and insulin 
content and prevented the development of overt
hyperglycaemia in animal 
models
of type