AURO-PIOGLITAZONE 45 pioglitazone (as hydrochloride) 45 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pioglitazone hydrochloride, Quantity: 49.604 mg (Equivalent: pioglitazone, Qty 45 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Pioglitazone hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; hyprolose; lactose monohydrate; carmellose calcium

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea

Product summary:

Visual Identification: White to off-white, round, flat faced, bevel edge, uncoated tablets debossed with '33' on one side and 'H' on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-12-16

Patient Information leaflet

AURO-PIOGLITAZONE
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 4
AURO-PIOGLITAZONE 15, 30 & 45
Pioglitazone hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AURO-
PIOGLITAZONE. It does not contain
all the available information and does
not take the place of talking with your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking AURO-PIOGLITAZONE
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 THIS MEDICINE.
You may need to read it again.
WHAT
AURO-PIOGLITAZONE
USED FOR
AURO-PIOGLITAZONE is a tablet
that is used to improve the action of
the body's naturally produced insulin.
AURO-PIOGLITAZONE is used in
the management of type 2 diabetes
not controlled by diet.
AURO-PIOGLITAZONE helps to
control the level of glucose in your
blood when you have type 2 diabetes.
This is the 'adult onset' type of
diabetes and is controlled by diet,
certain oral medications and
occasionally insulin.
This medicine is also called
pioglitazone hydrochloride and
belongs to a group of medicines
called glitazones. Glitazones decrease
insulin resistance.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
AURO-PIOGLITAZONE can be used
alone (when diet and exercise is not
enough to treat your diabetes) or
together with other anti-diabetic
medicines.
This medicine is available only with a
doctor's prescription.
The use of AURO-PIOGLITAZONE
has not been studied in children.
BEFORE YOU TAKE
AURO-PIOGLITAZONE
WHEN YOU MUST NOT TAKE
AURO-PIOGLITAZONE
DO NOT TAKE AURO-
PIOGLITAZONE IF:
•
you have heart failure requiring
treatment. Talk to your doctor if
you have heart failure
•
you have type 1 diabetes or diabetic
ketoacidosis (often caused by very
high blood glucose levels)
•
you have an allergy to any medicine

Summary of Product characteristics

Product Information:
AURO-PIOGLITAZONE (Pioglitazone Tablets 15, 30 & 45 mg)
Ver 1.2
Page 1 of 19
PRODUCT INFORMATION
AURO-PIOGLITAZONE 15 (15 MG PIOGLITAZONE AS HYDROCHLORIDE)
AURO-PIOGLITAZONE 30 (30 MG PIOGLITAZONE AS HYDROCHLORIDE)
AURO-PIOGLITAZONE 45 (45 MG PIOGLITAZONE AS HYDROCHLORIDE)
NAME OF THE MEDICINE
The active ingredient in AURO-PIOGLITAZONE tablets is pioglitazone
hydrochloride.
CHEMICAL NAME:
(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione
hydrochloride
_ _
MOLECULAR FORMULA:
C
19
H
20
N
2
O
3
S. HCl
MOLECULAR WEIGHT:
392.90
CAS REGISTRY NUMBER:
_[112529-15-4] _
DESCRIPTION
Pioglitazone is off-white to pale yellow colour powder. It is soluble
in methanol, practically
insoluble in water.
AURO-PIOGLITAZONE is available as tablets containing 15, 30 & 45 mg
pioglitazone as
hydrochloride.
AURO-PIOGLITAZONE tablets contain the following inactive ingredients:
Lactose, carmellose
calcium, hydroxypropylcellulose and magnesium stearate.
PHARMACOLOGY
Pioglitazone is an oral antidiabetic agent that acts primarily by
decreasing insulin resistance.
Pharmacological studies indicate that pioglitazone improves
sensitivity to insulin in muscle and
adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone
improves glycaemic control
while reducing circulating insulin levels.
Fasting and postprandial glycaemic control are improved in patients
with type 2 diabetes mellitus.
The
decreased
insulin
resistance
produced
by
pioglitazone
results
in
lower
blood
glucose
concentrations, lower plasma insulin levels and lower HbA
1c
values.
Product Information:
AURO-PIOGLITAZONE (Pioglitazone Tablets 15, 30 & 45 mg)
Ver 1.2
Page 2 of 19
MODE OF ACTION
Pioglitazone is a thiazolidinedione antidiabetic agent that depends on
the presence of insulin for
its unique mechanism of action. Pioglitazone decreases insulin
resistance in the periphery and in
the liver resulting in increased insulin-dependent glucose disposal
and decreased hepatic glucose
output. Unlike sulfonylureas, pioglitazone is not a