CANDESAN candesartan cilexetil 4 mg tablet blister pack

Main information

  • Trade name:
  • CANDESAN candesartan cilexetil 4 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANDESAN candesartan cilexetil 4 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195483
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195483

CANDESAN candesartan cilexetil 4 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

2/05/2013

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. CANDESAN candesartan cilexetil 4 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/10/2017

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

Not recorded

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. CANDESAN candesartan cilexetil 4 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink, round, biconvex uncoated mottled tablets debossed with 291 on

one side and break line on other side.

Active Ingredients

Candesartan cilexetil

4 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 04:09:47 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

Page 1 of 5

CANDESAN – Consumer Medicine Information

CANDESAN

contains the active ingredient candesartan cilexetil

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some

common questions about

CANDESAN.

It does not contain all of 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

risks of you taking CANDESAN

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine. You may need to read

it again.

What CANDESAN is used for

CANDESAN belongs to a group of

medicines known as angiotensin-II

receptor antagonists.

CANDESAN is used to treat:

high blood pressure, also called

hypertension

heart failure, usually in

combination with other

medicines.

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.

Regular blood pressure checks are

the only way of knowing that you

have hypertension. There are 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.

CANDESAN 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.

CANDESAN helps to treat heart

failure and may improve your

symptoms.

One of the ways CANDESAN helps

heart failure is that it widens the

blood vessels, so that the heart

does 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,

CANDESAN is almost always used

with other medicines called

diuretics or fluid tablets. These

medicines help the kidney get rid

of excess fluid from the body.

Your doctor will have explained

why you are being treated with

CANDESAN and told you what

dose to take.

Your doctor may have prescribed

CANDESAN for another reason.

Ask your doctor if you have any

questions about why CANDESAN

has been prescribed for you.

CANDESAN is available only with a

doctor's prescription.

Before you take CANDESAN

When you must not take it

Do not take CANDESAN if you are

allergic to medicines containing

candesartan cilexetil, other

angiotensin II receptor

antagonists, or any of the

ingredients listed at the end of

this leaflet.

Page 2 of 5

CANDESAN – Consumer Medicine Information

Symptoms of an allergic reaction

can include 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

Do not use CANDESAN if you

have:

severe liver disease and/or

conditions associated with

impaired bile flow

(cholestasis)

Do not use CANDESAN if you

are taking blood pressure

medicine containing aliskiren,

especially if you have diabetes

mellitus or have kidney

problems

.

Do not take CANDESAN if you are

pregnant. CANDESAN may affect

your developing baby if you take it

during pregnancy.

Do not breastfeed if you are

taking CANDESAN. It is not known

if CANDESAN passes into breast

milk.

Do not give CANDESAN to

children. There is no information

about its use in children, so

CANDESAN is not recommended

for children.

Do not take CANDESAN if the

expiry date (Exp.) printed on the

pack has passed.

Do not take CANDESAN if the

packaging is torn or shows signs

of tampering.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines, foods,

dyes or preservatives.

Tell your doctor if you have, or

have had, any medical conditions,

especially the following:

kidney problems

heart problems

liver problems

recent excessive vomiting or

diarrhoea

a condition called primary

hyperaldosteronism.

You may have to take a lower dose

of CANDESAN if you have these

conditions.

If you have not told your doctor

about any of the above, tell them

before you start taking

CANDESAN.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

any that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may be affected

by CANDESAN, or may affect how

well it works. These include:

fluid tablets or diuretics

lithium or lithium containing

medicines (e.g. Lithicarb)

potassium containing salt

substitutes (e.g. Pressor-K)

anti-inflammatory medicines,

used to relieve pain, swelling

and other symptoms of

inflammation, including

arthritis. These include

nonsteroidal anti-inflammatory

agents – NSAIDs (e.g. Voltaren,

Indocid) and COX-2 inhibitors

(e.g. Celebrex).

Angiotensin-converting-

enzyme (ACE) inhibitors,

medicines used to help lower

blood pressure, especially if

you have diabetes- related

kidney problems

Mineralocorticoid receptor

antagonists (MRAs), such as

spironolactone and

eplerenone, medicines used

to treat heart failure

Your doctor can tell you what to

do if you are taking any of these

medicines.

If you are not sure whether you

are taking any of these medicines,

check with your doctor or

pharmacist.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while

taking CANDESAN.

How to take CANDESAN

How much to take

The usual dose is one 8 mg tablet

or one 16 mg tablet taken daily.

Sometimes, this may need to be

increased to 32 mg taken daily.

Take CANDESAN once a day, at

about the same time each day.

Keeping a regular time for taking

your medicine will help to remind

you to take it.

Follow all directions given to you

by your doctor and pharmacist

carefully.

How to take CANDESAN

Swallow the tablets with a glass

of water.

It does not matter whether you

take CANDESAN tablets before or

after food.

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 the missed dose

as soon as you remember, and

Page 3 of 5

CANDESAN – Consumer Medicine Information

then go back to taking your

tablets as you would normally.

Do not take a double dose to

make up for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

How long to take it for

CANDESAN helps control your high

blood pressure but does not cure

it. To properly control your

condition, CANDESAN must be

taken every day.

Keep taking CANDESAN for as

long as your doctor recommends.

If you take too much (overdose)

Immediately telephone your

doctor, or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency at the nearest

hospital, if you think you or

anyone else may have taken too

much CANDESAN. Do this even if

there are no signs of discomfort

or poisoning. You may need

urgent medical attention.

If you take too much CANDESAN,

you may get a headache and feel

sick, dizzy and very tired.

While you are taking

CANDESAN

Things you must do

Before starting any new

medicine, tell your doctor or

pharmacist that you are taking

CANDESAN.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking CANDESAN.

Tell your doctor immediately if

you become pregnant or plan to

become pregnant while taking

CANDESAN. You should not use

CANDESAN if you are pregnant or

thinking about becoming

pregnant. Your doctor can discuss

different treatment options with

you.

If you plan to have surgery,

including dental surgery, that

needs a general anaesthetic, tell

your doctor or dentist that you

are taking CANDESAN.

Be sure to keep all of your

doctor's appointments so that

your progress can be checked.

Your doctor will check your

progress and may want to take

some tests (e.g. blood tests, blood

pressure) from time to time. These

tests may help to prevent side

effects.

Things you must not do

Do not use CANDESAN to treat

any other conditions unless your

doctor tells you to.

Do not give CANDESAN to anyone

else, even if they have the same

condition as you.

Do not stop taking CANDESAN

unless you have discussed it with

your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CANDESAN affects you.

CANDESAN may cause drowsiness,

dizziness or lightheadedness in

some people. If any of these

occur, do not drive, operate

machinery or do anything else that

could be dangerous.

Be careful getting up from a

sitting or lying position.

Dizziness, lightheadedness or

fainting may occur, especially

when you get up quickly. Getting

up slowly may help. This problem

can be more common if you are

also taking a diuretic (fluid

tablets). 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 you are taking CANDESAN for

high blood pressure, make sure

you drink enough water during

exercise and hot weather when

you are taking CANDESAN,

especially if you sweat a lot. If you

do not drink enough water while

taking CANDESAN, 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 are taking CANDESAN 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 these

possibilities if you think they may

bother you.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

CANDESAN.

Like all other medicines,

CANDESAN may have unwanted

side effects in some people.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of the side effects.

Page 4 of 5

CANDESAN – Consumer Medicine Information

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

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

chest or throat infection

flu-like symptoms

nausea/vomiting

back pain

dizziness.

These are common side effects.

They are generally mild and do not

normally require treatment to be

interrupted.

The following side effects have

been reported very rarely by

patients taking CANDESAN:

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 CANDESAN.

Tell your doctor immediately if

you notice any of the following:

aching muscles, tenderness or

weakness in the muscles.

This list includes serious side

effects that may require medical

attention. Serious 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

swelling of hands, feet or

ankles

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)

easy bruising or bleeding more

easily than normal

extreme fatigue, tiredness,

weakness

worsening of the 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.

These are very rare but serious

side effects. You may need urgent

medical attention or

hospitalisation.

Other side effects not listed

above may also occur in some

patients. Tell your doctor if you

notice anything that is making

you feel unwell.

After using CANDESAN

Storage

Keep CANDESAN 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.

Keep your tablets in a cool dry

place where the temperature

stays below 25°C.

Do not store CANDESAN or any

other medicine in the bathroom

or near a sink.

Do not leave CANDESAN in the

car or on window sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking CANDESAN, or your tablets

have passed their expiry date, ask

your pharmacist what to do with

any that are left over.

Product Description

What it looks like

CANDESAN comes in 4 strengths of

tablets:

CANDESAN 4mg – Light pink,

round, biconvex tablet with

‘291’ on one side and a break

line on the other side

CANDESAN 8mg – Light pink,

round, biconvex tablet with

‘292’ on one side and a break

line on the other side

CANDESAN 16mg – Light pink,

round, biconvex tablet with

‘L293’ on one side and a break

line on the other side

CANDESAN 32mg – Light pink,

round, biconvex tablet with

‘L294’ on one side and a break

line on the other side.

Each PVC/PE/PVDC/Aluminium or

Aluminium/Aluminium blister pack

contains 30 tablets.

Ingredients

The active ingredient in

CANDESAN is candesartan cilexetil.

Page 5 of 5

CANDESAN – Consumer Medicine Information

each CANDESAN 4mg tablet

contains 4 mg of candesartan

cilexetil

each CANDESAN 8mg tablet

contains 8 mg of candesartan

cilexetil

each CANDESAN 16mg tablet

contains 16 mg of candesartan

cilexetil

each CANDESAN 32mg tablet

contains 32 mg of candesartan

cilexetil.

The tablets also contain:

lactose monohydrate

carmellose calcium

maize starch

macrogol 8000

hyprolose

magnesium stearate

Pigment Blend PB-24880 Pink

(iron oxide red and lactose

monohydrate).

The tablets do not contain gluten,

sucrose, tartrazine or any other

azo dyes.

Sponsor

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne VIC 3121

Australia

Australian registration numbers:

CANDESAN 4mg - AUST R 195483

CANDESAN 8mg - AUST R 195509

CANDESAN 16mg - AUST R 195443

CANDESAN 32mg - AUST R 195459

Date of revision:

April 2018