Consumer medicine information

APO-Propranolol Tablets

Propranolol hydrochloride

BRAND INFORMATION

Brand name

APO-Propranolol

Active ingredient

Propranolol hydrochloride

Schedule

What is in this leaflet

This leaflet answers some common questions about propranolol. 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 risks of you using 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 want to read it again.

What this medicine is used for

Propranolol is used to treat or prevent a number of conditions, most of which are related to the heart:

to lower high blood pressure, also called hypertension
to prevent angina
to treat or prevent heart attacks, or reduce your risk of heart problems following a heart attack
to treat irregularities in heartbeat, including those caused by anxiety
essential tremor (shaking of head, chin, hands)
phaeochromocytoma
Fallot's Tetralogy
to prevent migraine headaches

Propranolol belongs to a group of medicines called beta-blockers.

How it works

Propranolol works by affecting the body's response to some nerve impulses, especially in the heart. This decreases the heart's need for blood and oxygen, which reduces the amount of work the heart must do. Propranolol also widens the blood vessels in the body and helps the heart to beat more regularly.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

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

This medicine is not addictive.

There is not enough information to recommend the use of this medicine in children under 7 years of age.

Before you take this medicine

When you must not take it

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

propranolol hydrochloride
any of the ingredients listed at the end of this leaflet.
Any other similar medicines such as beta-blockers

Some of the symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin.
Fast heart beats (palpitations)
Extreme tiredness or breathlessness and mild exercise

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

heart failure or an enlarged heart
problems with heart rhythm or a slow heartbeat
second and third degree atrioventricular block
low blood pressure (also known as hypotension)
blood circulation problems
Prinzmetal's angina
asthma or severe breathing problems
low blood sugar levels

Taking propranolol may make these conditions worse.

Do not take this medicine if you are pregnant or plan to become pregnant or are breastfeeding. Propranolol may affect your developing baby if you take it during pregnancy. It may also pass into breast milk. Your doctor can discuss with you the risks involved.

Do not take this medicine after the expiry date printed on the pack or 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 of the following medical conditions:

asthma or serious breathing problems
heart problems
low blood pressure
problems with your circulation
diabetes or low blood sugar
an overactive thyroid gland
liver problems
kidney problems

Tell your doctor if you are fasting or have been fasting recently. Propranolol may cover up some of the symptoms of low blood sugar, such as an increased heart rate.

Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic. When combined with anaesthetics, propranolol may cause a sudden drop in blood pressure.

If you have not told your doctor about any of the above, tell them before you start taking propranolol.

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 propranolol may interfere with each other. These include:

calcium channel blockers and beta blockers, medicines used to treat heart conditions
medicines used for heart rhythm problems (e.g. lignocaine, disopyramide, amiodarone, flecainide)
digoxin, a medicine used to treat heart failure
clonidine, a medicine used to treat high blood pressure
medicines used to treat migraine (e.g. rizatriptan)
medicines for diabetes
warfarin, a medicine that stops blood clots
theophylline, a medicine used to treat asthma
rifampicin, a medicine used to treat tuberculosis
ibuprofen and indomethacin, medicines used to treat pain and inflammation
cimetidine, a medicine used to treat ulcers
chlorpromazine, a medicine used to treat psychotic illnesses

These medicines may affect the way propranolol works or may be affected by propranolol. You may need to use different amounts of your medicines or take different medicines.

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

Other medicines not listed above may also interact with this medicine.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

If you are taking other medicines which lower blood pressure, your doctor may need change the dose of them to obtain the best results for you.

For high blood pressure

The usual starting dose is one 40 mg tablet taken twice a day.

After one week, the dose may be increased to between 120 mg to 320 mg daily.

For angina and tremor

The usual starting dose is one 40 mg tablet taken two to three times a day.

To treat or prevent heart attack

The usual dose is 80 mg taken twice a day, often starting with one 40 mg tablet taken four times a day for 2 or 3 days.

For migraine prevention

Adults
The usual dose is one 40 mg tablet taken twice a day. This may need to be increased up to 80 mg twice a day.

Children over 7 years
The starting dose is one 10 mg tablet taken once or twice daily. This can be increased if necessary.

How to take it

Swallow the tablet whole with a full glass of water.

When to take it

Take this 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.

It does not matter if you take propranolol with or without food.

How long to take it for

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

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose (within 6 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.

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

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

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Propranolol is severely toxic if you take too much.

Signs of an overdose may include difficulty in breathing, light headedness or dizziness, feeling very tired, fits, slow heart beat or coma.

While you are taking this medicine

Things you must do

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

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you have a severe allergic reaction to foods, medicines, or insect stings, tell your doctor immediately. If you have a history of allergies, there is a chance that propranolol may cause allergic reactions to be worse and harder to treat.

If you become pregnant whilst taking propranolol, tell your doctor immediately.

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 when you begin to take propranolol.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem gets worse or continues, talk to your doctor.

If you are going to have surgery, tell the surgeon and anaesthetist that you are taking propranolol. Your blood pressure may drop suddenly due to propranolol interacting with the anaesthetic.

If you are being treated for diabetes, make sure you check your blood sugar level regularly and report any changes to your doctor. Propranolol may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar (hypoglycaemia) such as an increased heart rate. It may also increase the time your body takes to recover from low blood sugar. Your doses of diabetic medicines, including insulin, may need to change.

Propranolol may also occasionally cause low blood sugar (hypoglycaemia) in non-diabetic patients. This may include newborn infants, toddlers, children, elderly, patients suffering from overdose, patients suffering from chronic liver disease, fasting patients or patients on haemodialysis.

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

Things you must not do

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

Do not take your medicine to treat any other complaints unless your doctor tells you to.

Do not stop taking your medicine or change the dosage without first checking with your doctor. Your doctor may want you to gradually reduce the amount of propranolol you are taking before stopping completely. This may help reduce the possibility of your condition getting worse.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you. Propranolol may cause dizziness, light-headedness, tiredness, or drowsiness in some people. Make sure you know how you react to this medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

Be careful when drinking alcohol while you are taking propranolol. Dizziness or light-headedness may be worse. Alcohol can also increase the effects of propranolol.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem gets worse or continues, talk to your doctor.

Dress warmly during cold weather, especially if you will be outside for a long time (for example when playing winter sports). Propranolol, like other beta-blocker medicines, may make you more sensitive to cold temperatures, especially if you have circulation problems.

Side effects

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

Propranolol helps most people but may have unwanted side effects in a few people. 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:

nausea (feeling sick) or vomiting
loss of appetite
diarrhoea, stomach pain, flatulence
cold hands or feet
dizziness, tiredness
rash, flushing
hair loss
feeling tired, lethargic, lack of energy

The above list contains the more common side effects of propranolol.

Tell your doctor as soon as possible if you notice any of the following.

disturbed sleep, vivid dreams or nightmares
conjunctivitis, dry eyes, visual disturbances
trouble passing urine
unexplained bruising
mood changes, confusion
sexual problems
loss of hearing
slow heart beats

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

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

extreme tiredness or breathlessness on mild exercise
wheezing, difficulty breathing or an asthma attack
fast heart beats (palpitations)
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin (signs of an allergic reaction)

The above list contains very serious side effects. You may need urgent medical attention or hospitalisation.

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

Storage and disposal

Storage

Keep the tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your medicine away from direct sunlight and in a cool dry place, where the temperature stays below 25°C.

Do not store your medicine 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

10 mg tablet
Orange coloured, round, biconvex tablets, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.

Bottles of 100 tablets.

AUST R 222958.

40 mg tablet
Green coloured, round, biconvex tablets, embossed with "P" and "40" on either side of the breakline on one side and plain on the other side.

Bottles of 100 tablets. AUST R 222969.

* Not all strengths may be available.

Ingredients

Each tablet contains 10 mg or 40 mg propranolol hydrochloride as the active ingredient.

It also contains the following:

lactose monohydrate
maize starch
sunset yellow FCF aluminium lake
quinoline yellow
povidone
sodium starch glycollate
magnesium stearate
brilliant blue FCF aluminium lake (40 mg only)

This medicine does not contain gluten, sucrose, tartrazine and other azo dyes.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in September 2023.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

APO-Propranolol

Active ingredient

Propranolol hydrochloride

Schedule

1 Name of Medicine

Propranolol hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains propranolol hydrochloride as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, sunset yellow FCF aluminium lake, quinoline yellow, povidone, sodium starch glycollate, magnesium stearate and brilliant blue FCF aluminium lake (40 mg only).

Excipients with known effect.

Sugars (as lactose monohydrate).

10 mg tablets.

Each tablet contains 10 mg of propranolol hydrochloride.
Orange coloured, round, biconvex tablets, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.

40 mg tablets.

Each tablet contains 40 mg of propranolol hydrochloride.
Green coloured, round, biconvex tablets, embossed with "P" and "40" on either side of the breakline on one side and plain on the other side.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

Angina pectoris.
Hypertension.
Prevention of migraine.
Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias; dysrhythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias (e.g. tachycardia due to digitalis or adrenaline overdosage).
Essential tremor, including familial and senile tremor.
Phaeochromocytoma (only with concurrent α-receptor blockade).
Hypertrophic subaortic stenosis.
Suspected or definite myocardial infarction.
Fallot's tetralogy.

4.2 Dose and Method of Administration

Note.

Tablets may be taken before or after food.

Adult.

Hypertension.

The standard starting dose is 40 mg twice daily, increasing by the same amount at weekly intervals according to patient response. An adequate response is usually seen in the range 120-320 mg/day. Although higher doses may be required, and have been used, the value and safety of doses exceeding 320 mg/day have not been established.

Angina pectoris and essential tremor.

40 mg two or three times daily, increasing by the same amount at weekly intervals according to patient response. An adequate response in essential tremor is usually seen in the range 80-160 mg/day and in angina 120-320 mg/day.

Migraine.

The standard starting dose is 40 mg twice daily. If a response occurs, this is usually in the range 80-160 mg/day and should be evident within three months.

Cardiac dysrhythmias, anxiety tachycardia, dysrhythmias associated with thyrotoxicosis and hypertrophic subaortic stenosis.

Most patients respond within the dosage range of 10-40 mg three or four times a day.

Phaeochromocytoma.

The patient must always receive concurrent alpha-receptor blockade.
Preoperative: 60 mg/day propranolol in divided doses for three days.
Maintenance: 30 mg/day propranolol in divided doses.

Myocardial infarction.

Treatment should start with 40 mg four times a day for 2 or 3 days. In order to improve compliance, the total daily dosage may then be given as 80 mg twice a day.

Paediatric.

The dose of propranolol should always be determined according to the cardiac status of the patient and the circumstances necessitating treatment. The doses given below are intended only as a guide.

Cardiac dysrhythmias, phaeochromocytoma, thyrotoxicosis.

0.25-0.5 mg/kg three or four times daily as required.

Fallot's tetralogy.

The value of propranolol in this condition is confined mainly to the relief of right ventricular outflow tract shut-down. It is also useful for treatment of associated dysrhythmias and angina. Dosage should be individually determined according to circumstances and the following is only a guide.
Up to 1 mg/kg repeated 3 or 4 times daily as required.

Migraine.

Commence with 10 mg once or twice daily and increase as required up to 2 mg/kg bodyweight/day in divided doses. If a response is to occur it should be evident in three months. There is no experience in children under the age of seven years.

Note.

With both children and adults in the treatment of migraine, if the attack frequency is reduced significantly, consideration may be given to gradually ceasing therapy as remission may be sustained in a proportion of patients.

Elderly.

Evidence concerning the relation between blood levels and age is conflicting. With regard to the elderly, the optimum dose should be individually determined according to clinical response.

4.3 Contraindications

Cardiovascular.

Congestive heart failure.
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.
Hypotension.
Severe peripheral arterial circulatory disturbances.
Prinzmetal's angina.

Hypoglycaemia, prolonged fasting and metabolic acidosis.

Propranolol must not be used in patients prone to hypoglycaemia, i.e. patients after prolonged fasting or patients with restricted counter regulatory reserves (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
In metabolic acidosis (e.g. in diabetes), the premonitory signs of hypoglycaemia may be masked in patients receiving hypoglycaemic agents.

Asthma/bronchospasm.

β-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 β-blockers are contraindicated in any patient with a history of bronchial asthma, airways obstruction or a tendency to bronchospasm. Use of cardioselective β-blockers can also result in severe bronchospasm. If such therapy must be used, great caution should be exercised. Alternative therapy should be considered.

Other.

Allergic disorders (including allergic rhinitis) which may suggest a predisposition to asthma or bronchospasm.
Shock (including cardiogenic and hypovolaemic shock).
Hypersensitivity to the drug.
Anaesthesia with agents that produce myocardial depression (e.g. ether, chloroform).
Untreated phaeochromocytoma.

4.4 Special Warnings and Precautions for Use

Asthma/bronchospasm.

β-adrenergic blockade of the smooth muscle of bronchi and bronchioles results in an increased airways resistance. This may be dangerous in susceptible patients and associated sometimes with a fatal outcome (see Section 4.3 Contraindications).

Cardiac failure.

β-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, the β-blocker 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 β-blockers, there is a growing literature on the experimental use of β-adrenergic blocking drugs in heart failure. As further trials are needed to identify which patients are most likely to respond to which drugs β-blockers should not normally be prescribed for heart failure outside of specialist centres.

Abrupt withdrawal of therapy.

Care should be taken if β-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 β-blockade in patients with ischaemic heart disease. Therefore, it is recommended that the dosage be reduced gradually over a period of about 8-14 days during which time the patient's progress should be assessed. 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, β-blockers should not be withdrawn, unless indicated.
Patients with angina should be warned against abrupt withdrawal of the drug and the need to ensure that supplies do not run out.

Concomitant therapy with calcium antagonists.

The concomitant use of β-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 β-blockers. If excessive hypotension develops, the calcium antagonist should be stopped or the dosage reduced.

First degree heart block.

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

Peripheral circulation.

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

Antiarrhythmic drugs.

Care should be taken when prescribing β-blockers with antiarrhythmic drugs. Interactions have been reported during concomitant β-blocker therapy with the Class IA agents disopyramide, and less frequently quinidine; Class IB agents, mexiletine and lignocaine; Class IC agent flecainide, the Class III agent, amiodarone; and the Class IV antiarrhythmic agents.

Prinzmetal angina.

There is a risk of exacerbating coronary artery spasm if patients with Prinzmetal or variant angina are treated with a β-blocker. If this treatment is essential, it should only be undertaken in a Coronary or Intensive Care Unit.

Euthyroid hyperthyroxinaemia.

The effects of β-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.

History of anaphylactic reaction.

While taking β-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 used to treat the allergic reaction.

Lignocaine.

Administration of propranolol during infusion of lignocaine may increase the plasma concentration of lignocaine by about 30%. Patients already receiving propranolol tend to have higher lignocaine levels than controls. The combination should be avoided.

Heart rate.

One of the pharmacological actions of β-adrenoreceptor blocking medicines is to reduce heart rate. In the rare instance when symptoms may be attributable to the slow heart rate, the dose may be reduced.

Hypoglycaemia.

Propranolol may block/modify the signs and symptoms of hypoglycaemia (especially tachycardia). Propranolol occasional causes hypoglycaemia, even in non-diabetic patients e.g. neonates, infants, children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. Severe hypoglycaemia associated with propranolol has rarely presented with seizures and/or coma in isolated patients. Caution must be exercised in the concurrent use of Propranolol and hypoglycaemic therapy in diabetic patients (see Section 4.4 Special Warnings and Precautions for Use, Diabetes; Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Propranolol may prolong the hypoglycaemic response to insulin.

Anaesthesia and the peri-operative period.

β-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 β-blockade be continued perioperatively. The anaesthetist must be made aware of β-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 well tolerated, although older agents (ether, methoxyflurane) were sometimes associated with severe circulatory depression in the presence of β-blockade.

Diabetes.

β-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, β-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia (see Section 4.4 Special Warnings and Precautions for Use, Hypoglycaemia; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). The dose of insulin or oral hypoglycaemic agent may need adjustment.

Other metabolic effects.

β-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.

Decompensated cirrhosis.

Propranolol hydrochloride should be used with caution in decompensated cirrhosis.

Portal hypertension.

In patients with portal hypertension, liver function will deteriorate and hepatic encephalopathy may develop. Propranolol may increase the risk of hepatic encephalopathy.

Use of catecholamine-depleting agents.

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

Clonidine.

Concurrent use of β-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 β-blocker. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped.

Phaeochromocytoma.

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

Eye and skin reactions.

Various skin rashes and conjunctival xerosis have been reported with β-blockers. Cross-reactions may occur between β-blockers, therefore, substitutions within the group may not necessarily preclude occurrence of symptoms.
During the long-term treatment with the β-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 oculo-mucocutaneous 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 β-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 β-blockers has been suggested but is not proven.

Allergic conditions.

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

Hyperthyroidism.

Because β-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 β-blockers.

Use in hepatic impairment.

Since the half-life may be increased in patients with significant hepatic impairment, care should be taken when starting treatment and selecting the initial dose.

Use in renal impairment.

Since the half-life may be increased in patients with significant renal impairment, caution must be exercised when starting treatment and selecting the initial dose. In patients with severe renal disease, haemodynamic changes following β-blockade may impair renal function further. β-blockers which are excreted mainly by the kidney may require dose adjustment in patients with renal failure.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Digitalis glycosides, in association with β-blockers, may increase atrioventricular conduction time.
Concomitant use of sympathomimetic agents (e.g. adrenaline), may counteract the effects of β-blockers. Caution must be exercised in the parenteral administration of preparations containing adrenaline to patients taking β-adrenoreceptor blocking drugs as, in rare cases, vasoconstriction, hypertension and bradycardia may result.
Propranolol modifies the tachycardia of hypoglycaemia. Caution should be exercised in the concurrent use of propranolol and hypoglycaemic therapy in diabetic patients. Propranolol may prolong the hypoglycaemic response to insulin (see Section 4.4 Special Warnings and Precautions for Use, Hypoglycaemia).
Simultaneous administration of rizatriptan and propranolol can cause an increase in rizatriptan plasma concentrations. The increased rizatriptan exposure is presumed to be caused by inhibition of first-passage metabolism of rizatriptan through inhibition of monoamine oxidase-A. If both drugs are to be used, a rizatriptan dose of 5 mg has been recommended.
Concomitant use of cimetidine or hydralazine will increase plasma levels of propranolol and concomitant use of alcohol may also increase the plasma levels of propranolol.
Care should be taken when using propranolol with ergotamine, dihydroergotamine or related compounds, since vasospastic reactions have been reported in a few patients.
Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen and indomethacin, may decrease the hypotensive effects of β-blockers.
The concomitant administration of propranolol and chlorpromazine may result in an increase in plasma levels of both drugs. This may lead to an enhanced antipsychotic effect for chlorpromazine and an increased antihypertensive effect for propranolol.
Pharmacokinetic studies have shown that the following agents may interact with propranolol due to effects on enzyme systems in the liver which metabolise propranolol and these agents: quinidine, rifampicin, theophylline, warfarin, thioridazine and dihydropyridine calcium channel blockers such as nifedipine, nisoldipine, and isradipine. Owing to the fact that blood concentrations of either agent may be affected dosage adjustments may be needed according to clinical judgement. See Section 4.4 Special Warnings and Precautions for Use, Concomitant therapy with calcium antagonists concerning the concomitant therapy with dihydropyridine calcium antagonists.
See also entries in Section 4.4 Special Warnings and Precautions for Use for calcium antagonists, antiarrhythmic drugs, lignocaine, anaesthesia and peri-operative period, catecholamine-depleting agents and clonidine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Propranolol should not be given during pregnancy unless its use is essential. β-blockers reduce placental perfusion, which may result in intra-uterine foetal death, immature and premature deliveries.
Perinatal complications, such as a small placenta and intra-uterine growth retardation, have been reported in a few cases where the mother took propranolol hydrochloride during pregnancy. Some infants born to mothers treated with propranolol hydrochloride were reported to have hypoglycaemia and/or bradycardia. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period.
β-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.
Most β-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breast feeding is therefore not recommended following administration of these compounds.

4.7 Effects on Ability to Drive and Use Machines

Use is unlikely to adversely affect the ability of patients to drive or operate machinery. When driving vehicles or operating machinery, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Adverse Effects (Undesirable Effects)

Propranolol hydrochloride is usually well tolerated and side effects are transient in nature, rarely necessitating withdrawal of treatment. The most serious adverse reactions encountered are congestive heart failure and bronchospasm in susceptible patients (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
Common adverse reactions include fatigue and/or lassitude (often transient), bradycardia, cold extremities and exacerbation of Raynaud's phenomenon, sleep disturbances including vivid dreams/nightmares. Other less frequently reported adverse reactions include: gastrointestinal disturbances (anorexia, nausea, vomiting, diarrhoea, abdominal pain), congestive heart failure, dizziness, bronchospasm. Rare cases of thrombocytopenia and purpura have been reported. CNS symptoms including mood changes and hallucinations have been reported rarely.
Reported adverse reactions according to organ systems are recorded below.

Cardiovascular.

Occasionally a patient may react to small doses and bradycardia and hypotension may develop with subjective dizziness or weakness. In such patients treatment should be discontinued. If this occurs it is advisable to regard such hypersensitivity as idiosyncratic and to try some other form of treatment. Alternatively, the drug may be reintroduced at a lower dosage level and the dose increased more slowly. Propranolol hydrochloride may exacerbate intermittent claudication in patients with peripheral vascular disease. There have also been some reports of paraesthesia of the hands or of coldness of the extremities in patients showing no signs of vascular disease.
Other cardiovascular adverse reactions reported include congestive heart failure, deterioration of previously controlled heart failure and intensification of A-V block. Propranolol hydrochloride may rarely cause heart block in susceptible patients. Rare cases of postural hypotension which may be associated with syncope have been recorded.

Gastrointestinal.

Gastrointestinal disturbances, including nausea, vomiting, flatulence and diarrhoea have been observed in some patients.

Endocrine.

Hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant anti-diabetic therapy, patients with prolonged fasting and patients with chronic liver have been reported (see Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Isolated reports of impotence have been recorded.

Central nervous system.

Lassitude, "muzziness", insomnia and visual disturbances have been reported in about 2% of patients but these complaints have been mild and are generally avoided by the gradual introduction of the drug. More serious side effects include severe nightmares and hallucinations. Psychiatric complications (depression, psychoses, psychotic reactions and acute confusional states) may occasionally occur but are unlikely to be severe. It would, however, be wise to restrict treatment in patients who have suffered previous depressive illness.

Respiratory.

Asthma/bronchospasm, laryngospasm and respiratory distress (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

Skin and eyes.

Isolated reports of purpura or erythematous rash have been received. Psoriasiform skin reactions and exacerbation of psoriasis have also been reported. Various other skin rashes and conjunctival xerosis have been reported with β-blocking agents, including propranolol hydrochloride. Such reactions may occur between β-blockers and substitution within the group may not necessarily preclude recurrence of symptoms.

Haemopoietic.

Reduction of platelet adhesiveness; thrombocytopenic purpura; nonthrombocytopenic purpura; agranulocytosis; eosinophilia. An increase in ANA (Antinuclear Antibodies) has been observed, however, the clinical relevance of this is not clear.

Miscellaneous.

Reduction or loss of libido; alopecia and rarely diminution and loss of hearing; tinnitus; visual disturbances; diminished vision; conjunctivitis; dry eyes; pharyngitis; fever combined with aching and sore throat; urinary retention associated with repeated bouts of paroxysmal tachycardia; flushing of the face. Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported.
Discontinuance of propranolol hydrochloride should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions. Cessation of therapy with a β-blocker should be gradual. In the rare event of intolerance, manifested as bradycardia and hypotension, the β-blocker should be withdrawn and, if necessary, treatment for overdosage instituted.

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 http://www.tga.gov.au/reporting-problems or contact Arrotex Medical Information enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has been taken.

Clinical features.

Cardiac.

Bradycardia, hypotension, and cardiogenic shock may develop. QRS complex prolongation, ventricular tachycardia, first to third degree AV block, ventricular fibrillation or asystole may also occur. Development of cardiovascular complications is more likely if other cardioactive drugs, especially calcium channel blockers, digoxin, cyclic antidepressants or neuroleptics have also been ingested.

CNS.

Drowsiness, seizures, and in severe cases coma may occur.

Other features.

Bronchospasm, hyperkalaemia and occasionally CNS-mediated respiratory depression may occur.

Management.

The common signs to be expected in overdosage are bradycardia, hypotension, bronchospasm or acute cardiac failure. If overdosage occurs, in all cases therapy with propranolol hydrochloride should be discontinued and the patient observed closely. In addition the following therapeutic measures are suggested:
General treatment should include: close supervision in a monitored environment (which may include treatment in an intensive care ward), the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of intravenous fluids to treat hypotension and shock.

Bradycardia.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously (incrementally in 0.6 mg doses) and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required this may be repeated or followed by an intravenous infusion of glucagon (1-10 mg/hour) depending on response. If no response to glucagon occurs or if glucagon is unavailable, a β-adrenoreceptor stimulant such as isoprenaline (25 microgram initially) or orciprenaline (0.5 mg) may be given by slow intravenous injection.

Cardiac failure.

Digitalisation and diuretics.

Hypotension.

Vasopressors e.g. noradrenaline or adrenaline. There is evidence that adrenaline is the drug of choice.

Bronchospasm.

Administer isoprenaline and aminophylline.
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.

Propranolol hydrochloride is a β-adrenoreceptor blocking agent which acts non-selectively on β-receptors (β₁ and β₂). It has little intrinsic sympathomimetic activity. It has some membrane stabilising effect. Propranolol is a racemic mixture and the active form is the S(-) isomer of propranolol. The most important effect of propranolol hydrochloride is to reduce the influence of excessive sympathetic nervous stimulation on the heart. Pulse rate, force of cardiac contraction and cardiac output are all reduced resulting in a significant reduction in myocardial oxygen demand, greater than the reduction in work. These effects, singly or in combination, are of therapeutic value in several cardiovascular diseases.
Propranolol hydrochloride reduces elevated blood pressure by an unknown mechanism. The drug also inhibits exercise-induced tachycardia and this effect is related to plasma concentration. No correlation has been found between the plasma concentration of propranolol and its antihypertensive effect.
The possible mechanism of the anti-anginal activity of propranolol hydrochloride appears to be due to a reduction in left ventricular work and oxygen utilisation resulting from inhibition of cardiac sympathetic nerve stimulation. Serotonin antagonism has been demonstrated with propranolol hydrochloride. The therapeutic benefit of this property in centrally mediated disorders is uncertain.
Propranolol hydrochloride, as with other β-adrenoreceptor blocking agents, has negative inotropic effects and is therefore contraindicated in congestive heart failure.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Studies with propranolol hydrochloride in humans indicate that it is almost completely absorbed from the intestine. A large part of the absorbed drug is lost to the systemic circulation due to the first pass metabolism in the liver. After repeated administration, the first pass removal process becomes saturated and, at steady state, the plasma concentration is proportional to the dose, although there is some variation between patients as to the blood levels achieved at a given dose. In addition, correlation of plasma level to therapeutic effect varies considerably with propranolol as with some other β-blockers. Blood level measurements show that after intravenous administration, the concentration in the circulation decreases rapidly due mainly to uptake by tissues generally.

Distribution.

Propranolol is absorbed from the circulation and is widely distributed throughout the body tissues.

Metabolism.

Propranolol is completely metabolised, primarily by the liver. Hydroxylation of the aromatic nucleus occurs with degradation of the isoprenaline side chain. Over 20 metabolites have been identified. One of these, the 4-hydroxy metabolite, found only after oral administration has β-adrenergic blocking properties.

Excretion.

Some 95-100% of a dose of propranolol hydrochloride is excreted as metabolites and their conjugates in the urine.

Bioavailability.

In general, the peak blood level occurs between 1-3 hours after oral administration, and will have an average value of 0.1 microgram/mL per 80 mg single dose. The peak blood level is proportional to the dose. With chronic administration the mean plasma half-life is from 3-6 hours, determined by clearance and plasma binding.
Following intravenous administration the plasma half-life of propranolol is about 2 hours and the ratio of metabolites to parent drug in the blood is lower than after oral administration. In particular, 4-hydroxypropranolol is not present after intravenous administration.

Protein binding.

Approximately 93% is plasma bound in humans.

Half-life.

The plasma half-life of oral propranolol is of the order of 3-6 hours. The pharmacological effect lasts much longer.

Clinical implications of pharmacokinetic data.

Propranolol hydrochloride has a variable bioavailability due to an avid hepatic binding mechanism. This first pass effect varies from individual to individual and will determine the drug plasma concentration. A good estimation of β-blockade and bioavailability can be clinically gauged by checking for reduction in standing or exercise heart rate. This also gives a simple guide to compliance.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

Teratogenicity.

There is no evidence of teratogenicity with propranolol hydrochloride.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

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.

6.5 Nature and Contents of Container

10 mg tablets.

Bottle pack (HDPE) of 100 tablets (AUST R 222958).

40 mg tablets.

Bottle pack (HDPE) of 100 tablets (AUST R 222969).

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Propranolol hydrochloride is an off-white to white crystalline solid with little or no odour. Propranolol hydrochloride dissolves in water to the extent of one part in twenty at 20°C and has a similar solubility in 95% ethanol, but is only slightly soluble in chloroform.
Propranolol is a β-adrenoreceptor blocking agent which is structurally related to other β-blocking agents such as atenolol, pindolol and oxprenolol, differing from these compounds by substitution on the aromatic ring.

Chemical structure.

Chemical Name: (2RS)-1-[(1-Methylethyl) amino]-3- (naphthalen-1-yloxy) propan-2-ol hydrochloride.
Molecular Formula: C₁₆H₂₁NO₂.HCl.
Molecular Weight: 295.8.

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