APO-CANDESARTAN

Main information

  • Trade name:
  • APO-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210530
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210530

APO-CANDESARTAN candesartan cilexetil 8 mg 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

2/07/2013

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-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

17/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of hypertension.,Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction

<=40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APO-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink, round, biconvex uncoated mottled tablets debossed with 292 on

one side and break line on other side.

Active Ingredients

Candesartan cilexetil

8 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 27.11.2017 at 09:40:27 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-Candesartan

Tablets

Contains the active ingredient candesartan cilexetil

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 candesartan. 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 APO-

Candesartan. It contains the active

ingredient candesartan cilexetil.

It is used to treat:

high blood pressure, also called

hypertension.

heart failure - increase survival,

reduce hospitalisation and

improve symptoms. It is used in

combination with other medicines

to treat your condition.

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.

There is no evidence that this

medicine is addictive.

How it works

Candesartan is a type of medicine

called an angiotensin II receptor

inhibitor (or antagonist).

Hypertension:

All people have blood pressure. This

pressure helps to push blood all

around your body. Your blood

pressure changes during the day,

depending on how busy you are or

how you are feeling.

You have hypertension (high blood

pressure) when your blood pressure

stays higher than is needed, even

when you are calm and relaxed.

Regular blood pressure checks are

the only way of knowing that you

have hypertension. There are usually

no symptoms of hypertension and

you may feel fine. If hypertension is

not treated, serious health problems

such as stroke or heart attack and

heart or kidney failure may occur.

Candesartan lowers blood pressure

by dilating (expanding) small blood

vessels from the heart, letting the

blood be pumped around the body

more easily.

Heart Failure:

Heart failure means that the heart

muscle cannot pump blood strongly

enough to supply all the blood

needed throughout the body. Heart

failure is not the same as heart attack

and does not mean that the heart

stops working.

Heart failure may start off with no

symptoms, but as the condition

progresses, patients may feel short of

breath or may get tired easily after

light physical activity such as

walking. Some patients may wake up

short of breath at night. Fluid may

collect in different parts of the body,

often first noticed as swollen ankles

and feet.

Candesartan helps to treat heart

failure and may improve your

symptoms.

One of the ways candesartan helps

heart failure is that it widens the

blood vessels, so that the heart does

APO-CANDESARTAN TABLETS

not have to pump as hard to move the

blood around the body. This also

means that when you place extra

demands on your heart, such as

during exercise, the heart may cope

better so you may not get short of

breath as easily.

When used to treat heart failure,

candesartan is almost always used

with other medicines called diuretics

or fluid tablets. These medicines help

the kidney to get rid of excess fluid

from the body.

Use in children

There is no information about its use

in children, so candesartan is not

recommended for children

Before you use this

medicine

When you must not use it

Do not use this medicine if you

have an allergy to:

candesartan cilexetil or any of

the ingredients listed at the end

of this leaflet.

angiotensin II receptor

inhibitor (or antagonist), e.g.

telmisartan, irbesartan,

olmesartan etc.

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;

rash, 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 candesartan if you

are also taking aliskiren-

containing medications and

have kidney problems or

diabetes.

Do not use candesartan if you

have severe hepatic impairment

and/or cholestasis (a condition

where bile does not flow from

the liver)

Do not use candesartan if you

are pregnant.

It may affect your baby if you

take it during pregnancy.

Do not breast-feed if you are

taking candesartan.

It is not known if candesartan

passes into breast milk..

Do not use this medicine if the

expiry date (EXP) printed on

the pack has passed.

Do not use this medicine if 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:

1.

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

2.

You have or have had any

medical conditions, especially

the following:

kidney problems

liver problems

heart or blood vessel problems

a condition called primary

hyperaldosteronism

You may have to take a lower

dose of candesartan if you have

these conditions.

3.

You are planning to have

surgery or an anaesthetic.

If you have not told your doctor

about any of the above, tell them

before you use this medicine.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy at the chemist,

supermarket or health food shop.

Some medicines and candesartan

may interfere with each other. These

include:

any medicines containing

potassium, including salt

substitutes

diuretics (fluid tablets)

lithium, a medicine used to treat

mood swings and some types of

depression

non-steroidal anti-inflammatory

drugs (NSAIDs), medicines used

to relieve pain, swelling and other

symptoms of inflammation,

including arthritis.

angiotensin converting enzyme

(ACE) inhibitors e.g. perindopril,

ramipril and captopril.

These medicines may be affected by

candesartan or may affect the way

candesartan works. You may need

different amounts of your medicines,

or may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

It may be necessary to have regular

blood tests done if you take any of

these medicines.

How to take this

medicine

Follow carefully all directions

given to you by your doctor

carefully.

Their instructions may be different to

the information in this leaflet.

If you are not sure how to take this

medicine, ask your doctor or

pharmacist for help.

How to take it

Your doctor or pharmacist 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.

APO-CANDESARTAN TABLETS

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

Take candesartan once a day, at

about the same time each day.

Taking candesartan at the same time

each day will help you remember

when to take it.

It does not matter whether you

take candesartan with food or on

an empty stomach.

How long to take it

Continue taking this medicine for as

long as your doctor tells you.

This medicine controls your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

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.

If you are not sure what to do, ask

your doctor or pharmacist.

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.

If you take too many candesartan you

will probably get a headache and feel

sick (nausea), dizzy and very tired.

While you are using

this medicine

Things you must do

If you become pregnant while

you are using this medicine, tell

your doctor.

Tell all doctors, dentists and

pharmacists who are treating you

that you are using this medicine.

If you are about to be started on

any new medicine, tell your

doctor or pharmacist that you are

using this medicine.

If you are going to have surgery,

inform your doctor and tell the

surgeon or anaesthetist that you

are using 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

Move slowly when getting out of

bed or standing up if you feel faint,

dizzy or light-headed.

Be careful driving or operating

machinery until you know how

candesartan affects you.

You may feel dizzy when you start

taking candesartan.

If you are taking candesartan for

high blood pressure, drink plenty

of water during exercise and hot

weather, especially if you sweat a

lot. If you do not drink enough

water while taking candesartan,

you may faint or feel light-headed

or sick. This is because your body

doesn't have enough fluid and your

blood pressure is low. If you

continue to feel unwell, tell your

doctor.

If you are taking candesartan for

heart failure, restricted fluid

intake is generally recommended.

Speak with your doctor about how

much water you should drink.

Please talk to your doctor or

pharmacist about any concerns you

may have about the above.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using this

medicine.

Your doctor will decide whether any

change in your treatment is needed.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects. If you are over 65

years of age, you may have an

increased chance of getting side

effects.

Candesartan helps most people, but it

may have side effects in a few

people.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following:

headache

chest or throat infection

flu-like symptoms

feeling sick (nausea, vomiting)

back pain

dizziness

These are all mild side effects of

candesartan.

The following side effects have been

reported very rarely by patients

taking candesartan: palpitations,

agitation, anxiety, depression, trouble

sleeping (insomnia), drowsiness

(somnolence), nervousness,

nightmare and sleep disorder. It is

not known if these side effects are

caused by candesartan.

APO-CANDESARTAN TABLETS

Tell your doctor as soon as possible

if you notice any of the following:

aching muscles, tenderness or

weakness in the muscle

The above list includes serious side

effects that may require medical

attention. These side effects are rare.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital.

swelling of the face, lips, tongue

or throat which may cause

difficulty in swallowing or

breathing

harsh sounds when breathing

signs of frequent infections such

as fever, severe chills, sore throat

or mouth ulcers

jaundice (yellowing of the skin

and/or eyes)

unusual skin reactions (severe

and sudden onset of rash),

itchiness, hives (itchy swellings

on the skin)

bruising easily

extreme fatigue, tiredness,

weakness

worsening kidney function,

including passing little or no

urine, drowsiness, nausea,

vomiting, breathlessness, loss of

appetite and weakness (especially

in patients with existing kidney

problems or heart failure)

changes in your potassium,

sodium and red or white blood

cell levels may occur. Such

changes are usually detected by a

blood test

symptoms that may indicate high

potassium levels in the blood

include nausea, diarrhoea, muscle

weakness and changes in heart

rhythm

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Other side effects not listed above

may occur in some people. Tell your

doctor if you notice any other side

effects.

Storage and disposal

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take candesartan out of the

blister pack it will not keep well.

Keep your tablets in a cool dry

place where the temperature will

stay below 30°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 or pharmacist 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 APO-Candesartan

looks like

APO-Candesartan 4 mg tablets: Light

pink, round, biconvex tablet with

'291' on one side and a break line on

the other side

APO-Candesartan 8mg tablets: Light

pink, round, biconvex, uncoated

mottled tablet with '292' on one side

and a break line on the other side

APO-Candesartan 16 mg tablets:

Light pink, round, biconvex uncoated

mottled tablet with 'L293' on one side

and a break line on the other side

APO-Candesartan 32 mg tablets:

Light pink, , round, biconvex

uncoated mottled tablet with 'L294'

on one side and a break line on the

other side.

Ingredients

Each tablet contains 4mg or 8mg or

16mg or 32mg of the active

ingredient candesartan cilexetil.

It also contains the following inactive

ingredients:

lactose

maize starch

hydroxypropylcellulose

carmellose calcium

magnesium stearate

Pigment Blend PB-24880 Pink

(iron oxide red and lactose).

macrogol 8000

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

APO-Candesartan is available in:

Blister packs of 7, 28 and 30 tablets.

Not all strengths, pack types and/or

pack sizes may be available

Australian Registration

Numbers

APO-Candesartan 4 mg blister pack:

AUST R 210529

APO-Candesartan 8 mg blister pack:

AUST R 210530

APO-Candesartan 16 mg blister

pack: AUST R 210531

APO-Candesartan 32 mg blister

pack: AUST R 210532

Sponsor

Apotex Pty Ltd

16 Giffnock Ave

Macquarie Park, NSW 2113

Australia

APO and APOTEX are registered

trade marks of Apotex Inc.

APO-CANDESARTAN TABLETS

This leaflet was prepared in July

2014.

APO-CANDESARTAN TABLETS

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