Consumer medicine information

Deralin

Propranolol hydrochloride

BRAND INFORMATION

Brand name

Deralin

Active ingredient

Propranolol hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Deralin.

SUMMARY CMI

DERALIN®

Consumer Medicine Information (CMI) summary

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

1. Why am I taking DERALIN?

DERALIN contains the active ingredient propranolol hydrochloride. DERALIN is used to treat or prevent a number of conditions, most of which are related to the heart. For more information, see Section 1. Why am I taking DERALIN? in the full CMI.

2. What should I know before I take DERALIN?

Do not take it if you have ever had an allergic reaction to propranolol hydrochloride 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 take DERALIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DERALIN 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 take DERALIN?

  • Take DERALIN as prescribed by your doctor. The dose depends on your condition and whether you are taking other medicines.

More instructions can be found in Section 4. How do I take DERALIN? in the full CMI.

5. What should I know while taking DERALIN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking DERALIN.
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking DERALIN.
  • Call your doctor straight away if you have a severe allergic reaction to foods, medicines or insect stings, feel light-headed, dizzy or faint, and this problem gets worse or continues, plan to have surgery (even at the dentist) that needs a general anaesthetic or become pregnant while taking DERALIN.
Things you should not do
  • Do not give DERALIN to anyone else even if they have the same condition as you.
  • Do not use DERALIN to treat any other complaints unless your doctor tells you to.
  • Do not stop taking DERALIN without checking with your doctor.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how DERALIN affects you.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
  • Alcohol may increase the effects of DERALIN.
Looking after your medicine
  • Store below 30°C in a cool, dry place away from young children.
  • Keep your medicine in the bottle until it is time to take them.

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

6. Are there any side effects?

Less serious side effects include: nausea (feeling sick), vomiting, loss of appetite, diarrhoea, stomach pain, flatulence, cold hands or feet, dizziness, tiredness, rash, flushing, hair loss, feeling tired, lethargic or lack of energy. Serious side effects include: depression, disturbed sleep, vivid dreams or nightmares, conjunctivitis, dry eyes, visual disturbances, trouble passing urine, unexplained bruising, mood changes, confusion, sexual problems, loss of hearing or slow heart beats. Very serious side effects include: extreme tiredness or breathlessness on mild exercise, wheezing, difficulty breathing or an asthma attack or fast, slow or irregular heart beats (palpitations). 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

DERALIN®

Active ingredient: propranolol hydrochloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I taking DERALIN?

DERALIN contains the active ingredient propranolol hydrochloride. DERALIN belongs to a group of medicines called beta-blockers. It works by affecting the body's response to some 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 also widens the blood vessels in the body, as well as helping the heart to beat more regularly.

DERALIN 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 heart beat or heart rhythm, including those caused by anxiety or an overactive thyroid gland
  • to treat essential tremor (shaking of head, chin, hands)
  • to treat phaeochromocytoma, a rare tumour of the adrenal gland (only when used in combination with another medicine)
  • to treat Fallot's Tetralogy, a congenital heart disease
  • to prevent migraine headaches

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

Your doctor may have prescribed DERALIN for another reason.

2. What should I know before I take DERALIN?

Warnings

Do not take DERALIN if you:

  • are allergic to propranolol hydrochloride, or any of the ingredients listed at the end of this leaflet.
  • are allergic to other similar medicines such as beta-blockers. Always check the ingredients to make sure you can take this medicine.
    Some of the symptoms of an allergic reaction may include:
  • wheezing or shortness of breath
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • rash, itching or hives on the skin
  • fast heart beat (palpitations)
  • extreme tiredness or breathlessness on mid exercise.

Taking DERALIN may make these conditions worse.

Check with your doctor if you:

  • have any of the following medical conditions, including
    - asthma or serious breathing problems
    - heart problems including angina
    - low blood pressure
    - problems with your circulation
    - diabetes or a history of low blood sugar
    - an overactive thyroid gland
    - liver problems
    - kidney problems
    - any medical condition affecting your blood vessels or circulation
  • take any medicines for any other condition
  • have allergies to any other medicines, food, preservatives or dyes
  • are fasting or have been fasting recently
  • plan to have surgery, including dental surgery, especially if it requires a general anaesthetic

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

Your doctor may want to take special care if you have any of these conditions.

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.

DERALIN should not be taken during pregnancy unless advised by your doctor.

This medicine like other medicines in its group have been associated with unwanted effects in the unborn or newborn baby.

Check with your doctor if you are breastfeeding or intend to breastfeed.

DERALIN should not be taken if you are breastfeeding unless advised by your doctor.

Like other beta-blocker medicines, your baby can take in DERALIN from the breast milk if you are breastfeeding. Breastfeeding is not recommended while taking DERALIN.

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 DERALIN and affect how it works, and some medicines may be affected by DERALIN These medicines include:

  • calcium channel blockers - medicines used to treat high blood pressure, angina and other heart conditions, such as verapamil, diltiazem, nifedipine
  • digoxin - a medicine used to treat heart failure
  • medicines for migraines such as ergotamine, dihydroergotamine, rizatriptan
  • medicines used to treat diabetes including insulin
  • warfarin - a medicine that stops blood clots
  • theophylline - a medicine used to treat asthma
  • rifampicin - a medicine used to treat tuberculosis
  • ibuprofen, indomethacin - medicine used to treat pain, arthritis or inflammation
  • cimetidine - a medicine used to treat reflux and stomach ulcers
  • chlorpromazine and thioridazine - medicines used to treat psychiatric disorders
  • adrenaline (epinephrine) - a medicine used in emergency situations

You may need to take different amounts of your medicines or take different medicine. Your doctor will advise you. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking DERALIN.

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

4. How do I take DERALIN?

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

If you do not understand the instructions on the bottle, ask your pharmacist.

How much to take

  • For high blood pressure:
    - The usual starting dose is one 40 mg tablet taken twice a day for one week.
    - The dose is then usually increased to between 120 mg to 320 mg daily.
    - If you are taking other medicines which lower blood pressure, your doctor may need to change the dose of them to obtain the best results for you.
  • For angina and tremor:
    - The usual dose is 40 mg taken two or three times a day.
  • To treat or prevent heart attack
    - The usual dose is 80 mg taken twice a day, often starting with 40 mg taken four times a day for 2 or 3 days.
  • For migraine prevention
    - Adults: The usual dose is 40 mg 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 10 mg taken once or twice daily. This can be increased if necessary.
  • Other conditions
    - Your doctor will tell you what dose to take.
    - Your doctor may tell you to take a different amount of DERALIN to the one given in this leaflet.
    - Follow your doctors' instructions carefully until your doctor tells you to stop.

How to take DERALIN

  • Swallow the tablets with a glass of water.

When to take DERALIN

  • DERALIN should be taken regularly at the same time each day.
  • DERALIN can be taken with or without food.

How long to take DERALIN for

  • Keep taking DERALIN for as long as your doctor recommends. Do not stop taking DERALIN, or lower the dose, without checking with your doctor.

If you forget to take DERALIN

If it is almost time for 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 tablets as 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 have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much DERALIN

If you think that you or anyone else has taken too much DERALIN, urgent medical attention may be needed.

DERALIN is severely toxic if you take too much. If you take too much DERALIN, you may have difficulty breathing, light-headedness or dizziness, feeling very tired, fits, have a slow heart beat, or coma.

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 taking DERALIN?

Things you should do

  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking DERALIN.
  • Tell any doctors, dentists, and pharmacists who are treating you that you are taking this medicine.
  • Since DERALIN is meant to be taken regularly every day, keep a continuous supply of medicine so you don't run out, especially over weekends or on holidays.

Call your doctor straight away if you:

  • have a severe allergic reaction to foods, medicines or insect stings.
    - If you have a history of allergies, there is a chance that DERALIN may cause allergic reactions to be worse and harder to treat.
  • feel light-headed, dizzy or faint, and this problem gets worse or continues.
    - You may feel light-headed, dizzy or faint when you begin to take DERALIN.
    - Get up slowly when getting out of bed or standing up. 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.
  • plan to have surgery (even at the dentist) that needs a general anaesthetic.
    - Your blood pressure may drop suddenly if DERALIN interacts with the anaesthetic.
  • become pregnant while taking DERALIN.
  • have diabetes and notice any blood sugar level changes
    - DERALIN may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar (hypoglycaemia) such as increased heart rate.
    - DERALIN may prolong the blood glucose lowering effect of your diabetic medicine or increase the time your body takes to recover from low blood sugar. Your doses of diabetic medicines, including insulin, may need to change.
  • do not have diabetes and notice a low blood sugar (hypoglycaemia)
    - These may include the newly born, toddlers, children, elderly, patients suffering from overdose, patients suffering from chronic liver disease, fasting patients or patients on haemodialysis.

Remind any doctor, dentist or pharmacist you visit that you are taking DERALIN.

Visit your doctor regularly so they can check on your progress.

Things you should not do

  • Do not give DERALIN to anyone else even if they have the same condition as you.
  • Do not take DERALIN to treat any other complaints unless your doctor tells you to.
  • Do not stop taking DERALIN without checking with your doctor.
    - Stopping DERALIN suddenly may worsen your angina or cause other heart complications to occur. Your doctor will tell you how to gradually reduce the amount of DERALIN you are taking before stopping completely. This may help reduce the possibility of your condition getting worse.

Driving or using machines

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

DERALIN may cause dizziness light-headedness, tiredness, or drowsiness in some people. Make sure you know how you react to DERALIN before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the effects of DERALIN. Dizziness or light-headedness may be worse.

Things to be careful of

Make sure you drink enough water in hot weather and during exercise, especially if you sweat a lot.

If you do not drink enough water while taking DERALIN, you may feel faint, lightheaded or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.

Dress warmly during cold weather, especially if you will be outside for a long time (for example when playing winter sports).

DERALIN, like other beta-blocker medicines tend to make you more sensitive to cold temperatures, especially if you have circulation problems.

Looking after your medicine

  • Keep your tablets in the bottle until it is time to take them.
  • Store below 30°C.

Follow the instructions on the bottle 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.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

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

Getting rid of any unwanted medicine

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

Do not take this medicine after the expiry date or if the packaging shows signs of tampering or the tablets do not look quite right.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DERALIN, even if you do not think that it is connected with the medicine.

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 effectsWhat to do
Gut-related:
  • nausea (feeling sick), vomiting
  • loss of appetite
  • diarrhoea, stomach pain, flatulence
Other:
  • cold hands or feet
  • dizziness, tiredness
  • rash, flushing
  • hair loss
  • feeling tired, lethargic, lack of energy
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Head-related:
  • depression
  • disturbed sleep, vivid dreams or nightmares
  • visual disturbances
  • mood changes, confusion
  • loss of hearing
Other:
  • unexplained bruising
  • sexual problems
  • conjunctivitis, dry eyes
  • trouble passing urine
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very serious side effectsWhat to do
Allergic reaction-related:
  • extreme tiredness or breathlessness on mid exercise, which may occur together with swelling of feet or legs due to fluid build-up
  • chest tightness, wheezing, difficulty breathing or an asthma attack
  • fast, slow or irregular heart beats (palpitations)
  • any type of skin rash
  • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing
Stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital.

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

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

Reporting side effects

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

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

7. Product details

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

DERALIN is not addictive.

What DERALIN contains

Active ingredient
(main ingredient)		propanol hydrochloride
Other ingredients
(inactive ingredients)
  • calcium carbonate
  • croscarmellose sodium
  • gelatin
  • pregelatinised maize starch
  • magnesium stearate
  • Opadry Red OY-7601
Potential allergenssulfites

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

What DERALIN looks like

DERALIN comes in 10 mg, 40 mg and 160 mg tablet strengths.

DERALIN 10 mg: round red tablet marked "PP/10" on one side and "G" on the other.

Each bottle contains 100 tablets.

AUST R 17612

DERALIN 40 mg: round red tablet marked "PP/40" on one side and "G" on the other.

Each bottle contains 100 tablets.

AUST R 17614

DERALIN 160 mg: round red tablet marked "PP/160" on one side and "G" on the other.

Each bottle contains 50 tablets.

AUST R 17613

Who distributes DERALIN

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 July 2024.

DERALIN® is a Viatris company trade mark

DERALIN_cmi\Jul24/00

Published by MIMS September 2024

BRAND INFORMATION

Brand name

Deralin

Active ingredient

Propranolol hydrochloride

Schedule

S4

 

1 Name of Medicine

Propranolol hydrochloride.

2 Qualitative and Quantitative Composition

Each Deralin tablet contains 10 mg, 40 mg or 160 mg of propranolol hydrochloride as the active ingredient.

Excipients of known effect.

Sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Deralin 10 tablet: red film coated, marked PP/10 on one side, G on reverse.
Deralin 40 tablet: red film coated, marked PP/40 on one side, G on reverse.
Deralin 160 tablet: red film coated, marked PP/160 on one side, G on reverse.

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 (epinephrine) 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.

Deralin tablets may be taken before or after food.

Adults.

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 to 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 to 160 mg/day and in angina 120 to 320 mg/day.

Migraine.

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

Note.

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.

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

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

Phaeochromocytoma.

The patient must always receive concurrent α-receptor blockade.
Preoperative: 60 mg daily in divided doses for three days.
Maintenance: 30 mg daily 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.

Children.

The dose of Deralin 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 to 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 shutdown. 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 three or four times daily as required.

Migraine.

Commence with 10 mg once or twice daily and increase as required up to 2 mg/kg bodyweight per 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.

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 relationship 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 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, Deralin 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 to 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 perioperative 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 Deralin 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.

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 dosage may be reduced.

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 lidocaine (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 (epinephrine) used to treat the allergic reaction.

Lidocaine (lignocaine).

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

Hypoglycaemia.

Propranolol may block/ modify the signs and symptoms of hypoglycaemia (especially tachycardia). Propranolol occasionally causes hypoglycaemia, even in nondiabetic 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 Deralin and hypoglycaemic therapy in diabetic patients (see Section 4.4 Special Warnings and Precautions for Use, Diabetes; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy). Propranolol may prolong the hypoglycaemic response to insulin.

Anaesthesia and the perioperative period.

β-Blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the postoperative period. It is currently recommended that maintenance 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 noninsulin 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.

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 α-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 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 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 honey 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.

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 if hepatic encephalopathy.

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.

Digitalis glycosides, in association with β-blockers, may increase atrioventricular conduction time.

Sympathomimetic agents.

Concomitant use of sympathomimetic agents e.g. adrenaline (epinephrine), may counteract the effects of β-blockers. Caution must be exercised in the parenteral administration of preparations containing adrenaline (epinephrine) to patients taking β-adrenoreceptor blocking drugs as, in rare cases, vasoconstriction, hypertension and bradycardia may result.

Hypoglycaemics.

Propranolol modifies the tachycardia of hypoglycaemia. Caution should be exercised in the concurrent use of propranolol and hypoglycaemic therapy in diabetic patients. Deralin may prolong the hypoglycaemic response to insulin (see Section 4.4 Special Warnings and Precautions for Use).

Rizatriptan.

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.

Cimetidine, hydralazine and alcohol.

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.

Ergot alkaloids.

Care should be taken when using propranolol with ergotamine, dihydroergotamine, or related compounds, since vasospastic reactions have been reported in a few patients.

Prostaglandin synthetase inhibiting drugs.

Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen and indometacin, may decrease the hypotensive effects of β-blockers.

Chlorpromazine.

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.

Other.

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 judgment. Also see Section 4.4 Special Warnings and Precautions for Use above concerning the concomitant therapy with dihydropyridine calcium antagonists.
Also see Section 4.4 Special Warnings and Precautions for Use for calcium antagonists, antiarrhythmic drugs, lidocaine (lignocaine), anaesthesia and the perioperative period, catecholamine depleting agents and clonidine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Deralin should not be given during pregnancy unless its use is essential. β-Blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries.
Perinatal complications, such as a small placenta and intrauterine 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 postnatal period.
There is no evidence of teratogenicity with propranolol hydrochloride.
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. Breastfeeding 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 are: gastrointestinal disturbances (anorexia, nausea, vomiting, diarrhoea, abdominal pain); congestive heart failure; dizziness; bronchospasm. Rare cases of thrombocytopenia and purpura have been reported. Bradycardia and 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. These cases are uncommon, but when they do occur, it may be 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 reported.

Gastrointestinal.

Gastrointestinal disturbances, such as 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 antidiabetic therapy, patients with prolonged fasting and patients with chronic liver have been reported (see Section 4.3 Contraindications; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
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.

Haematopoietic.

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; 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 Deralin should be considered if, according to clinical judgment, the wellbeing 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 www.tga.gov.au/reporting-problems.

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.

Symptoms.

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.

Treatment.

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.

Note.

Activated charcoal may reduce absorption of the drug if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

Bradycardia.

Excessive bradycardia can be countered with atropine 1 to 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 to 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 micrograms initially) or orciprenaline (0.5 mg), may be given by slow intravenous injection.

Cardiac failure.

Digitalisation and diuretics.

Hypotension.

Vasopressors, e.g. noradrenaline (norepinephrine) or adrenaline (epinephrine) (there is evidence that adrenaline (epinephrine) 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 nonselectively on β-receptors (β1 and β2). It has little intrinsic sympathomimetic activity. It has some membrane stabilising effect.
Chemically, it 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 raised 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 antianginal 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.

Bioavailability.

In general, the peak blood level occurs between 1 and 3 hours after the dose, 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 to 6 hours, determined by clearance and plasma binding.

Distribution.

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

Protein binding.

Approximately 93% is plasma bound in humans.

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

Half-life.

The plasma half-life of oral propranolol is of the order of 3 to 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets contain the following inactive ingredients: calcium carbonate, croscarmellose sodium, gelatin, magnesium stearate, Opadry Red OY-7601 (Proprietary Ingredient Number: 1349) and pregelatinized maize starch.

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 30°C.

6.5 Nature and Contents of Container

Container type: bottle (HDPE).
Pack sizes: 30 (40 mg), 50 (160 mg), 90, 100 (10 mg and 40 mg) and 500 (10 mg and 40 mg) film coated tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 17612 - Deralin 10 Propranolol hydrochloride 10 mg tablet bottle.
AUST R 17614 - Deralin 40 Propranolol hydrochloride 40 mg tablet bottle.
AUST R 17613 - Deralin 160 Propranolol hydrochloride 160 mg tablet bottle.

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

Chemical structure.

Propranolol hydrochloride is a white or almost white powder; odourless or almost odourless. Propranolol is soluble in 20 parts of water and in 20 parts of ethanol (96%); 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 name: (2RS)-1-[(1-methylethyl) amino]-3-(naphthalen-1-yloxy) propan-2-ol hydrochloride.
Molecular formula: C16H21NO2,HCl.
Molecular weight: 295.8.

CAS number.

318-98-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes