IRBESAT

Main information

  • Trade name:
  • IRBESAT GH irbesartan 150mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRBESAT GH irbesartan 150mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 192815
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192815

IRBESAT GH irbesartan 150mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alembic Pharmaceuticals Australia Pty Ltd

Postal Address

Level 2 108 Power Street,HAWTHORN, VIC, 3122

Australia

ARTG Start Date

13/11/2012

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. IRBESAT GH irbesartan 150mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

15/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Irbesartan is indicated for the following:

For the treatment of hypertension.

For delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria

(equal to or greater than 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

Irbesartan is indicated for the following:

For the treatment of hypertension.

For delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria

(equal to or greater than 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. IRBESAT GH irbesartan 150mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval shaped, biconvex, film coated tablet, debossed with

"L173" on one side and "150" on the other side.

Active Ingredients

Irbesartan

150 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 28.11.2017 at 08:26:17 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

Irbesat GH CMI v1 24 October 2012

Page 1 of 5

CONSUMER MEDICINE INFORMATION

IRBESAT GH

Irbesartan film-coated tablets

What is in this leaflet

This leaflet answers some

common questions about Irbesat

It does not contain all the

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

the benefits of you taking this

medicine against the risks it will

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

medicine. You may need to read

it again.

What Irbesat GH is used for

Irbesat GH is used to lower high

blood pressure, which doctors

call hypertension.

Everyone has blood pressure.

This pressure helps get your

blood all around your body. Your

blood pressure may be different

at different times of the day,

depending on how busy or

worried you are. You have

hypertension (high blood

pressure) when your blood

pressure stays higher than is

needed, even when you are calm

and relaxed.

There are often no symptoms of

high blood pressure. The only

way of knowing that you have

high blood pressure is to have

your blood pressure checked on

a regular basis.

If high blood pressure is not

treated it can lead to serious

health problems, such as stroke,

heart disease and kidney failure.

Irbesat GH is also used in the

treatment of kidney disease in

patients with high blood pressure

and type 2 diabetes.

How Irbesat GH works

Irbesat GH belongs to a group of

medicines known as angiotensin-

II receptor antagonists.

Angiotensin II is a substance

produced in the body that causes

blood vessels to narrow. Irbesat

GH blocks angiotensin-II and

therefore widens your blood

vessels, making it easier for your

heart to pump blood throughout

your body. This helps to lower

your blood pressure.

Irbesat GH also slows the

decrease of kidney function in

patients with high blood pressure

and type 2 diabetes.

Your doctor may have prescribed

Irbesat GH for another reason.

Ask your doctor if you have any

questions about why Irbesat GH

has been prescribed for you.

This medicine is only available

with a doctor's prescription.

There is no evidence that this

medicine is addictive.

Before you take Irbesat GH

When you must not take it

Do not take Irbesat GH if:

you are pregnant (or think

you may be pregnant) or are

planning to become

pregnant. Irbesat GH may

affect your developing baby if

you take it during pregnancy.

you are breast-feeding. It is

not known if Irbesat GH

passes into breast milk,

therefore it is recommended

that you not take it while you

are breast-feeding.

you are allergic to irbesartan

or to any of the ingredients

listed at the end of this

leaflet.

the packaging is torn or

shows signs of tampering.

the expiry date on the pack

has passed. If you take this

medicine after the expiry date

has passed, it may not work.

If you are not sure if you should

start taking Irbesat GH, talk to

your doctor.

Irbesat GH should not be given

to children.

Irbesat GH CMI v1 24 October 2012

Page 2 of 5

Before you start to take it

Tell your doctor if you have any

allergies to:

any of the ingredients listed at

the end of this leaflet,

including lactose;

any other medicines;

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Tell your doctor if you are breast

feeding or plan to breastfeed.

Tell your doctor if you have or

have had any medical

conditions, especially the

following:

recent excessive vomiting or

diarrhoea;

any kidney or heart problems,

liver problems, or have had

liver problems in the past;

you are strictly restricting

your salt intake.

Tell your doctor if you plan to

have surgery (even at the

dentist) that needs a general

anaesthetic.

If you have not told your doctor

about any of the above, tell

them before you take Irbesat

GH.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

any that you buy without a

prescription from your

pharmacy, supermarket or

health food shop.

Some medicines may affect the

way others work. Also, some

other medicines used to treat

high blood pressure may have an

additive effect with Irbesat GH in

lowering blood pressure. This

may happen with diuretics (fluid

tablets). As a result you may

need different amounts of your

medicines.

It may be necessary to have

blood tests done regularly if you

take potassium supplements,

potassium containing salt

substitutes or some medicines

such as diuretics (fluid tablets).

It may also be necessary to have

blood tests done regularly if you

take a medicine containing

lithium while you are taking

Irbesat GH.

Your doctor and pharmacist may

have more information on

medicines to be careful with or

avoid while taking Irbesat GH.

How to take Irbesat GH

How much to take

Your doctor will tell you how

many tablets to take each day.

Usually patients start with one

150 mg tablet once a day.

However, some patients may

need a lower starting dose. Your

doctor will tell you if this is

necessary. The full blood

pressure lowering effect of

Irbesat GH should be reached

about 4-6 weeks after starting

treatment.

Depending on how your blood

pressure responds, your daily

dose of Irbesat GH may need to

be increased. Most patients take

either 150 mg or 300 mg each

day.

In patients with high blood

pressure and type 2 diabetes,

300 mg once daily is the

preferred maintenance dose for

slowing the progression of

associated kidney disease.

Ask your doctor or pharmacist if

you are unsure of the correct

dose for you. They will tell you

exactly how much to take.

Follow the instructions they give

you.

How to take it

Swallow the tablet whole with a

glass of water.

It does not matter whether you

take Irbesat GH tablets before or

after food.

When to take it

Take Irbesat GH at about the

same time each day. Taking your

tablets at the same time each

day will have the best effect. It

will also help you remember

when to take the tablets.

How long to take it

Continue taking Irbesat GH until

your doctor tells you to stop.

Irbesat GH helps to control your

high blood pressure, but it does

not cure it. Therefore Irbesat GH

must be taken every day.

To help you remember to take

your tablets each day, Irbesat GH

tablets are supplied in a calendar

pack with the foil backing marked

with the days of the week. This is

just a way to help you to

remember to take your tablets.

All of the tablets in the pack are

the same.

Irbesat GH CMI v1 24 October 2012

Page 3 of 5

When you start a new strip of

tablets, take the tablet marked

"START" at the end of the blister

strip. On the next day, take the

tablet marked with the relevant

day of the week.

Continue taking your tablets

each day until all of the tablets

are taken. Commence the next

strip at "START" and continue as

before.

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 go back to

taking your tablets as you would

normally.

Do not take a double dose to

make up for the dose you

missed. This may increase the

chance of you getting any

unwanted side effects.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble

remembering to take your

tablets, ask your pharmacist for

some hints.

If you take too much (overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone: 13 11 26) or

go to Accident and Emergency at

your nearest hospital, if you

think that you or anyone else

may have taken too much

Irbesat GH. Do this even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention.

If you take too many Irbesat GH

tablets you will probably feel

light-headed or dizzy.

While you are using Irbesat GH

Things you must do

Tell any other doctors, dentists,

and pharmacists who are

treating you that you are taking

Irbesat GH.

If you become pregnant while

taking Irbesat GH tell your

doctor immediately.

Have your blood pressure

checked when your doctor tells

you to, to make sure Irbesat GH

is working.

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking Irbesat GH.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you

are taking Irbesat GH. Your

blood pressure may drop

suddenly.

Make sure you drink enough

water during exercise and hot

weather when you are taking

Irbesat GH, especially if you

sweat a lot.

If you do not drink enough water

while taking Irbesat GH, you may

faint or feel light-headed or sick.

This is because your body does

not have enough fluid and your

blood pressure is low. If you

continue to feel unwell, tell your

doctor.

If you have excessive vomiting

and/or diarrhoea while taking

Irbesat GH, tell your doctor. You

may lose too much water and

salt and your blood pressure may

drop too much.

If you feel light-headed or dizzy

after taking your first dose of

Irbesat GH, or when your dose is

increased, tell your doctor

immediately.

Things you must not do

Do not give Irbesat GH tablets to

anyone else, even if they have

the same condition as you.

Do not take Irbesat GH to treat

any other complaints unless

your doctor or pharmacist tells

you to.

Do not stop taking Irbesat GH, or

lower the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially

when you get up from bed or

chairs, will help your body get

used to the change in position

and blood pressure. If this

problem continues or gets worse,

talk to your doctor.

Be careful driving or operating

machinery until you know how

Irbesat GH affects you.

As with many other medicines

used to treat high blood

pressure, Irbesat GH may cause

dizziness or light-headedness in

some people. If this occurs do

not drive.

Irbesat GH CMI v1 24 October 2012

Page 4 of 5

Make sure you know how you

react to Irbesat GH before you

drive a car, operate machinery or

do anything else that could be

dangerous if you are dizzy or

light-headed.

If you drink alcohol, dizziness or

light-headedness may be worse.

Things that would be helpful for

lowering your blood pressure

Some self help measures

suggested below may help your

condition. Talk to your doctor or

pharmacist about these

measures and for more

information.

Alcohol - your doctor may

advise you to limit your

alcohol intake.

Weight - if you are

overweight, your doctor may

suggest losing some weight to

help lower your blood

pressure and help lessen the

amount of work your heart

has to do. Some people may

need a dietician's help to lose

weight.

Diet - your doctor may advise

you to eat a healthy low-fat

diet which includes plenty of

fresh vegetables, fruit, bread,

cereals and fish.

Salt - your doctor may advise

you to watch the amount of

salt in your diet. To reduce

your salt intake you should

avoid using salt in cooking or

at the table.

Exercise - regular exercise

helps to reduce blood

pressure and helps get the

heart fitter, but it is important

not to overdo it. Walking is

good exercise, but try to find

a route that is reasonably flat.

Before starting any exercise,

ask your doctor about the

best kind of program for you.

Smoking - your doctor may

advise you to stop smoking or

at least cut down.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Irbesat GH.

Irbesat GH helps most people

with high blood pressure, but it

may have unwanted side effects

in a few people. All medicines

can have side effects. Sometimes

they are serious, most of the

time they are not. You may need

medical treatment if you get

some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

headache,

dizziness or light-headedness

(vertigo),

unusual tiredness or

weakness,

fatigue,

nausea/vomiting.

These are common side effects.

They are generally mild and do

not normally require treatment

to be interrupted.

Tell your doctor immediately if

you notice any of the following:

skin rash or itchiness,

aching muscles, not caused by

exercise,

muscle pain or weakness,

buzzing, ringing or other

persistent noise in the ear,

yellowing of the skin and/or

eyes, also called jaundice,

symptoms that may indicate

kidney disease, such as

passing little or no urine,

drowsiness, nausea, vomiting,

breathlessness, loss of

appetite and weakness,

symptoms that may indicate

high potassium levels in the

blood, such as nausea,

diarrhoea, muscle weakness,

change in heart rhythm,

symptoms that may indicate

liver disease such as nausea,

vomiting, loss of appetite,

feeling generally unwell,

fever, itching, yellowing of the

skin and eyes and dark

coloured urine.

These are serious side effects.

Skin rash and itchiness may be

symptoms of an allergic reaction.

You may need medical attention.

These side effects are not

common.

If any of the following happen,

stop taking Irbesat GH and

either tell your doctor

immediately or go to

Accident and Emergency

Department at your nearest

hospital:

swelling of the face, lips,

tongue or throat which may

cause difficulty in swallowing

or breathing;

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or

nettlerash.

Irbesat GH CMI v1 24 October 2012

Page 5 of 5

These are very serious side

effects. You may need urgent

medical attention or

hospitalisation. These side effects

are very rare.

Other side effects not listed

above may occur in some

patients. Tell your doctor or

pharmacist if you notice

anything that is making you feel

unwell.

After using Irbesat GH

Storage

Keep your Irbesat GH tablets in

the blister pack until it is time to

take them. If you take the tablets

out of the blister pack they may

not keep well.

Keep Irbesat GH tablets in a cool

dry place where the

temperature stays below 25

o

C.

Do not store Irbesat GH or any

other medicine in the bathroom

or near a sink. Do not leave

them near a radiator, in a car on

hot days or on a window sill.

Heat and dampness can destroy

some medicines.

Keep all medicines out of the

reach of children. 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 Irbesat GH or the tablets

have passed their expiry date,

ask your pharmacist what to do

with any tablets that are left

over.

Product Description

What it looks like

IRBESAT GH 75 mg tablets are

white to off-white, oval and

biconvex film-coated tablets,

debossed with "L172" on one

side and "75" on the other side.

Available in blister packs of 30

tablets.

IRBESAT GH 150 mg tablets are

white to off-white, oval and

biconvex film-coated tablets,

debossed with "L173" on one

side and "150" on the other side.

Available in blister packs of 30

tablets.

IRBESAT GH 300 mg tablets are

white to off-white, oval and

biconvex film-coated tablets,

debossed with "L174" on one

side and "300" on the other side.

Available in blister packs of 30

tablets.

Active ingredient

Irbesartan.

Other Ingredients

Irbesat GH tablets also contain

Lactose

Croscarmellose sodium

Povidone

Magnesium stearate

Opadry II complete film

coating system 30F58652

white (ARPING 107860

consisting of hypromellose,

macrogol 4000, titanium

dioxide)

Australian Registration Numbers

Irbesat GH 75 mg: AUST R

192808

Irbesat GH 150 mg: AUST R

192815

Irbesat GH 300 mg: AUST R

192802

Distributor

Generic Health Pty Ltd

Suite 1, 1175 Toorak Road

Camberwell VIC 3124

This

leaflet

prepared

October 2012.