Consumer medicine information

Barbloc

Pindolol

BRAND INFORMATION

Brand name

Barbloc

Active ingredient

Pindolol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Barbloc.

What is in this leaflet

This leaflet answers some common questions about Barbloc.

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

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Barbloc against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Barbloc is used for

Barbloc is used to:

  • lower high blood pressure, also called hypertension
  • prevent angina
  • treat irregular heart beat (arrhythmia).

Hypertension
Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure.

Angina
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or neck and sometimes to the shoulders and back. This may be caused by too little blood and oxygen getting to the heart. The pain of angina is usually brought on by exercise or stress but it can also happen while you are resting. Barbloc helps to prevent angina from happening. It is not used to treat an attack of angina once it starts.

Irregular heart beat
Irregular heartbeat, also known as arrhythmia, means that there is a disturbance of the normal rhythm or beat of the heart. Arrhythmias may be caused by a number of factors, including some heart diseases, an overactive thyroid gland, or chemical imbalances. Barbloc helps to restore the normal rhythm of the heart.

Barbloc belongs to a group of medicines called beta-blockers. It works by affecting the body's response to certain nerve impulses, especially in the heart. As a result, it decreases the heart's need for blood and oxygen and reduces the amount of work that the heart has to do. It also widens the blood vessels in the rest of the body, causing blood pressure to fall. Barbloc also helps the heart to beat more regularly.

Barbloc can be used alone or in combination with other medicines to treat your condition.

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

Barbloc is not recommended for use in children, as there is not enough information on its effects in children.

Barbloc is available only with a doctor's prescription.

There is no evidence that Barbloc is addictive.

Before you take Barbloc

When you must not take it

Do not take Barbloc if you have an allergy to:

  • any medicines containing pindolol
  • any other beta-blocker medicine
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take Barbloc if you have any of the following health problems/medical conditions:

  • a history of bronchial asthma, wheezing or difficulty breathing, chronic cough or other severe lung problems
  • a history of allergic problems, including hay fever
  • irregular or a very slow heartbeat, less than 45 to 50 beats per minute
  • an alteration in the structure and function of the right ventricle of the heart caused by a primary disorder of respiratory system (called "Cor pulmonale")
  • sudden loss of consciousness in the past
  • chest pain, mainly occurring when at rest
  • severe heart disease or certain other heart conditions
  • severe blood flow disturbances of your blood vessels causing paleness or poor circulation in the arms and legs

too much acid in your blood (metabolic acidosis).Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you start to take it

Tell your doctor if you have allergies to honey bee or wasp stings, or to any other medicines, foods, preservatives or dyes. Your doctor will want to know if you are prone to allergies. Beta-blocker medicines can make an allergic reaction worse.

Tell your doctor if you have or have had any of the following health problems/medical conditions:

  • diabetes mellitus (sugar diabetes)
  • an overactive thyroid gland
  • severe kidney problems
  • certain types of angina such as Prinzmetal angina (also known as variant angina)
  • milder forms of circulatory disturbances of blood vessels (conditions marked e.g. by paleness, cold hands or feet)
  • phaeochromocytoma (a rare tumour of the adrenal gland) which is not being treated already with other medicines
  • psoriasis (a skin disease characterised by thickened patches of red skin, often with silvery scales)
  • shock or severely low blood pressure.

Tell your doctor if you are pregnant or plan to become pregnant. Barbloc may affect your baby, especially if you take it in the last stages of pregnancy. Your doctor will discuss the risks and benefits of taking Barbloc during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Very small amount of Barbloc passes into breast milk and could affect your baby.

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

Taking other medicines

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

Some medicines may be affected by Barbloc, or may affect how well it works. These include:

  • other beta-blocker medicines including eye drops
  • other medicines used to treat high blood pressure such as calcium channel blockers or calcium antagonists
  • clonidine, a medicine used to treat high blood pressure
  • disopyramide, quinidine, and other medicines used to treat irregular heart beat (arrhythmias)
  • insulin, and oral medicines to treat diabetes
  • medicines used to treat high blood pressure, chest pain (angina pectoris), disturbances of heart rhythm
  • digoxin, a medicine used to treat heart failure
  • digitalis glycosides
  • medicines commonly used during surgery or in emergency situations, such as dopamine, noradrenaline (norepinephrine), and certain anaesthetics
  • medicines containing adrenaline (noradrenalin) or similar substances that raise blood pressure, such as those found in some nose and eye drops, cough medicines, or remedies for the common cold
  • non-steroidal anti-inflammatory drugs (known as NSAIDs), which are medicines used to relieve pain or inflammation or to treat arthritis
  • ergot alkaloids, a class of medicines used in the prevention and treatment of migraine headaches
  • monoamine oxidase inhibitors, a class of medicines used to treat depression
  • cimetidine, a medicine used to relieve heartburn and
  • gastrointestinal ulcers

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Barbloc.

How to take Barbloc

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 doctor or pharmacist for help.

How much to take

Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on your condition, on how you respond to this medicine and whether or not you are taking any other medicines.

The dose of this medicine will be different for different patients. Also, the number of doses you take each day and the time allowed between doses depend on the condition for which you are taking Barbloc.

Treatment is usually started with the lowest dose. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

For high blood pressure, the usual dose is 15 mg per day but can range from 10 mg to 30 mg per day. Doses above 15 mg should be divided into two or three smaller doses.

For angina, the usual dose is from 7.5 mg to 20 mg each day, divided into three doses.

For irregular heartbeat (arrhythmia), the usual dose is from 10 mg to 30 mg each day, divided into three doses.

Patients with kidney problems may need smaller doses.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take it

Swallow the tablets with a glass of water.

Barbloc tablets can be broken in half if your doctor has prescribed half a tablet.

When to take it

Take Barbloc at about the same time each day.

How long to take it for

Do not stop taking this medicine without first checking with your doctor. Your doctor may want to gradually reduce the amount of medicine you are taking before stopping it completely. This helps to reduce the chance of your condition becoming worse and to prevent other unwanted effects on your heart.

Continue taking Barbloc as your doctor tells you.

Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose 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. This may increase the chance of you getting an unwanted side effect.

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

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

If you take too much Barbloc (overdose)

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

If you take too much Barbloc, you may feel dizzy, sick (nausea), vomit, have a slow heart beat and even collapse.

While you are taking Barbloc

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Barbloc.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Barbloc.

If you become pregnant while taking Barbloc, tell your doctor.

If you have an allergic reaction to a food, another medicine or an insect sting while you are taking Barbloc, tell your doctor immediately.

If you have a history of allergies, there is a chance that Barbloc may make allergic reactions worse or harder to treat.

If you are being treated for diabetes, make sure you check your blood sugar regularly and report any problems to your doctor. Barbloc may change how well your diabetes is controlled. It may also prevent some of the warning signs of low blood sugar, such as fast heart beat, and may make low blood sugar last longer. The dose of your diabetes medicines may need to be changed.

If you plan to have surgery, including dental surgery, and will need an anaesthetic, tell your doctor or dentist that you are taking Barbloc. This will help your doctor to prevent unwanted side effects such as a sudden drop in blood pressure.

If this medicine makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. These symptoms may be due to a sudden fall in your blood pressure.

If this problem does not go away, talk to your doctor.

To avoid symptoms of low blood pressure, here are some hints that may help:

  • stand up slowly to help your body get used to the change in position and blood pressure
  • if you feel dizzy, sit or lie down until you feel better
  • if you feel faint, breathe deeply and bend forward with your head between your knees
  • take extra care when exercising, driving or standing for long periods, especially in hot weather. Drink plenty of fluids, especially if you sweat a lot.

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

Things you must not do

Do not stop taking Barbloc, or change the dose, without checking with your doctor. Stopping Barbloc suddenly may worsen your angina or irregular heartbeat, or cause other heart problems. Your doctor may want you to gradually reduce the amount of Barbloc you are taking before stopping completely.

Do not let yourself run out of Barbloc over the weekend or on holidays.

Do not use this medicine to treat any other conditions unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Barbloc affects you. Barbloc may cause drowsiness, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Be careful getting up from a sitting or lying position. Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.

Make sure you drink enough water in hot weather and during exercise when you are taking Barbloc, especially if you sweat a lot. If you do not drink enough water while taking Barbloc, you may feel faint or lightheaded or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.

Be careful to dress warmly during cold weather, especially if you will be outside for a long time. Like other beta-blocker medicines, Barbloc may make you more sensitive to cold temperatures, especially if you have problems with your blood circulation. These medicines tend to decrease blood circulation in the skin, fingers and toes.

Talk to your doctor if you experience eye problems (dry, gritty, or burning eyes), Barbloc can be used by older people at the same dose as for younger people. Older people may experience more side effects than young people, and so might be monitored closely by their doctor.

Lifestyle measures that help reduce heart disease risk

By following these simple measures, you can further reduce the risk from heart disease.

  • Quit smoking and avoid second-hand smoke.
  • Limit alcohol intake.
  • Enjoy healthy eating by:
    - eating plenty of vegetables and fruit;
    - reducing your saturated fat intake (eat less fatty meats, full fat dairy products, butter, coconut and palm oils, most take-away foods, commercially-baked products).
  • Be active. Progress, over time, to at least 30 minutes of moderate-intensity physical activity on 5 or more days each week. Can be accumulated in shorter bouts of 10 minutes duration. If you have been prescribed anti-angina medicine, carry it with you when being physically active.
  • Maintain a healthy weight.
  • Discuss your lifestyle and lifestyle plans with your doctor.
  • For more information and tools to improve your heart health, call Heartline, the Heart Foundation's national telephone information service, on 1300 36 27 87 (local call cost).

Know warning signs of heart attack and what to do:

  • Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw, throat, shoulders, arms or back.
  • You may also have difficulty breathing, or have a cold sweat or feel dizzy or light headed or feel like vomiting (or actually vomit).
  • If you have heart attack warning signs that are severe, get worse or last for 10 minutes even if they are mild, call triple zero (000). Every minute counts.

Side effects

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

Like all other medicines, Barbloc may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

Tell your doctor if you notice any of the following and they worry you:

  • tiredness, drowsiness, decreased alertness
  • dizziness or light-headedness (sometimes with fainting), especially on standing up
  • shakiness or trembling
  • headache or other aches and pains
  • disturbed sleep, vivid dreams
  • feeling depressed
  • stomach upset (mainly nausea or feeling sick) or vomiting
  • diarrhoea or abdominal discomfort
  • runny, itchy, red, dry or irritated eyes
  • excess sweating
  • sleep disturbances
  • muscle cramps

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

  • skin reactions (rash, itching, hives, flaking of skin, worsening of psoriasis)
  • abnormal thinking, or hallucinations (seeing or hearing things that are not there)
  • numbness

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

  • serious signs of allergy such as swelling of the face, lips or tongue which may cause problems with swallowing or breathing
  • coldness, burning, tingling or numbness in arms and legs
  • changes in heart rate, such as abnormally slow heart beat (called bradycardia), irregular heart beat or palpitations
  • disturbed heart rhythm (called cardiac conduction disorder)
  • weakness, hunger, trembling, flushing or paleness
  • convulsions, fits or seizures
  • chest tightness, wheezing, rattly breathing
  • sudden, oppressive chest pain
  • shortness of breath, sometimes with tiredness, weakness and reduced ability to exercise, swelling of the feet or legs due to fluid build up
  • difficulty breathing with coughing or wheezing.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients.

After taking Barbloc

Storage

Keep your 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 tablets in a cool dry place where the temperature stays below 30°C.

Do not store Barbloc 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

Barbloc comes in 2 strengths of tablets:

  • Barbloc 5 - round, white scored tablet marked PL over 5 on one side and G on the reverse. Each bottle of Barbloc 5 contains 100 tablets
  • Barbloc 15 - round, white scored tablet marked PL over 15 on one side and G on the reverse. Each bottle of Barbloc 15 contains 50 tablets.

Ingredients

The active ingredient in Barbloc is pindolol. Each Barbloc tablet contains 5 mg or 15 mg of pindolol.

The tablets also contain:

  • microcrystalline cellulose
  • pregelatinised maize starch
  • colloidal anhydrous silica
  • magnesium stearate

The tablets are gluten free.

Manufacturer

Barbloc is made in Australia by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration numbers:

Barbloc 5 - Aust R 17589

Barbloc 15 - Aust R 17588

This leaflet was prepared in August 2019.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Barbloc

Active ingredient

Pindolol

Schedule

S4

 

1 Name of Medicine

Pindolol.

6.7 Physicochemical Properties

Chemical name: (±)-4-(2-hydroxy-3-isopropylaminopropoxy)-indole.
Molecular formula: C14H20N2O2. Molecular weight: 248.33.
Pindolol is a white crystalline powder and a weak base (pKa 9.2), practically insoluble in water (< 0.1% w/v at neutral pH); slightly soluble in absolute ethanol (0.62% in 95% v/v) and in chloroform; sparingly soluble in methanol; but readily soluble in acidic, aqueous buffers. Its melting point is between 170-171°C.

Chemical structure.

Structural formula:

CAS number.

13523-86-9.

2 Qualitative and Quantitative Composition

Each tablet 5 mg tablet contains 5 mg of pindolol as the active ingredient.
Each tablet 15 mg tablet contains 15 mg of pindolol as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Barbloc 5: white, flat bevel edged, marked PL/5 on one side, G on reverse.
Barbloc 15: white, flat bevel edged, marked PL/15 on one side, G on reverse.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pindolol is a competitive nonselective beta-adrenergic receptor blocking drug (beta-blocker) with intrinsic sympathomimetic activity but insignificant membrane stabilising activity.
The exact mechanism of the antihypertensive action of pindolol is as yet unknown.
In patients with excessive sympathetic nervous activity, heart rate, force of cardiac contraction and cardiac output are all reduced by pindolol, leading to a reduction in myocardial oxygen demand.
In hypertensive patients, a single oral administration of pindolol may reduce blood pressure, heart rate and cardiac output, but under chronic administration, cardiac output returns to pretreatment levels, while systemic vascular resistance is reduced; blood pressure remains lowered.
Plasma renin activity is reduced by both single doses and chronic administration of pindolol.
In addition to its beta-adrenoreceptor antagonist activity, pindolol also exhibits intrinsic sympathomimetic activity (ISA). The full significance of the various clinical manifestations of this partial agonist activity is not yet established.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Studies in fasting normal subjects indicate that pindolol is completely absorbed from the small intestine, with peak plasma concentrations being reached between 1 and 2 hours after oral ingestion. It is highly bioavailable since it is not subject to significant first-pass elimination by the liver. The peak plasma level after a single oral dose is directly proportional to dosage over the therapeutic range and there is only a two to threefold intersubject variation. Consequently, establishment of therapeutic blood levels is rapid. Food taken immediately after administration of the drug does not alter significantly the extent or rate of absorption.

Distribution.

The available data relates to tissue distribution of radioactivity following intravenous administration of 14C-pindolol in rats. Immediately following initial distribution (0.5 hours) the level of radioactivity in virtually all tissues is greater than in blood (particularly liver, kidneys, lungs, salivary glands and small intestine). After 2 hours many tissues, including the brain, have comparable or lower levels of radioactivity than does blood. Low but significant levels, probably of slowly excreted metabolites, reside in the liver, adrenals, skin, thyroid and kidneys at 24 hours. The volume of distribution is 2 to 3 L per kg.

Metabolism.

In man, approximately 60% of the drug is metabolised, mainly by conjugation. There are no known active metabolites.

Excretion.

Over 90% of the drug is excreted by the kidney, with approximately 40% of the excreted drug remaining unchanged. The half-life of elimination of pindolol averages 3.3 hours.

Protein binding.

In human plasma, pindolol is about 40% bound to plasma proteins; the degree of binding being independent of concentration.

Placental transfer.

Pindolol may diffuse across the placental barrier.

Food effects.

No significant differences in absorption of pindolol were observed with or without food.

Characteristics in special populations.

Patients with hepatic/ renal impairment.

Patients with impaired renal or hepatic function may usually be treated with normal doses. Only severe cases may require a reduction of the daily dose.

Elderly patients.

The elderly population may show higher plasma concentrations of pindolol as a combined result of a decreased metabolism of the drug in elderly population, a decreased hepatic blood flow and a decreased renal elimination.

Pregnancy.

The elimination half-life of pindolol does not differ significantly between pregnant and nonpregnant patients (see Section 4.4 Special Warnings and Precautions for Use).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Hypertension (either alone or in combination with other anti-hypertensive drugs).
Angina pectoris (prevention of attacks).
Cardiac arrhythmias (sinus tachycardia, paroxysmal tachycardia, supraventricular and ventricular extrasystoles, drug induced extrasystoles (digitalis), atrial flutter and fibrillation to slow the ventricular rate).
Functional hyperadrenergic cardiac disturbances (hyperkinetic heart syndrome, neurocirculatory asthenia).

4.3 Contraindications

1. Bronchospasm. Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance. These drugs also reduce the effectiveness of asthma treatment. This may be dangerous in susceptible patients.
Therefore, beta-blockers are contraindicated in any patient with a history of airways obstruction or a tendency to bronchospasm. Use of cardioselective beta-blockers can also result in severe bronchospasm. If such therapy must be used, great caution should be exercised. Alternative therapy should be considered.
2. Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm.
3. Right ventricular failure secondary to pulmonary hypertension.
4. Cor pulmonale.
5. Sinus bradycardia (less than 45-50 beats/minute).
6. Sick sinus syndrome.
7. Second and third degree A-V block.
8. Shock (including cardiogenic and hypovolaemic shock).
9. Hypersensitivity to pindolol, any of the excipients, or cross sensitivity to other beta-blockers.
10. Decompensated cardiac failure.
11. Prinzmetal's angina (variant angina).
12. Severe peripheral arterial circulatory disturbances.
13. Untreated pheochromocytoma.
14. History of bronchospasm.
15. Bronchial asthma.
16. Chronic obstructive lung disease.

4.4 Special Warnings and Precautions for Use

Cardiovascular system.

Beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy. In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. If cardiac failure develops, pindolol should be withdrawn.

Note.

Although congestive heart failure has been considered to be a contraindication to the use of beta-blockers, there is a growing literature on the experimental use of beta-adrenergic blocking drugs in heart failure. As further trials are needed to identify which patients are most likely to respond to which drugs, beta-blockers should not normally be prescribed for heart failure outside of specialist centres.
Although pindolol produces less depression of resting myocardial function than beta-blockers without intrinsic sympathomimetic activity (ISA), patients with incipient or manifested heart failure must be adequately compensated before treatment with pindolol. Similarly, if pindolol is used for the treatment of acute myocardial infarction, it is necessary to monitor cardiovascular parameters closely.

Abrupt withdrawal.

Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease. Severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias has occurred following abrupt discontinuation of beta-blockade in patients with ischaemic heart disease. Therefore, it is recommended that the dosage be reduced gradually over a period of about 8-14 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, beta-blockers should not be withdrawn, unless there are strong clinical reasons to do so.

Concomitant therapy with calcium antagonists.

The concomitant use of beta-blockers and calcium antagonists with myocardial depressant and sinus node activity, e.g. verapamil and, to a lesser extent, diltiazem, may cause hypotension, bradycardia and asystole. Extreme caution is required if these drugs have to be used together. Owing to the danger of cardiac arrest, a calcium channel blocker of the verapamil type must not be administered intravenously to a patient already receiving treatment with a beta-blocker.
The dihydropyridine calcium antagonists (e.g. nifedipine) have a weaker myocardial depressant effect and can be administered cautiously with beta-blockers. If excessive hypotension develops, the calcium antagonist should be stopped or the dosage reduced (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Psoriasis.

Since beta-blockers may aggravate psoriasis, pindolol should only be prescribed after careful consideration of benefits and risks in patients with history of psoriasis.

Oculomucocutaneous syndrome.

The full development of oculomucocutaneous syndrome, as previously described with practolol, has not yet been reported with pindolol. However, some features of this syndrome have been noted such as dry eyes and skin rash. In most cases the symptoms cleared after withdrawal of treatment. Discontinuation of pindolol should be considered and switch to another therapeutic agent might be advisable.

Peripheral vascular disease.

Beta-blockade may impair the peripheral circulation and exacerbate the symptoms of peripheral vascular disease. However, because of its sympathomimetic effects mediated at the vascular beta2-receptors (vasodilatation), peripheral vascular side effects (cold extremities) are only rarely encountered during pindolol therapy.

Antiarrhythmic drugs.

Care should be taken when prescribing beta-blockers with antiarrhythmic drugs. Interactions have been reported during concomitant beta-blocker therapy with the class IA agents disopyramide, and less frequently quinidine; class IB agents, tocainide, mexiletine and lidocaine; class IC agents, flecainide and propafenone (not available in Australia); 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 beta-blocker. If this treatment is essential, it should only be undertaken in a coronary or intensive care unit.

Euthyroid hyperthyroxinaemia.

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

Anaesthesia and the peri-operative period.

It is essential to monitor cardiovascular function closely during general anaesthesia in patients treated with a beta-blocker.
Beta-blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the post-operative period. It is currently recommended that maintenance beta-blockade be continued peri-operatively. The anaesthetist must be made aware of beta-blockade because of the potential for interactions with other drugs, resulting in severe bradyarrhythmias and hypotension, the decreased reflex ability to compensate for blood loss, hypovolaemia and regional sympathetic blockade, and the increased propensity for vagal induced bradycardia. Incidents of protracted severe hypotension or difficulty restoring normal cardiac rhythm during anaesthesia have been reported. Modern inhalational anaesthetic agents are generally well tolerated, although older agents (ether, cyclopropane, methoxyflurane, trichlorethylene) were sometimes associated with severe circulatory depression in the presence of beta-blockade (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Anaphylactic reaction.

Pindolol is less likely to cause a rebound super sensitivity to beta-adrenoceptor stimulation following abrupt cessation of chronic therapy than are beta-blockers without ISA. However, if interruption of therapy is considered necessary, it is advisable to reduce the dose of Barbloc progressively.
Anaphylactic reactions precipitated by other agents may be particularly severe in patients taking beta-blockers, especially non-selective beta-blockers, and may be resistant to normal doses of adrenaline (epinephrine). Whenever possible, beta-blockers should be avoided in patients who are at increased risk for anaphylaxis.

Diabetes.

Diabetic patients, especially those dependent on insulin, should be warned that beta-blockers affect glucose metabolism, and may mask some important premonitory signs of acute hypoglycaemia (e.g. palpitations, tachycardia, and tremor), whereas sweating is not inhibited.
In patients with insulin or non-insulin dependent diabetes, especially labile diabetes, or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. The concurrent use of beta-blockers and antidiabetic medication should always be monitored to confirm that diabetic control is well maintained. The dose of insulin or oral hypoglycaemic agent may need adjustment (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Other metabolic effects.

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

Use of catecholamine depleting agents.

Concomitant use of drugs such as reserpine and guanethidine requires careful monitoring since the added effect of beta-blockade may produce an excessive reduction of the resting sympathetic nervous tone (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Clonidine.

Concurrent use of beta-blockers and clonidine should be avoided because of the risk of adverse interaction and severe withdrawal symptoms. If administered concomitantly, the clonidine should not be discontinued until several days after the withdrawal of the beta-blocker (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Phaeochromocytoma.

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

Eye and skin reactions.

Various skin rashes and conjunctival xeroses have been reported with beta-blockers. Cross reactions may occur between beta-blockers, therefore substitutions within the group may not necessarily preclude occurrence of symptoms.

Allergic conditions.

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

Hyperthyroidism.

Because beta-blockers may mask the clinical signs of developing or continuing hyperthyroidism (e.g. tachycardia), resulting in symptomatic improvement without any change in thyroid hormone status, special care should be exercised in those patients who are hyperthyroid and are also receiving beta-blockers. These patients should be carefully monitored for thyroid function.

Use in renal impairment.

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

Use in the elderly.

Geriatric patients should be treated cautiously. An excessive decrease in blood pressure or pulse rate may reduce blood supply to vital organs to inadequate levels.

Paediatric use.

At the present time, the data on the use of pindolol in children are too limited to recommend its use.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticipated interactions resulting in concomitant use not being recommended.

Monoamine oxidase (MAO) inhibitors.

Concurrent use with beta-blockers is not recommended. Possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the MAO inhibitor.

Anticipated interactions to be considered.

Antidiabetic agents.

Beta-blockers may interfere with the usual hemodynamic response to hypoglycaemia and produce a rise in blood pressure associated with severe bradycardia. Although the clinical importance of these effects with pindolol is probably small in most diabetic patients, but beta-blockers should be avoided in unstable diabetic patients prone to episodes of hypoglycaemia (see Section 4.4 Special Warnings and Precautions for Use).

Calcium channel blocking agents.

Experience has shown that the concomitant use of oral beta-blockers and calcium antagonists of the dihydropyridine type can be useful in hypertension or angina pectoris. However, because of their potential effect on the cardiac conduction system and contractility, the intravenous route must be avoided. Oral treatment requires careful monitoring, especially when the beta-blocker is combined with a verapamil type calcium antagonist.
The possibility of severe reduction in blood pressure upon the concomitant administration of dihydropyridine derivatives such as nifedipine with pindolol in patients with latent cardiac insufficiency cannot be excluded.

Antiadrenergic agents.

Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by beta-blockers.
When therapy is discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blockers should be gradually discontinued several days before clonidine is discontinued, in order to reduce the potential risk of a clonidine withdrawal hypertensive crisis.

Nonsteroidal anti-inflammatory drugs (NSAIDs).

Concomitant administration of nonsteroidal anti-inflammatory drugs including COX-2 inhibitors with a beta-blocker, may decrease its antihypertensive effect, possibly as a result of the inhibition of renal prostaglandin synthesis and sodium and fluid retention caused by NSAIDs.

Phenothiazines.

Concurrent use with beta-blockers may result in an increased plasma concentration of either drug.

Sympathomimetic drugs.

Concomitant administration of sympathomimetic drugs such as adrenaline (epinephrine), noradrenaline (norepinephrine), isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, or xanthine derivatives with a nonselective beta-blocker may enhance the pressor response resulting in hypertension due to antagonistic effects.

Anaesthetic agents.

Beta-blockers and certain anaesthetics may be additive in their cardiodepressant effect. However, continued use of beta-blockers during anaesthesia reduces the risk of cardiac arrhythmias and hypertension (see Section 4.4 Special Warnings and Precautions for Use). Anaesthetic agents causing myocardial depression, such as cyclopropane and trichloroethylene, are best avoided.

Antiarrhythmic agents.

Concomitant administration of beta-blockers with class I antiarrhythmic agents such as disopyramide, tocainide, flecainide or amiodarone may have potentiating effect on atrial conduction time and induce negative inotropic effect. Although this potentiation effect is weak for pindolol, the possibility of interactions with antiarrhythmic agents can not be eliminated.

Digitalis glycosides.

Beta-blockers and digitalis glycosides may be additive in their depressant effect on myocardial conduction, particularly through the atrioventricular node, resulting in bradycardia or heart block.

Ergot alkaloid.

Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.

Cimetidine.

Cimetidine is a moderate inhibitor of multiple cytochrome enzymes such as CYP2D6, CYP3A4, CYP2C19, CYP2E1, CYP2C9, and CYP1A2. Concomitant administration of cimetidine may inhibit the hepatic metabolism of pindolol resulting in increased plasma concentrations of pindolol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the foetus and newborn infant. During the later stages of pregnancy these drugs should only be given after weighing the needs of the mother against the risk to the foetus.
Experimental studies in animals with pindolol give no evidence of teratogenicity. However, the effects on the human foetus and pregnant uterus are not yet fully known; Barbloc should therefore only be administered under compelling circumstances.
 Pindolol can pass in minute quantities into breast milk but there is no evidence that it affects the infant. Nevertheless, Barbloc should not be given to lactating women unless the expected benefit outweighs the potential risk.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions have been derived from postmarketing experience with pindolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
The adverse drug reactions are, in most cases, mild and transient in nature, and the necessity for interruption of pindolol therapy is rarely observed (see Section 4.4 Special Warnings and Precautions for Use).
Adverse drug reactions are listed according to system organ classes in MedDRA.

Psychiatric disorders.

Sleep disorders (similar to those observed with other beta-blockers), depression, hallucinations.

Nervous system disorders.

Dizziness, tremor, headache, paraesthesia.

Cardiac disorders.

Bradycardia, conduction disorder, cardiac failure.

Vascular disorders.

Hypotension, symptoms of peripheral vascular disorders (peripheral coldness), Raynaud’s-like symptoms.

Respiratory, thoracic and mediastinal disorders.

Bronchospasm, dyspnea.

Gastrointestinal disorders.

Nausea, vomiting, diarrhoea, abdominal discomfort.

Skin and subcutaneous tissue disorders.

Skin reaction, hyperhidrosis, worsening of psoriasis, erythematous rashes, pruritus, allergic psoriasiform rashes (but not the severe oculomucocutaneous syndrome, see Section 4.4 Special Warnings and Precautions for Use).

Musculoskeletal disorders.

Muscle cramps, aching legs, cold extremities.

Ocular.

Keratitis and conjuctivitis.

General disorders and administration site conditions.

Weakness, fatigue.

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.

4.2 Dose and Method of Administration

Dosage should be adapted to the requirements of the individual patient. Barbloc is best administered shortly before meals.

Hypertension.

The usual dosage is 15 mg per day; most patients respond to 10 to 30 mg daily. Up to 15 mg may be given as a single daily dose usually in the morning. Doses above 15 mg should be divided into 2 or 3 daily doses.
In mild and moderate hypertension, Barbloc alone may be sufficient. In more severe or resistant cases, addition of other antihypertensive drugs may be required.

Angina pectoris.

7.5 to 20 mg daily, generally divided into 3 single doses.

Cardiac arrhythmias.

15 to 30 mg daily, generally divided into 3 single doses.

Functional hyperadrenergic cardiac disturbances.

10 to 20 mg daily.

Note.

Hypertensive crises are unsuitable for treatment with beta-blockers.

4.7 Effects on Ability to Drive and Use Machines

Because dizziness or fatigue may occur during initiation of treatment with beta-adrenoceptor blocking drugs, patients driving a vehicle or operating machinery should exercise caution until they have determined their individual reaction to treatment.

4.9 Overdose

Symptoms.

An overdosage of a beta-blocker may lead to pronounced bradycardia, nausea, vomiting, orthostatic disturbances, collapse, hypotension, cardiac failure, cardiogenic shock, conduction abnormalities, cardiac arrest, dyspnea, bronchospasm, hypoglycaemia, depressed levels of consciousness, generalised convulsions, coma and death. In rare circumstances, overdose of beta-blockers with intrinsic sympathomimetic activity (ISA), like pindolol, may present with tachycardia and hypertension. Concomitant ingestion of alcohol, antihypertensives, antidepressants, or antiarrhythmics may aggravate the signs and symptoms of overdose.

Treatment.

In case of overdosage or hypersensitivity to beta-blockers (very rare), 0.5 to 1 mg (or more) atropine sulfate monohydrate should be given intravenously.
Should bronchospasm occur in susceptible patients, therapy with a beta2-stimulant such as salbutamol or terbutaline or therapy with aminophylline may be considered. If necessary, isoprenaline hydrochloride may be given by slow intravenous injection beginning with approximately 5 microgram/minute until the desired effect is achieved, in order to stimulate beta-adrenergic receptors. In refractory cases one may consider the intravenous administration of 8 to 10 mg of glucagon hydrochloride; the injection may be repeated within one hour and followed, if necessary, by an intravenous infusion of 1 to 3 mg per hour. The patient must be continuously monitored during these procedures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Pindolol tablets contain the following as excipients: microcrystalline cellulose, pregelatinised maize starch, magnesium stearate and colloidal anhydrous silica.

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: HDPE bottle with PP child-resistant closure.
Barbloc 5: Available in bottles of 90's* or 100's.
Barbloc 15: Available in bottles of 50's.
*Not marketed in Australia.

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.

Summary Table of Changes