CHEMMART IRBESARTAN HCTZ 300/ 25 irbesartan and hydrochlorothiazide 300/ 25mg tablet blister pack

Main information

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

Documents

Localization

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

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 216082
  • Last update:
  • 20-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216082

CHEMMART 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

29/11/2013

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. CHEMMART 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. CHEMMART 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 07:39:48 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

Chemmart Irbesartan

HCTZ Tablets

Irbesartan and hydrochlorothiazide

Consumer Medicine Information

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

What is in this leaflet

This leaflet answers some common

questions about irbesartan HCTZ. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

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.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What this medicine is

used for

Irbesartan HCTZ is used to treat high

blood pressure (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

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.

How it works

This product contains both irbesartan

and hydrochlorothiazide (HCTZ).

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.

HCTZ 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.

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.

This medicine is not addictive.

There is not enough information to

recommend the use of this medicine

for children.

Before you take this

medicine

When you must not take it

Do not take this medicine if you have

an allergy to:

irbesartan

hydrochlorothiazide

sulfonamide derived medicines,

any of the ingredients listed at the

end of this leaflet.

Some of the 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.

Do not take this medicine if you

are pregnant or intend to become

pregnant.

Irbesartan HCTZ may affect your

developing baby if you take it during

pregnancy.

Do not take this medicine if you

are not producing urine.

Do not take this medicine if 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

CHEMMART IRBESARTAN HCTZ

Inhibitor (used to treat high blood

pressure).

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

psoriasis or a history of psoriasis

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

recent excessive vomiting or

diarrhoea, dehydration

hypersensitivity to, or have had

an allergic reaction to, penicillin.

Do not take this medicine if you

are taking diuretics.

Do not take this medicine if you

are breastfeeding until you and

your doctor have discussed the

risks and benefits involved.

Do not take this medicine if you

are planning to have surgery,

dental treatment or an anaesthetic.

If you have not told your doctor

about any of the above, tell them

before you start taking this

medicine.

Taking other medicines

Tell your doctor and pharmacist if

you are taking 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:

medicines for the heart or high

blood pressure (e.g. digoxin,

sotalol, other fluid tablets or

diuretics)

lithium, used for mood disorders

potassium tablets, potassium

containing salt substitutes or

other medicinal products that may

increase potassium

anti-inflammatory medicines used

to relieve pain. 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 (e.g. Vitamin D

therapy)

medicines for gout

powder or granules used to help

reduce cholesterol

corticosteroid medicines such as

prednisone, cortisone or ACTH

medicines used to treat cancer

(cytotoxic medicines)

medicines used to treat

Parkinson's disease (e.g.

amantadine, anticholinergic

medicines)

medicines used during surgery

medicines used in an emergency

such as adrenaline.

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.

They may differ to the information

contained in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take,

depending on your condition and if

you are taking any other medicines.

The usual dose is one tablet taken

once a day. Depending on how your

blood pressure responds, your doctor

may increase your dose.

How to take it

The tablets should be swallowed

whole with a drink of water.

When to take it

Take this 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.

To help you remember to take your

tablets each day, Chemmart

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

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 the tablets are taken.

Commence the next strip at

"START" and continue as before.

It does not matter if you take this

medicine before or after food.

How long to take it

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

CHEMMART IRBESARTAN HCTZ

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.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice or

go to the Emergency Department

at your nearest hospital if you

think that you or anyone else may

have taken too much of this

medicine. Do this even if there are

no signs of discomfort or

poisoning. You may need urgent

medical attention.

While you are using

this medicine

Things you must do

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

this medicine.

Tell any other doctors, dentists and

pharmacists who are treating you

that you take this medicine. If you

become pregnant whilst taking this

medicine, tell your doctor

immediately.

Tell your doctor if you are about to

have any blood tests, 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.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not take your medicine to treat

any other complaint unless your

doctor tells you to.

Do not 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.

Side effects

Tell your doctor and pharmacist as

soon as possible if you do not feel

well while you are taking

irbesartan HCTZ.

All medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

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:

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

blurred vision, eye pain

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

excessive thirst, passing greatly

increased amounts of urine,

CHEMMART IRBESARTAN HCTZ

increased appetite with weight

loss, feeling tired, drowsy, weak,

depressed, irritable and generally

unwell (signs of diabetes)

passing little or no urine,

drowsiness, nausea, vomiting,

breathlessness, loss of appetite

and weakness (signs of kidney

disease)

nausea, diarrhoea, muscle

weakness and changes in heart

rhythm (signs of high potassium

levels in the blood)

nausea, vomiting, loss of appetite,

feeling generally unwell, fever,

itching, yellowing of the skin and

eyes (jaundice) and dark coloured

urine (signs of liver disease)

exacerbation of psoriasis

increased tendency of bleeding or

bruising

The above list includes serious side

effects that may need medical

attention:

If any of the following occur, tell

your doctor immediately or go to

the Emergency department at your

nearest hospital:

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, hay fever-like symptoms

(signs of an allergic reaction)

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may occur in some patients.

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

their expiry date, your pharmacist

can dispose of the remaining

medicine safely.

Product description

What it looks like

150/12.5 mg tablets: peach, oval,

biconvex film-coated tablet debossed

with "L183" on one side and plain on

the other side. AUST R 216080.

300/12.5 mg tablets: peach, oval,

biconvex film-coated tablet debossed

with "L184" on one side and plain on

the other side. AUST R 216081.

300/25 mg tablets: pinkish brown,

oval, biconvex film-coated tablet

debossed with "L185" on one side

and plain on the other side.

AUST R 216082.

Available in blister packs of 30

tablets.

* Not all strengths may be available.

Ingredients

Each tablet contains either 150 mg or

300 mg of irbesartan and 12.5 mg or

25 mg of hydrochlorothiazide as the

active ingredients.

It also contains the following inactive

ingredients:

Lactose monohydrate

croscarmellose sodium

povidone

pigment blend PB-24899

(ARPING 107861 consisting of

iron oxide red, iron oxide yellow

and lactose)

magnesium stearate.

150/12.5 and 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).

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 does not contain

gluten, tartrazine or any other azo

dyes.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks Apotex Inc.

This leaflet was prepared in June

2019.

CHEMMART IRBESARTAN HCTZ