CANDELEM candesartan cilexetil 8 mg tablet blister pack

Main information

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

Documents

Localization

  • Available in:
  • CANDELEM candesartan cilexetil 8 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195475
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195475

CTAN candesartan cilexetil 8 mg 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

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. CTAN candesartan cilexetil 8 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

6/10/2017

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

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

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

30 tablets

(S4) Prescription Only Medicine

Components

1. CTAN 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 28.11.2017 at 04:15:08 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

CTAN/122016/CMI-1

CTAN

contains the active ingredient candesartan cilexetil

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about CTAN.

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 CTAN 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 CTAN is used for

CTAN belongs to a group of

medicines known as angiotensin-II

receptor antagonists.

CTAN is used to treat:

high blood pressure, also called

hypertension; and

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.

CTAN 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.

CTAN helps to treat heart failure

and may improve your symptoms.

One of the ways CTAN 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,

CTAN 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 CTAN

and told you what dose to take.

Your doctor may have prescribed

CTAN for another reason.

Ask your doctor if you have any

questions about why CTAN has

been prescribed for you.

CTAN is available only with a

doctor's prescription.

Before you take CTAN

When you must not take it

Do not take CTAN 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 CTAN if you are

pregnant. CTAN may affect your

developing baby if you take it

during pregnancy.

Do not breastfeed if you are taking

CTAN. It is not known if CTAN

passes into breast milk.

Do not give CTAN to children.

There is no information about its

use in children, so CTAN is not

recommended for children

CTAN/122016/CMI-1

Do not take CTAN if the expiry date

(Exp.) printed on the pack has

passed.

Do not take CTAN 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; or

a condition called primary

hyperaldosteronism.

You may have to take a lower dose

of CTAN if you have these

conditions.

If you have not told your doctor

about any of the above, tell them

before you start taking CTAN.

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

CTAN, or may affect how well it

works. These include:

fluid tablets or diuretics;

lithium or lithium containing

medicines (e.g. Lithicarb);

potassium tablets (e.g. Span-K,

Slow-K, Mag-K);

potassium containing salt

substitutes (e.g. Pressor-K); or

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).

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

CTAN.

How to take CTAN

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 CTAN 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 CTAN

Swallow the tablets with a glass of

water.

It does not matter whether you

take CTAN 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

CTAN helps control your high blood

pressure but does not cure it. To

properly control your condition,

CTAN must be taken every day.

Keep taking CTAN 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 CTAN. Do this even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention.

If you take too much CTAN, you

may get a headache and feel sick,

dizzy and very tired.

While you are taking CTAN

Things you must do

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking CTAN.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking CTAN.

Tell your doctor immediately if you

become pregnant or plan to

become pregnant while taking

CTAN. You should not use CTAN if

you are pregnant or thinking about

becoming pregnant. Your doctor

can discuss different treatment

options with you.

CTAN/122016/CMI-1

If you plan to have surgery,

including dental surgery, that

needs a general anaesthetic, tell

your doctor or dentist that you are

taking CTAN.

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 CTAN to treat any other

conditions unless your doctor tells

you to.

Do not give CTAN to anyone else,

even if they have the same

condition as you.

Do not stop taking CTAN unless

you have discussed it with your

doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CTAN affects you.

CTAN may cause drowsiness,

dizziness or light-headedness 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, light-headedness 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 CTAN for high

blood pressure, make sure you

drink enough water during exercise

and hot weather when you are

taking CTAN, especially if you

sweat a lot. If you do not drink

enough water while taking CTAN,

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 CTAN 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 CTAN.

Like all other medicines, CTAN 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.

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; or

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 CTAN: 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 CTAN.

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; or

CTAN/122016/CMI-1

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 CTAN

Storage

Keep CTAN 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. Store in original

container.

Do not store CTAN or any other

medicine in the bathroom or near a

sink.

Do not leave CTAN in the car or on

window sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking CTAN, 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

CTAN comes in 4 strengths of

tablets:

CTAN 4 mg – Light pink, round,

biconvex tablet with ‘291’ on one

side and a break line on the other

side

CTAN 8 mg – Light pink, round,

biconvex tablet with ‘292’ on one

side and a break line on the other

side

CTAN 16 mg – Light pink, round,

biconvex tablet with ‘L293’ on one

side and a break line on the other

side

CTAN 32 mg – Light pink, round,

biconvex tablet with ‘L294’ on one

side and a break line on the other

side.

Each Aluminium/Aluminium blister

pack contains 30 tablets.

Ingredients

The active ingredient in CTAN is

candesartan cilexetil.

each CTAN 4mg tablet contains

4 mg of candesartan cilexetil

each CTAN 8mg tablet contains

8 mg of candesartan cilexetil

each CTAN 16mg tablet contains

16 mg of candesartan cilexetil

each CTAN 32mg tablet contains

32 mg of candesartan cilexetil.

The tablets also contain:

lactose monohydrate;

carmellose calcium;

maize starch;

macrogol 8000;

hyprolose;

magnesium stearate; and

Pigment Blend PB-24880 Pink

(iron oxide red and lactose

monohydrate).

The tablets do not contain gluten,

sucrose, tartrazine or any other azo

dyes.

Supplier

Generic Partners Pty Ltd

313 Burwood Road

Hawthorn, VIC 3122,

Australia

Australian registration numbers:

CTAN 4 mg - AUST R 195481

CTAN 8 mg - AUST R 195475

CTAN 16 mg - AUST R 195489

CTAN 32 mg - AUST R 195477

Date of preparation:

December 2016