PIOZONE 45 pioglitazone (as hydrochloride) 45mg tablet blister pack

Main information

  • Trade name:
  • PIOZONE 45 pioglitazone (as hydrochloride) 45mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIOZONE 45 pioglitazone (as hydrochloride) 45mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173472
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173472

PIOZONE 45 pioglitazone (as hydrochloride) 45mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Torrent Australasia Pty Ltd

Postal Address

Coleman & Greig L9/10 George St,PARRAMATTA, NSW, 2150

Australia

ARTG Start Date

26/10/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. PIOZONE 45 pioglitazone (as hydrochloride) 45mg tablet blister pack

Product Type

Single Medicine Product

Effective date

26/10/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of type 2 diabetes 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/PE

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

7 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

50 tablets

(S4) Prescription Only Medicine

98 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off white, round, flat faced beveled edge uncoated tablets

debossed with'T' shape break-line on both sides

Active Ingredients

Pioglitazone hydrochloride

49.608 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 04:06:07 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PIOZONE

pioglitazone hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

PIOZONE. 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

PIOZONE 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 PIOZONE is used for

PIOZONE is a tablet that is

used to improve the action of

the body's naturally produced

insulin.

PIOZONE is used in the

management of type 2 diabetes

not controlled by diet.

It 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.

PIOZONE 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 PIOZONE has not

been studied in children.

Before you take PIOZONE

When you must not take it

Do not take PIOZONE 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

listed at the end of this

leaflet (see 'Product

Description'). Some of the

symptoms of an allergic

reaction may include

shortness of breath,

wheezing or difficulty

breathing; swelling of the

face, lips, tongue or other

parts of the body; rash,

itching or hives on the skin.

Do not take this medicine

after the date printed on the

pack or if the packaging is

torn or shows signs of

tampering.

If it has expired or

is damaged, return

it to your

pharmacist for disposal.

If you are not sure whether

you should start taking this

medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other

medicines, foods,

preservatives or dyes.

Tell your doctor if you have

or have had any of the

following medical conditions:

heart disease with shortness

of breath after minimal

physical activity

heart disease with severe

symptoms at rest

swelling of hands, ankles or

feet

bladder cancer or symptoms

associated with bladder

cancer such as blood in the

urine (haematuria) often

accompanied by pain and

burning

problems with your liver

problems with your kidneys

that requires dialysis.

PIOZONE is not

recommended for use if you

are on dialysis

some women who do not

have monthly periods and

have not been through

menopause may restart their

periods when taking

PIOZONE. These women

may be at increased risk of

pregnancy

bone fractures, usually in

the hand, upper arm or foot,

have been seen in some

women when taking

PIOZONE. Talk to your

doctor for advice on how to

keep your bones healthy.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-

feeding.

Like most medicines,

PIOZONE is not

recommended

for use during

pregnancy. If

there is a need to

consider

PIOZONE during your

pregnancy, your doctor will

discuss

with you the benefits

and risks of

taking PIOZONE.

It is recommended

that you do

not breast-feed while

taking

PIOZONE, as it is not known

whether PIOZONE passes into

breast milk.

Tell your doctor if you are

using another medicine for

diabetes. PIOZONE can

enhance the action of

other medicines. You may be

at risk of low blood sugar

(hypoglycaemia).

If this

happens, your doctor may

need

to adjust the dose of your other

medicines.

Tell your doctor if you suffer

from lactose intolerance

(because PIOZONE tablets

contain lactose).

If you have not told your

doctor about any of the

above, tell him/her before you

start taking PIOZONE.

Taking other medicines

Tell your doctor or

pharmacist if you are taking

any other medicines,

including any that you get

without a prescription from

your pharmacy, supermarket

or health food shop.

Some medicines and

PIOZONE may

interfere with

each other. These

include:

chlorpropamide

gemfibrozil

glibenclamide

gliclazide

insulin

metformin

oral contraceptives

rifampicin

tolbutamide

These medicines may be

affected by PIOZONE or may

affect how well it works. You

may need different amounts of

your medicines, or you may

need to take different

medicines.

Your doctor or pharmacist has

more information on medicines

to be careful with or to avoid

while taking this medicine.

How to take PIOZONE

Follow all directions given to

you by your doctor or

pharmacist carefully.

They

may differ from the

information contained in this

leaflet.

If you do not understand the

instructions on the carton,

ask your doctor or

pharmacist for help.

How much to take

Your doctor will tell you how

many PIOZONE tablets you

should take. The dose your

doctor will prescribe for you

will usually be in the range of

15 mg to 45 mg per day.

PIOZONE tablets should be

taken once a day as advised

by your doctor.

Your doctor

may increase or decrease

your

dose in order to find the

appropriate dose for your

condition.

How to take it

PIOZONE tablets should be

swallowed whole with a glass

of water.

When to take it

Take your medicine at about

the same time each day.

Taking it at the same time each

will have the best effect. It

will also

help you remember

when to take it.

It does not matter if you take

this medicine before or after

food.

How long to take it

Continue taking your

medicine for as long as your

doctor tells you.

This medicine

helps to control your condition,

but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take your next

dose when you are meant to.

Otherwise, take it as soon as

you remember, and then go

back to taking your medicine

as you would normally.

Do NOT take a double dose

to make up for the dose that

you missed.

If you are not sure what to

do, ask your doctor or

pharmacist.

If you have trouble

remembering to take your

medicine, ask your

pharmacist for some hints.

If you take too much

(Overdose)

Immediately telephone your

doctor, the Poisons

Information Centre (13 11

26) or go to Accident and

Emergency at the nearest

hospital if you think that you

or anyone else may have

taken too many PIOZONE

tablets. Do this even if there

are no signs of discomfort or

poisoning.

You may need

urgent medical

attention.

While you are taking

PIOZONE

Things you must do

It is important that you

remember to take PIOZONE

daily and at the dose

prescribed by your doctor.

Tell any other doctors,

dentists and pharmacists who

treat you that you are taking

PIOZONE.

If you are about to be started

on any new medicine remind

your doctor and pharmacist

that you are taking

PIOZONE.

If you are going to have

surgery, tell the surgeon or

anaesthetist that you are

taking this medicine.

It may

affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any

blood tests, tell your doctor

that you are taking this

medicine.

It may interfere with

the results of

some tests.

Keep all of your doctor's

appointments so that your

progress can be checked.

Your doctor may do some tests

from

time to time to make sure

medicine is working and to

prevent

unwanted side effects.

Tell your doctor if you have

gained weight since taking

PIOZONE.

Weight gain can

be associated with

improved

blood sugar control

however it

may also be a symptom

of heart

failure.

Things you must not do

Do not take PIOZONE to

treat any other complaints

unless your doctor tells you

to.

Do not give your medicine to

anyone else, even if their

symptoms seem similar to

yours or they have the same

condition as you.

Do not stop taking your

medicine or lower the dosage

without checking with your

doctor.

If you stop taking it

suddenly, your

condition may

worsen or you may

have

unwanted side effects.

Things to be careful of

PIOZONE alone is unlikely

to affect your ability to drive

or operate machinery.

However, be careful to avoid

hypoglycaemia whilst driving

or operating machinery if

using PIOZONE in

combination with other

diabetes medicines.

Side effects

Tell your doctor or

pharmacist as soon as

possible if you experience any

undesirable effect or feel

unwell while you are taking

PIOZONE.

This medicine helps most

people with type 2 diabetes not

controlled by diet, but it may

have unwanted side effects in

some people.

All medicines can have side

effects. Sometimes they are

serious, most of the time they

are not. You may need medical

attention if you get some of the

side effects.

Some side effects may be

related to the dose of

PIOZONE. Accordingly, it is

important that you tell your

doctor as soon as possible

about any unwanted effects.

Your doctor may then decide to

adjust the dose of PIOZONE

you are taking.

Do not be alarmed by the

following list of side effects.

You may not experience any

of them.

Ask your doctor or

pharmacist to answer any

questions you may have.

A few patients have

experienced the following side

effects whilst taking

PIOZONE:

a small increase in weight

low blood sugar levels

(hypoglycaemia). This

occurs more often when

PIOZONE is taken with a

sulfonylurea or insulin

heart failure which may

show as localised swelling

of the ankles, feet and hands

(oedema) and/or fluid in the

lungs (pulmonary oedema).

This has been reported in

clinical trials mainly in

patients who are taking

PIOZONE in combination

with insulin

increased risk of fracture in

women

macular oedema (an eye

disorder that can affect

vision)

altered or impaired liver

function.

Tell your doctor if you notice

any of the following side

effects:

weight gain

signs of hypoglycaemia

which may include

weakness, trembling or

shaking, sweating, light-

headedness, headache,

dizziness, lack of

concentration, tearfulness or

crying, irritability, hunger,

numbness around the lips

and fingers

eye problems including

blurred or double vision.

The above list includes the

more common side effects of

your medicine.

Tell your doctor as soon as

possible if you notice any of

the following:

dark urine or pale stools,

yellowing of the skin or

eyes, severe cramps of the

stomach, nausea or

vomiting, loss of weight,

tiredness

shortness of breath when at

rest or after minimal

physical activity with

swelling of legs, feet and

hands, rapid increase in

weight

blood in the urine often

accompanied by pain and

burning. These can be

symptoms of bladder cancer

The above list includes serious

side effects, which may require

medical attention. Serious side

effects are rare.

Tell your doctor or

pharmacist if you notice

anything that is making you

feel unwell.

Other side effects

not listed above may also occur

in some people.

After using PIOZONE

Storage

Keep your tablets in the pack

until it is time to take them.

Keep your tablets in a cool,

dry place where the

temperature stays below

30°C.

Do not store PIOZONE or

any other medicine in the

bathroom or near a sink. Do

not leave it on a windowsill or

in the car.

Heat and dampness

can destroy some

medicines.

Keep it where children

cannot reach it.

A locked

cupboard at least

one-and-a-

half metres above the

ground is

a good place to store

medicines.

Disposal

If your doctor tells you to

stop taking PIOZONE or the

expiry date has passed, ask

your pharmacist what to do

with any medicine that is left

over.

Product Description

What it looks like

PIOZONE 15mg:

White to off white, round, flat

faced

bevelled

edge

uncoated

tablets debossed with ‘140’ on

one side and ‘15’ on other side.

PIOZONE 30mg:

White to off white, round, flat

faced bevelled edge uncoated

tablets debossed with breakline

separating

‘11’ & ‘19’ on one

side and breakline on other

side.

PIOZONE 45mg:

White to off white, round, flat

faced bevelled edge uncoated

tablets debossed with ‘T’ shape

breakline on both sides.

PIOZONE tablets are available

in blister packs containing 28

tablets.

Ingredients

PIOZONE contains 15mg,

30mg or 45mg of pioglitazone

hydrochloride as the active

ingredient.

It also contains:

lactose

hydroxypropylcellulose

carmellose calcium

magnesium stearate

This medicine does not contain

sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

Torrent Australasia Pty Ltd

100 George St

Parramatta NSW 2150

Australian Registration

Numbers:

15 mg:

AUST R 173470

30 mg:

AUST R 173471

45 mg:

AUST R 173472

This leaflet was prepared in

September 2011.