APO-ATENOLOL

Main information

  • Trade name:
  • APO-ATENOLOL Atenolol 50 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-ATENOLOL Atenolol 50 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214939
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214939

APO-ATENOLOL Atenolol 50 mg film coated tablets 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

28/11/2013

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-ATENOLOL Atenolol 50 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

20/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Atenolol is indicated in the management of:,(i) All grades of hypertension, including hypertension of renal origin.

(ii) Frequent disabling angina without evidence of cardiac failure.

(iii) Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction),

(iv) Myocardial infarction - Late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

Components

1. Atenolol 50 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Atenolol tablets 50 mg are white to off-white, circular biconvex film coated

tablets with "50" embossed on one side and break line on other side.

Active Ingredients

Atenolol

50 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 26.11.2017 at 09:08:23 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-Atenolol

Contains the active ingredient, atenolol

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 atenolol. 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. Some more recent

information on the medicine may be

available. You should ensure that you

speak to your pharmacist or doctor to

obtain the most up to date

information on the medicine.

All medicines have risks and

benefits. Your doctor has weighed

the risk of you taking atenolol against

the benefits it is expected to 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 want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Atenolol. It contains the active

ingredient, atenolol.

Atenolol is used to:

lower high blood pressure

(hypertension)

prevent angina (chest pain or

discomfort)

treat an irregular heart beat or

rhythm, also called arrhythmia

reduce your risk of heart

complications following a heart

attack.

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 and you may feel fine.

If hypertension is not treated, serious

health problems such as stroke, heart

disease and kidney failure may occur.

Atenolol helps to lower your blood

pressure.

Angina:

Angina is a pain or uncomfortable

feeling in the chest, often spreading

to the arms or neck and sometimes to

the shoulders and back. This may be

because there is not enough blood

and oxygen getting to the heart. The

pain of angina is usually brought on

by exercise or stress, but can also

occur at rest.

Atenolol helps prevent angina. It is

not used to relieve a sudden attack of

angina.

Irregular heart beat (arrhythmia):

Irregular heartbeat, also known as

arrhythmia, means that there is a

disturbance of the heart's normal

rhythm or beat. Arrhythmias may be

caused by a number of factors,

including some heart diseases, an

overactive thyroid gland, or chemical

imbalances.

Atenolol helps restore your heart's

normal rhythm.

Reducing heart complications after

heart attack:

After a heart attack, you may have

complications such as an irregular

heart beat or an increased chance of

having another heart attack.

Atenolol helps to prevent these

complications from occurring.

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.

How it works

This medicine contains atenolol.

Atenolol belongs to a group of

medicines called beta-blockers. It

decreases the heart's need for blood

and oxygen and therefore reduces the

amount of work the heart has to do. It

widens the blood vessels in the body,

causing blood pressure to fall. It also

helps the heart to beat more

regularly.

There is no evidence that this

medicine is addictive.

It is available only with a doctor's

prescription.

This medicine is not expected to

affect your ability to drive a car or

operate machinery, but make sure

APO-ATENOLOL

you know how it affects you before

driving.

There is not enough information to

recommend the use of this medicine

for children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

1.

you have or have had asthma

(difficulty breathing, wheezing

and coughing), bronchitis or

other lung problems in the past.

2.

you have the following

conditions:

a history of allergic problems,

including hayfever. Symptoms of

an allergic reaction may include

skin rash, itchiness, shortness of

breath, swelling of the face, lips

or tongue, muscle pain or

tenderness or joint pain

a very slow heart beat (less than

45-50 beats per minute)

a severe blood vessel disorder

causing poor circulation in the

arms and legs

certain other problems with your

heart

phaeochromocytoma (a rare

tumour of the adrenal gland),

which is not being treated with

other medicines

low blood pressure (hypotension)

too much acid in your blood

(metabolic acidosis).

3.

you are receiving:

certain anaesthetics for medical

or dental procedures

emergency treatment for shock or

low blood pressure

4.

you have an allergy or have had

a hypersensitivity reaction to

atenolol or any of the

ingredients mentioned at the

end of this leaflet, or any other

beta blocker medicine

5.

you are pregnant or breast

feeding, or if there is a chance

that this may occur.

Your doctor will discuss the possible

risks and benefits of using atenolol

during pregnancy and breast feeding.

Atenolol passes into breast milk and

may therefore affect the breast-fed

baby.

If you are not sure whether any of

these apply to you, check with your

doctor.

Do not use this product if the

packaging is torn or shows signs of

tampering

Do not use this product after the

expiry date (EXP) printed on the

pack.

The medicine may not work as well

after this date.

Do not use this product if the

tablets change in appearance,

colour or taste.

If it has expired or is damaged or

does not seem quite right, return it

to your pharmacist for disposal.

If you are not sure whether you

should start taking atenolol, talk to

your doctor.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines including

eye drops, or other beta-blocker

medicines.

any other substances, including

foods, preservatives or dyes.

insect stings

Atenolol may make allergies worse

or make them harder to treat.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

heart problems

diabetes

an overactive thyroid

(hyperthyroidism).

kidney problems

circulation problems

phaeochromocytoma, which is

being treated with other

medicines

a particular type of angina called

prinzmetal angina or variant

angina.

any medical condition affecting

your blood vessels.

Tell your doctor if you plan to

become pregnant or breast-feed.

If you have not told your doctor

about any of the above, tell them

before you start taking atenolol.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

The medicines below may be

affected by atenolol, or may affect

how well it works. It is especially

important that you tell your doctor if

you are taking any of the following:

other beta-blocker medicines,

including beta-blocker eye drops

medicines used to treat high

blood pressure or angina, or

example verapamil, diltiazem,

nifedipine, clonidine

medicines to treat heart problems,

such as disopyramide, quinidine,

digoxin, amiodarone,

guanethidine

insulin and tablets used to treat

diabetes

certain medicines used to treat

arthritis, pain, or inflammation,

for example indomethacin or

ibuprofen

cold remedies

medicines commonly used during

surgery or in emergency

situations (e.g. dopamine,

adrenaline, noradrenaline and

certain anaesthetics.

You may need to use different

amounts of your medicine, or you

may need to take different medicines.

Your doctor and pharmacist have

APO-ATENOLOL

more information on medicines to be

careful with or avoid while taking

atenolol.

Ask your doctor or pharmacist if you

are not sure if you are taking any of

these medicines.

How to take this

medicine

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many tablets you will

need to take each day and how

long to take them for. This depends

on your condition and whether or

not you are taking any other

medicines.

Hypertension:

The usual dose is from 50mg (1

tablet) up to 200mg (4 tablets) of

atenolol daily. If your dose is 100mg

or less, take it once a day. If you

need to take more than 100mg (2

tablets), take half of your atenolol in

the morning and the other half in the

evening.

Angina or Irregular Heart Beat:

The usual dose is from 50mg (1

tablet) up to 100mg (2 tablets) taken

as a single dose or half the dose in

the morning and half at night.

Heart attack:

The usual dose is 50mg (1 tablet) of

atenolol daily.

Certain people e.g. the elderly or

those with kidney problems, may

require a lower dose.

How to take it

Swallow the tablet(s) with a little

fluid.

To break atenolol tablets into two

equal halves place on a flat surface

and press down on either side of

break line with thumb and forefinger.

Your atenolol tablets may be

provided in a calendar pack which is

designed to remind you when to take

this medication. To do this, take your

first dose from the position marked

"First Day ". On the following day

take the first tablet which is labelled

with the appropriate day. When you

have taken all doses in this pack, take

your next atenolol prescription in the

same way.

When to take it

Take your medicine at the same

time every day.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

It does not matter if you take it

before or after food.

How long to take it for

Take your medicine every day.

Keep taking it until your doctor

tells you to stop.

It helps to treat high blood pressure,

irregular heartbeat, and heart attacks

and prevent angina but does not cure

Make sure you have enough tablets

to last over weekends and holidays.

Do not stop taking this medicine

without checking with your doctor.

Your doctor may want you to

gradually reduce the amount of

atenolol you are taking. This should

take place over a period of about 2

weeks before stopping completely.

Do not stop suddenly as this may

worsen your condition.

If you forget to take it

If you forget to take one or more

doses of atenolol, and 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 then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed. Do

not take any more than your

doctor prescribed for you.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Tel: 13 11 26 for Australia) or go

to the Accident and Emergency

Department at the nearest hospital,

if you think that you or anyone else

may have taken too much atenolol.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much atenolol, you

may faint, feel dizzy or light-headed,

wheeze or have difficulty breathing.

You may also have a very slow heart

beat.

While you are taking

this medicine

Things you must do

Always follow your doctor's

instructions carefully.

Keep all of your doctor's

appointments so that your progress

can be checked.

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking atenolol.

Tell your doctor immediately if

you become pregnant while taking

atenolol.

APO-ATENOLOL

If you are about to start taking a

new medicine, remind your doctor

and pharmacist that you are taking

atenolol.

If you are going to have surgery

(even at the dentist), tell your

surgeon, anaesthetist or dentist

that you are taking atenolol.

Atenolol may affect some of the

medicines used during surgery, or

may cause your blood pressure to

drop suddenly.

If you have to have any medical

tests while you are taking atenolol,

tell your doctor.

Atenolol may affect the results of

some tests.

Drink lots of water when

exercising and during hot weather

when taking atenolol, especially if

you sweat a lot.

If you do not drink enough water

while taking atenolol, you may feel

faint, light-headed or sick. The

recommended healthy minimum

water intake is 6-8 glasses a day.

Tell your doctor immediately if

you have an allergic reaction to

foods, medicines or insect stings.

Atenolol can cause allergic reactions

to be worse and harder to treat.

If you have diabetes, check your

blood sugar level regularly and

report any changes to your doctor.

Atenolol may affect your diabetes. It

may hide the symptoms of low blood

sugar levels, such as a fast heart beat.

It may also take longer for your

blood sugar level to get back to

normal even if you follow the usual

treatment for diabetes. Your diabetic

medicines may have to be changed or

the doses

If you keep having angina attacks,

or have more of them whilst taking

atenolol, tell your doctor.

Atenolol is used to help prevent

angina, so your angina attacks should

become less severe and occur less

often.

Things you must not do

Do not stop taking your medicine,

or lower the dosage, without

checking with your doctor.

Do not take any new medicines

with atenolol, unless your doctor

has told you to.

Do not take your medicine to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not give this medication to

anyone else, even if their symptoms

seem similar to yours.

Things to be careful of

As with other beta-blockers, atenolol

may cause dizziness or light-

headedness in some people,

especially after the first dose, or after

your dose is increased. . This is

because your blood pressure is

dropping suddenly.

If this problem gets worse or

continues, talk to your doctor.

To help your body get used to the

change in blood pressure, the

following hints may be useful:

Stand up slowly when getting up

from a chair or bed. This will

allow your body get used to the

change in position and blood

pressure.

If you feel dizzy, sit or lie down

until you feel better.

If you feel faint, sit down and put

your head between your knees.

Be careful driving or operating

machinery until you know how

atenolol affects you.

As with other beta blocker

medicines, atenolol may cause

dizziness, faintness, fatigue or light-

headedness in some people. Make

sure you know how you react to

atenolol before you drive a car,

operate machinery, or do anything

else that could be dangerous if you

are dizzy or light-headed. If you have

any of these symptoms stop driving,

operating machinery or performing

dangerous tasks.

If you drink alcohol, dizziness or

light-headedness may be worse.

Be careful not to over-exercise

when you first start taking

atenolol.

Atenolol helps prevent angina

resulting from physical activity and

exercise. You may be tempted to

exercise too much. Talk to your

doctor about how much exercise you

can do.

Dress warmly during cold weather,

especially if you will be outside for

a long time (for example, when

playing or watching sport in

winter).

Atenolol, like other beta-blocker

medicines, may make you more

sensitive to cold temperatures,

especially if you have circulation

problems. Beta-blockers tend to

decrease blood circulation in the

skin, fingers and toes.

Things that would be helpful

for your blood pressure

The suggestions 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:

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:

Eat a healthy low-fat diet which

includes plenty of fresh vegetables,

fruit, bread, cereals and fish. Also eat

less fat and sugar.

Salt:

Your doctor may advise you to watch

the amount of salt in your diet. To

reduce your salt intake avoid using

salt in cooking or at the table.

APO-ATENOLOL

Possible side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not. Your doctor has

weighed the risks of using this

medicine against the benefits he/she

expects it will have for you.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking atenolol.

Ask your doctor or pharmacist to

answer any questions you may

have.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

stomach upsets such as diarrhoea,

constipation, abdominal pain or

heartburn (indigestion).

dry mouth, change in taste

sensation

dizziness, headache or buzzing or

ringing in the ears, difficulty

hearing

slow or irregular heartbeat

dry eyes, problems with vision

runny or blocked nose

difficulty sleeping, nightmares

skin reactions (e.g. rash, itching,

worsening of psoriasis)

cold fingers and toes

increased hair loss.

tingling, "pins and needles"

sexual problems.

weakness, fatigue, lack of energy

feeling generally unwell

The above list includes the more

common side effects. Mostly, these

are mild.

Tell your doctor immediately if

you notice any of the following:

confusion or disorientation

depression or mood changes or a

worsening of these

unusual thoughts, hallucinations

(seeing, feeling or hearing things

that are not there).

dizziness or light-headedness

(sometimes with fainting),

especially on standing up, which

may be due to low blood

pressure.

coldness, burning, numbness or

pain in the arms and/or legs.

irritated eyes (red, runny, itchy or

dry), visual disturbances (e.g.

blurred vision).

difficulty in speaking.

unsteadiness when walking.

These may be serious side effects.

You may need urgent medical

attention. Serious side effects are

rare.

If any of the following happen,

STOP taking atenolol, and tell

your doctor immediately, or go to

Accident and Emergency at your

nearest hospital:

shortness of breath, sometimes

with tiredness, weakness and

reduced ability to exercise,

swelling of the feet or legs due to

fluid build up

unusual bruising or bleeding

chest pain, changes in heart rate

(fast, slow or irregular),

palpitations

chest tightness, wheezing, rattly

breathing

yellowing of the skin and/or eyes

(jaundice)

signs of a serious allergic reaction

such as shortness of breath,

wheezing or troubled breathing,

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty in swallowing or

breathing, or swelling of other

parts of the body

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.

Storage and disposal

Storage

Keep atenolol in the original

packaging until you need to take it.

If you take the tablets out of their

original packaging, they may not

keep well.

Keep your tablets in a cool, dry

place where the temperature will

stay below 25°C.

Do not store the tablets or any

other medicines in the bathroom or

near a sink.

Do not leave the tablets in the car

on hot days or on windowsills.

Heat and dampness can destroy some

medicines.

Keep the tablets where children

cannot reach them.

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

if it has passed its expiry date, ask

your pharmacist what to do with

any medicine that is left over.

Where to go for further

information

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition.

APO-ATENOLOL

Product description

What APO-Atenolol looks

like

New formulation

50 mg tablets: white to off white,

circular biconvex film coated tablets

with "50" embossed on one side and

break line on other side.

Blister packs or bottles containing 30

tablets.

*Not all pack sizes and/or types may

be available.

Ingredients

New formulation

Active Ingredient:

Each tablet contains 50mg of

atenolol.

It also contains the following inactive

ingredients:

magnesium stearate

maize starch

sodium lauryl sulphate

colloidal anhydrous silica

sodium starch glycollate

magnesium carbonate

Hypromellose

macrogol 6000

titanium dioxide

purified talc

Australian Registration

Numbers

New formulation

APO-Atenolol 50 mg tablets

(blister): AUST R 214939

APO-Atenolol 50 mg tablets (bottle):

AUST R 214940

Old formulation

APO-Atenolol 50 mg tablets

(blister): AUST R 129861

APO-Atenolol 50 mg tablets (bottle):

AUST R 129862

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was prepared in

November 2016

APO-ATENOLOL

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