TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS IRBESARTAN irbesartan 75mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS IRBESARTAN irbesartan 75mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216059
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216059

TERRY WHITE CHEMISTS IRBESARTAN irbesartan 75mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

28/11/2013

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. TERRY WHITE CHEMISTS IRBESARTAN irbesartan 75mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

18/05/2017

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.

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. TERRY WHITE CHEMISTS IRBESARTAN irbesartan 75mg 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

"L172" on one side and "75" on the other side.

Active Ingredients

Irbesartan

75 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 26.11.2017 at 07:43:35 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

Terry White Chemists

Irbesartan

Contains the active ingredient irbesartan

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about Terry White

Chemists Irbesartan. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is Terry

White Chemists Irbesartan. It

contains the active ingredient

irbesartan.

It is used to treat:

high blood pressure

kidney disease in patients with

high blood pressure and type 2

diabetes.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

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. Irbesartan blocks

angiotensin-II and therefore relaxes

your blood vessels. This helps to

lower your blood pressure.

Irbesartan slows the decrease of

kidney function in patients with high

blood pressure and type 2 diabetes.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are taking a medicine

containing aliskiren and either

have diabetes or moderate to

severe kidney impairment.

You have damage to your

kidneys caused by diabetes,

called diabetic nephropathy,

and are on an ACE Inhibitor

(used to treat high blood

pressure).

You are pregnant.

Irbesartan may affect your

developing baby if you take it

during pregnancy.

You are hypersensitive to, or

have had an allergic reaction to,

irbesartan or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

TERRY WHITE CHEMISTS IRBESARTAN

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

kidney problems, kidney

transplant or dialysis

heart problems

liver problems

diabetes

high levels of potassium in your

blood

recent excessive vomiting or

diarrhoea

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are strictly restricting your

salt intake.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

irbesartan. These include:

other tablets for high blood

pressure

fluid tablets or diuretics

lithium or lithium containing

medicines (e.g. lithium carbonate)

potassium tablets and potassium

containing salt substitutes (e.g.

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

other medicinal products that may

increase potassium

anti-inflammatory medicines

(these are used to relive pain,

swelling and other symptoms of

inflammations, including

arthritis) and include non-

steroidal inflammatory agents -

NSAIDs (e.g. diclofenac,

indomethacin) and COX-2

inhibitors (e.g. celecoxib).

Taking a combination of irbesartan

with a thiazide diuretic (fluid tablet)

and an anti-inflammatory medicine

may damage your kidneys.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with irbesartan.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

The tablets should be taken as

directed by your doctor. The tablets

should be swallowed whole with a

glass of water.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

TERRY WHITE CHEMISTS IRBESARTAN

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Make sure you drink enough water

during exercise and hot weather

while you are on the medication,

especially if you sweat a lot.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking Terry White Chemists

Irbesartan or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

headache

dizziness or light-headedness

(vertigo)

unusual tiredness or weakness,

fatigue

nausea/vomiting

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention

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.

Allergic reactions

If you think you are having an

allergic reaction to is Terry White

Chemists Irbesartan, do not take

any more of this medicine and tell

your doctor immediately or go to

the Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine 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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

TERRY WHITE CHEMISTS IRBESARTAN

Product description

What Terry White Chemists

Irbesartan looks like

75 mg tablets: white to off-white,

oval shaped, biconvex, film-coated

tablet debossed with "L172" on one

side and "75" on the other side.

150 mg tablets: white to off-white,

oval shaped, biconvex, film-coated

tablet debossed with "L173" on one

side and "150" on the other side.

300 mg tablets: white to off-white,

oval shaped, biconvex, film-coated

tablet debossed with "L174" on one

side and "300" on the other side.

Terry White Chemists Irbesartan is

available in blister packs of 30

tablets.

* Not all strengths may be available.

Ingredients

Each tablet contains 75 mg, 150 mg

or 300 mg of irbesartan as the active

ingredient.

It also contains the following inactive

ingredients:

lactose

croscarmellose sodium

povidone

magnesium stearate

Opadry II complete film coating

system 30F58652 white

(ARPING 107860 consisting of

hypromellose, macrogol 4000 and

titanium dioxide).

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Terry White Chemists Irbesartan 75

mg tablets (blister pack): AUST R

216059.

Terry White Chemists Irbesartan 150

mg tablets (blister pack): AUST R

216060.

Terry White Chemists Irbesartan 300

mg tablets (blister pack): AUST R

216061.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in June

2017.

TERRY WHITE CHEMISTS IRBESARTAN

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

1-8-2018

Aprovel (Sanofi Clir SNC)

Aprovel (Sanofi Clir SNC)

Aprovel (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)5198 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

17-7-2018

Karvea (Sanofi-Aventis groupe)

Karvea (Sanofi-Aventis groupe)

Karvea (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4781 of Tue, 17 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety