Consumer medicine information

Noten

Atenolol

BRAND INFORMATION

Brand name

Noten

Active ingredient

Atenolol

Schedule

SUMMARY CMI

NOTEN^®

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 NOTEN?

NOTEN contains the active ingredient atenolol. NOTEN is used to lower high blood pressure, which is called hypertension, prevent angina, treat irregular heart rhythm or beat called 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 NOTEN? in the full CMI.

2. What should I know before I use NOTEN?

Do not use if you have ever had an allergic reaction to NOTEN 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 NOTEN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NOTEN 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 NOTEN?

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 NOTEN? in the full CMI.

5. What should I know while using NOTEN?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using NOTEN. Keep all of your doctor's appointments so that your progress can be checked.
Things you should not do	Do not take NOTEN to treat any other complaints 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 dose without checking with your doctor. Do not take any new medicines with NOTEN unless your doctor has told you to.
Driving or using machines	Be careful driving or operating machinery until you know how NOTEN affects you.
Looking after your medicine	Keep your tablets in the pack until it is time to take them. Store below 25°C in a cool, dry place

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

6. Are there any side effects?

Common side effects include stomach upsets such as diarrhea, constipation, abdominal pain or heartburn, dry mouth, change in taste sensation, dizziness, headache or buzzing or ringing in the ears, slow or irregular heartbeat, 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

NOTEN^®

Active ingredient(s): atenolol

Consumer Medicine Information (CMI)

This leaflet provides important information about using NOTEN. 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 NOTEN.

Where to find information in this leaflet:

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

1. Why am I using NOTEN?

NOTEN contains the active ingredient atenolol. NOTEN is 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.

NOTEN is used to:

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

2. What should I know before I use NOTEN?

Warnings

Do not use NOTEN if:

you are allergic to atenolol, or any of the ingredients listed at the end of this leaflet.
any of the ingredients listed at the end of this leaflet.
any other beta-blocker medicines.
Always check the ingredients to make sure you can use this medicine
you have or have had asthma (difficulty in breathing, wheezing and coughing), bronchitis or other lung problems in the past.
a history of allergic problems, including hay fever.
Symptoms of an allergy may include rash, itching, watery eyes or sneezing.
a very slow heartbeat, less than 45 to 50 beats per minute
a severe blood vessel disorder causing poor circulation in the arms and legs
certain other heart conditions, such as heart failure
phaeochromocytoma (a rare tumour of the adrenal gland) that is not being treated with other medicines
low blood pressure, also called hypotension
too much acid in your blood (metabolic acidosis)
you are receiving certain anaesthetics for medical or dental procedures
you are receiving emergency treatment for shock or very low blood pressure

Check with your doctor if you:

have any other medical conditions. These include heart problems, diabetes, an overactive thyroid gland (called hyperthyroidism), kidney problems and any blood vessel disorders causing poor blood circulation in the arms and legs
take any medicines for any other condition
you have allergies to any other medicines (including eye drops), foods, preservatives, dyes or insect stings

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?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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 NOTEN and affect how it works.

other beta-blocker medicines
medicines used to treat high blood pressure, angina or an irregular heartbeat, such as verapamil or clonidine
medicines used to treat other heart problems
insulin and other medicines used to treat diabetes
medicines used to treat arthritis, pain or inflammation such as indometacin or ibuprofen
medicines commonly used during surgery or in emergency situations such as adrenaline (epinephrine), noradrenaline (norepinephrine) and certain anaesthetics

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

4. How do I use NOTEN?

How much to take

Follow the instructions provided and use NOTEN until your doctor tells you to stop.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help
Hypertension - The usual dose is from 50 mg (1 tablet) up to 200 mg (4 tablets) daily. If your dose is 100 mg or less, you may take it once a day. If you need to take more than 100 mg (2 tablets), take half of your dose in the morning and the other half at night.
Angina or arrhythmia (irregular heart beat) - The usual dose is from 50 mg daily (1 tablet) as a single dose up to 100 mg (2 tablets) either as a single dose or a divided dose given as 1 tablet in the morning and 1 tablet at night.
Heart attack - The usual dose is 50 mg (1 tablet) daily. Certain people such as the elderly or those with kidney problems may require a lower dose.

When to take NOTEN

NOTEN should be used at the same time everyday
It does not matter if you take NOTEN before or after food.
Continue taking your medicine for as long as your doctor tells you to

How to take NOTEN

Swallow NOTEN whole with a glass of water

If you forget to use NOTEN

NOTEN 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 are not sure what to do, ask your doctor or pharmacist.

If you use too much NOTEN

If you think that you have used too much NOTEN, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.

5. What should I know while using NOTEN?

Things you should do

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

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking NOTEN.

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

Make sure you drink enough water in hot weather and during exercise while you are taking NOTEN, especially if you sweat a lot

Call your doctor straight away if you:

become pregnant while taking this medicine, tell your doctor immediately
have an allergic reaction to any foods, medicines or insect stings, tell your doctor immediately
going to have surgery, tell your surgeon or dentist that you are taking this medicine
have diabetes, check your blood sugar level regularly and report any changes to your doctor
have angina and continue to have angina attacks or have more of them while you are taking this medicine
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly
have to have any medical tests

Things you should not do

Do not stop using this medicine suddenly
Do not stop taking your medicine or lower the dose without checking with your doctor
Do not take NOTEN to treat any other complaints unless your doctor tells you to
Do not take NOTEN to treat any other complaints unless your doctor tells you to
Do not take any new medicines with NOTEN unless your doctor has told you to

Things to be careful of

Be careful not to over exercise when you first start taking NOTEN
Dress warmly during cold weather, especially if you will be outside for a long time (for example, when playing or watching sports in winter).

Driving or using machines

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

NOTEN may cause dizziness, tiredness, light headedness or faintness in some people

Looking after your medicine

Keep your tablets in the pack until it is time to take them
Keep your tablets in a cool dry place where the temperature stays below 25°C

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

Store it in a cool dry place 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.

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.

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.

Less serious side effects

Less serious side effects

What to do

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, vivid dreams
skin reactions (e.g. rash, itching, worsening of psoriasis
increased hair loss
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.

Serious side effects

Serious side effects	What to do
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)	Call your doctor as soon as possible if you have any of these serious side effects

Very serious side effects

Very Serious side effects	What to do
wheezing, chest tightness or difficulty breathing unusual bruising or bleeding fast, slow or irregular heartbeat swelling of the face, lips, tongue or other parts of the body	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.

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 NOTEN contains

Active ingredient (main ingredient)	atenolol
Other ingredients (inactive ingredients)	lactose monohydrate maize starch povidone microcrystalline cellulose colloidal anhydrous silica hydrogenated vegetable oil crospovidone sodium starch glycollate purified talc magnesium stearate.
Potential allergens	sulfites sugars as lactose

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

What NOTEN looks like

NOTEN tablets are a 10.5 mm x 5.5 mm white, normal convex, oblong tablet marked with AT/50 and α on the reverse. (AUST R 46250).

Who distributes NOTEN

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in August 2023.

NOTEN^® is a Viatris company trade mark

NOTEN_cmi\Aug23/00

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Noten

Active ingredient

Atenolol

Schedule

1 Name of Medicine

Atenolol.

2 Qualitative and Quantitative Composition

Each Noten tablet contains 50 mg of atenolol as the active ingredient.

Excipients with known effect.

Sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The tablets are 10.5 x 5.5 mm white, normal convex, oblong tablet marked AT/50 on one side, α on reverse.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Adults.

Hypertension.

Therapy should be initiated with 50 mg atenolol 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 with other antihypertensive agents.
Patients can be transferred to atenolol from other antihypertensive treatments with the exception of clonidine (see Section 4.4 Special Warnings and Precautions for Use).

Angina pectoris.

Therapy should be initiated with 50 mg of atenolol 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, Noten given orally at a dosage of 50 to 100 mg daily will help maintain control.

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

Atenolol 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 post-infarction 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 non-fatal reinfarction if the beta blocker is continued for 1 to 3 years.
Maintenance oral therapy of 50 mg daily of Noten is recommended for 1 to 3 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.

Impaired renal function.

Since Noten is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of Noten occurs at a creatinine clearance greater than 35 mL/min/1.73 m² (normal range is 100 to 150 mL/min/1.73 m²). For patients with a creatinine clearance of 15 to 35 mL/min/1.73 m² (equivalent to serum creatinine of 300 to 600 micromol/L) the dose should be 50 mg daily or 100 mg on alternate days. For patients with a creatinine clearance less than 15 mL/min/1.73 m² (equivalent to serum creatinine of greater than 600 micromol/L) the 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.

Children.

There is no experience with atenolol in children.

Elderly.

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

4.3 Contraindications

1. Bronchospasm. Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance. These drugs 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 a 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.
2. Congestive heart failure.
3. Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm.
4. Right ventricular failure secondary to pulmonary hypertension.
5. Significant right ventricular hypertrophy.
6. Sick sinus syndrome.
7. Sinus bradycardia (less than 45 to 50 beats/minute).
8. Second- and third-degree A-V block.
9. Shock (including cardiogenic and hypovolaemic shock).
10. Hypersensitivity to the drug.
11. Anaesthesia with agents that produce myocardial depression (e.g. ether, chloroform, cyclopropane).
12. Metabolic acidosis.
13. Hypotension.
14. Severe peripheral arterial circulatory disturbances.
15. Untreated phaeochromocytoma.
16. Pregnancy and lactation (see Section 4.6 Fertility, Pregnancy and Lactation).

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 present, the patients should be fully digitalised and/or given an ACE inhibitor or vasodilators, with or without a diuretic, and carefully monitored. If cardiac failure persists, atenolol should be withdrawn (see Section 4.4 Special Warnings and Precautions for Use, Abrupt withdrawal of therapy).

Note.

Although congestive heart failure has been considered to be a contraindication to the use of beta-blockers, there is a growing literature on the experimental use of beta-adrenergic blocking drugs in heart failure. As further trials are needed to identify which patients are most likely to respond to which drugs, 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 peri-operative period, beta-blockers should not be withdrawn, unless indicated.

History of anaphylactic reaction.

While taking beta-blockers, 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 (epinephrine) used to treat the allergic reactions.

First degree heart block.

Due to its negative effect on conduction time, caution must be exercised if Noten is given to patients 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.

Bradycardia.

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

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 Noten:
a) Systolic blood pressure less than 120 mmHg (systolic blood pressure less than 120 mmHg in combination with a heart rate greater than 90 beats/min has a particularly poor prognosis).
b) 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 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 Noten therapy is commenced.

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.

Anaesthesia and the peri-operative period.

Beta-blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the post-operative period. It is currently recommended that maintenance of beta-blockade be continued peri-operatively. The anaesthetist must be made aware of beta-blockade because of the potential for interactions with other drugs, 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 non-insulin 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 drugs affect the lipid profile adversely, although the long-term clinical significance of this change is unknown and the effect appears to be less for drugs with intrinsic sympathomimetic activity.

Phaeochromocytoma.

In patients with this condition, an alpha-blocking drug (e.g. phentolamine/phenoxybenzamine) should be administered 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 the long-term treatment with the beta-blocking drug, 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, serous 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 hepatic impairment.

No data available.

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 by the kidney may require dose adjustment in patients with renal failure.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

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 drugs 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 drugs.

Care should be taken when prescribing beta-blockers with antiarrhythmic drugs. Class I antiarrhythmic drugs (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 lidocaine (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 Noten (see Section 4.4 Special Warnings and Precautions for Use, Anaesthesia and the peri-operative period).

Digitalis/digitalis glycosides.

Digitalis/digitalis glycosides and beta-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 (epinephrine), may counteract the effects of beta blockers.

Prostaglandin synthetase inhibitors.

Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen and indometacin 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 pharmacological effects such as bradycardia in the foetus and newborn infant. During the final part of pregnancy and parturition, these drugs should therefore 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 intra-uterine 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 equal to or greater than 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 nursing 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)

Adverse effects reported in clinical trials of atenolol are mainly attributable to pharmacological actions. The adverse effects listed below have been observed in patients in clinical trials who have received dosages of about 100 mg per 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 effects.

More common adverse effects.

Gastrointestinal.

Gastrointestinal disturbances including indigestion, dry mouth, constipation.

Nervous system.

Fatigue, dizziness.

Respiratory.

Wheezing, bronchospasm (see Section 4.3 Contraindications).

Less common adverse effects.

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 rashes, 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.

Haemopoietic.

Thrombocytopenia, purpura. An increase in ANA (antinuclear antibodies) has been observed, however, the clinical relevance of this is not clear.

Serious or life-threatening adverse effects.

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

There have been no reports of overdosage to date with atenolol, but in overdosage with other beta-blockers, 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 microgram 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 (norepinephrine). 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 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Atenolol is a beta-adrenoreceptor antagonist 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 anti-anginal 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. Peak blood levels occur 2 to 4 hours after administration of a single 100 mg oral dose and vary between 0.4 and 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.

Atenolol is distributed throughout the body tissues.

Metabolism.

Less than 10% of a dose of atenolol is metabolised, the minor urinary metabolite identified being a hydroxylated derivative.
Plasma half-life, measured by blood level decay or urinary build up, varies from 7 to 9 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, that is control of raised blood pressure, lasts for at least 24 hours following a 50 mg oral dose.

Excretion.

The main route of elimination is renal excretion.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets contain the following inactive ingredients: colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, purified talc, maize starch, crospovidone, sodium starch glycollate, povidone, magnesium stearate, hydrogenated vegetable oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Container type.

PVC/PVDC/AL blister packs or polypropylene pails (bulk dispensing use only).

Pack sizes.

7, 10 or 30 tablets (blister packs); 11,940 or 59,700 tablets (pails).
Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

AUST R 46250 - Noten atenolol 50 mg tablet blister pack.
AUST R 306815 - Noten atenolol 50 mg tablet bulk pack.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Atenolol is structurally related to propranolol and differing from it by substitution on the aromatic ring. It is sparingly soluble in water, soluble in absolute ethanol, practically insoluble in ether.

Chemical structure.

Chemical name: 2-[4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide.
Molecular formula: C₁₄H₂₂N₂O₃.
Molecular weight: 266.3 g/mol.

CAS number.

29122-68-7.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

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Noten 50 mg