CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle

Main information

  • Trade name:
  • CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195445
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195445

CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

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. CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle

Product Type

Single Medicine Product

Effective date

10/11/2016

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

Bottle

HDPE

12 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. CANDESARTAN AN candesartan cilexetil 16 mg tablet bottle

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink, round, biconvex uncoated mottled tablets debossed with L293

on one side and break line on other side.

Active Ingredients

Candesartan cilexetil

16 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 04:26:19 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

Candesartan AN tablets – Consumer Medicine Information

Doc ID: 46.AN.M.1.0

Page 1

Candesartan AN tablets

Candesartan cilexetil

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

CANDESARTAN AN.

does

contain

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

risks

taking

CANDESARTAN AN 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 need to read it again.

What CANDESARTAN

AN is used for

CANDESARTAN AN belongs to

a group of medicines known as

angiotensin-II

receptor

antagonists.

CANDESARTAN AN is used to

treat:

high

blood

pressure,

also

called hypertension

heart

failure,

usually

combination

with

other

medicines.

Hypertension

Everyone

blood

pressure.

This

pressure

helps

your

blood all around your body. Your

blood pressure may be different

different

times

day,

depending

busy

worried

are.

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

have

hypertension.

There

symptoms

hypertension and you may feel

fine.

hypertension

treated, serious health problems

such as stroke or heart attack

and heart or kidney failure may

occur.

CANDESARTAN

lowers

blood

pressure

dilating

(expanding) small blood vessels

from the heart, letting the blood

pumped

around

body

more easily.

Heart Failure

Heart

failure

means

that

heart muscle cannot pump blood

strongly enough to supply all the

blood

needed

throughout

body.

Heart

failure

same as heart attack and does

not mean that the heart stops

working.

Heart failure may start off with

symptoms,

condition

progresses,

patients

may feel short of breath or may

tired

easily

after

light

physical activity such as walking.

Some

patients

wake

short

breath

night.

Fluid

may collect in different parts of

the body, often first noticed as

swollen ankles and feet.

CANDESARTAN

helps

treat

heart

failure

improve your symptoms.

ways

CANDESARTAN AN helps heart

failure is that it widens the blood

vessels, so that the heart does

have

pump as hard

move the blood around the body.

This also means that when you

place

extra

demands

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

almost

always

used

with

other

medicines

called

diuretics

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

CANDESARTAN

told

you what dose to take.

Your

doctor

have

prescribed CANDESARTAN AN

for another reason.

Ask your doctor if you have

any

questions

about

why

CANDESARTAN AN has been

prescribed for you.

CANDESARTAN AN is available

only with a doctor's prescription.

Before You Take

CANDESARTAN AN

When you must not use it

Do

not

take

CANDESARTAN

AN

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.

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.

Do

not

take

CANDESARTAN

AN

if

you

are

pregnant.

CANDESARTAN AN may affect

your developing baby if you take

it during pregnancy.

Candesartan AN tablets – Consumer Medicine Information

Doc ID: 46.AN.M.1.0

Page 2

Do not breastfeed if you are

taking CANDESARTAN AN. It

is not known if CAMDESARTAN

AN passes into breast milk.

Do

not

give

CANDESARTAN

AN

to

children.

There

information

about

children, so CANDESARTAN AN

is not recommended for children.

Do

not

take

CANDESARTAN

AN

if

the

expiry

date

(Exp.)

printed

on

the

pack

has

passed.

Do

not

take

CANDESARTAN

AN 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

condition

called

primary

hyperaldosteronism.

You may have to take a lower

dose of CANDESARTAN AN if

you have these conditions.

If

you

have

not

told

your

doctor about any of the above,

tell

them

before

you

start

taking CANDESARTAN AN.

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

affected

CANDESARTAN

AN, or may affect how well it

works. These include:

fluid tablets or diuretics

lithium

lithium

containing

medicines (eg. Lithicarb)

potassium tablets (eg. Span-

K, Slow-K, Mag-K)

potassium

containing

salt

substitutes (eg. Pressor-K)

anti-inflammatory

medicines,

used to relieve pain, swelling

other

symptoms

inflammation,

including

arthritis.

These

include

nonsteroidal

anti-

inflammatory

agents

NSAIDs

(eg.

Voltaren,

Indocid) and COX-2 inhibitors

(eg. Celebrex).

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

pharmacist

have

more

information

medicines to be careful with or

avoid

while

taking

CANDESARTAN AN.

How to take

CANDESARTAN AN

How much to take

usual

dose

tablet or one 16 mg tablet taken

daily. Sometimes, this may need

to be increased to 32 mg taken

daily.

Take CANDESARTAN AN 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 it

Swallow

the

tablets

with

a

glass of water.

It does not matter whether you

take CANDESARTAN AN 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 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

CANDESARTAN

helps

control your high blood pressure

but does not cure it. To properly

control

your

condition,

CANDESARTAN

must

taken every day.

Keep

taking

CANDESARTAN

AN 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 CANDESARTAN AN.

Do this even if there are no

signs

of

discomfort

or

poisoning.

You

may

need

urgent medical attention.

If

you

take

too

much

CANDESARTAN AN, you may

get a headache and feel sick,

dizzy and very tired.

While you are taking

CANDESARTAN AN

Candesartan AN tablets – Consumer Medicine Information

Doc ID: 46.AN.M.1.0

Page 3

Things you must do

Before

starting

any

new

medicine, tell your doctor or

pharmacist that you are taking

CANDESARTAN AN.

Tell all the doctors, dentists

and

pharmacists

who

are

treating

you

that

you

are

taking CANDESARTAN AN.

Tell your doctor immediately if

you become pregnant or plan

to

become

pregnant

while

taking

CANDESARTAN

AN.

should

CANDESARTAN AN if you are

pregnant

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

CANDESARTAN AN.

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

CANDESARTAN

AN

to

treat

any

other

conditions unless your doctor

tells you to.

Do

not

give

CANDESARTAN

AN

to

anyone

else,

even

if

they have the same condition

as you.

Do

not

stop

taking

CANDESARTAN

AN

unless

you

have

discussed

it

with

your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CANDESARTAN

AN

affects

you.

CANDESARTAN AN may cause

drowsiness,

dizziness

lightheadedness in some people.

these

occur,

drive, operate machinery or do

anything

else

that

could

dangerous.

Be careful getting up from a

sitting or lying position.

Dizziness,

lightheadedness

fainting

occur,

especially

when you get up quickly. Getting

slowly

help.

This

problem can be more common if

also

taking

diuretic

(fluid

tablets).

Standing

slowly, especially when you get

up from bed or chairs, will help

your

body

used

change

position

blood

pressure.

If

you

are

taking

CANDESARTAN

AN

for

high

blood

pressure,

make

sure

you

drink

enough

water

during

exercise

and

hot

weather when you are taking

CANDESARTAN

AN,

especially if you sweat a lot. If

you do not drink enough water

while

taking

CANDESARTAN

AN, 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.

continue

feel

unwell, tell your doctor.

If

you

are

taking

CANDESARTAN AN for heart

failure, restricted fluid intake

is

generally

recommended.

Speak with your doctor about

how much water you should

drink.

Please

talk

your

doctor

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 CANDESARTAN AN.

Like

other

medicines,

CANDESARTAN AN may have

unwanted side effects in some

people.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

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

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

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

face,

lips,

tongue or throat which may

Candesartan AN tablets – Consumer Medicine Information

Doc ID: 46.AN.M.1.0

Page 4

cause difficulty in swallowing

or breathing

swelling

hands,

feet

ankles

harsh sounds when breathing

signs

frequent

infections

such as fever, severe chills,

sore throat or mouth ulcers

jaundice

(yellowing

skin and /or eyes)

unusual

skin

reactions

(severe and sudden onset of

rash,

itchiness,

hives

(itchy

swellings on the skin)

easy

bruising

bleeding

more easily than normal

extreme

fatigue,

tiredness,

weakness

worsening

kidney

function

(including

passing

little or no urine, drowsiness,

nausea,

vomiting,

breathlessness,

loss

appetite

weakness

(especially

patients

with

existing

kidney

problems

heart failure)

changes in your potassium,

sodium

white

blood cell levels may occur.

Such

changes

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.

need

urgent

medical

attention

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 taking

CANDESARTAN AN

Storage

Keep

CANDESARTAN

AN

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 CANDESARTAN

AN or any other medicine in

the bathroom or near a sink.

Do not leave CANDESARTAN

AN in the car or on window

sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking CANDESARTAN AN, 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

CANDESARTAN AN 4 mg are

light

pink,

round,

biconvex

uncoated

mottled

tablets

debossed with 291 on one side

break

line

other

side

containing

cadesartan

cilexetil

available

blister

pack of 30 (AUST R 195453) or

bottle

pack

30 (AUST

R

195505).

CANDESARTAN AN 8 mg are

light

pink,

round,

biconvex

uncoated

mottled

tablets

debossed with 292 on one side

break

line

other

side

containing

cadesartan

cilexetil

available

blister

pack of 30 (AUST R 195486) or

bottle

pack

30 (AUST

R

195444).

CANDESARTAN AN 16 mg are

light

pink,

round,

biconvex

uncoated

mottled

tablets

debossed with L293 on one side

break

line

other

side

containing

cadesartan

cilexetil

available

blister

pack of 30 (AUST R 195497) or

bottle

pack

30 (AUST

R

195445).

CANDESARTAN AN 32 mg are

light

pink,

round,

biconvex

uncoated

mottled

tablets

debossed with L294 on one side

break

line

other

side

containing

cadesartan

cilexetil

available

blister

pack of 30 (AUST R 195466) or

bottle

pack

30 (AUST

R

195458).

Ingredients

Active Ingredient:

Candesartan cilexetil

Other Ingredients:

Carmellose calcium

Hydroxypropylcellulose

Lactose (bovine)

Macrogol 8000

Magnesium stearate

Pigment Blend PB-24880 PINK

(PI)

Maize starch

Name

and

Address

of

the

Sponsor

Scentia Pharmaceuticals Pty Ltd

8 – 12 Ordish Road

Dandenong South,

VIC – 3175

Australia

Date of Preparation

February 2014

Doc ID: 46.AN.M.1.0