ACTAZE Tablets 15 mg pioglitazone (as hydrochloride) 15 mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

pioglitazone hydrochloride, Quantity: 16.53 mg

Saatavilla:

Arrow Pharma Pty Ltd

INN (Kansainvälinen yleisnimi):

Pioglitazone hydrochloride

Lääkemuoto:

Tablet, uncoated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

7 tablets, 28 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: White to off white, round, biconvex, uncoated tablets debossed with 'P' on one side and '15' on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2015-09-30

Pakkausseloste

ACTAZE TABLETS 15 MG, 30 MG & 45 MG
pioglitazone (as hydrochloride) Tablets
CONSUMER MEDICINE INFORMATION
V 2.0
Page 1 of 5
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
ACTAZE Tablets. It does not
contain
all
the
available
information and 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 ACTAZE
Tablets 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 ACTAZE
TABLETS ARE USED FOR
ACTAZE Tablets are used to
improve
the
action
of
the
body’s
naturally
produced
insulin. ACTAZE Tablets are
used in the management of
type 2 diabetes not controlled
by diet.
ACTAZE
Tablets
help
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.
ACTAZE Tablets 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 ACTAZE Tablets
has
not
been
studied
in
children.
BEFORE YOU TAKE
ACTAZE TABLETS
_WHEN _
_YOU _
_MUST _
_NOT _
_TAKE IT _
DO
NOT
TAKE
ACTAZE
TABLETS 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 containing
pioglitazone
hydrochloride or any of
the ingredients list

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
ACTAZE (PIOGLITAZONE (AS HYDROCHLORIDE)) TABLETS
1
NAME OF THE MEDICINE
Pioglitazone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15, 30 or 45 mg of pioglitazone (as the
hydrochloride).
Excipients of known effect: Contains sugars as lactose.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ACTAZE TABLETS 15 MG (AUST R 254272): White to off white, round,
biconvex, uncoated tablets
debossed with 'P' on one side and '15' on other side.
ACTAZE TABLETS 30 MG (AUST R 254292): White to off white, round, flat,
uncoated tablets with
bevelled edges debossed with 'PIO' on one side and '30' on the other
side.
ACTAZE TABLETS 45 MG (AUST R 254312): White to off white, flat, round
uncoated tablets with
bevelled edges debossed with ‘PIO' on one side and '45' on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus inadequately controlled by diet
and exercise:
as monotherapy;
2
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
D
OSE AND METHOD OF ADMINISTRATION
Actaze tablets should be taken once daily with or without food.
After initiation of 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 increased
cautiously, paying attention to the development of oedema.
MONOTHERAPY: The recommended dose of 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 pioglitazone is 30 mg once daily
in combination with
sulfonylureas, insulin or metformin. It may be possible t