NOUMED PIOGLITAZONE pioglitazone (as hydrochloride) 30mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pioglitazone hydrochloride, Quantity: 33.07 mg (Equivalent: pioglitazone, Qty 30 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

INN (International Name):

Pioglitazone hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

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

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, round tablet, with imprint "PGT 30" on one side and with score line on both sides; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-06-08

Patient Information leaflet

NOUMED PIOGLITAZONE
1
NOUMED PIOGLITAZONE
_pioglitazone hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Noumed
Pioglitazone. It does not contain all
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 Noumed
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 THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Noumed 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 used:
•
to improve the action of the
body's naturally produced insulin.
•
in the management of type 2
diabetes not controlled by diet.
•
alone (when diet and exercise is
not enough to treat your diabetes)
or together with other anti-
diabetic medicines.
It contains the active ingredient
pioglitazone hydrochloride.
Pioglitazone hydrochloride belongs
to a group of medicines called
glitazones.
It works by decreasing 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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
The use of Noumed Pioglitazone has
not been studied in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
Pioglitazone hydrochloride, the
active ingredient, or to any of the
other ingredients listed at the end
of this leaflet under Product
Description.
•
any other similar medicines
(Rosiglitazone maleate).
Some of the symptoms of an allergic
reaction may include:
•
short

Summary of Product characteristics

Product Information - Australia
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – NOUMED
PIOGLITAZONE
(PIOGLITAZONE (AS HYDROCHLORIDE))
1. NAME OF THE MEDICINE
Pioglitazone hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as
hydrochloride) as the active ingredient.
Excipient with known effect: Contains sugars as lactose.
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
NOUMED PIOGLITAZONE 15mg tablets are white, round tablet, with imprint
“PGT 15” on one side.
NOUMED PIOGLITAZONE 30mg tablets are white, round tablet, with imprint
“PGT 30” on one side and with score
line on both sides.
NOUMED PIOGLITAZONE 45mg tablets are white, round tablet, with imprint
“PGT 45” on one side.
4. CLINICAL PARTICULARS
4.1 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
NOUMED PIOGLITAZONE should be taken once daily with or without food.
After initiation of NOUMED PIOGLITAZONE or with dose increase,
patients should be carefully monitored for
adverse events related to fluid retention (see _section 4.4 Special
warnings and precautions for use_).
FEMALE PATIENTS
Oedema has been reported more often in women. Dosage should start at
15 mg and be increase cautiously, paying
attention to the development of oedema.
MONOTHERAPY
The recommended dose of NOUMED PIOGLITAZONE is 15 or 30 mg once daily,
increasing after four weeks, if
greater therapeutic effect is needed, to 45 mg once daily.
DUAL THERAPY
The recommended dose of NOUMED PIOGLITAZONE is 30 mg once daily in
combination with sulfonylureas,
insulin or metformin. It may be possible to achieve metabolic control
at a reduced dose of the sulfo