CHEMMART
Main information
- Trade name:
- CHEMMART ATENOLOL Atenolol 50 mg film coated tablets blister pack
- Active ingredient:
- Atenolol
- Available from:
- Apotex Pty Ltd
- INN (International Name):
- Atenolol
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Patient Information leaflet
-
- for healthcare professionals:
- Summary of Product characteristics
-
- for the general public:
- Public Assessment Report
-
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 214942
- Last update:
- 09-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
214942
CHEMMART 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. CHEMMART 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
14 tablets
(S4) Prescription Only Medicine
10 tablets
(S4) Prescription Only Medicine
28 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 09:06:30 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
Chemmart 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
Chemmart 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
CHEMMART 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
CHEMMART 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.
CHEMMART 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.
CHEMMART 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.
CHEMMART ATENOLOL
Product description
What Chemmart 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
Chemmart Atenolol 50 mg tablets
(blister): AUST R 214942
Old formulation
Chemmart Atenolol 50 mg tablets
(blister): AUST R 129865
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in
November 2016
CHEMMART ATENOLOL
- Access to this document is only available to registered users.
Register now for full access