CARDIOPLAST

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
NITROGLYCERIN (GLYCERYL TRINITRATE)
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
ATC code:
C01DA02
INN (International Name):
NITROGLYCERIN (GLYCERYL TRINITRATE)
Dosage:
0.6
Pharmaceutical form:
Transdermal Patch
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
glyceryl trinitrate
Authorization status:
Not Marketed
Authorization number:
PA0577/174/003
Authorization date:
2013-07-19

PACKAGE LEAFLET

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Package leaflet: Information for the user

Cardioplast 0.2 mg/h transdermal patches

Cardioplast 0.4 mg/h transdermal patches

Cardioplast 0.6 mg/h transdermal patches

Glyceryl trinitrate

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Cardioplast is and what it is used for

What you need to know before you use Cardioplast

How to use Cardioplast

Possible side effects

How to store Cardioplast

Contents of the pack and other information

The full name of your product is Cardioplast 0.2 mg/h transdermal patch, Cardioplast 0.4 mg/h

transdermal patch or Cardioplast 0.6 mg/h transdermal patch, however, throughout the leaflet it will be

referred to as Cardioplast.

1.

What Cardioplast is and what it is used for

Cardioplast is an adhesive patch that delivers a medicine called glyceryl trinitrate.

Glyceryl trinitrate is contained in the adhesive and when the patch is in contact with the skin the

glyceryl trinitrate passes slowly and steadily from the patch through the skin and into the bloodstream.

Glyceryl trinitrate belongs to a group of medicines called nitrate vasodilators which are used to treat

the symptoms of angina (chest pain). Vasodilators work by widening of the blood vessels and

therefore an increase in blood flow, letting more blood and oxygen reach the heart.

Angina usually occurs as a pain or tightness in the chest although it may be felt in the neck or arm.

The pain occurs when the heart muscle does not receive the oxygen it needs to do the work it has to

Cardioplast is used to prevent symptoms of angina; it is not for treatment of an acute attack.

You should use your usual tablets or spray under the tongue for treatment of acute attacks.

2.

What you need to know before you use Cardioplast

Do not use Cardioplast:

if you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed

in section 6)

if you are allergic to any other medicines containing nitrates

if you have low levels of haemoglobin – a substance contained within the red blood cells

which is responsible for carrying oxygen around the body (anaemia)

if you have heart problems other than angina like disorders of the heart valves, inflammation

of the heart lining (constrictive pericarditis), thickening of the heart muscle (hypertrophic

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obstructive cardiomyopathy), build-up of fluid or blood in the space between the heart muscle

and covering sac of the heart (cardiac tamponade)

if you have low blood pressure or blood volume

if you have had a serious head injury, cerebral haemorrhage (bleeding in the brain) or a

disease which is accompanied by increased pressure on the brain

if you have an eye condition which causes a sudden increase in pressure in the eye causing

visual disturbances) (closed-angle glaucoma)

if you have failure of the circulation with very low blood pressure (shock)

if you are taking medicines for failure to achieve an erection such as sildenafil, tadalafil or

vardenafil. If you use these medicines together with Cardioplast, a severe and possibly

dangerous fall in blood pressure can occur. This could result in collapse, unconsciousness and

could be fatal.

Warning and precautions

Talk to your doctor or pharmacist before using Cardioplast if you have any of the following

conditions:

an underactive thyroid gland

severe lack of food (malnourishment)

liver or kidney disease

very low body temperature (hypothermia)

have had recent heart attack or heart failure

have lung disease

have previously suffered from closed-angle glaucoma.

If you are having certain procedures which use magnetic or electrical fields like a magnetic resonance

imaging scan (MRI scan), cardioversion or defibrillation (an electric shock used to return the heart to

its normal rhythm) or diathermy (where body tissues are heated electrically to treat or help certain

conditions), you will need to remove your patch.

Children and adolescents

Cardioplast should not be used by children and adolescents because the safety and efficacy has not

been established.

Other medicines and Cardioplast

Do not take Cardioplast with medicines used for failure to achieve an erection such as sildenafil,

tadalafil or vardenafil. If you use these medicines together with Cardioplast, a severe and possibly

dangerous fall in blood pressure can occur. This could result in collapse, unconsciousness and could

be fatal.

Talk to your doctor or pharmacist if you are taking any of the following medicines. Taking these at the

same time as Cardioplast may lower your blood pressure too much:

medicines to lower your blood pressure such as beta-blockers (e.g. propranolol), ACE

inhibitors (e.g. enalapril, perindopril), calcium channel blockers (e.g. felodipine, diltiazem)

water tablets (diuretics)

medicines for anxiety or depression such as tricyclic antidepressants or tranquillisers

aspirin

amifostine (a medicine used to reduce the side effects of certain cancer treatments or

radiotherapy)

Dihydroergotamine, a medicine used to treat migraine, neutralizes the effect of Cardioplast. This

causes the blood vessels in the heart to contract.

The effect of Cardioplast may be reduced if you take anti-inflammatory pain killers (e.g. diclofenac) at

the same time as you use your patch.

Page 16 of 21

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other

medicines.

Cardioplast with alcohol

Do not drink alcohol whilst using Cardioplast as it may cause your blood pressure to fall. This may

make you feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

There is no information on the excretion of this medicine into breast milk.

Driving and using machines

Cardioplast may impair your reactions, or make you feel dizzy, light-headed upon standing or faint,

especially at the start of treatment or when the dose is adjusted. Do not drive or use machines if you

are affected in this way.

3.

How to use Cardioplast

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Your doctor may tell you to remove the patch after a period shorter than 24 hours to prevent tolerance

developing to the medicine (reduced effect due to your body getting used to the medicine).

He may also tell you to apply the patch in the morning or at night. You should usually apply a new

patch at the same time each day on a different area of clean and dry skin to prevent local irritation.

The recommended dose is one Cardioplast 0.2 mg/h equivalent to 5 mg/24 h patch applied to the skin

once daily for a period of approximately 12 -16 hours with patch-free interval of 8-12 hours.

If necessary, the dosage may be increased to one Cardioplast 0.4 mg/h equivalent to 10 mg/24 h patch

once daily or to a maximum of one Cardioplast 0.6 mg/h equivalent to 15 mg/24 h patch in each 24

hour period.

How to apply your patch

The patch should be placed on a reasonably hair-free area on the outer upper arm or chest. If

there is hair, do not shave it (shaving irritates the skin). Instead, clip the hair as close to the

skin as possible. Avoid areas below the waist or elbow, skin folds, scars or burnt or irritated

area.

Do not use any greasy substances (creams, ointments) on the skin before applying the patch.

Do not apply the patch immediately after showering or bathing. It is best to wait until you are

certain the skin is completely dry.

Do not tear or cut your patch.

Putting a patch on

Each Cardioplast patch is individually sealed in a protective package.

Wash your hands before putting the patch on.

Open the sachet at the tear mark.

Carefully remove the patch.

The patch is printed accordingly with the wording:

“Glyceryl trinitrate 0.2 mg/h (5mg/24 h)” for Cardioplast 0.2 mg/h transdermal patch

“Glyceryl trinitrate 0.4 mg/h (10mg/24 h)” for Cardioplast 0.4 mg/h transdermal patch

“Glyceryl trinitrate 0.6 mg/h (15mg/24 h)” for Cardioplast 0.6 mg/h transdermal patch

The liner has a slit which divides it into two strips.

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Hold the patch with the wording facing away from you.

The slit should now be facing toward you.

Rotate the patch as necessary to place the slit in an up and down position.

Bend both sides of the clear peelable liner away from you at the slit.

Slowly peel off only one of the strips of the clear liner. Do not touch the exposed side of the patch.

Using the remaining strip as a ‘handle’, apply the sticky side of the patch to the skin. Press the sticky

side on the chosen skin site and smooth down.

Fold back the unattached side of the patch.

Grasp the remaining strip and remove it while applying the remainder of the patch to the skin.

Press the patch on the skin and smooth down.

Once the patch is in place, do not test how well it is stuck on by pulling on it.

When Cardioplast is applied to your body, the active ingredient contained in the patch begins

to flow from the sticky surface through your skin at a regular rate.

After applying the patch, wash your hands to remove any drug.

Please Note:

Once the patch is in place, swimming, showering or bathing should not affect it.

However, if the patch does fall off, dispose of it carefully and put a new patch on a different skin site.

How to remove your patch

Press down the centre of the patch to raise its outer edge away from the skin.

Grasp the edge gently and slowly peel off the patch.

Wash the skin where the patch was applied with soap and water and towel dry. Wash your

hands.

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How to dispose of the patch

As soon as you take the patch off, fold it firmly in half so that the sticky side sticks to itself.

If possible, put it back in its original pouch and put the pouch in the bin with your household

rubbish.

Even used patches contain some medicine which may harm children, so keep your used patches out of

the reach and sight of children.

If you use more Cardioplast than you should

If you or someone else applies too many patches at once, remove the patches carefully and wash the

skin thoroughly to prevent any more medicines being absorbed. Too much glyceryl trinitrate can cause

your blood pressure to drop with a fast heart rate, make you feel light-headed or cause you to faint.

If you forget to use Cardioplast

If you forget to change your patch, do so as soon as you remember. Then go on as before. Do not

apply two patches to make up for the forgotten dose.

If you stop using Cardioplast

Do not stop using your patches without talking to your doctor. If you want to stop your treatment this

must be done gradually and your doctor will need to give you a different medicine to control your

angina.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines including Cardioplast can cause allergic reactions. You should contact your doctor

immediately if you experience any of the following symptoms after taking Cardioplast:

sudden wheeziness

difficulty in breathing or dizziness

swelling of the eyelids, face, lips or throat.

Other side effects:

Very common (may affect more than 1 in 10 people):

Feeling sick (nausea)

Being sick (vomiting).

Common (may affect up to 1 in 10 people):

Headache, especially at the start of treatment. You can take some mild pain killers (such as

paracetamol) for this (if they continue or are very severe, consult your doctor).

Uncommon (may affect up to 1 in 100 people):

Redness, itching, burning or irritation of the skin where you have placed the patch (some

redness is normal but this should disappear after a short time)

Inflammation of the skin with symptoms such as red, itchy, scaly skin (contact dermatitis).

Rare (may affect up to 1 in 1,000 people):

Low blood pressure when standing up, especially when getting up from a sitting or lying

position (orthostatic hypotension)

A fast heart beat or pulse (tachycardia)

Flushing.

Very rare (may affect up to 1 in 10,000 people):

Page 19 of 21

Dizziness.

Not known (frequency cannot be estimated from available data):

Fast or irregular heart beat called palpitations

Rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly (see details below). By reporting side effects you can help

provide more information on the safety of this medicine.

Ireland

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6767836

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

5.

How to store Cardioplast

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton. The expiry date

refers to the last day of that month.

Do not store above 30ºC.

Return any unused patches to your pharmacist and dispose of the used ones carefully as they may still

contain some active medication.

Do not throw away any unused medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help the environment.

6.

Contents of the pack and other information

What Cardioplast contains

The active substance is glyceryl trinitrate.

Each Cardioplast 0.2 mg/h transdermal patch contains 20.7 mg of glyceryl trinitrate in a patch size of

7.4 cm

, releasing 0.2 mg of glyceryl trinitrate per hour (4.8 mg/24 h).

Each Cardioplast 0.4 mg/h transdermal patch contains 41.4 mg of glyceryl trinitrate in a patch size of

14.8 cm

, releasing 0.4 mg of glyceryl trinitrate per hour (9.6 mg/24 h).

Each Cardioplast 0.6 mg/h transdermal patch contains 62.2 mg of glyceryl trinitrate in a patch size of

22.2 cm

, releasing 0.6 mg of glyceryl trinitrate per hour (14.4 mg/24 h).

The other ingredients are acrylic adhesive (containing 2- ethylhexylacrylate, vinyl acetate, acrylic acid

and aluminium (tris)acetylacetoneate), polyolefin film, white printing ink, silicone-coated polyester

film.

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What Cardioplast looks like and contents of the pack

Cardioplast is a translucent rectangular patch with rounded corners printed with the following:

“Glyceryl trinitrate 0.2 mg/h (5mg/24 h)”

“Glyceryl trinitrate 0.4 mg/h (10mg/24 h)”

“Glyceryl trinitrate 0.6 mg/h (15mg/24 h)”

The patch is covered by a transparent protective liner, which is removed prior to application to expose

the sticky back so that it can be stuck onto the skin.

Patches are individually packaged in sachets constructed from Paper/LDPE/Aluminium foil/LDPE

film and contained in a cardboard carton, in pack sizes of 7, 10, 15, 28, 30 and 100 transdermal

patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

McDermott Laboratories Ltd. T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13, Ireland

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the EEA

under the following names:

Belgium:

Nitroglycerine Jenson 5 10 15 mg/24 h pleisters voor transdermaal gebruik

France:

TRINITRINE MYLAN PHARMA 5 10 15 mg/24 heures, dispositif

transdermique

Greece:

Glyceryl Trinitrate / Mylan Transdermal Patch 0.2, 0.4, 0.6 mg/h

Ireland:

Cardioplast

Italy:

Nitroglicerina Mylan

Netherlands:

Nitroglycerine Pleister Mylan 5 10 15 pleister voor transdermaal gebruik 0,2

mg/uur, 0,4 mg/uur, 0,6 mg/uur

Portugal:

Nitroglicerina Mylan

Spain:

Nitroglicerina Mylan 5 mg 10mg 15mg parches transdérmicos EFG

This leaflet was last revised in: 06/ 2013.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cardioplast 0.6mg/h transdermal patches

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Glyceryl trinitrate

Each Cardioplast 0.6mg/h transdermal patch contains 62.2 mg of glyceryl trinitrate in a patch size of 22.2 cm

releasing 0.6 mg of glyceryl trinitrate per hour (14.4 mg/24 h).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Transdermal Patch

A translucent rectangular patch with rounded corners, marked with “Glyceryl trinitrate” and the release rate. The

following is printed on each patch:

“Glyceryl trinitrate 0.6 mg/h (15mg/24 h)”

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For prophylaxis of angina pectoris either alone or in combination with other anti-anginal therapy.

4.2 Posology and method of administration

Posology

Adults including elderly patients:

Cardioplast transdermal patch it is not indicated for the immediate treatment of an acute anginal attacks. If anginal

attacks occur, rapid-acting nitrate preparations (like spray) should be used.

In order to avoid an attenuation of effect, in patients being treated with sustained release nitrate preparations,

intermittent therapy is recommended.

The recommended initial dose is one Cardioplast 0.2 mg/h equivalent to 5 mg/24 h patch applied to the skin once daily

for a period of approximately 12 hours. The patch is then removed to provide a nitrate-free interval of at least 8 hours

which may be increased up to 12 hours to suit individual patients (a daily patch-off period of 8-12 hours).

In case of insufficient efficacy, the posology can be progressively increased to one Cardioplast 0.4 mg/h equivalent to

10 mg/24 h patch once daily, and if necessary to a maximum of one Cardioplast 0.6 mg/h equivalent to 15 mg/24 h

patch daily.

Maximum dose is one Cardioplast 0.6 mg/h patch in each 24 hour period (15mg/24 h).

The nitrate-free interval should correspond to a time period when patient does not usually experience crises, and should

be covered by another anti-anginal treatment (beta-blocker or calcium channel blocker). This may be especially of

relevance in patients with severe angina.

Prescribers should clearly mention on the prescription the hours of application and removal of the patch.

Continuous administration may exceptionally be appropriate for patients in whom clinical responsiveness can be

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reliably assessed.

Patients experiencing nocturnal angina may benefit from overnight treatment with a nitrate-free interval during the day.

In this patient group additional anti-anginal therapy may be needed during the day.

Paediatric patients:

Safety and efficacy of glyceryl trinitrate have not been established in children and adolescents.

Therefore,

the use of

glyceryl trinitrate is not recommended in these populations.

Method of administration

Cardioplast transdermal patches may be applied to any convenient skin area; the recommended site is the chest or outer

upper arm. Application sites should be rotated and hair on suitable areas may beif necessary clipped as close to the skin

as possible but not shaved.

Cardioplast transdermal patches should not be applied to the distal part of the extremities.

Instructions for use

Cardioplast transdermal patches are applied only to intact skin after removal from protective sachet. The clear peelable

liner on the adhesive side of the patch has a slit which divides it into two strips. Hold the patch with the wording away

from the user and with the slit facing the user. Bend the edges away to break open the clear liner. The halves of the

cover are peeled off, being careful not to touch the sticky side of the patch, and the patch applied firmly to the skin.

Hands should be washed thoroughly after application.

Patients should be advised to dispose of patches carefully to avoid accidental application or use.

4.3 Contraindications

Hypersensitivity to the active substance, related organic nitrates or to any of the excipients listed in section 6.1

Marked anaemia

Acute circulatory failure associated with marked hypotension (shock)

Severe hypotension (systolic blood pressure less than 90 mmHg)

Severe hypovolaemia

Conditions associated with elevated intracranial pressure e.g. cerebral haemorrhage, head trauma

Myocardial insufficiency due to obstruction, as in aortic or mitral stenosis or left ventricular outflow obstruction,

hypertrophic obstructive cardiomyopathy, cardiac tamponade, constrictive pericarditis

Closed-angle glaucoma

Concomitant use of Cardioplast transdermal patches and phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil,

tadalafil, vardenafil are contraindicated, because PDE5 inhibitors may amplify the vasodilatory effects of Cardioplast

resulting in severe hypotension.

4.4 Special warnings and precautions for use

Cardioplast is not indicated for the immediate treatment of acute anginal attacks.

As with other nitrate preparations, when transferring the patient on long-term therapy to another form of medication,

glyceryl trinitrate should be gradually withdrawn and overlapping treatment started.

Cardioplast transdermal patch must be removed before applying magnetic or electrical fields to the body during

procedures such as MRI (Magnetic Resonance Imaging), cardioversion or DC defibrillation, or diathermy treatment.

Caution should be

exercised in patients

suffering from hypothyroidism,

malnutrition,

severe

renal

hepatic

impairment, hypothermia and recent history of myocardial infarction.

In cases of recent myocardial infarction or acute or congestive heart failure, treatment with Cardioplast transdermal

patch should be carried out cautiously under strict medical surveillance and/or haemodynamic monitoring.

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In some patients severe hypotension may occur particularly with upright posture, even with small doses of glyceryl

trinitrate. Thus Cardioplast should be used with caution in patients who may have volume depletion from diuretic

therapy and in patients who have low systolic blood pressure. See also section 4.3

Paradoxical bradycardia and increased angina may accompany glyceryl-trinitrate-induced hypotension.

Removal of the patch should be considered as part of the management of patients who develop significant hypotension.

Severe postural

hypotension with light-headedness and dizziness is frequently observed after

the consumption of

alcohol by patients being treated with glyceryl trinitrate.

Hypoxaemia:

Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia (including G6PD deficiency

induced forms), because in such patients the biotransformation of glyceryl trinitrate is reduced. Similarly, caution is

called for in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart

failure. In patients with alveolar hypoventilation a vasoconstriction occurs within the lung to shift perfusion from areas

of alveolar hypoxia to better ventilated regions of the lung (Euler-Liljestrand mechanism).Patients with angina pectoris,

myocardial infarction, or cerebral ischaemia frequently suffer from abnormalities of the small airways (especially

alveolar hypoxia). Under these circumstances vasoconstriction occurs within the lung to shift perfusion from areas of

alveolar hypoxia to better ventilated regions of the lung. As a potent vasodilator, glyceryl trinitrate could reverse this

protective vasoconstriction and thus result in increased perfusion of poorly ventilated areas, worsening of the

ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.

Hypertrophic cardiomyopathy:

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Increased angina:

The possibility of increased frequency of angina during patch-off periods should be considered. In such cases the use of

concomitant anti-anginal therapy is desirable.

Tolerance to sublingual glyceryl trinitrate:

As tolerance to glyceryl trinitrate patches develops, the effect of sublingual glyceryl trinitrate on exercise tolerance may

be partially diminished.

This product should be used with extreme caution in patients pre-disposed to closed angle glaucoma.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions resulting in a concomitant use contraindicated:

Concomitant administration of Cardioplast transdermal patch and other vasodilators (e.g. PDE5 inhibitors such as

sildenafil, tadalafil, vardenafil potentiates the blood-pressure-lowering effect of Cardioplast transdermal patch.

Interactions to be considered:

Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic

antidepressants and major tranquillisers may potentiate the blood-pressure-lowering effect of Cardioplast transdermal

patch, as may alcohol.

Concurrent administration of Cardioplast transdermal patch with dihydroergotamine may increase the bioavailability of

dihydroergotamine. This warrants special attention in patients with coronary artery disease, because dihydroergotamine

antagonises the effect of glyceryl trinitrate and may lead to coronary vasoconstriction.

Non-steroidal anti-inflammatory drugs, with the exception of acetyl salicylic acid, may diminish the therapeutic

response of Cardioplast transdermal patch.

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Concurrent administration of Cardioplast transdermal patch with amifostine and acetyl salicylic acid may potentiate the

blood pressure lowering effects of Cardioplast transdermal patch.

4.6 Fertility, pregnancy and lactation

Fertility

There is no data available on the effect of Cardioplast transdermal patch on fertility in humans.

Animal

data do not

indicate a risk of adverse effects on fertility.

Pregnancy

Results from animal reproductive toxicity studies do not indicate a risk of adverse effects on embryo-foetal

development. It is not known whether glyceryl trinitrate in transdermal form can affect reproductive capacity or cause

foetal harm in humans. Thus Cardioplast should only be administered to pregnant women if the potential benefit to the

mother clearly outweighs the potential hazard to the foetus. Caution should be advised during the first trimester of

pregnancy.

Breast-feeding

It is not known whether glyceryl trinitrate is excreted in human milk. Caution should therefore be exercised when

Cardioplast is administered to nursing mothers.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cardioplast transdermal

patch therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

4.7 Effects on ability to drive and use machines

Cardioplast transdermal patch has moderate influence on the ability to drive and use machines.

Especially at the start of treatment or dose adjustments, Cardioplast transdermal patch may impair the reactions or

might rarely cause orthostatic hypotension and dizziness (as well as exceptionally syncope after overdosing). Patients

experiencing these effects should refrain from driving or using machines.

4.8 Undesirable effects

Adverse drug reactions are listed by MedDRA System-Organ Class (SOC).

Within each System-Organ Class the

adverse drug reactions are ranked by frequency, with the most frequent first. Within each frequency grouping, adverse

drug reactions are ranked in order of decreasing seriousness. In addition, the corresponding frequency category, using

the following convention (CIOMS III): Very common (

1/10); common (

1/100 to < 1/10); uncommon (

1/1,000 to

< 1/100);

rare (

1/10,000 to < 1/1000);

very rare (< 1/10,000);

known (cannot

be estimated from the available

data).

System Organ

Class

Very

Common

Common

Uncommon

Rare

Very

Rare

Not known

Nervous system

disorders

Headache

Dizziness

Cardiac

disorders

Tachycardia

Palpitation

Vascular

disorders

Orthostatic

hypotension,

Flushing

Gastrointestinal

disorders

Nausea,

Vomiting

Skin and

subcutaneous

tissue disorders

Contact

dermatitis

Rash

generalised

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Like other nitrate preparations, Cardioplast transdermal patch commonly causes dose-dependent headaches due to

cerebral vasodilatation. These often regress after a few days despite the maintenance of therapy. If headaches persist

during intermittent therapy, they should be treated with mild analgesics. Unresponsive headaches are an indication for

reducing the dosage of glyceryl trinitrate or discontinuing treatment.

A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to combined treatment with a

beta-blocker.

Upon removal of the patch, any slight reddening of the skin will usually disappear within a few hours. The application

site should be changed regularly to prevent local irritation.

The adverse drug reactions have been derived from post-marketing experience with Cardioplast via spontaneous case

reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is

not possible to reliably estimate their frequency which is therefore categorized as not known.

4.9 Overdose

Signs

High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to collapse and syncope.

Methaemoglobinaemia has also been reported following accidental overdosage.

Management

The nitrate effect of Cardioplast can be rapidly terminated by removal of the patch or reduction of dose, depending on

severity.

Thorough scrubbing of underlying skin may reduce absorption more quickly after removal.

Intravenous infusion of

normal saline or similar fluid may be necessary to increase the central fluid volume. Any fall in blood pressure or signs

of collapse that may occur may be managed by general supportive or resuscitative measures. These include elevation,

necessary,

compression bandaging of

the patient’s legs.

Adrenaline and related products are ineffective in

reversing the severe hypotensive events associated with overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilators used in cardiac disease, ATC code: C01D A02.

Glyceryl trinitrate, (as other organic nitrates), is a potent dilator of vascular smooth muscle. The effect on veins

predominates over that on arteries resulting in decreased cardiac preload. Systemic vascular resistance is relatively

unaffected, heart rate is unchanged or slightly increased and pulmonary vascular resistance is consistently reduced.

In normal individuals or those with coronary artery disease (in the absence of heart failure)

glyceryl trinitrate decreases cardiac output slightly. Doses which do not alter systemic arterial pressure often produce

arteriolar dilatation in the face and neck resulting in flushing.

Dilatation of the meningeal arterioles may explain the

headache which is often reported. Rapid administration of high doses of glyceryl trinitrate decreases blood pressure and

cardiac output resulting in pallor, weakness, dizziness and activation of compensatory sympathetic reflexes. A marked

hypotensive effect may occasionally occur especially in the upright position.

General

disorders and

administration

site conditions

Application site

erythema,

Pruritus,

Burning,

Irritation

Investigations

Heart rate

increase

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5.2 Pharmacokinetic properties

Glyceryl trinitrate is rapidly hydrolysed by liver enzymes which are a major factor in bioavailability. Orally

administered glyceryl trinitrate is ineffective as a therapeutic agent due to first-pass metabolism and administration has

therefore routinely been via the sub-lingual route thus bypassing the hepatic circulation initially. Peak concentrations of

glyceryl trinitrate following sub-lingual administration occur within 4 minutes in man with a half-life of 1 to 3 minutes.

Transdermal delivery systems provide an alternative route to bypass the hepatic circulation with longer term gradual

absorption providing prophylactic dosing. Steady state plasma concentrations of approximately 200 pg/ml are achieved

within approximately 2 hours of application of Cardioplast

and are maintained for 24 hours. Rate of absorption is

controlled by the skin.

5.3 Preclinical safety data

Glyceryl trinitrate showed mutagenic activity against one strain of Salmonella typhimurium and carcinogenicity in an

oral long term study in rats, with increased incidence of hepatocellular carcinomas and interstitial tumours of the testis.

However,

carcinogenicity in rats

occurred at

high doses,

and glyceryl

trinitrate was

carcinogenic in mice.

Moreover,

was not

mutagenic against

other bacterial

strains and in other tests,

including in vivo tests.

The risk of

carcinogenicity following the therapeutic use of the medicinal product is considered negligible.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acrylic adhesive containing 2- ethylhexylacrylate, vinyl acetate, acrylic acid and aluminium (tris)acetylacetoneate

Polyolefin film

White printing ink

Silicone-coated polyester film

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 30ºC.

6.5 Nature and contents of container

Patches are individually packaged in sachets constructed from Paper/LDPE/Aluminium foil/LDPE film and contained

in a cardboard carton.

Pack sizes: 7, 10, 15, 28, 30 and 100 transdermal patches

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Cardioplast transdermal patch should be used according to the instruction under section 4.2.

Patients should be advised to dispose of patches carefully to avoid accidental application or use.

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7 MARKETING AUTHORISATION HOLDER

McDermott Laboratories Limited

T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

8 MARKETING AUTHORISATION NUMBER

PA577/174/3

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 19

July 2013

10 DATE OF REVISION OF THE TEXT

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