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

Main information

  • Trade name:
  • PIOGLITAZONE AN pioglitazone (as hydrochloride) 30 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIOGLITAZONE AN pioglitazone (as hydrochloride) 30 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176381
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176381

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

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

16/12/2011

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. PIOGLITAZONE AN pioglitazone (as hydrochloride) 30 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

28/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off-white, round, flat faced, bevel edge, uncoated tablets debossed

with '32' on one side and 'H' on the other side

Active Ingredients

Pioglitazone hydrochloride

33.069 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 01:01:11 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

Pioglitazone AN tablets – Consumer Medicine Information

Doc ID: 88.AN.M.2.0

Page 1

PIOGLITAZONE AN tablets

Pioglitazone Hydrochloride

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

PIOGLITAZONE AN.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed

risks

taking

PIOGLITAZONE AN against the

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What PIOGLITAZONE

AN is used for

PIOGLITAZONE AN is a tablet

that

used

improve

action

body's

naturally

produced

insulin.

PIOGLITAZONE AN is used in

management

type

diabetes not controlled by diet.

PIOGLITAZONE AN helps to

control the level of glucose in

your blood when you have type

diabetes.

This

'adult

onset' type of diabetes and is

controlled

diet,

certain

oral

medications

occasionally

insulin.

This

medicine

also

called

pioglitazone

hydrochloride

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

have

prescribed it for another reason.

PIOGLITAZONE

used

alone

(when

diet

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 PIOGLITAZONE AN

has not been studied in children

Before You Take

PIOGLITAZONE AN

When you must not take

PIOGLITAZONE AN

Do

not

take

PIOGLITAZONE

AN 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 b very high

blood glucose levels)

you have had an allergy to

any

medicine

containing

pioglitazone hydrochloride

or any of the ingredients

listed

at

the

end

of

this

leaflet

(see

‘product

description’).

Some

symptoms

allergic

reaction

include

shortness of breath, wheezing or

difficulty

breathing;

swelling

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

PIOGLITAZONE AN

Tell

your

doctor

if

you

are

allergic

to

any

other

medicines,

foods,

dyes

or

preservatives.

Tell your doctor if you have

had

any

of

the

following

medical conditions:

heart disease with shortness

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 n the

urine

(hematuria)

often

accompanied

pain

burning

problems with your liver

problems with your kidneys

that

requires

dialysis.

PIOGLITAZONE

recommended for use if you

are on dialysis

some

women

don’t

have

monthly

periods

have

been

through

menopause may restart their

periods

when

taking

PIOGLITAZONE AN. These

women may be at increased

risk of pregnancy.

Bone

fractures,

usually

Pioglitazone AN tablets – Consumer Medicine Information

Doc ID: 88.AN.M.2.0

Page 2

the hand, upper arm or foot

have

been

seen

some

women

when

taking

PIOGLITAZONE AN. Talk to

your

doctor

advice

keep

your

bones

healthy.

Tell

your

doctor

if

you

are

pregnant

or

plan

to

become

pregnant

or

are

breast

feeding.

Like

most

medicines,

PIOGLITAZONE AN is not

recommended

during

pregnancy. If there is a need to

consider

PIOGLITAZONE

during

your

pregnancy,

your

doctor will discuss with you the

benefits

risks

taking

PIOGLITAZONE

recommended that you do not

breast

feed

while

taking

PIOGLITAZONE AN, as it is not

known

whether

this

medicine

passes into breast milk.

Tell

your

doctor

if

you

are

using

another

medicine

for

diabetes.

PIOGLITAZONE

AN

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

PIOGLITAZONE

AN

contain lactose).

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including

any

that

you

buy

without a prescription from a

pharmacy,

supermarket

or

health food shop.

Some

medicines

PIOGLITAZONE

interfere with each other. These

include:

Chlorpropamide

Gemfibrozil

Glibenclamide

Gliclazide

Insulin

Metformin

Oral contraceptives

Rifampicin

Tolbutamide

These

medicines

affected by PIOGLITAZONE AN

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 avoid while

taking this medicine.

How to take

PIOGLITAZONE AN

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

They

differ

from

information

contained

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

many

PIOGLITAZONE

tablets

should

take.

dose your doctor will prescribe

for you will usually be in the

range of 15 mg to 45 mg per day

PIOGLITAZONE AN tablets

should be taken once a day as

advised by your doctor.

Your

doctor

increase

decrease your dose in order to

find

appropriate

dose

your condition

How to take

PIOGLITAZONE AN

PIOGLITAZONE AN should be

swallowed whole with a glass

of water.

When to take

PIOGLITAZONE AN

Take your medicine at about

the same time each day.

Taking it at the same time each

day will have the best effect. It

will also help you remember

when to take it.

It does not mater if you take this

medicine before or after food.

How long to take

PIOGLITAZONE AN

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

PIOGLITAZONE AN

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

the

missed

dose

as

soon

as

you

remember, and then go back

to taking your tablets as you

would normally.

Do not take a double dose to

make

up

for

the

dose

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

or

the

Poisons

Information Centre (telephone

13 11 26) for advice, or go to

Accident

and

Emergency

at

the

nearest

hospital,

if

you

think you or anyone else may

have taken

too much PIOGLITAZONE AN.

Pioglitazone AN tablets – Consumer Medicine Information

Doc ID: 88.AN.M.2.0

Page 3

Do this even if there are no

signs

of

discomfort

or

poisoning.

You may need urgent medical

attention.

While you are taking

PIOGLITAZONE AN

Things you must do

It

is

important

that

you

remember

to

take

PIOGLITAZONE AN daily and

at the dose prescribed by your

doctor.

Tell

any

other

doctors,

dentists and pharmacists who

treat you that you are taking

PIOGLITAZONE AN.

If you are about to be started

on any new medicine, remind

your

doctor

and

pharmacist

that

you

are

taking

PIOGLITAZONE AN.

If

you

are

going

to

have

surgery,

tell

the

surgeon

or

anaesthetist

that

you

are

taking this medicine.

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

the medicine is working and to

prevent unwanted side effects.

Tell your doctor if you have

gained

weight

since

taking

PIOGLITAZONE AN.

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

PIOGLITAZONE

AN

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

worsen

have

unwanted

side

effects.

Things to be careful of

PIOGLITAZONE

AN

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 PIOGLITAZONE AN 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 PIOGLITAZONE AN.

This medicine helps most people

with

type

diabetes

controlled

diet,

have

unwanted

side

effects

some people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

attention if you get some of the

side effects.

Some

side

effects

related

dose

PIOGLITAZONE

Accordingly, it is important that

you tell your doctor as soon as

possible

about

unwanted

effects.

Your

doctor

then

decide

adjust

dose

PIOGLITAZONE

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 PIOGLITAZONE AN:

A small increase in weight

blood

sugar

levels

(hyprglycaemia). This occurs

more

often

with

PIOGLITAZONE AN is taken

with

sulfonylurea

insulin.

Heart

failure

which

show as localised swelling of

the ankles, feet and hands

(oedema) and/or fluid in the

lungs (pulmonary oedema).

This

been

reported

clinical

trials

mainly

patients

taking

pioglitazone

combination

with insulin.

Increased risk of fracture in

women

Macular

oedema

disorder

than

affect

vision)

Altered

impaired

liver

function.

Tell your doctor if you notice

any of the following:

weight gain

signs

hypoglycaemia

which

include

weakness,

trembling

shaking,

sweating,

light-

headedness,

headache,

dizziness,

lack

concentration, tearfulness or

crying,

irritability,

hunger,

numbness

around

lips

and fingers

problems

including

blurred or double vision

The above list includes the more

common

side

effects

this

Pioglitazone AN tablets – Consumer Medicine Information

Doc ID: 88.AN.M.2.0

Page 4

medicine.

Tell your doctor as soon as

possible if you notice ant of

the following:

dark

urine

pale

stools,

yellowing of the skin or eyes,

severe

cramps

stomach,

nausea

vomiting,

loss

weight,

tiredness

shortness of breath when at

rest or after minimal activity

with

swelling

legs,

feet

and hands, rapid increase in

weight

blood

urine

often

accompanied

pain

burning.

These

symptoms

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

patients.

After taking

PIOGLITAZONE AN

Storage

Keep

your

tablets

in

the

aluminium blister pack until it

is time to take them.

Keep your tablets in a cool dry

place where the temperature

stays below 25 degrees C.

Do not store PIOGLITAZONE

AN or any other medicine in

the bathroom or near a sink.

Do not leave it on the window

sill 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

ground is a good please to store

medicines..

Disposal

If your doctor tells you to stop

taking

PIOGLITAZONE

the expiry date has passed, ask

your pharmacist what to do with

any medicine that is left over.

Product description

What PIOGLITAZINE AN looks

like

PIOGLITAZONE AN 15, 30 & 45

is presented in pack size of 28

tablets in a blister.

PIOGLITAZONE AN 15mg

(AUST R 176388)

White to off white, round,

biconvex, uncoated tablets,

debossed with ‘31’ on one side

and ‘H’ on the other side

PIOGLITAZONE AN 30mg

(AUST R 176381)

White to off white, round, flat

faced, bevel edge, uncoated

tablets, debossed with ‘32’ on

one side and ‘H’ on the other

side

PIOGLITAZONE AN 45mg

(AUST R 176387)

White to off white, round, flat

faced, bevel edge, uncoated

tablets, debossed with ‘33’ on

one side and ‘H’ on the other

side.

Ingredients

Active Ingredient:

Pioglitazone (as hydrochloride)

Each tablet may contain either

&

pioglitazone as hydrochloride.

Other Ingredients:

lactose

carmellose calcium

hydroxypropylcellulose

magnesium stearate

Please read this leaflet carefully

before

start

taking

PIOGLITAZONE AN. You may

wish to keep it to read again.

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

Ltd.

12 River St, South Yarra

VIC – 3141

Australia

Date of Preparation

July 2014

Doc ID: 88.AN.M.2.0