DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack

Main information

  • Trade name:
  • DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190513
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190513

DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

20/11/2012

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. DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

28/03/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ò for the treatment of hypertension.

ò for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (equal to or greater than 30mg per 24

hours) or urinary protein in excess of 900mg per 24 hours.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. DR REDDY'S IRBESARTAN irbesartan 150 mg film coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval shaped, film coated tablets debossed with 'IRB' on

one side and '150' on 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

Public Summary

Page 1 of

Produced at 28.11.2017 at 11:03:32 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

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

Public Summary

Page 2 of

Produced at 28.11.2017 at 11:03:32 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

DR REDDY'S IRBESARTAN Tablets

V1 October 2011

DR REDDY’S IRBESARTAN Tablets

Irbesartan

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking

DR REDDY’S IRBESARTAN. This

leaflet answers some common

questions about DR REDDY’S

IRBESARTAN. It does not contain all

the available information. It does not

take the place of talking to your doctor

or pharmacist. Do not throw this leaflet

away. You may need to refer to it again

later.

Always follow the instructions that

your doctor and pharmacist give you

about DR REDDY’S IRBESARTAN.

If you have any concerns about taking

DR REDDY’S IRBESARTAN, ask

your doctor or pharmacist.

What is DR REDDY’S

IRBESARTAN

DR REDDY’S IRBESARTAN is a

trade name (manufacturer's name) for

the medicine, irbesartan. This medicine

is in the tablets your doctor has

prescribed for you.

What DR REDDY’S

IRBESARTAN is used for

DR REDDY’S IRBESARTAN lowers

high blood pressure, which doctors call

hypertension

Your doctor measured your blood

pressure and found it to be too high.

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)

which means your blood pressure stays

high, even when you are calm and

relaxed.

There are usually no symptoms of

high blood pressure. The only way of

knowing that you have hypertension is

to have your blood pressure checked

on a regular basis. High blood

pressure, if not treated, can damage

blood vessels in several organs such as

the heart, the kidneys, the brain and

the eyes. This may lead to heart

attacks, heart or kidney failure,

strokes, or blindness. There are

usually no symptoms of high blood

pressure before damage

occurs, so your doctor needs to

measure your blood pressure to see if

it is too high.

High blood pressure can be treated

and controlled with medicines such as

DR REDDY’S IRBESARTAN. Your

doctor may also have recommended

that you adjust your lifestyle to help to

lower your high blood pressure (losing

weight, avoiding smoking, reducing

alcohol consumption and restricting

the amount of salt in the diet). Your

doctor may also have encouraged the

practice of regular, mild (not

strenuous) exercise such as walking,

swimming, etc...

DR REDDY’S IRBESARTAN is also

used in the treatment of kidney disease

patients with high blood pressure and

type 2 diabetes

What DR REDDY’S

IRBESARTAN does and how

it works

DR REDDY’S IRBESARTAN

belongs to a group of medicines

known as angiotensin-II receptor

antagonists. Angiotensin II is a

substance produced in the body which

causes blood vessels to tighten. DR

REDDY’S IRBESARTAN blocks

angiotensin-II and therefore relaxes

your blood vessels. This helps to

lower your blood pressure.

DR REDDY’S IRBESARTAN slows

the decrease of kidney function in

patients with high blood pressure and

type 2 diabetes.

Your doctor may have prescribed DR

REDDY’S IRBESARTAN for another

use. If you want more information, ask

your doctor

When you must not

take DR REDDY’S

IRBESARTAN

Do not take DR REDDY’S

IRBESARTAN if:

you are pregnant (or think you

may be pregnant) or are planning

to become pregnant

Your baby may absorb this medicine in

the womb and there is a possibility of

harm to the baby.

you are breast-feeding

It is not known if DR REDDY’S

IRBESARTAN passes into breast milk,

therefore it is not recommended to be

taken while you are breast-feeding.

you are allergic to irbesartan or to

any of the ingredients listed under

Product Description 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 DR REDDY’S IRBESARTAN,

talk to your doctor.

DR REDDY’S IRBESARTAN should

not be given to children.

DR REDDY'S IRBESARTAN Tablets

V1 October 2011

Before you start to take

DR REDDY’S

IRBESARTAN

Tell your doctor if:

you are or intend to become

pregnant or plan to breast-feed

DR REDDY’S IRBESARTAN

should

not be used during pregnancy or

while breast- feeding

you have recently had excessive

vomiting or diarrhoea

you suffer from any medical

conditions especially -

kidney or heart problems, liver

problems, or have had liver

problems in the past

you are strictly restricting your

salt intake

you are lactose intolerant or

have had any allergies to any

other medicine or any other

substances, such as foods,

preservatives or dyes.

Be sure you tell your doctor about any

of these things before you take any DR

REDDY’S IRBESARTAN.

Taking DR REDDY’S

IRBESARTAN with other

medicines

Tell your doctor if you are taking or

intend to take any other medicines,

including medicines that you buy

without a prescription from your

pharmacy, supermarket or health

food shop.

It is especially important that you tell

your doctor if you are taking, or plan to

take any of the following:

other tablets for high blood

pressure

fluid tablets or diuretics

lithium or lithium containing

medicines (for example

Lithicarb)

potassium tablets (for example

Span-K, Slow-K, Mag-K)

potassium containing salt

substitutes (for example Pressor-

anti-inflammatory medicines

(these are used to relieve pain,

swelling and other symptoms of

inflammation, including arthritis) and

include nonsteroidal anti-

inflammatory agents - NSAIDs (for

example Voltaren, Indocid) and COX-

2 inhibitors (for example Celebrex).

Taking a combination of DR

REDDY’S IRBESARTAN with a

thiazide diuretic (fluid tablet) and an

anti-inflamatory medicine may

damage your kidneys.

Your doctor will decide whether your

treatment needs to be altered or

whether you should have check ups

or blood tests more frequently

How to take DR

REDDY’S

IRBESARTAN

The tablets should be taken regularly

as directed by your doctor. The tablets

should be swallowed with a glass of

water

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 DR REDDY’S

IRBESARTAN should be reached

about 4-6 weeks after starting

treatment.

Depending on how your blood

pressure responds, your daily dose of

DR REDDY’S IRBESARTAN may

need to be increased. Most patients

take either 150mg or 300mg each day.

In patients with high blood pressure

and type 2 diabetes, 300mg once daily

is the preferred maintenance dose for

the treatment of associated kidney

disease.

Follow all directions given to you by

your doctor carefully. They may differ

from the information contained in this

leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

When to take it:

You should try to take your daily dose

of DR REDDY’S IRBESARTAN at

about the same time each day. Taking

your DR REDDY’S IRBESARTAN

tablets at the same time each day will

have the best effect.

It does not matter whether you take DR

REDDY’S IRBESARTAN tablets

before or after food.

How long to take it:

DR REDDY’S IRBESARTAN helps to

control your high blood pressure, but it

does not cure it. Therefore DR

REDDY’S IRBESARTAN must be

taken every day. Continue taking DR

REDDY’S IRBESARTAN until your

doctor tells you to stop.

If you miss a dose:

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.

If you are not sure whether to skip the

dose, talk to your doctor or pharmacist.

Do not take a double dose to make up

for the missed dose.

If you have trouble remembering to take

your tablets, ask your pharmacist for

some hints.

If you take too much

DR REDDY’S IRBESARTAN

(overdose)

Immediately telephone your doctor or

Poisons Information Centre (telephone

131126) or go to the Accident and

Emergency Department at your nearest

hospital, if you or anyone else may have

taken too much DR REDDY’S

IRBESARTAN. Do this even if there

are no signs of discomfort or poisoning.

If you take too many DR REDDY’S

IRBESARTAN tablets you will

probably feel lightheaded or dizzy

DR REDDY'S IRBESARTAN Tablets

V1 October 2011

While you are using

DR REDDY’S

IRBESARTAN

Things you must do:

If you become pregnant while taking

DR REDDY’S IRBESARTAN tell

your doctor immediately.

Have your blood pressure checked

when your doctor tells you to, to make

sure DR REDDY’S IRBESARTAN is

working.

If you are about to start on any new

medicine, tell your doctor and

pharmacist that you are taking DR

REDDY’S IRBESARTAN.

Get up slowly when getting out of bed

or standing up.

You may feel light-headed or dizzy

while taking DR REDDY’S

IRBESARTAN, especially if you are

also taking a diuretic (fluid tablet). This

may become worse if you stand up

quickly as your blood pressure may fall.

Standing up slowly, especially when

you get up from bed or chairs

will help

your body

blood pressure may become too low.

Things you must not do:

Do not give DR REDDY’S

IRBESARTAN tablets to anyone else,

even if they have the same condition

as you.

Things to be careful of:

Be careful driving or operating

machinery until you know how DR

REDDY’S IRBESARTAN affects

you.

As with many other medicines used to

treat high blood pressure, DR

REDDY’S IRBESARTAN may cause

dizziness or light-headedness in some

people. Make sure you know how you

react to DR REDDY’S

IRBESARTAN 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.

skin rash or itchiness

aching muscles or aching joints,

not caused by exercise

muscle pain

buzzing, ringing or other

persistent noise in the ears

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 and change in heart

rhythm

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 DR REDDY’S IRBESARTAN

and tell your doctor immediately or go

to Accident and Emergency Department

at your nearest hospital.

get used to the change in position

and blood pressure. This problem is not

common. If it occurs talk to your

doctor.

If you plan to have surgery (even at the

dentist) that needs a general anaesthetic,

tell your doctor or dentist that you are

taking DR REDDY’S IRBESARTAN.

Make sure you drink enough water

during exercise and hot weather when

you are taking DR REDDY’S

IRBESARTAN, especially if you sweat

a lot.

If you do not drink enough water while

taking DR REDDY’S IRBESARTAN,

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 DR REDDY’S

IRBESARTAN, tell your doctor.

This can also mean that you are losing

too much water and your

Side effects

DR REDDY’S IRBESARTAN 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.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking DR

REDDY’S IRBESARTAN.

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-

swelling to 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.

These are serious side effects. If you

have them you have had a serious

allergic reaction to DR REDDY’S

IRBESARTAN. 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. If you notice any

other unwanted effects, you should tell

your doctor or pharmacist and ask for

their advice.

DR REDDY'S IRBESARTAN Tablets

V1 October 2011

After using DR

REDDY’S IRBESARTAN

Storage:

Keep your DR REDDY’S

IRBESARTAN tablets in the original

packaging until it is time to take them.

If you take the tablets out of the original

packaging they may not keep well.

Keep DR REDDY’S IRBESARTAN

tablets in a cool dry place where the

temperature stays below 25°C. Do not

store DR REDDY’S IRBESARTAN 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

DR REDDY’S IRBESARTAN 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

DR REDDY’S IRBESARTAN 75 mg

tablets - White to off-white, oval

shaped, film coated tablets debossed

with ‘IRB’ on one side and ‘75’ on

other side.

Pack & pack sizes:

Blister Pack: 30’s, 14’s, 98’s, 56’s, 3’s,

5’s, 7’s and 28’s tablets.

Bottle pack: 30’s, 7’s, 90’s and 14’s

tablets.

AUST R 190511

AUST R 190501

DR REDDY’S IRBESARTAN 150 mg

tablets - White to off-white, oval

shaped, film coated tablets debossed

with

‘IRB’ on one side and ‘150’ on

other side.

Pack & Pack sizes:

Blister Pack: 30’s, 14’s, 98’s, 56’s, 3’s,

5’s, 7’s and 28’s tablets.

Bottle pack: 30’s, 7’s, 90’s and 14’s

tablets.

AUST R 190513

AUST R 190525

DR REDDY’S IRBESARTAN 300 mg

tablets - White to off-white, oval

shaped, film coated tablets debossed

with ‘IRB’ on one side and ‘300’ on

other side.

Pack & Pack sizes:

Blister Pack: 30’s, 14’s, 98’s, 56’s, 3’s,

5’s, 7’s and 28’s tablets.

Bottle pack: 30’s, 7’s, 90’s and 14’s

tablets.

AUST R 194198

AUST R 190509

Active ingredients

DR REDDY’S IRBESARTAN 75 mg

tablets - 75 mg irbesartan per tablet.

DR REDDY’S IRBESARTAN 150 mg

tablets - 150 mg irbesartan per tablet.

DR REDDY’S IRBESARTAN 300 mg

tablets - 300 mg irbesartan per tablet.

Other Ingredients

DR REDDY’S IRBESARTAN tablets

also contain lactose, cellulose-

microcrystalline, crospovidone,

povidone, silica- colloidal anhydrous,

magnesium stearate, hypromellose,

titanium dioxide and macrogol 4000.

How current is this

information and where can I

find out more?

This leaflet was produced based on

information known by Dr. Reddy's

Laboratories (Australia) Pty Ltd in

October 2011. You need to consult your

doctor regularly as your doctor has

access to information on any changes

which may affect you.

Who makes DR

REDDY’S

IRBESARTAN?

DR REDDY’S IRBESARTAN is made

available by

Dr. Reddy's Laboratories

(Australia) Pty Ltd

Level 1, 181 Bay Street

Brighton VIC 3186

Australia

This information in no way replaces the

advice of your doctor or pharmacist.