ATENOLOL

Main information

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

Documents

Localization

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

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 197759
  • Last update:
  • 12-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197759

ATENOLOL RBX Atenolol 50 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

13/09/2013

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. ATENOLOL RBX Atenolol 50 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

20/04/2015

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

56 tablets for dispensing only

(S4) Prescription Only Medicine

60 tablets for dispensing only

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

50 tablets for dispensing only

(S4) Prescription Only Medicine

120 tablets for dispensing only

(S4) Prescription Only Medicine

84 tablets for dispensing only

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

98 tablets for dispensing only

(S4) Prescription Only Medicine

112 tablets for dispensing only

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

30 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

Public Summary

Page 1 of

Produced at 28.11.2017 at 11:53:57 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

© 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 2 of

Produced at 28.11.2017 at 11:53:57 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

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 1 -

PIP-ATENOLOL

(Atenolol 25mg, 50mg & 100mg Film Coated Tablets)

Consumer Medicine Information

What Is In This Leaflet

This leaflet answers some common questions about PIP-ATENOLOL.

It does not contain all 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 PIP-

ATENOLOL against the benefits they expect it will have for you.

This medicine may also be used in emergency situations where you may be unconscious. In this

case, this leaflet may be given to you after the medicine has been used.

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 PIP-ATENOLOL Is Used For

PIP-ATENOLOL belongs to a group of medicines called beta-blockers.

It works by affecting the body's response to certain nerve impulses, especially in the heart. As a

result, 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.

PIP-ATENOLOL is used to:

lower high blood pressure, which is called hypertension

prevent angina

treat irregular heart rhythm or beat called arrhythmias

treat heart attacks, or reduce your risk of heart complications following a heart attack

PIP-ATENOLOL may be either used alone or in combination with other medicines to treat your

condition.

PIP-ATENOLOL may also be used in emergency situations or during surgery to treat a fast heart

beat before, during or after surgery.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 2 -

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 of hypertension and you may feel fine. If

hypertension is not treated, serious health problems such as stroke, heart disease and kidney failure

may occur. PIP-ATENOLOL helps to lower your blood pressure.

Angina:

Angina is a discomfort or pain felt in your chest. The pain may also be felt down your arms or neck

and sometimes your shoulders and back. This may be caused by not enough oxygen or blood

reaching

areas

your

heart.

Angina

pain

often

brought

exercise

stress.

PIP-

ATENOLOL is used to prevent angina. It is not used to relieve a sudden attack of angina.

Irregular heart beat (arrhythmia):

A number of factors such as some heart diseases, an over active thyroid gland or chemical

imbalances may cause your heart to have an irregular heart beat or rhythm. PIP-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. PIP-ATENOLOL helps to prevent these complications from

occurring.

Ask your doctor if you have any questions about why it has been prescribed for you.

Your doctor may have prescribed PIP-ATENOLOL for another reason. PIP-ATENOLOL is not

recommended for use in children, as there have been no studies of its effects in children. There is no

evidence that PIP-ATENOLOL is addictive.

Before You Take PIP-ATENOLOL

When you must not take it

Do not take PIP-ATENOLOL if :

1. you have or have had asthma (difficulty in 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 allergy may include:

rash, itching, watery eyes or sneezing.

a very slow heart beat (less than 45-50 beats/minute)

a severe blood vessel disorder causing poor circulation in the arms and legs

certain other heart conditions

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 3 -

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 dental procedures

emergency treatment for shock or severely low blood pressure

4. you have an allergy to PIP-ATENOLOL or any of the ingredients listed at the end of this

leaflet, or to any other beta-blocker medicine.

5. you are pregnant, intend to become pregnant, are breast feeding or intend to breast feed.

Your

doctor

will

discuss

possible

risks

benefits

using

PIP-ATENOLOL

during

pregnancy and breast feeding. PIP-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 PIP-ATENOLOL if the package is torn or shows signs of tampering.

Do not use PIP-ATENOLOL if the expiry date (EXP) printed on the pack has passed.

This medicine may not work as well after this date.

Before you start to take it

Tell your doctor if:

1. you have any allergies to:

any other medicine, including eye drops, or other beta-blocker medicines

any other substances, such as foods, preservatives or dyes

insect stings

PIP-ATENOLOL may make allergies worse or make them harder to treat.

2. you have or have had a history of any of the following conditions:

heart problems

diabetes

an over active thyroid gland called hyperthyroidism.

kidney problems

circulation problems

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 4 -

If you have not told your doctor about any of the above, tell them before you take PIP-

ATENOLOL.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy from a

pharmacy, supermarket or health food shop without a prescription.

Some medicines and PIP-ATENOLOL may interfere with each other. These include:

other beta-blocker medicines

medicines used to treat high blood pressure or angina

medicine used to treat heart problems

insulin and tablets used to treat diabetes

medicines used to treat arthritis, pain, or inflammation

If any of these medicines and PIP-ATENOLOL are taken together, it may affect how each of them

work. You may need to take different amounts of your medicine, or you may need to take different

medicines. Your doctor will advise you on which medicines to be careful with or to avoid while

taking PIP-ATENOLOL.

How To Take PIP-ATENOLOL

How much to take

Follow all directions given to you by your doctor and 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.

Please note, PIP-ATENOLOL tablets are available in 25mg, 50mg and 100mg tablets. Your doctor

may prescribe different strengths or multiple tablets to treat your condition.

Hypertension:

The usual dose is from 50mg up to 200mg of PIP-ATENOLOL daily.

If your dose is 100mg or less, take it once a day. If you need to take more than 100mg, take half of

your PIP-ATENOLOL in the morning and the other half in the evening.

Angina or Irregular Heart Beat:

The usual dose is from 50mg up to 100mg taken as a single dose or half the dose in the morning and

half at night.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 5 -

Heart attack:

The usual dose is 50mg of PIP-ATENOLOL daily.

Certain people e.g. the elderly or those with kidney problems, may require a lower dose.

When to take it

It does not matter if you take your medicine before or after food.

Swallow PIP-ATENOLOL with a glass of water, during or immediately after a meal.

Take your tablet at the same time everyday.

This will help you remember when to take the tablet.

How long to take it

Take PIP-ATENOLOL every day.

Continue taking PIP-ATENOLOL until your doctor advises you to stop.

It helps to treat high blood pressure, irregular heart beat, heart attacks and prevent angina but does

not cure it.

Do not stop taking PIP-ATENOLOL without checking with your doctor.

Your doctor may want you to gradually reduce the amount of PIP-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 it is less than six hours from when you missed your dose, take it as soon as you remember,

and then go back to taking your tablets at the same time you would normally.

If it is more than six hours since your last dose, skip the dose you missed and take your next

dose when you would normally.

Do not take a double dose of PIP-ATENOLOL to make up for the dose that you missed.

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 (telephone 13 11 26), or

go to Accident & Emergency at your nearest hospital, if you think that you or anyone else

may have taken too much PIP-ATENOLOL. Do this even if there are no signs of discomfort

or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.

If you take too much PIP-ATENOLOL, you may feel faint or dizzy or you may find it difficult to

breathe.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 6 -

While You Are Taking PIP-ATENOLOL

Things you must do

Attend all of your doctor's appointments so that your progress can be checked.

Tell all the doctors, dentists and pharmacists that are treating you that you are taking

PIP-

ATENOLOL.

Tell your doctor immediately if you become pregnant while taking PIP-ATENOLOL.

Immediately tell your doctor if you have an allergic reaction to any foods, medicines or insect

stings.

PIP-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.

PIP-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 adjusted.

If you continue to have angina attacks, or have more of them whilst taking PIP-ATENOLOL,

tell your doctor.

PIP-ATENOLOL is used to help prevent angina, so your angina attacks should become less severe

and occur less often.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

You may feel light-headed or dizzy after taking PIP-ATENOLOL. This is because your blood

pressure is falling suddenly.

If this problem gets worse or continues, talk to your doctor.

To help your body get used to the change in blood pressure, you may find the following hints

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.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 7 -

Drink lots of water when exercising and during hot weather when taking PIP-ATENOLOL,

especially if you sweat a lot.

If you do not drink enough water while taking PIP-ATENOLOL, you may feel faint, light-headed

or sick. The recommended healthy minimum water intake is 6-8 glasses a day.

If you are having surgery (even at the dentist), tell your doctor or dentist that you are taking

PIP-ATENOLOL.

PIP-ATENOLOL may affect some of the medicines used during surgery.

If you have to have any medical tests while you are taking PIP-ATENOLOL, tell your doctor.

PIP-ATENOLOL may affect the results of some tests.

Things you must not do

Do not stop taking PIP-ATENOLOL without checking with your doctor.

Do not take any new medicines with PIP-ATENOLOL, unless your doctor has told you to.

Do not give PIP-ATENOLOL to anyone else, even if they have the same condition as you.

Do not use PIP-ATENOLOL to treat any other complaint unless your doctor tells you to.

Things to be careful of

Take care driving or operating machinery until you know how PIP-ATENOLOL affects you.

PIP-ATENOLOL may cause dizziness, fatigue, light-headedness or faintness in some people.

Be careful not to over exercise when you first start taking PIP-ATENOLOL.

It 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).

PIP-ATENOLOL,

like

other

beta-blocker

medicines,

make

more

sensitive

cold

temperatures, especially if you have circulation problems. Beta-blockers tend to decrease blood

circulation in the skin, fingers and toes.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking

PIP-ATENOLOL, even if you think the problems are not connected with the medicine.

If you get any side effects, do not stop taking PIP-ATENOLOL without first talking to your

doctor.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 8 -

Like other medicines PIP-ATENOLOL can cause some side effects. If they occur, most are likely to

be minor and last only a short time. However, some may be serious and need medical attention.

Tell your doctor 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

slow or irregular heart beat

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' or walking unsteadily

sexual problems

For the most part these side effects have been 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)

light-headedness or fainting which may be due to low blood pressure

yellowing of the skin and/or eyes (jaundice)

These are serious side effects. You may need urgent 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:

wheezing, chest tightness or difficulty breathing

unexplained bruising

swelling of the face, lips or throat

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 9 -

These are very serious side effects and you may need urgent medical attention or hospitalisation.

These side effects are rare.

Ask your doctor or pharmacist to answer any questions you may have.

Some people may get other side effects while taking PIP-ATENOLOL.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After Using PIP-ATENOLOL

Storage

Keep your tablets in a cool, dry place where the temperature will stay below 25°C. Protect

from light. Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they may not work as well.

Do not keep PIP-ATENOLOL in the bathroom or near a sink.

Do not leave PIP-ATENOLOL in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep this medicine out of reach of children.

A locked cupboard which children cannot reach is a good place to store medicines.

Disposal

If your doctor tells you to stop using the tablets, or the tablets have passed their expiry date,

ask your pharmacist what to do with any that are left over.

Product Description

What PIP-ATENOLOL tablets look like

PIP-ATENOLOL Tablets 25 mg are white to off-white, circular biconvex film coated tablets with

“25” embossed on one side and plain on other side.

PIP-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.

PIP-ATENOLOL Tablets 100 mg are white to off-white, circular biconvex film coated tablets with

“100” embossed on one side and break line on other side.

PIP-ATENOLOL tablets come in blister pack sizes of 10, 14, 28, & 30 tablets.

PIP-ATENOLOL

CONSUMER MEDICINE INFORMATION

September 2013 / Version 1

COMMERCIAL-IN-CONFIDENCE

Ipca Pharma (Australia) Pty. Ltd-atenolol 25mg, 50mg & 100 mg film coated tablets 2013

- 10 -

Tablet Ingredients

Each PIP-ATENOLOL tablet contains atenolol as the active ingredient, plus:

Magnesium stearate

maize starch

Sodium lauryl sulphate

colloidal anhydrous silica

Sodium starch glycollate

Magnesium carbonate

Hypromellose

Macrogol 6000

Titanium dioxide

Purified talc

Water-purified

PIP-ATENOLOL

does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

IPCA PHARMA (AUSTRALIA) PTY. LTD

6 Morotai Avenue

Ashburton VIC 3147

Australian Register Numbers (AUST R):

PIP-ATENOLOL Atenolol 100 mg film coated tablets blister pack. 197761

PIP-ATENOLOL Atenolol 100 mg film coated tablets bottle 197762

PIP-ATENOLOL Atenolol 25 mg film coated tablets blister pack 197757

PIP-ATENOLOL Atenolol 25 mg film coated tablets bottle 197758

PIP-ATENOLOL Atenolol 50 mg film coated tablets blister pack 197759

PIP-ATENOLOL Atenolol 50 mg film coated tablets bottle 197760

Date of Preparation: September 2013