APO-IRBESARTAN

Main information

  • Trade name:
  • APO-IRBESARTAN HCTZ 300/25 irbesartan and hydrochlorothiazide 300/25mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-IRBESARTAN HCTZ 300/25 irbesartan and hydrochlorothiazide 300/25mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213305
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213305

APO-IRBESARTAN HCTZ 300/25 irbesartan and hydrochlorothiazide 300/25mg 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

26/09/2013

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. APO-IRBESARTAN HCTZ 300/25 irbesartan and hydrochlorothiazide 300/25mg tablet blister pack

Product Type

Single Medicine Product

Effective date

24/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

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. APO-IRBESARTAN HCTZ 300/25 irbesartan and hydrochlorothiazide 300/25mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pinkish brown, oval shaped, biconvex, film coated tablet, debossed with

"L185" on one side and plain on the other side.

Active Ingredients

Hydrochlorothiazide

25 mg

Irbesartan

300 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 11:18:15 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

APO-Irbesartan HCTZ

Tablets

Contains the active ingredients, irbesartan and hydrochlorothiazide

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 APO-Irbesartan

HCTZ. 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.

Use in Children

There is not enough information to

recommend the use of this medicine

for children.

What this medicine is

used for

The name of your medicine is APO-

Irbesartan HCTZ. It contains the

active ingredient irbesartan and

hydrochlorothiazide (HCTZ).

It is used to treat 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)

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 regularly basis.

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

APO-Irbesartan HCTZ contains

irbesartan and hydrochlorothiazide.

Both medicines reduce blood

pressure in different ways.

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.

Hydrochlorothiazide belongs to the

class of medicines known as

diuretics. Diuretics cause an increase

in the volume of urine. They also

help with lowering blood pressure

particularly when combined with

other blood pressure reducing

medicines.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be given to

a child.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

APO-IRBESARTAN HCTZ TABLETS

You are pregnant or intend to

become pregnant.

Irbesartan HCTZ may affect your

developing baby if you take it

during pregnancy.

You are not producing urine.

You are taking a medicine

containing aliskiren and either

have diabetes or moderate to

severe kidney impairment.

Do not take this medicine if you

have damage to your kidneys

caused by diabetes, called

'diabetic nephropathy', and are

on an ACE Inhibitor (used to

treat high blood pressure

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.

You have had an allergic

reaction to irbesartan or

hydrochlorothiazide or to

sulfonamide derived medicines,

or any of the ingredients listed

at the end of this leaflet.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue,

throat or other parts of the body,

itching or hives on the skin.

If you think you are having an

allergic reaction, contact your

doctor immediately or go to the

Accident and Emergency

department at the nearest

hospital.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not give this medicine to anyone

else.

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

gout

lupus erythematosus

high or low levels of potassium or

sodium or other electrolytes in

your blood or you are restricting

your salt intake

primary aldosteronism

sympathectomy

allergies or asthma.

You have recently had excessive

vomiting or diarrhoea or think

you are dehydrated.

You are taking diuretics

You are hypersensitive to, or

have had an allergic reaction to,

penicillin.

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.

Taking other medicines

Before you start taking this medicine,

tell your doctor if 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 HCTZ. These include:

other medicines for high blood

pressure

other fluid tablets or diuretics

lithium or lithium-containing

medicines

potassium tablets, potassium

containing salt substitutes or

other medicinal products that may

increase potassium

anti-inflammatory medicines

(these are used to relieve pain,

swelling and other symptoms of

inflammation, including arthritis)

and include nonsteroidal anti-

inflammatory agents - NSAIDS

and COX-2 inhibitors. Taking a

combination of Irbesartan HCTZ

and an anti-inflammatory

medicine may damage your

kidneys

alcohol

sleeping tablets

strong pain killing medicines

such as codeine or morphine

medicines for diabetes (oral

tablets or capsules or insulins)

calcium supplements, medicines

containing calcium or calcium

sparing drugs (for example

Vitamin D therapy)

medicines for gout

powder or granules used to help

reduce cholesterol

heart medicines such as digoxin

or antiarrhythmic medicines such

as sotalol

corticosteroid medicines such as

prednisone, cortisone or ACTH

medicines used to treat cancer

(cytotoxic medicines)

amantadine, a medicine used to

treat Parkinson's disease or to

prevent influenza

anticholinergic medicines, these

can be used to treat Parkinson's

disease, to relieve stomach

cramps or spasms or used to

prevent travel sickness

medicines used during surgery

medicines used in an emergency

situation such as adrenaline.

APO-IRBESARTAN HCTZ TABLETS

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

HCTZ.

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.

Usually patients start with one

150/12.5 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

Irbesartan HCTZ should be reached

about 6-8 weeks after starting

treatment.

Depending on how your blood

pressure responds, your daily dose of

Irbesartan HCTZ may need to be

increased. Most patients take either

150/12.5mg or 300mg/12.5 each day.

However the daily dose should not

exceed 300/25 mg.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

The tablets should be swallowed

whole with a drink 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.

To help you remember to take your

tablets each day, APO-Irbesartan

HCTZ tablets are supplied in a

Calendar pack with the foil backing

marked with the days of the week.

This may help you to remember to

take your tablets. All of the tablets in

the pack are the same.

When you start a new strip of tablets,

take the tablet marked "START". 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.

It does not matter if you take APO-

Irbesartan HCTZ before 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

unwanted 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

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 become pregnant or plan to

breastfeed

you are about to have any blood

tests

you are going to have surgery or

dental treatment.

Get up slowly when getting out of

bed or standing up especially during

the first few doses or if your dose is

increased. You may feel light-headed

or dizzy while taking this medicine.

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 get

used to the change in position and

blood pressure. If this occurs, talk to

your doctor.

Make sure you drink enough water

during exercise and hot weather,

especially if you sweat a lot. If you

do not drink enough water, you may

faint or feel lightheaded 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 this

medicine, tell your doctor. This can

also mean that you are losing too

much water and your blood pressure

may become too low.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

APO-IRBESARTAN HCTZ TABLETS

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 or pharmacist 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.

As with many other medicines used

to treat high blood pressure,

Irbesartan HCTZ may cause

dizziness or light-headedness in some

people.

If you drink alcohol, dizziness or

light-headedness may be worse.

The hydrochlorothiazide contained in

this medicine could produce a

positive analytical result in an anti-

doping test.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking irbesartan HCTZ 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

unusual tiredness or

weakness,

fatigue

pain in the stomach or gut; nausea

and/or vomiting

sexual problems

Tell your doctor as soon as possible

if you notice any of the following:

These may be serious side effects.

You may need medical attention:

skin rash or itchiness

aching muscles or aching joints,

not caused by exercise

muscle pain, weakness or

paralysis of muscles

buzzing, ringing or other

persistent noise in the ears

changes in heart rhythm

you are not urinating (passing

water) as much as normal

numbness or tingling in fingers or

toes

painful, swollen joints which may

be symptoms of gout

fainting

yellowing of the skin and/or eyes,

also known as jaundice

symptoms that may occur if you

have developed diabetes, such as

excessive thirst, passing greatly

increased amounts of urine,

increased appetite with weight

loss, feeling tired, drowsy, weak,

depressed, irritable and generally

unwell

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 changes in heart

rhythm

symptoms that may indicate liver

disease with nausea, vomiting,

loss of appetite, feeling generally

unwell, fever, itching, yellowing

of the skin and eyes and dark

coloured urine.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to Irbesartan

HCTZ, 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,

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 they have passed

APO-IRBESARTAN HCTZ TABLETS

their expiry date, your pharmacist

can dispose of the remaining

medicine safely.

Product description

What it looks like

APO-Irbesartan HCTZ 150/12.5 mg

is a peach, oval, biconvex film-

coated tablet debossed with "L183"

on one side and plain on the other

side.

APO-Irbesartan HCTZ 300/12.5 mg

is a peach, oval, biconvex film-

coated tablet debossed with "L184"

on one side and plain on the other

side.

APO-Irbesartan HCTZ 300/25 mg is

a pinkish brown, oval, biconvex film-

coated tablet debossed with "L185"

on one side and plain on the other

side.

Ingredients

Each APO-Irbesartan HCTZ

150/12.5 mg tablet contains 150 mg

of irbesartan and 12.5 mg of

hydrochlorothiazide as the active

ingredients.

Each APO-Irbesartan HCTZ

300/12.5 mg tablet contains 300 mg

of irbesartan and 12.5 mg of

hydrochlorothiazide as the active

ingredients.

Each APO-Irbesartan HCTZ 300/25

mg tablet contains 300 mg of

irbesartan and 25 mg of

hydrochlorothiazide as the active

ingredients.

It also contains the following inactive

ingredients:

lactose

croscarmellose sodium

povidone

pigment blend PB-24899

(ARPING 107861 consisting of

iron oxide red, iron oxide yellow

and lactose)

magnesium stearate.

APO-Irbesartan HCTZ 150/12.5

and APO-Irbesartan HCTZ

300/12.5 tablets also contain

Opadry II complete film coating

system 30F84418 pink (ARPING

107862 consisting of iron oxide

yellow, iron oxide red,

hypromellose, lactose, macrogol

4000 and titanium dioxide).

APO-Irbesartan HCTZ 300/25

tablets also contain Opadry II

complete film coating system

30F86974 brown (ARPING

107863 consisting of iron oxide

yellow, iron oxide red, iron oxide

black, hypromellose, lactose,

macrogol 4000 and titanium

dioxide).

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

APO-Irbesartan HCTZ is available in

blister packs of 30 tablets.

* Not all strengths may be available.

Australian Registration

Numbers

APO-Irbesartan HCTZ 150/12.5 mg

tablets (blister pack): AUST R

213302

APO-Irbesartan HCTZ 300/12.5 mg

tablets (blister pack): AUST R

213303.

APO-Irbesartan HCTZ 300/25 mg

tablets (blister pack): AUST R

213305.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks Apotex Inc.

This leaflet was last updated in June

2017.

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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

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

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

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety