Consumer medicine information

Atenolol Sandoz

Atenolol

BRAND INFORMATION

Brand name

Atenolol Sandoz

Active ingredient

Atenolol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Atenolol Sandoz.

SUMMARY CMI

Atenolol Sandoz®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Atenolol Sandoz?

Atenolol Sandoz contains the active ingredient atenolol. Atenolol Sandoz is used to lower high blood pressure, which is called hypertension, prevent angina, treat irregular heart rhythm, or beat called cardiac arrhythmias and treat heart attacks, or reduce your risk of heart complications following a heart attack. For more information, see Section 1. Why am I using Atenolol Sandoz? in the full CMI.

2. What should I know before I use Atenolol Sandoz?

Do not use if you have ever had an allergic reaction to Atenolol Sandoz or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Atenolol Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Atenolol Sandoz and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Atenolol Sandoz?

  • Follow all directions given to you by your doctor or pharmacist carefully.
  • If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

More instructions can be found in Section 4. How do I use Atenolol Sandoz? in the full CMI.

5. What should I know while using Atenolol Sandoz?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using Atenolol Sandoz.
  • Attend all of your doctor's appointments so that your progress can be checked.
Things you should not do
  • Do not stop taking Atenolol Sandoz or change the dosage without checking with your doctor.
  • Do not take any new medicines with Atenolol Sandoz, unless your doctor has told you to.
  • Do not use Atenolol Sandoz to treat any other complaint unless your doctor tells you to.
  • Do not give Atenolol Sandoz to anyone else, even if their symptoms seem similar or they have the same condition as you.
Driving or using machines
  • Make sure you know how you react to Atenolol Sandoz before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or lightheaded.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
  • Alcohol may impact the effects of Atenolol Sandoz.
Looking after your medicine
  • Store below 25°C in a cool, dry place.
  • Protect from light.

For more information, see Section 5. What should I know while using Atenolol Sandoz? in the full CMI.

6. Are there any side effects?

Common side effects include: stomach upsets such as diarrhoea, constipation, abdominal pain or heartburn, 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, cold fingers and toes, increased hair loss, tingling 'pins and needles' or walking unsteadily or sexual problems. Serious side effects include: confusion or disorientation, depression or mood changes or a worsening of these, unusual thoughts, hallucinations, light-headedness or fainting which may be due to low blood pressure or yellowing of the skin and/or eyes. Very serious side effects include: allergic reaction. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Atenolol Sandoz®

Active ingredient(s): atenolol


Consumer Medicine Information (CMI)

This leaflet provides important information about using Atenolol Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Atenolol Sandoz.

Where to find information in this leaflet:

1. Why am I using Atenolol Sandoz?
2. What should I know before I use Atenolol Sandoz?
3. What if I am taking other medicines?
4. How do I use Atenolol Sandoz?
5. What should I know while using Atenolol Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Atenolol Sandoz?

Atenolol Sandoz contains the active ingredient atenolol. Atenolol Sandoz 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.

Atenolol Sandoz is used to:

  • lower high blood pressure which is called hypertension
  • prevent angina
  • treat irregular heart rhythm or beat called cardiac arrhythmias)
  • treat heart attacks or reduce your risk of heart complications following a heart attack.

2. What should I know before I use Atenolol Sandoz?

Warnings

Do not use Atenolol Sandoz if:

  • you are allergic to atenolol, or any of the ingredients listed at the end of this leaflet, or to any other beta-blocker medicine. Always check the ingredients to make sure you can use this medicine.
    Some of the symptoms of an allergic reaction may include
    - shortness of breath,
    - wheezing or difficulty breathing,
    - swelling of the face, lips, tongue or other parts of the body,
    - rash, itching or hives on the skin or
    - you may feel faint
  • you have or have had asthma (difficulty in breathing, wheezing, and coughing), bronchitis or other lung problems in the past
  • you have the following conditions:
    - a history of allergic problems, including hay fever.
    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
    - phaeochromocytoma (a rare tumour of the adrenal gland) which is not being treated with other medicines
    - low blood pressure (hypotension)
    - too much acid in the blood (metabolic acidosis)
  • you are receiving
    - certain anaesthetics for medical dental procedures
    - emergency treatment for shock or severely low blood pressure

Check with your doctor if you:

  • have any other medical conditions
    - heart problems
    - an overactive thyroid gland called hyperthyroidism
    - kidney problems
    - diabetes
    - circulation problems
  • have allergies to:
    - any other medicine, including eye drops, or other beta blocker medicines.
    - any other medicines, foods, preservatives, or dyes
    - insect stings
  • Atenolol Sandoz may make allergies worse or make them harder to treat.
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Use in Children

Atenolol Sandoz is not recommended for use in children, as there have been no studies of its effects in children.

Pregnancy and breastfeeding

Do not take Atenolol Sandoz if you are pregnant or intend to be pregnant, are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of using Atenolol Sandoz during pregnancy and breast feeding.

Atenolol Sandoz passes into breast milk and may therefore affect the breast-fed baby.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines may interfere with Atenolol Sandoz and affect how it works. These medicines 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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins, or supplements you are taking and if these affect Atenolol Sandoz.

4. How do I use Atenolol Sandoz?

How much to take

  • Follow all directions given to you by your doctor or pharmacist carefully.
  • If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
  • Hypertension:
    - The usual dose is from 50 mg (1 tablet) up to 200 mg (4 tablets) of Atenolol Sandoz daily.
    - If your dose is 100 mg or less, take it once a day. If you need to take more than 100 mg (2 tablets), take half of your Atenolol Sandoz dose in the morning and the other half of your dose in the evening.
  • Angina or Irregular Heart Beat:
    - The usual dose is from 50 mg (1 tablet) up to 100 mg (2 tablets) taken as a single dose or half the dose in the morning and half at night.
  • Heart attack
    - The usual dose is 50 mg (1 tablet) of Atenolol Sandoz daily.
    - Certain people such as the elderly or those with kidney problems, may require a lower dose.
    Follow the instructions provided and use Atenolol Sandoz until your doctor tells you to stop.

When to take Atenolol Sandoz

  • Take your medicine at about the same time everyday.
  • It does not matter if you take your Atenolol Sandoz before or after food.

How to take Atenolol Sandoz

  • Swallow Atenolol Sandoz whole with a drink or a glass of water, during or immediately after food.
  • If you need to break Atenolol Sandoz, hold the tablet with both hands and snap along the break line.

How to long to take Atenolol Sandoz

  • Take Atenolol Sandoz everyday. Continue taking Atenolol Sandoz for as long as your doctor advises you to stop
    - Atenolol Sandoz helps treat your condition but does not cure it.
  • Do not stop taking Atenolol Sandoz without checking with your doctor.
    - Your doctor may want you to gradually reduce the amount of Atenolol Sandoz 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.
  • Make sure you keep enough Atenolol Sandoz to last over weekends and holidays.

If you forget to use Atenolol Sandoz

Atenolol Sandoz should be used regularly at the same time each day.

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 to make up for the dose you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much Atenolol Sandoz

If you think that you have used too much Atenolol Sandoz, you may need urgent medical attention. If you take too much Atenolol Sandoz, you may feel faint or dizzy or you may find it difficult to breathe.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

5. What should I know while using Atenolol Sandoz?

Things you should do

  • Attend all of your doctor's appointments so that your progress can be checked.
  • Tell any doctors, dentists and pharmacists who are treating you that you are taking Atenolol Sandoz.
  • If you are about to be started on any new medicines, tell your doctor, dentist, or pharmacist that you are taking Atenolol Sandoz.

Call your doctor straight away if you:

  • become pregnant while taking Atenolol Sandoz.
  • have an allergic reaction to any foods, medicines or insect stings.
    - Atenolol Sandoz can cause allergic reactions to be worse and harder to treat.
  • have diabetes and notices any blood sugar level changes
    - Atenolol Sandoz may affect your diabetes. It may hide the symptoms of low blood sugar levels, such as a fast heartbeat. 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.
  • continue to have angina attacks or have more of them whilst taking Atenolol Sandoz.
    - Atenolol Sandoz is used to help prevent angina, so your angina attacks should become less severe and occur less often.
  • feel light-headed, dizzy, or faint, and this problem gets worse or continues
    - Get up slowly when getting out of bed or standing up
    - You may feel light-headed or dizzy after taking Atenolol Sandoz. This is because your blood pressure is falling suddenly.
    - To help you 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.
  • are having surgery (even at the dentist), tell your doctor or dentist that you are taking Atenolol Sandoz.
    - Atenolol Sandoz may affect some of the medicines used during surgery.
  • have any medical tests while you are taking Atenolol Sandoz
    - Atenolol Sandoz may affect the results of some tests.

Things you must do

  • Drink lots of water when exercising and during hot weather when taking Atenolol Sandoz, especially if you sweat a lot.
    - If you do not drink enough water while taking Atenolol Sandoz, you may feel faint, light-headed, or sick. The recommended healthy minimum water intake is 6-8 glasses a day.

Remind any doctor, dentist or pharmacist you visit that you are using Atenolol Sandoz.

Things you should not do

  • Do not stop taking Atenolol Sandoz or change the dose without checking with your doctor.
  • Do not take any new medicines with Atenolol Sandoz, unless your doctor has told you to.
  • Do not take Atenolol Sandoz to treat any other complaint unless your doctor tells you to.
  • Do not give Atenolol Sandoz to anyone else, even if their symptoms seem similar or they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Atenolol Sandoz affects you.

Atenolol Sandoz may cause dizziness, fatigue, light-headedness or faintness in some people.

Make sure you know how you react to Atenolol Sandoz before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or lightheaded.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may impact the effects of Atenolol Sandoz.

Things to be careful of

Be careful not to over exercise when you first start taking Atenolol Sandoz.

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).

Atenolol Sandoz, 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.

Looking after your medicine

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

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 25°C away from moisture, heat, or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

If you get any side effects, do not stop taking Atenolol Sandoz without first talking to your doctor.

Less serious side effects

Less serious side effectsWhat to do
Gut related:
  • stomach upsets such as diarrhoea, constipation, abdominal pain, or heartburn (indigestion)
Respiratory or breathing related:
  • runny or blocked nose
Other:
  • dry mouth, change in taste sensation
  • slow or irregular heart beat
  • dry eyes, problems with vision
  • difficulty sleeping, nightmares
  • skin reactions (e.g., rash, itching, worsening of psoriasis)
  • increased hair loss
  • dizziness, headache or buzzing or ringing in the ears
  • cold fingers and toes
  • tingling, 'pins and needles' or walking unsteadily
  • sexual problems
Speak to your doctor if you have any of these less serious side effects and they worry you.
They are generally mild and do not cause patients to stop taking Atenolol Sandoz.

Serious side effects

Serious side effectsWhat to do
Neurological or brain related:
  • confusion or disorientation
  • depression or mood changes or 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
Liver related:
  • yellowing of the skin and/or eyes (jaundice)
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very serious side effectsWhat to do
Allergy related:
  • wheezing, chest tightness or difficulty breathing
  • swelling of the lips, face or throat
Other:
  • unexplained bruising
Tell your doctor immediately, or go to straight to the Emergency department at your nearest hospital

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Atenolol Sandoz contains

Active ingredient
(main ingredient)
Atenolol
Other ingredients
(inactive ingredients)
  • maize starch
  • sodium lauryl sulfate
  • magnesium carbonate hydrate
  • magnesium stearate
  • gelatin
  • hypromellose
  • titanium dioxide
  • macrogol 4000.
Potential allergens
  • lactose monohydrate
This medicine does not contain sucrose, gluten, tartrazine, or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What Atenolol Sandoz looks like

Atenolol Sandoz 50 mg tablets - white, round, convex film-coated tablet scored on one side
(AUST R 101462).

Available in blisters of 30 tablets.

Who distributes Atenolol Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was revised in July 2022.

Published by MIMS October 2022

BRAND INFORMATION

Brand name

Atenolol Sandoz

Active ingredient

Atenolol

Schedule

S4

 

1 Name of Medicine

Atenolol.

2 Qualitative and Quantitative Composition

Each Atenolol Sandoz 50 mg tablet contains 50 mg atenolol.

Excipients with known effect.

Each tablet contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Atenolol Sandoz 50 mg tablets are white, round, convex film-coated tablets, scored on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Atenolol Sandoz is indicated in the management of:
all grades of hypertension, including hypertension of renal origin;
frequent disabling angina without evidence of cardiac failure;
cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias, including those associated with acute myocardial infarction);
myocardial infarction: late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

4.2 Dose and Method of Administration

Dosage.

Adults.

Hypertension.

Therapy should be initiated with Atenolol Sandoz 50 mg daily. This may be increased each week in daily doses of 50 mg up to a maximum of 200 mg. Where patients are controlled on daily doses of 50 to 100 mg this may be given once daily. Doses above 100 mg daily should be given on a divided basis. Where necessary, a further reduction in blood pressure may be achieved by combining Atenolol Sandoz with other antihypertensive agents.
Patients can be transferred to Atenolol Sandoz from other antihypertensive treatments with the exception of clonidine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Clonidine).

Angina pectoris.

Therapy should be initiated with Atenolol Sandoz 50 mg daily. This may be increased if required to 100 mg daily given as a single or divided dose. It is unlikely that additional benefit will be gained by increasing the dose.

Cardiac dysrhythmias.

Having controlled the dysrhythmias with other intravenous agents, atenolol given orally at a dosage of 50 mg to 100 mg daily will help maintain control.

Acute myocardial infarction - late intervention (> 12 hours from onset of chest pain).

Atenolol Sandoz has been shown to reduce infarct size, reduce the incidence of ventricular dysrhythmias, reduce the need for opiate analgesics and reduce mortality in the first 7 postinfarction days, most of the benefit being in the first 48 hours. Data from other beta-blocker trials suggest that there is a significant reduction in mortality and a reduced incidence of nonfatal reinfarction if the beta-blocker is continued for one to three years.
Hence, maintenance oral therapy of Atenolol Sandoz 50 mg daily is recommended for one to three years following myocardial infarction, beginning after early intervention with other agents, or immediately in those patients who present more than 12 hours after suffering an acute myocardial infarction.

Dosage adjustment.

Renal impairment.

Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs at a creatinine clearance greater than 35 mL/minute/1.73 m2 (normal range is 100 to 150 mL/minute/1.73 m2). For patients with a creatinine clearance of 15 to 35 mL/minute/1.73 m2 (equivalent to serum creatinine of 300 to 600 micromol/L), the oral dose should be 50 mg daily or 100 mg on alternate days. For patients with a creatinine clearance of less than 15 mL/minute/1.73 m2 (equivalent to serum creatinine greater than 600 micromol/L), the oral dose should be 50 mg on alternate days or 100 mg every fourth day.
Patients on haemodialysis should be given 50 mg orally after each dialysis: this should be done under hospital supervision as marked falls in blood pressure can occur.

Elderly.

Dosage requirements may be reduced especially in patients with impaired renal function.

Children.

There is no experience with atenolol in children.

4.3 Contraindications

Bronchospasm. Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance. These medicines also reduce the effectiveness of asthma treatment. This may be dangerous in susceptible patients.
Therefore beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm. Use of cardioselective beta-blockers can also result in severe bronchospasm. If such therapy must be used, great caution should be exercised. Alternative therapy should be considered.
Congestive heart failure.
Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm.
Right ventricular failure secondary to pulmonary hypertension.
Significant right ventricular hypertrophy.
Sick sinus syndrome.
Sinus bradycardia (less than 45 to 50 beats/minute).
Second and third degree A-V block.
Shock (including cardiogenic and hypovolaemic shock).
Anaesthesia with agents that produce myocardial depression (e.g. ether, chloroform, cyclopropane).
Hypotension.
Metabolic acidosis.
Severe peripheral arterial circulatory disturbances.
Untreated pheochromocytoma.
Pregnancy and lactation (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy, Use in lactation).
Known hypersensitivity to the active ingredient or any of the excipients.

4.4 Special Warnings and Precautions for Use

Cardiac failure.

Beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy as may occur in chronic alcoholism. In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. If signs of cardiac failure are present, the patient should be fully digitalised and/or given an ACE inhibitor or vasodilators with or without a diuretic and carefully monitored. If cardiac failure persists, the beta-blocker should be withdrawn (see Abrupt withdrawal of therapy, below).

Note.

Although congestive heart failure has been considered to be a contraindication to the use of beta-blockers, there is growing literature on the experimental use of beta-adrenergic blocking medicines in heart failure. As further trials are needed to identify which patients are most likely to respond to which medicines, beta-blockers should not normally be prescribed for heart failure outside of specialist centres.

Abrupt withdrawal of therapy.

Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease. Severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of beta-blockade in patients with ischaemic heart disease. Therefore, it is recommended that the dosage be reduced gradually over a period of about 8 to 14 days during which time the patient's progress should be reassessed. The drug may be reinstituted temporarily if the angina worsens. If the drug must be withdrawn abruptly, close observation is required. In the perioperative period, beta-blockers should not be withdrawn unless indicated.

History of anaphylactic reaction.

While taking beta-adrenoreceptor blocking drugs, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

First degree heart block.

Due to its negative effect on conduction time, caution must be exercised if atenolol is given to patient with first degree heart block.

Peripheral circulation.

Beta-blockade may impair the peripheral circulation and exacerbate the symptoms of peripheral vascular disease.

Prinzmetal angina.

There is a risk of exacerbating coronary artery spasm if patients with Prinzmetal or variant angina are treated with a beta-blocker. If this treatment is essential, it should only be undertaken in a coronary or intensive care unit.

Euthyroid hyperthyroxinaemia.

The effects of beta-blockers on thyroid hormone metabolism may result in elevations of serum free thyroxine (T4) levels. In the absence of any signs or symptoms of hyperthyroidism, additional investigation is necessary before a diagnosis of thyrotoxicosis can be made.

Use in acute myocardial infarction.

In addition to the contraindications listed (see Section 4.3 Contraindications), patients with the following conditions are not suitable for treatment with atenolol.

Systolic blood pressure less than 120 mmHg.

Systolic blood pressure less than 120 mmHg in combination with a heart rate greater than 90 beats/minute has a particularly poor prognosis.

First degree A-V block.

There is an increased incidence of cardiogenic shock (and need for inotropes), complete heart block and cardiovascular death in these patients following use of atenolol.
Patients with atrial fibrillation following myocardial infarction who were treated with atenolol also had increased cardiovascular mortality compared with those not treated with atenolol. It is suggested that such patients be digitalised before atenolol therapy is commenced.

Bradycardia.

If a treated patient develops symptoms which may be attributable to a slow heart rate the dose may be reduced.

Anaesthesia and the perioperative period.

Beta-blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the postoperative period. It is currently recommended that maintenance beta-blockade be continued perioperatively. The anaesthetist must be made aware of beta-blockade because of the potential for interactions with other medicines, resulting in severe bradyarrhythmias and hypotension, the decreased reflex ability to compensate for blood loss, hypovolaemia and regional sympathetic blockade, and the increased propensity for vagal induced bradycardia. Incidents of protracted severe hypotension or difficulty restoring normal cardiac rhythm during anaesthesia have been reported. Modern inhalational anaesthetic agents are generally well tolerated, although older agents (ether, cyclopropane, methoxyflurane, trichloroethylene) were sometimes associated with severe circulatory depression in the presence of beta-blockade.

Diabetes.

Beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia.
In patients with insulin or noninsulin dependent diabetes, especially labile diabetes, or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. The dose of insulin or oral hypoglycaemic agent may need adjustment.

Other metabolic effects.

Beta-adrenoreceptors are involved in the regulation of lipid as well as carbohydrate metabolism. Some medicines affect the lipid profile adversely although the long-term clinical significance of this change is unknown and the effect appears to be less for medicines with intrinsic sympathomimetic activity.

Pheochromocytoma.

In patients with this condition, an alpha-blocker (e.g. phentolamine/phenoxybenzamine) should be given before the beta-blocker to avoid exacerbation of hypertension.

Eye and skin reactions.

Various skin rashes and conjunctival xerosis have been reported with beta-blockers. Cross reactions may occur between beta-blockers, therefore substitutions within the group may not necessarily preclude occurrence of symptoms.
During long-term treatment with the beta-blocking medicine practolol, a specific rash bearing a superficial resemblance to psoriasis was occasionally described. In a number of patients affected, this rash was accompanied by adverse effects on the eye (xerophthalmia and/or keratoconjunctivitis) of varying severity. This condition is called the oculomucocutaneous syndrome or practolol syndrome. In a few patients, these eye changes occurred independently of a skin rash. On rare occasions, serious otitis media, sclerosing peritonitis, pericarditis and pleurisy have been reported. Although the practolol syndrome has not been observed in patients taking other beta-blockers, the possibility of such side effects occurring should be borne in mind.
More recently an association between Peyronie's disease (a fibrosing induration of the penis) and various beta-blockers has been suggested but is not proven.

Allergic conditions.

These may be exaggerated by beta-blockade (e.g. allergic rhinitis during the pollen season and allergic reactions to bee and wasp stings). Beta-blockers should be avoided if there is a risk of bronchospasm.

Hyperthyroidism.

Because beta-blockers may mask the clinical signs of developing or continuing hyperthyroidism, resulting in symptomatic improvement without any change in thyroid hormone status, special care should be exercised in those patients who are hyperthyroid and are also receiving beta-blockers.

Use in renal impairment.

In patients with severe renal disease, haemodynamic changes following beta-blockade may impair renal function further. Beta-blockers which are excreted mainly be the kidney, may require dose adjustment in patients with renal failure.

Use in the elderly.

Atenolol should be used with caution in the elderly, starting with a lesser dose.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant therapy with calcium antagonists.

The concomitant use of beta-blockers and calcium antagonists with myocardial depressant and sinus node activity, e.g. verapamil and to a lesser extent diltiazem, may cause hypotension, bradycardia and asystole, particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities. Extreme caution is required if these medicines have to be used together.
The dihydropyridine calcium antagonists (e.g. nifedipine) have a weaker myocardial depressant effect and can be administered cautiously with beta-blockers. If excessive hypotension develops, the calcium antagonist should be stopped or the dosage reduced.

Antiarrhythmic medicines.

Class 1 anti-arrhythmic medicines (e.g. disopyramide) and the Class III agent, amiodarone may have potentiating effect on atrial conduction time and induce negative inotropic effect, this is seen less frequently with quinidine; Class IB agents, tocainide, mexiletine and lignocaine; Class IC agents, flecainide and propafenone (not available in Australia); and the Class IV antiarrhythmic agents.

Use of catecholamine depleting agents.

Concomitant use of drugs such as reserpine and guanethidine requires careful monitoring since the added effect of beta-blockade may produce an excessive reduction of the resting sympathetic nervous tone.

Clonidine.

Concurrent use of beta-blockers and clonidine should be avoided because of the risk of adverse interaction and severe withdrawal symptoms. If administered concomitantly, the clonidine should not be discontinued until several days after the withdrawal of the beta-blocker.

Insulin and oral hypoglycaemics.

(see Section 4.4 Special Warnings and Precautions for Use, Diabetes).

Anaesthetics.

Anaesthetics such as methoxyflurane are contraindicated with atenolol (see Section 4.4 Special Warnings and Precautions for Use, Anaesthesia and the perioperative period).

Digitalis/ digitalis glycosides.

Digitalis/ digitalis glycosides and β-blockers are commonly used together, although there have been reports of excessive bradycardia when beta-blockers are used to treat digitalis intoxication.

Sympathomimetic agents.

Concomitant use of sympathomimetic agents, e.g. adrenaline, may counteract the effect of beta-blockers.

Prostaglandin synthetase inhibitors.

Concomitant use of prostaglandin synthetase inhibiting medicines, e.g. ibuprofen and indomethacin, may decrease the hypotensive effects of beta-blockers.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Beta-adrenergic blocking agents may cause bradycardia in the foetus and newborn infant. During the later stages of pregnancy and parturition, these medicines should only be given after weighing the needs of the mother against the risk to the foetus.
Atenolol crosses the placental barrier in pregnant women, and under steady-state conditions, maternal and foetal blood levels of atenolol are approximately equal.
No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of atenolol for longer periods to pregnant women in the management of mild to moderate hypertension has been associated with intrauterine growth retardation. The use of atenolol in women who are, or may become, pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters. In general, beta-blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion and early labour.
Atenolol has been shown to produce a dose related increase in embryo/ foetal resorptions in rats at doses ≥ 50 mg/kg. Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg.
There is significant accumulation of atenolol in breast milk. Caution should be exercised when atenolol is administered to breastfeeding women and the infant should be regularly assessed for signs of beta-blockade.

4.7 Effects on Ability to Drive and Use Machines

Use is unlikely to result in any impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

Adverse effects reported in clinical trials of atenolol are mainly attributable to pharmacological actions. The adverse reactions listed below have been observed in patients in clinical trials who have received dosages of about 100 mg/day. It is not possible to give percentage incidences for each reaction, but if all mild and transient reactions are included as well as more serious ones, up to 10% of patients may experience some form of adverse reaction.
More common reactions.

Gastrointestinal.

Disturbances including indigestion, constipation, dry mouth.

Nervous system.

Fatigue, dizziness.

Respiratory.

Wheezing, bronchospasm (see Section 4.3 Contraindications).
Less common reactions.

Biochemical abnormalities.

Increases in SGOT, blood urea and serum creatinine have been reported.

Cardiovascular.

Bradycardia, left ventricular insufficiency, postural hypotension (which may be associated with syncope), intermittent claudication may occur if already present, Raynaud's phenomenon, cold extremities, deterioration in heart failure, heart block.

Dermatological.

Rash, alopecia, psoriasiform skin reaction, exacerbation of psoriasis.

Gastrointestinal.

Diarrhoea.

Hepatic.

Elevations of transaminase levels have been seen infrequently, rare cases of hepatic toxicity including intrahepatic cholestasis have been reported.

Genitourinary.

Impotence.

Musculoskeletal.

Ataxia.

Nervous system.

Vivid dreams, nightmares, paraesthesia, tinnitus, vertigo, malaise, headache, insomnia, mood changes, confusion.

Ocular.

Dry eyes, visual disturbances.

Psychiatric.

Hallucinations, depression, psychoses.

Respiratory.

Asthma, dyspnoea, nasal congestion.

Haemapoietic.

Thrombocytopenia, purpura. An increase in ANA (antinuclear antibodies) has been observed, however, the clinical relevance of this is not clear.
Severe or life-threatening reactions. Myocardial insufficiency may require treatment with digitalis and diuretics. Bradycardia may respond to atropine. Bronchospasm may be reversed with a beta2-stimulant. Hypotension, if severe, may require use of a vasopressor.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Overdosage has not been reported with atenolol, but in overdosage with other beta-blocking agents, severe bradycardia and hypotension are commonly found. Acute heart failure and bronchospasm may also occur.

Treatment.

Severe bradycardia.

Atropine 1 to 2 mg intravenously may be used to induce vagal blockade. If bradycardia persists an inotrope, such as intravenous isoprenaline (25 micrograms initially) may be given. In refractory cases, the use of a cardiac pacemaker may be considered.

Hypotension.

Severe hypotension should respond to a sympathomimetic amine such as noradrenaline. In refractory cases, the use of glucagon hydrochloride should be considered.

Bronchospasm.

Therapy with a beta2-stimulant such as salbutamol or terbutaline or therapy with aminophylline may be considered.

Acute cardiac failure.

Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases, the use of intravenous isoprenaline, followed if necessary by glucagon hydrochloride or intravenous aminophylline, should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Atenolol is a beta-adrenoceptor blocking agent which acts preferentially on beta-receptors in the heart. Selectivity decreases with increasing dose. It has little intrinsic sympathomimetic activity and no membrane stabilising activity. Atenolol is a racemic mixture and its activity resides in the S(-) enantiomer. It reduces raised blood pressure by an unknown mechanism and also inhibits exercise induced tachycardia and decreases plasma renin concentration. It causes slight airways obstruction but less than that seen with nonselective beta-blockers. The inhibition of exercise induced tachycardia is correlated with blood levels but there is no correlation between plasma concentrations and antihypertensive effect. Atenolol is effective and well tolerated in most ethnic populations although the response may be less in Afro-Caribbean black patients.
The possible mechanism of the antianginal activity of atenolol appears to be due to a reduction in left ventricular work and oxygen utilisation resulting (mainly) from the decrease in heart rate and contractility.
The antiarrhythmic effect of atenolol is apparently due to its antisympathetic effect. There is no evidence that membrane stabilising activity or intrinsic sympathomimetic activity are necessary for antiarrhythmic efficacy. By its antisympathetic effect, atenolol depresses sinus node function, atrioventricular node function and prolongs atrial refractory periods. It has no direct effect on electrophysiological properties of the His-Purkinje system.
Because of their negative inotropic effects, beta-adrenoreceptor blocking agents should be avoided in uncontrolled heart failure.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Although absorption of atenolol is variable and incomplete (40 to 60%), the virtual lack of hepatic metabolism results in relatively consistent systemic bioavailability compared to other beta-blockers. Blood levels in humans peak two to four hours after a single 100 mg oral dose and are of the order of 0.4 to 0.9 microgram/mL. Blood levels are consistent and the levels after chronic oral administration are in good agreement with those predicted from single dose results.

Distribution.

The medicine is distributed throughout the body tissues.

Metabolism.

Less than 10% of the dose is metabolised, the minor urinary metabolite identified being a hydroxylated derivative.

Excretion.

The main route of elimination is renal excretion. The plasma half-life, measured by blood level decay or urinary build up is approximately seven to nine hours. In patients with impaired renal function, there is a progressive prolongation of the half-life. In patients with normal renal function, the therapeutic effect (i.e. control of raised blood pressure) lasts for at least 24 hours following a 50 mg oral dose.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients in Atenolol Sandoz tablets include maize starch, sodium lauryl sulfate, magnesium carbonate hydrate, magnesium stearate, gelatin, lactose monohydrate, hypromellose, titanium dioxide and macrogol 4000.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light and moisture.

6.5 Nature and Contents of Container

Atenolol Sandoz film-coated tablets are available in PVC/Al blister packs of 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Atenolol is a white or almost white powder, sparingly soluble in water, soluble in ethanol, slightly soluble in methylene chloride and practically insoluble in ether.

Chemical structure.


Chemical name: (RS)-4-(2-hydroxy-3-isopropylaminopropoxy) phenyl] acetamide.
Molecular formula: C14H22N2O3.
Molecular weight: 266.3.
Atenolol is a beta-adrenoceptor blocking agent structurally related to propranolol and differing from it by substitution on the aromatic ring.

CAS number.

29122-68-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes