Cardinol LA

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Propranolol hydrochloride 160 mg
Available from:
Mylan New Zealand Ltd
INN (International Name):
Propranolol hydrochloride 160 mg
Dosage:
160 mg
Pharmaceutical form:
Modified release capsule
Composition:
Active: Propranolol hydrochloride 160 mg Excipient: Gelatin Maize starch Purified talc Shellac Sucrose
Units in package:
Blister pack, 30 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Cosma SpA
Therapeutic indications:
· Control of hypertension.
Product summary:
Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with white PP wadded (Cello LDPE & Alcoflex foil) tampertel closure - 100 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with white PP tamper evident cap and LDPE wad - 100 capsules - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-3046/1
Authorization date:
1984-02-22

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

CARDINOL LA

Propranolol hydrochloride,

modified release capsules 160mg

What is in this leaflet

This leaflet answers some common

questions about CARDINOL LA.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What CARDINOL LA

is used for

CARDINOL LA capsules contain the

active ingredient propranolol

hydrochloride, which belongs to a

group of medicines called beta-

blockers. These medicines work by

changing the body's response to

some nerve impulses, especially in

the heart.

CARDINOL LA is used to lower

blood pressure, help in the

prevention of chest pain (angina)

and for the long-term prevention of

future heart attacks.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribe it

for another reason.

There is no evidence that

CARDINOL LA is addictive.

This medicine is available only with

a doctor’s prescription.

CARDINOL LA is not recommended

for use in children.

Before you take

CARDINOL LA

When you must not take

it

Do not take CARDINOL LA if you

have an allergy to:

propranolol

any of the ingredients listed at

the end of this leaflet

any other similar medicines such

as beta-blockers

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 CARDINOL LA if you

have:

asthma or severe breathing

problems

heart problems such as, heart

failure, low blood pressure,

problems with your circulation,

Prinzmetal’s angina or a slow

heart beat

low blood sugar levels

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 take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

asthma or serious breathing

problems

heart problems

low blood pressure

problems with your circulation

diabetes or low blood sugar

an overactive thyroid gland

liver problems

kidney problems

Tell your doctor if you are fasting

or have been fasting recently.

Tell your doctor if you plan to

have surgery.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

CARDINOL LA.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Medicines that may interfere with

CARDINOL LA include:

insulin and other medications

used to treat diabetes

medicines used in the treatment

and prevention of migraines

such as ergotamine and

ergotamine type compounds, or

rizatriptan

medicines used to treat angina

or an irregular heartbeat, e.g.

Page 2 of 4

disopyramide, amiodarone,

nifedipine, clonidine, quinidine,

propafenone

calcium channel blockers e.g.

verapamil, diltiazem, medicines

used to treat high blood pressure

digoxin, a medicine used to treat

heart failure

lidocaine, a local anaesthetic

sympathomimetic agents e.g.

adrenalin (used in emergency

situations)

hydralazine, a medicine used to

relax and widen blood vessels

cimetidine, a medicine

commonly used to treat reflux

and ulcers

medicines used to treat pain or

inflammation such as ibuprofen

or indometacin

chlorpromazine and thioridazine,

medicines used to treat

psychiatric disorders

warfarin, a medicine used to

prevent blood clots

theophylline, a medicine used to

treat asthma

rifampicin, an antibiotic

These medicines may be affected

by CARDINOL LA or may affect

how well CARDINOL LA works.

You may need different amounts of

your medicines or you may need to

take different medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

CARDINOL LA.

How to take

CARDINOL LA

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the bottle, ask

your doctor or pharmacist for

help.

How much to take

Your doctor will tell you how much

CARDINOL LA you need to take

each day.

It is important that you take

CARDINOL LA as directed by your

doctor. Do not take more than the

recommended dose.

The usual starting dose of

CARDINOL LA for high blood

pressure and chest pain is one

capsule daily, taken either in the

morning or evening.

For the prevention of further heart

attacks the treatment will usually

begin between 5 and 21 days

following the heart attack. The usual

dose for prevention of further heart

attacks is usually one 40mg tablet,

four times a day for around two to

three days. This dose may be given

as one capsule of CARDINOL LA

daily.

How to take it

Swallow the capsule whole with a

full glass of water.

How long to take it

Continue taking your medicine

for as long as your doctor tells

you.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you stop taking your medicine

suddenly, it may worsen your chest

pain (angina) or cause other heart

complications to occur. Your doctor

may want you to gradually reduce

the amount of CARDINOL LA you

are taking before stopping

completely.

If you forget a dose

If you forget a dose, just take the

next dose when it is due. Do not

take more than one dose at a

time to make up for missed

doses.

Taking your medicine at the same

time each day may help you to

remember to take it regularly. If you

have trouble remembering to take

your medicine, ask you pharmacist

for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the National Poisons

Information Centre (0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much CARDINOL LA.

Do this even if there are no signs

of discomfort or poisoning. You

may need urgent medical attention.

Symptoms of an overdose may

include fatigue, dizziness,

weakness, fainting, irregular

heartbeat and difficulty breathing.

While you are taking

CARDINOL LA

Things you must do

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking CARDINOL

LA.

Tell your doctor or pharmacist

that you are taking CARDINOL LA

before you start any new

medicine.

If you become pregnant while

taking CARDINOL LA, tell your

doctor immediately.

If you are going to have a

surgery, tell the surgeon or

anaesthetist that you are taking

CARDINOL LA.

It may affect other medicines used

during surgery.

If you are going to have any

blood tests, tell your doctor that

you are taking CARDINOL LA.

It may interfere with the results of

some tests.

If you are being treated for diabetes,

make sure you check your blood

sugar level regularly. CARDINOL

LA may affect how well your

diabetes is controlled. It may also

cover up some of the symptoms of

low blood sugar (also called

hypoglycaemia) such as a fast

heartbeat. CARDINOL LA may also

make an episode of low blood sugar

last longer. Your doctor may need

to adjust the dose of your insulin or

diabetic medicines.

Things you must not do

Page 3 of 4

Do not take CARDINOL LA to

treat any other complaints unless

your doctor tells you to.

Do not give this medicine to

anyone else, even if they have

the same condition as you.

Do not stop taking your medicine

or lower the dose without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CARDINOL LA affects you.

This medicine may cause dizziness

or tiredness in some people. If you

have any of these symptoms, do not

drive, operate machinery or do

anything else that could be

dangerous.

Be careful when drinking alcohol

while you are taking this

medicine.

If you drink alcohol, dizziness or

light-headedness may be worse.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues

or gets worse, talk to your doctor.

Side effects

Tell your pharmacist or doctor as

soon as possible if you do not

feel well while you are taking

CARDINOL LA.

All medicines can have some

unwanted effects. Sometimes they

are serious, most of the time they

are not. You may need medical

treatment if you get some of the

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 or pharmacist if

you notice any of the following

and they worry you:

tiredness

dizziness, lightheadedness or

fainting, especially when you get

up quickly

sleep disturbances or

nightmares

hair loss

mood changes or confusion

dry eyes

feeling sick (nausea), vomiting,

diarrhoea, stomach pain

cold fingers and toes

numbness and spasm in the

fingers which is followed by

warmth and pain (Raynaud’s

phenomenon)

These are the mild side effects of

propranolol hydrochloride.

Tell your doctor immediately if

you notice any of the following:

irritated eyes, blurred vision

skin rashes

signs of low blood sugar

(hypoglycaemia) such as

sweating, weakness, hunger,

dizziness, trembling, headache,

flushing or paleness, numbness

seizure linked to low blood sugar

hallucinations

changes to mood

confusion

memory loss

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

Tell your doctor immediately or

got to Accident and Emergency

at the nearest hospital if you

notice any of the following:

swelling of the face, lips, tongue

or throat which may cause

difficulty in swallowing

chest tightness, difficulty

breathing, wheezing

fast, slow or irregular heart beat

bruising or bleeding more easily

than usual

signs of frequent infection such

as fever, chills, sore throat and

mouth ulcers

shortness of breath (sometimes

with tiredness, weakness and

reduced ability to exercise),

which may occur together with

swelling of the feet or legs due to

fluid build-up.

These are very serious side effects.

If you have them, you may have

had a serious allergic reaction to

CARDINOL LA. You may need

urgent medical attention or

hospitalisation.

All of these side effects are very

rare.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects, for

example, changes to platelets or

antibodies in the blood, can only be

found when your doctor does tests

from time to time to check your

progress.

After taking

CARDINOL LA

Storage

Keep your capsules in the bottle

until it is time to take them.

If you take the capsules out of the

bottle they may not keep well.

Keep your capsules in a cool dry

place where the temperature

stays below 25°C.

Do not store CARDINOL LA 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

Page 4 of 4

What CARDINOL LA

capsules look like

CARDINOL LA 160mg capsules are

half clear and half green coloured

capsules containing cream and

white coloured pellets.

Each CARDINOL LA capsule

contains the active ingredient,

propranolol hydrochloride.

Each CARDINOL LA 160mg

capsule also contains the

ingredients sucrose, maize starch,

shellac, talc and the gelatin capsule.

CARDINOL LA 160 mg does not

contain gluten or lactose.

If you want to know

more

Should you have any questions

regarding this product, please

contact your doctor or pharmacist.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland.

Telephone: (09) 579 2792

Date of information

08 January 2018

(Based on datasheet dated 08

January 2018 )

Page 1 of 9

NEW ZEALAND DATA SHEET

CARDINOL LA

1. Product Name

CARDINOL LA, 160mg, modified release capsule.

2. Qualitative and Quantitative Composition

Each modified release capsule contains 160mg of propranolol hydrochloride BP.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

CARDINOL LA is presented as size 1 gelatin capsules with a clear colourless body and opaque,

green cap containing cream and white pellets.

CARDINOL LA capsules contain spheroids of

the beta-blocker propranolol hydrochloride which

have a sustained release coating to provide long action.

4. Clinical Particulars

4.1

Therapeutic indications

CARDINOL LA is indicated for the following:

Control of hypertension.

Management of agina pectoris.

Long term prophylaxis after recovery from acute myocardial infarction.

4.2

Dose and method of administration

Adults

Hypertension

The starting dose is one capsule daily, taken either morning or evening. An adequate response is

seen in most patients at this dosage. If necessary, it can be increased to two capsules and a

further reduction in blood pressure can be attained if a diuretic or other antihypertensive agent is

given in addition to CARDINOL LA.

Angina

An adequate response is usually obtained with one capsule daily either morning or evening,

dependant on patient convenience.

Post Myocardial infarction

Page 2 of 9

Treatment should start between days 5 and 21 after myocardial infarction with one 40 mg

propranolol tablet four times a day for 2 or 3 days.

In order to achieve maximum compliance,

the total daily dosage of 160 mg propranolol may

thereafter be given as a single CARDINOL LA capsule. Compliance is extremely important as

beta-blockade may have to be continued indefinitely.

Special populations

Elderly

Evidence concerning the relation between blood level and age is conflicting. With regard to the

elderly, the optimum dose should be individually determined according to clinical response.

Children

CARDINOL LA is not recommended for use in children.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

CARDINOL LA must not be used if there is a history of bronchial asthma or bronchospasm

Bronchospasm can usually be reversed by beta

agonist bronchodilators such as salbutamol.

Large doses of the beta

agonist bronchodilator may be required to overcome the beta blockade

produced by propranolol and the dose should be titrated according to the clinical response; both

intravenous

inhalational

administration

should

considered.

intravenous

aminophylline

and/or

ipratropium

(given

nebuliser)

also

considered.

Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator

effect in asthmatic patients. Oxygen or artificial ventilation may be required in severe cases.

CARDINOL LA as with other beta-blockers must not be used in patients with any of the following

conditions: known hypersensitivity to the substance; bradycardia; cardiogenic shock; hypotension;

metabolic acidosis; after prolonged fasting; severe peripheral arterial circulatory disturbances;

second

third-degree

heart

block;

sick

sinus

syndrome;

untreated

phaeochromocytoma;

uncontrolled heart failure; Prinzmetal’s angina.

CARDINOL LA must not be used in patients prone to hypoglycaemia, i.e., patients after prolonged

fasting or patients with restricted counter-regulatory reserves. Patients with restricted counter-

regulatory reserves may have reduced autonomic and hormonal responses to hypoglycaemia

which includes glycogenolysis, gluconeogenesis and/or impaired modulation of insulin secretion.

Patients at risk for an inadequate response to hypoglycaemia includes individuals with malnutrition,

prolonged fasting, starvation, chronic liver disease, diabetes and concomitant use of drugs which

block the full response to catecholamines.

4.4

Special warnings and precautions for use

Propranolol as with other beta-blockers:

although contraindicated in uncontrolled heart failure, may be used in patients whose signs

of heart failure have been controlled. Caution must be exercised in patients whose cardiac

reserve is poor.

should not be used in combination with calcium channel blockers with negative inotropic

effects (e.g. verapamil, diltiazem), as it can lead to an exaggeration of these effects

particularly in patients with impaired ventricular function and/or SA or AV conduction

abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.

Neither

beta-blocker

calcium

channel

blocker

should

administered

intravenously within 48 hours of discontinuing the other.

Page 3 of 9

should not be used in patients with Prinzmetal’s angina and beta

selective agents should

be used with care.

although contraindicated in severe peripheral arterial circulatory disturbances, may also

aggravate less severe peripheral arterial circulatory disturbances.

due to its negative effect on conduction time, caution must be exercised if propranolol is

given to patients with first degree heart block.

may block/modify the signs and symptoms of hypoglycaemia (especially tachycardia).

Propranolol

occasionally

causes

hypoglycaemia,

even

non-diabetic

patients,

e.g.,

neonates, infants, children, elderly patients, patients on haemodialysis or patients suffering

from chronic liver disease and patients suffering from overdose. Severe hypoglycaemia

associated with propranolol long-acting has rarely presented with seizures and/or coma in

isolated patients. Caution must be exercised in the concurrent use of propranolol and

hypoglycaemic therapy in diabetic patients. Propranolol may prolong the hypoglycaemic

response to insulin.

may mask the signs of thyrotoxicosis.

should

used

untreated

phaeochromocytoma.

However,

patients

with

phaeochromocytoma, an alpha-blocker may be given concomitantly.

will reduce heart rate as a result of its pharmacological action. In the rare instances when a

treated patient develops symptoms that may be attributable to a slow heart rate, the dose

may be reduced.

may cause a more severe reaction to a variety of allergens when given to patients with a

history of anaphylactic reaction to such allergens. Such patients may be unresponsive to

the usual doses of adrenaline used to treat the allergic reactions.

Abrupt withdrawal of beta-blockers is to be avoided. The dosage should be withdrawn gradually

over a period of 7 to 14 days. An equivalent dosage of another beta-blocker may be substituted

during the withdrawal period to facilitate a reduction in dosage below CARDINOL LA 160 mg.

Patients should be followed during withdrawal especially those with ischaemic heart disease.

When a patient is scheduled for surgery and a decision is made to discontinue beta-blocker

therapy, this should be done at least 24 hours prior to the procedure. The risk/benefit of stopping

beta blockade should be made for each patient.

Since the half-life may be increased in patients with significant hepatic or renal impairment, caution

must be exercised when starting treatment and selecting the initial dose.

Propranolol must be used with caution in patients with decompensated cirrhosis.

In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may

develop. There have been reports suggesting that treatment with propranolol may increase the risk

of developing hepatic encephalopathy.

Interference with laboratory tests: Propranolol has been reported to interfere with the estimation

of serum bilirubin by the diazo method and with the determination of catecholamines by methods

using fluorescence.

4.5

Interaction with other medicines and other forms of interaction

Propranolol

modifies

tachycardia

hypoglycaemia.

Caution

must

exercised

concurrent

propranolol-long

acting

hypoglycaemic

therapy

diabetic

patients.

Propranolol may prolong the hypoglycaemic response to insulin.

Page 4 of 9

Simultaneous administration of rizatriptan and propranolol can cause an increased rizatriptan AUC

and C

by approximately 70 - 80%. 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.

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on

atrial-conduction time and induce negative inotropic effect.

Digitalis glycosides in association with beta blockers may increase atrioventricular conduction time.

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects (e.g.

verapamil, diltiazem) can lead to an exaggeration of these effects particularly in patients with

impaired ventricular function and/or sino-atrial or atrio-ventricular conduction abnormalities. This

may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-blocker nor the

calcium channel blocker should be administered intravenously within 48 hours of discontinuing the

other.

Concomitant therapy with dihydropyridine calcium channel blockers e.g. nifedipine, may increase

the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

Concomitant use of sympathomimetic agents e.g. adrenaline, may counteract the effect of beta-

blockers. Caution must be exercised in the parenteral administration of preparations containing

adrenaline to patients taking beta-blockers as, in rare cases, vasoconstriction, hypertension and

bradycardia may result.

Administration of propranolol during infusion of lignocaine may increase the plasma concentration

of lignocaine by about 30%. Patients already receiving propranolol tend to have higher lignocaine

levels than controls. The combination should be avoided.

Concomitant use of cimetidine or hydralazine will increase plasma levels of propranolol, and

concomitant use of alcohol may increase the plasma levels of propranolol.

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of

clonidine. If the two medicines are co-administered, the beta-blocker should be withdrawn several

days before discontinuing clonidine. If replacing clonidine by beta-blocker therapy, the introduction

of beta-blockers should be delayed for several days after clonidine administration has stopped.

Caution must be exercised if ergotamine, dihydroergotamine or related compounds are given in

combination with propranolol since vasospastic reactions have been reported in a few patients.

Concomitant use of prostaglandin synthetase inhibiting medicines e.g. ibuprofen and indometacin,

may decrease the hypotensive effects of propranolol.

Concomitant administration of propranolol and chlorpromazine may result in an increase in plasma

levels of both medicines. This may lead to an enhanced antipsychotic effect for chlorpromazine

and an increased antihypertensive effect for propranolol.

Caution must be exercised when using anaesthetic agents with propranolol. The anaesthetist

should be informed and the choice of anaesthetic should be an agent with as little negative

inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation

of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing

myocardial depression are best avoided.

Pharmacokinetic studies have shown that the following agents may interact with propranolol due to

effects on the enzyme systems in the liver which metabolise propranolol and these agents:

quinidine, propafenone, rifampicin, theophylline, warfarin, thioridazine, and dihydropyridine calcium

channel blockers such as nifedipine, nisoldipine, nicardipine, isradipine and lacidipine. Owing to

the fact that blood concentrations of either agent may be affected, dosage adjustments may be

Page 5 of 9

needed according to clinical judgement (see also the interaction above concerning concomitant

therapy with dihydropyridine calcium channel blockers).

4.6

Fertility, pregnancy and lactation

Pregnancy

As with all other medicines, propranolol should not be given in pregnancy unless its use is

essential. There is no evidence of teratogenicity with propranolol. However, beta-blockers reduce

placental perfusion, which may result in intra-uterine foetal death, immature and premature

deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia in the neonate

and bradycardia in the foetus) may occur. There is an increased risk of cardiac and pulmonary

complications in the neonate in the post-natal period.

Breast-feeding

Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a

variable extent. Breast feeding is therefore not recommended following administration of these

compounds.

Fertility

No data available.

4.7

Effects on ability to drive and use machines

The use of

propranolol is unlikely to result in any impairment of the ability of patients to drive or

operate machinery. However it should be taken into account that occasionally dizziness or fatigue

may occur.

4.8

Undesirable effects

Propranolol is usually well tolerated. In clinical studies, the undesired events reported are usually

attributable to the pharmacological actions of propranolol.

The following undesired events, listed by body system, have been reported. The following

definitions of frequencies are used:

Very

common

(≥1/10),

common

(≥1/100

<1/10),

uncommon

(≥1/1,000

<1/100),

rare

(≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available

data).

System Organ class

Frequency

Undesirable Effect

Blood and lymphatic

system disorders

Rare

Thrombocytopaenia

Endocrine disorders

Not known

Hypoglycaemia in neonates, infants, children, elderly

patients,

patients

haemodialysis,

patients

concomitant

antidiabetic

therapy,

patients

with

prolonged fasting and patients with chronic liver disease

has been reported, seizure linked to hypoglycaemia

Nervous system

disorders

Common

Sleep disturbances, nightmares

Rare

Hallucinations,

psychoses,

mood

changes,

confusion, memory loss, paraesthesia

Page 6 of 9

Discontinuance of the medicine should be considered if, according to clinical judgement, the well-

being of the patient is adversely affected by any of the above reactions. Cessation of therapy with

a beta-blocker should be gradual. In the rare event of intolerance, manifested as bradycardia and

hypotension, the medicine should be withdrawn and, if necessary, treatment for overdosage

instituted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency

and bronchospasm.

General treatment should include: close supervision, treatment in an intensive care ward, the use

of gastric lavage, activated charcoal and a laxative to prevent absorption of any medicine still

Very rare

Isolated

reports

myasthenia

gravis

like

syndrome or exacerbation of myasthenia gravis

have been reported

Eye disorders

Rare

Dry eyes, visual disturbances

Cardiovascular disorders

Common

Bradycardia,

cold

extremities,

Raynaud’s

phenomenon

Rare

Heart failure,

deterioration, precipitation of heart

block,

postural

hypotension,

which

associated

with

syncope,

exacerbation

intermittent claudication

Respiratory, thoracic and

mediastinal disorders

Rare

Bronchospasm

occur

patients

with

bronchial

asthma

history

asthmatic

complaints, sometimes with fatal outcome

Gastrointestinal disorders

Uncommon

Gastrointestinal

disturbances,

such

nausea,

vomiting, diarrhoea

Skin

subcutaneous

tissue disorders

Rare

Purpura,

alopecia,

psoriasiform skin

reactions,

exacerbation of psoriasis, skin rashes

General

disorders

administration

site

conditions

Common

Fatigue and/or lassitude (often transient)

Rare

Dizziness

Investigations

Very rare

An increase in ANA (Antinuclear Antibodies) has

been observed, however, the clinical relevance of

this is not clear

Page 7 of 9

present in the gastrointestinal tract, the use of plasma or plasma substitutes to treat hypotension

and shock.

Excessive bradycardia can be countered with atropine 1 to 2 mg intravenously 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 beta-

adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous

infusion may be given.

Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and

acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac

effects of beta blockade if a large overdose has been taken. The dose of dobutamine should

therefore be increased if necessary to achieve the required response according to the clinical

condition of the patient.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: beta blocking agents, ATC code: C07AA05

Mechanism of action

Propranolol is a competitive antagonist at both the beta

and beta

-adrenoceptors. It has no

agonist activity at the beta-adrenoceptor, but has membrane stabilising activity at concentrations

exceeding 1 to 3 mg/litre, though such concentrations are rarely achieved during oral therapy.

Competitive beta blockade has been demonstrated in man by a parallel shift to the right in the

dose-heart rate response curve to beta-agonists such as isoprenaline.

Propranolol,

with

other

beta-blockers,

negative

inotropic

effects,

therefore

contraindicated in uncontrolled heart failure.

Propranolol is a racemic mixture and the active form is the S (-) isomer. With the exception of

inhibition of the conversion of thyroxine to triiodothyronine it is unlikely that any additional ancillary

properties possessed by R (+) propranolol, in comparison with the racemic mixture will give rise to

different therapeutic effects.

Clinical efficacy and safety

Propranolol is effective and well-tolerated in most ethnic populations, although the response may

be less in black patients.

The sustained release preparation of propranolol maintains a higher degree of beta

-blockade 24

hours after dosing compared with conventional propranolol.

5.2

Pharmacokinetic properties

Absorption

Propranolol is completely absorbed after oral administration and peak plasma concentrations occur

1 to 2 hours after dosing in fasting patients. Following oral dosing with the sustained release

preparation of propranolol the blood profile is flatter than after conventional propranolol but the

half-life is increased to between 10 and 20 hours.

Distribution

Page 8 of 9

Propranolol is widely and rapidly distributed throughout the body with highest levels occurring in

the lungs, liver, kidney, brain and heart. Propranolol is highly protein bound (80 to 95%).

Elimination

The liver removes up to 90% of an oral dose with an elimination half-life of 3 to 6 hours.

5.3

Preclinical safety data

Propranolol is a drug where there is an extensive clinical

experience has been obtained. Relevant information for the

prescriber

is

provided

elsewhere

in

this

data

sheet.6.

Pharmaceutical Particulars

6.1

List of excipients

Sucrose, maize starch, talc, shellac and gelatin capsule.

CARDINOL LA is gluten and lactose free.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Blister pack: 2 years.

Bottle pack: 2 years.

6.4

Special precautions for storage

Blister pack: store at or below 30°C.

Bottle pack: store at or below 25°C.

6.5

Nature and contents of container

Blister pack of 30 capsules.

HDPE bottle with a tamper evident PP cap. Pack-size of 100 capsules.

Not all pack types and sizes may be marketed.

6.6

Special precautions for disposal

Not applicable.

7. Medicines Schedule

Prescription Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

Page 9 of 9

AUCKLAND

Telephone 09-579-2792

9. Date of First Approval

22 February 1984

10. Date of Revision of the Text

08 January 2018 Revised to SmPC format. Shelf-life reduction to 2 years for the bottle pack.

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