IRBEVEL HCTZ 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack

Main information

  • Trade name:
  • IRBEVEL HCTZ 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IRBEVEL HCTZ 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192842
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192842

HYDESTIDE HCT 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg 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. HYDESTIDE HCT 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

1/12/2016

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. HYDESTIDE HCT 300/12.5 irbesartan and hydrochlorothiazide 300/12.5mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Peach coloured, oval shaped, biconvex, film coated tablet, debossed with

"L184" on one side and plain on the other side.

Active Ingredients

Hydrochlorothiazide

12.5 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 28.11.2017 at 08:03:35 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

IRBESATZIDE GH CMI v1 24Oct2012

Page 1 of 6

CONSUMER MEDICINE INFORMATION

IRBESATZIDE GH

Irbesartan and hydrochlorothiazide film-coated tablets

What is in this leaflet

This leaflet answers some

common questions about

Irbesatzide GH. 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 is Irbesatzide GH used for

Irbesatzide 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.

How Irbesatzide GH works

Irbesatzide GH 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

that causes blood vessels to

narrow. Irbesartan 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.

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.

Your doctor may have prescribed

Irbesatzide GH for another

reason.

Ask your doctor if you have any

questions about why Irbesatzide

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 Irbesatzide GH

When you must not take it

Do not take Irbesatzide GH if:

you are pregnant (or think

you may be pregnant) or are

planning to become

pregnant. Irbesatzide GH may

affect your developing baby if

you take it during pregnancy.

you are breast-feeding or are

planning to breast-feed.

you are allergic to irbesartan

or hydrochlorothiazide or to

sulphonamide derived

medicines (commonly known

as sulphur drugs), or to any of

the ingredients listed at the

end of this leaflet.

you are not producing urine.

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 Irbesatzide GH, talk

to your doctor.

Irbesatzide GH should not be

given to children.

IRBESATZIDE GH CMI v1 24Oct2012

Page 2 of 6

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, including

sulfonamide derived

medicines (commonly known

as sulphur drugs);

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

breastfeeding or plan to

breastfeed.

Tell your doctor if you have or

have had any medical

conditions, especially the

following:

recent excessive vomiting or

diarrhoea or think you are

dehydrated;

kidney problems, or have had

a kidney transplant or dialysis;

heart problems;

liver problems, or have had

liver problems in the past;

diabetes;

gout or have had gout in the

past;

lupus erythematosus;

high or low levels of

potassium or sodium or other

electrolytes in your blood;

primary aldosteronism;

you are strictly restricting

your salt intake;

you have had a

sympathectomy;

you have been taking

diuretics;

you have a history of allergy

or asthma.

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

Irbesatzide 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.

It is especially important that you

tell your doctor if you are taking

or plan to take any of the

following:

other medicines for high

blood pressure;

other fluid tablets or diuretics;

lithium or lithium-containing

medicines (for example

Lithicarb);

potassium tablets (for

example Span-K, Slow-K, Mag-

potassium-containing salt

substitutes (for example

Pressor-K);

anti-inflammatory medicines

(these are used to relieve

pain, swelling and other

symptoms of inflammation,

including arthritis) and include

non-steroidal anti-

inflammatory agents – NSAIDs

(for example Voltaren,

Indocid) and COX- 2 inhibitors

(for example Celebrex). Taking

a combination of Irbesatzide

GH and an anti-inflammatory

medicine may damage your

kidneys;

alcoholic drinks;

sleeping tablets;

strong pain killing medicines

such as codeine or morphine;

medicines for diabetes (oral

tablets or capsules or

insulins);

calcium supplements or

medicines containing calcium;

Vitamin D;

medicines for gout;

powder or granules used to

help reduce cholesterol

(Questran Lite or Colestid

Granules);

heart medicines such as

digoxin or antiarrhythmic

medicines (for example

Sotacor);

corticosteroid medicines such

as prednisone, cortisone or

ACTH;

medicines used to treat

cancer (cytotoxic medicines);

amantadine (Symmetrel), 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.

Your doctor will decide whether

your treatment needs to be

altered or whether you should

have check-ups more frequently.

Your doctor and pharmacist may

have more information on

medicines to be careful with or

avoid while taking Irbesatzide

IRBESATZIDE GH CMI v1 24Oct2012

Page 3 of 6

How to take Irbesatzide GH

How much to take

Irbesatzide GH will usually be

prescribed by your doctor if

previous treatment does not

produce a sufficient drop in your

blood pressure. Your doctor will

tell you how to switch from your

previous treatment to Irbesatzide

The usual dose of Irbesatzide GH

is one tablet a day. The full blood

pressure lowering effect should

be reached 6-8 weeks after

beginning treatment.

If your blood pressure is not

satisfactorily reduced with

Irbesatzide GH, your doctor may

prescribe another medicine to be

taken with Irbesatzide GH.

How to take it

Swallow the tablet whole with a

glass of water. It does not matter

whether you take Irbesatzide GH

tablets before or after food.

When to take it

Take Irbesatzide 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 Irbesatzide GH

until your doctor tells you to

stop.

Irbesatzide GH helps control your

high blood pressure but does not

cure it.

Therefore Irbesatzide GH must

be taken every day.

To help you remember to take

your tablets each day, Irbesatzide

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.

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.

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 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

Irbesatzide GH.

Do this even if there are no signs

of discomfort or poisoning. You

may need urgent medical

attention.

If you take too many Irbesatzide

GH tablets, you will probably feel

light-headed or dizzy.

While you are using Irbesatzide

GH

Things you must do

Tell any other doctors, dentists

and pharmacists who are

treating you that you are taking

Irbesatzide GH.

If you become pregnant while

taking Irbesatzide GH tell your

doctor immediately.

Have your blood pressure

checked when your doctor tells

you to, to make sure Irbesatzide

GH is working.

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking Irbesatzide GH.

If you plan to have surgery or

other treatment (even at the

dentist) that needs an

anaesthetic, make sure that you

tell your doctor or dentist that

you are taking Irbesatzide GH.

Your blood pressure may drop

suddenly.

IRBESATZIDE GH CMI v1 24Oct2012

Page 4 of 6

Make sure you drink enough

water during exercise and hot

weather when you are taking

Irbesatzide GH, especially if you

sweat a lot.

If you do not drink enough water

while taking Irbesatzide 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

Irbesatzide 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

Irbesatzide GH, or when your

dose is increased, tell your

doctor immediately.

Things you must not do

Do not give Irbesatzide GH

tablets to anyone else, even if

they have the same condition as

you.

Do not take Irbesatzide GH to

treat any other complaints

unless your doctor or pharmacist

tells you to.

Do not stop taking Irbesatzide

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

Irbesatzide GH affects you. As

with many other medicines used

to treat high blood pressure,

Irbesatzide GH may cause

dizziness or light-headedness in

some people. If this occurs do

not drive.

Make sure you know how you

react to Irbesatzide 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.

The hydrochlorothiazide

contained in this medicine could

produce a positive analytical

result in an antidoping test.

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

Irbesatzide GH.

Irbesatzide 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.

IRBESATZIDE GH CMI v1 24Oct2012

Page 5 of 6

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,

pain in the stomach or gut,

nausea and/or vomiting,

sexual problems.

These 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 or sore joints,

not caused by exercise,

muscle pain or weakness,

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 that

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 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 Irbesatzide GH and

either tell your doctor

immediately or go to Accident

and Emergency at your nearest

hospital:

swelling to the face, lips,

tongue or throat, which may

cause difficulty in swallowing

or breathing;

severe and a sudden onset of

pinkish, itchy swellings on the

skin, also called hives or

nettlerash.

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 Irbesatzide GH

Storage

Keep your Irbesatzide GH tablets

in the blister pack until it is time

to take them.

If you take the tablets out of the

blister pack they will not keep

well.

Keep Irbesatzide GH tablets in a

cool dry place where the

temperature stays below 25°C.

Do not store Irbesatzide GH or

any other medicine in the

bathroom near a sink. Do not

leave them near a radiator, in a

car on a hot day 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 Irbesatzide 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

IRBESATZIDE GH 150/12.5 are

peach coloured, oval, biconvex

film-coated coated tablets

debossed with “L183” on one

side and plain on the other side.

Available in blister packs of 30

tablets.

IRBESATZIDE GH CMI v1 24Oct2012

Page 6 of 6

IRBESATZIDE GH 300/12.5 are

peach coloured, oval, biconvex

film-coated tablets debossed

with “L184” on one side and plain

on the other side. Available in

blister packs of 30 tablets.

IRBESATZIDE GH 300/25 are

peach coloured, oval, biconvex

film-coated tablets debossed

with “L185” on one side and plain

on the other side. Available in

blister packs of 30 tablets.

Active Ingredients

Irbesartan.

Hydrochlorothiazide.

Other Ingredients

Irbesatzide GH tablets also

contain:

Lactose

Croscarmellose sodium

Povidone

Pigment blend PB-24899

(ARPING 107861 consisting of

iron oxide red, iron oxide

yellow, lactose)

Magnesium stearate

Irbesatzide GH 150/125 and

Irbesatzide GH 300/12.5

tablets contain Opadry II

complete film coating system

30F84418 pink (ARPING

107862 consisting of iron

oxide yellow, iron oxide red,

hypromellose, lactose,

macrogol 400, titanium

dioxide)

Irbesatzide GH 300/25 tablets

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 400,

titanium dioxide).

Australian Registration Numbers

Irbesatzide GH 150/12.5: AUST R

192827

Irbesatzide GH 300/12.5: AUST R

192842

Irbesatzide GH 300/25: AUST R

192830

Distributor

Generic Health Pty Ltd

Suite 1, 1175 Toorak Road

Camberwell VIC 3124

This

leaflet

prepared

October 2012.