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.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Atenolol Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking this medicine against the benefits they expect it will 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 need to read it again.

WHAT ATENOLOL SANDOZ IS USED FOR

Atenolol Sandoz contains the active ingredient atenolol. 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

This medicine is used to:

  • lower high blood pressure (hypertension)
  • prevent angina (chest pain)
  • treat irregular heart rhythm or beat (cardiac arrhythmias)
  • treat heart attacks, or reduce your risk of heart complications following a heart attack.

Atenolol Sandoz may be either used alone or in combination with other medicines to treat your condition.

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.

Atenolol Sandoz 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 of your heart. Angina pain is often brought on by exercise or stress.

Atenolol Sandoz 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.

Atenolol Sandoz 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 Sandoz 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 it for another reason.

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

This medicine is not addictive.

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

BEFORE YOU TAKE ATENOLOL SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:

  • atenolol, the active ingredient or to any of the other ingredients listed at the end of this leaflet under Product Description
  • any other similar 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.

Do not take this medicine if you have or have had any of the following medical conditions:

  • asthma (difficulty in breathing, wheezing and coughing), bronchitis or other lung problems in the past
  • 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
  • phaeochromocytoma (a rare tumour of the adrenal gland) which is not being treated with other medicines
  • low blood pressure (hypotension)
  • a condition called metabolic acidosis (too much acid in the blood).

Do not take this medicine if you are receiving:

  • certain anaesthetics for medical dental procedures
  • emergency treatment for shock or severely low blood pressure.

Do not take this medicine if you are pregnant or intend to be pregnant. If may affect your developing baby if you take it during pregnancy.

Do not take this medicine if you are breastfeeding or plan to breastfeed. The active ingredient in Atenolol Sandoz passes into breast milk and there is a possibility that your baby may be affected.

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

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • an overactive thyroid
  • a particular type of angina called prinzmetal angina or variant angina
  • problems with your kidney function
  • diabetes
  • any medical condition affecting your blood vessels
  • any other heart problem.

If you have not told your doctor about any of the above, tell him/her before you start taking Atenolol Sandoz.

Taking other medicines

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

Some medicines and Atenolol Sandoz may interfere with each other. These include:

  • other beta-blocker medicines including beta-blocker eye drops
  • calcium channel blockers, medicines used to treat high blood pressure and angina e.g. verapamil, diltiazem and nifedipine
  • any other medicines used to treat irregular heart beat (arrhythmia), high blood pressure (hypertension) or severe chest pain (angina)
  • clonidine or hydralazine, medicines used to treat high blood pressure
  • certain medicines used to treat abnormal or irregular heartbeat e.g. disopyramide, quinidine
  • insulin or other medication used to treat diabetes
  • certain medicines used to treat arthritis, pain, or inflammation e.g. indomethacin or ibuprofen
  • digoxin, a medicine used to treat heart failure
  • guanethidine, a medicine used to treat certain heart conditions
  • cold remedies.

These medicines may be affected by Atenolol Sandoz, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE ATENOLOL SANDOZ

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

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

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. If you need to break Atenolol Sandoz, hold the tablet with both hands and snap along the break line.

How to take it

Atenolol Sandoz tablets should be swallowed whole with a drink or a glass of water, during or immediately after food.

When to take Atenolol Sandoz

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take Atenolol Sandoz

Continue taking your medicine for as long as your doctor tells you.

This medicine helps control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

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 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 to make up for the dose you missed. 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 when 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 Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Atenolol Sandoz. Do this even if there are no signs of discomfort or poisoning. 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.

WHILE YOU ARE TAKING ATENOLOL SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Atenolol Sandoz.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell your surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Tell your doctor if you have a severe allergic reaction to foods, medicines or insect stings. This medicine 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. This medicine 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 Atenolol Sandoz, tell your doctor. This medicine 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 Atenolol Sandoz. 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.

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.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take Atenolol Sandoz to treat any other complaint unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This may help reduce the possibility of withdrawal symptoms such as worsening of angina or other heart complications occurring.

Things to be careful of

Be careful driving or operating machinery until you know how Atenolol Sandoz affects you. As with other beta-blockers, Atenolol Sandoz may cause dizziness or light-headedness in some people, especially after the first dose.

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.

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.

SIDE EFFECTS

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

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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
  • slow or irregular heart beat
  • dry eyes, problems with vision
  • runny or blocked nose
  • difficulty sleeping, nightmares
  • skin reaction (e.g. rash, itching, worsening of psoriasis)
  • cold fingers and toes
  • increased hair loss
  • tingling, 'pins and needles' or walking unsteadily
  • sexual problems.

These are mild side effects of the medicine.

Tell your doctor as soon as possible 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).

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, stop taking Atenolol Sandoz, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • unusual bruising or bleeding
  • chest tightness, wheezing, difficulty breathing

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING ATENOLOL SANDOZ

Storage

Keep your medicine in the original container. If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Atenolol Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Atenolol Sandoz 50 mg tablets - white, round, convex film-coated tablet scored on one side. Available in blisters of 30 tablets.

Ingredients

Active ingredients:

  • Atenolol Sandoz 50mg - 50mg atenolol.

Inactive ingredients:

  • maize starch
  • sodium lauryl sulfate
  • magnesium carbonate hydrate
  • magnesium stearate
  • gelatin
  • lactose monohydrate
  • hypromellose
  • titanium dioxide
  • macrogol 4000.

Supplier

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

Novartis New Zealand Limited
PO Box 99102
Newmarket, Auckland 1149
New Zealand
Tel: 0800 354 335

This leaflet was revised in November 2018.

Australian Register Number

50 mg tablets: AUST R 101462 (blister)

Published by MIMS January 2019

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