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GLYCERYL TRINITRATE SPRAY

Active substance(s): GLYCERYL TRINITRATE / GLYCERYL TRINITRATE / GLYCERYL TRINITRATE

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Package leaflet: Information for the user

Glyceryl Trinitrate Spray
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
1 What Glyceryl Trinitrate Spray is and what it
is used for
2 What you need to know before you use
Glyceryl Trinitrate Spray
3 How to use Glyceryl Trinitrate Spray
4 Possible side effects
5 How to store Glyceryl Trinitrate Spray
6 Contents of the pack and other information
1 What Glyceryl Trinitrate Spray is and what it

is used for

Glyceryl Trinitrate Spray is a smooth muscle relaxant. The
walls of many of the body’s veins and arteries are made of
smooth muscle, and so glyceryl trinitrate helps to widen
these vessels.
When you spray Glyceryl Trinitrate Spray under your tongue
it is quickly absorbed in the bloodstream. The action of
Glyceryl Trinitrate Spray allows blood to flow more quickly
and more easily. This means that your heart does not need
to work so hard. The greater blood flow through the heart
also means that the heart works more efficiently. These
actions of glyceryl trinitrate bring relief in an attack of
angina and can prevent an attack coming on.
Glyceryl Trinitrate Spray is for the relief and prevention of
angina attacks (chest pains).
2 What you need to know before you use

Glyceryl Trinitrate Spray

Do not use Glyceryl Trinitrate Spray if you:
•A
 re allergic to glyceryl trinitrate, to other nitrates, or any of
the other ingredients of this medicine (listed in section 6)
(you have previously had swelling of the face, extremities,
lips, inside of the mouth, tongue, glottis and/or larynx
while using any of the nitrate preparations)
•H
 ave marked hypotension (low blood pressure with a
systolic pressure below 90mmHg)
•H
 ave too little circulating blood (due to blood loss or
dehydration)
• S uffer from conditions where your heart is unable to
supply enough oxygenated blood to the rest of your body
(cardiac shock or left sided heart failure)
•H
 ave angina pectoris caused by hypertrophic, obstructive
cardiomyopathy (abnormal heart growth)
•H
 ave constrictive pericarditis (an inflammation of the
smooth membrane that surrounds the heart)
•H
 ave pericardial tamponade (an accumulation of fluid in
the sac that surrounds the heart)
•H
 ave aortic and mitral stenosis (heart valve disease)
• S uffer from primary pulmonary hypertension (an
increased resistance to blood flow through the lungs)
•H
 ave had a heart attack with low blood supply to the heart
•A
 re very anaemic
• T ake sildenafil, tadalafil or vardenafil (these drugs are used
for the treatment of male impotence)
• S uffer from any condition with possible raised pressure
within your head including that caused by an accident.

Warnings and precautions

Talk to your doctor or pharmacist before using Glyceryl
Trinitrate Spray.
• If you are prone to postural hypotension (low blood
pressure) which can lead to dizziness and/or fainting on
sitting up or standing up

• If you suffer from narrow angle glaucoma (increased
pressure in the eye), or migraine
• If you suffer from liver disease, alcoholism, epilepsy,
cerebral trauma and other nervous system diseases (the
spray contains small amounts of alcohol and may be
harmful to patients with the above conditions)
• If you suffer from a disease of the blood vessels supplying
the brain (cerebrovascular disease)
• If you suffer from lung disease or lung disease related
heart disease
• If you had a recent heart attack (myocardial infarction).
If your dose is increased, you may become tolerant to this
medicine (where you need to use higher doses to prevent
or relieve the symptoms of an angina attack) or to other
medicines containing nitrates.
If this medicine does not work it may be an early sign of
a myocardial infarction (heart attack). If this occurs, you
should see your doctor immediately or go to the casualty
department.
Tell your doctor or nurse that you are using this medicine
if you are having blood or urine tests, as it may affect the
results.

Children

The use of Glyceryl Trinitrate Spray is not recommended for
children.

Other medicines and Glyceryl Trinitrate Spray
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Never use Glyceryl Trinitrate Spray with:
• S ildenafil, vardenafil or tadalafil containing erectile
dysfunction medicines. The blood-pressure lowering effect
of Glyceryl Trinitrate Spray may be increased, possibly
resulting in collapse, unconsciousness and even death.
Take care when using Glyceryl Trinitrate Spray with:
•M
 edicines with blood pressure lowering effect, such
as vasodilators and other antihypertensive agents,
neuroleptics (used to treat mental illness), drugs used to
treat depression (e.g. tricyclic antidepressants), sapropterin
(used to treat phenylketonuria) and N-acetylcysteine
(amino acid supplement). Any one of these medicines
could increase the blood pressure lowering effect of
glyceryl trinitrate.
•D
 ihydroergotamine containing medicines for the
treatment of abnormal bleeding from the female
reproductive system as the effect of this drug can be
increased by glyceryl trinitrate.
•H
 eparin containing blood-thinning medicines (the
effectiveness of heparin may decrease).
You may need a higher dose of glyceryl trinitrate if you
have been previously treated with long-acting nitrates (e.g.
isosorbide-dinitrate, isosorbide mononitrate).
If your doctor has prescribed tablets to be placed under the
tongue for your angina, you should not use your spray for
the same attack.

Glyceryl Trinitrate Spray with alcohol

Consumption of alcoholic beverages during the use of this
medicine is strictly forbidden as some of the side effects
may be worse than usual (see section 4).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
Glyceryl Trinitrate Spray should only be used in women
during pregnancy or breast-feeding, if the doctor considers
that the benefit for the mother exceeds any possible risk to
the baby.

Driving and using machines

It is not recommended to drive or use machinery when you
start using this product as the hypotensive (blood pressure
lowering) effect may lead to dizziness and/or feeling faint or
unwell. After you have got used to the spray, it may be that
you have no problems and are able to drive safely.

Continued top of the next column
BBBA0055

Continued over page

Glyceryl Trinitrate Spray 400mcg 180 Dose PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0055

Originator:
Origination Date: 30.09.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
30.09.16
Date received:

Dimensions:
165 x 300
Min Body Text Size: 8pts
Supplier:
Egis

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Glyceryl Trinitrate Spray contains small amounts
of ethanol (alcohol) and propylene glycol
This product contains 79.2 volume% of ethanol (alcohol).
Each dose (spray) contains up to 0.04 g of alcohol. This
product may be harmful for patients suffering from liver
disease, alcoholism, epilepsy, brain injury or disease.
Propylene glycol may cause skin irritation.

Uncommon (may affect up to 1 in 100 people)
• S yncope (loss of consciousness)
• S low heart beat
• F acial flushing
•C
 irculatory collapse (failure of the blood circulation)
•N
 ausea (feeling sick)
•V
 omiting (being sick)
Very rare (may affect up to 1 in 10,000 people)
•R
 estlessness
•H
 eartburn
•B
 ad breath
•D
 ifficulty breathing
• S kin rash

3 How to use Glyceryl Trinitrate Spray
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Before using the spray for the first time, check that the
pump is working by pressing the pump button a few times
until it produces a fine mist of liquid. Practice aiming the
spray onto a tissue or similar item so that you will be able
to aim it correctly under the tongue (sublingual use) when
you need to use it. If you do not need to use the spray very
often, remember to check the pump regularly to see that it
still works properly.
If possible, sit down before using your spray. Rest or sit
quietly, as you may feel faint or dizzy otherwise, particularly
if you are elderly. Take off the plastic cap and hold the spray
bottle upright. There is no need to shake the canister before
dosing.
The spray outlet should then be placed close to the mouth.
Hold your breath for a moment to avoid breathing in the
spray, then open your mouth and spray a dose under
your tongue by pressing down on the pump button then
letting go. The mouth should be closed immediately after
each dose (spray). The spray should not be breathed in. It is
useful to become aware of the position of the spray outlet
so that its using at night can be easily achieved.
At the onset of an attack use one or two doses (sprays)
under your tongue, and then immediately close your
mouth before breathing normally through your nose again.
If symptoms do not resolve, this dose may be repeated at
five minute intervals for a total of three doses (sprays).

*Particularly upon initiation of therapy and following an
increase in dose. The first dose, or the first higher dose, may
cause a blood pressure drop and/or postural hypotension
(fainting or feeling faint when standing up or getting out
of bed), tachycardia (your heart may seem to speed up),
dizziness and weakness.
The following side effects may also occur in approximately
30-40% of patients: taste disturbance (metallic taste), mild
burning or stinging sensation in the mouth or tongue, and
palpitations (feeling your heartbeat). These are usually mild
and disappear within a few minutes.
Headache may occur at the beginning of the treatment.
Sometimes the heart rate may slow and even lead to
feeling faint or actually fainting.

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 via the Yellow
Card Scheme (Website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.
5 How to store Glyceryl Trinitrate Spray

If symptoms have not resolved after a total of three doses
(sprays), seek prompt medical attention.

Store below 25ºC, in the original package in order to protect
from light and radiant heat!

For the prevention of an attack use one or two doses
(sprays) immediately before the event.

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

Put the cap back on the spray bottle.
If you are not sure how to use the spray, ask your
pharmacist to show you.

If you use more Glyceryl Trinitrate Spray than you
should

Do not use this medicine after the expiry date which is
stated on the carton and on the base of the canister.
This medicinal product is flammable, explosive. Storage
and application near open fire and while smoking are
forbidden.

If you use too many sprays some of the side effects (see
below) may be worse than usual.
In this case you should see your doctor immediately.

Do not use it near to anyone that is smoking; or spray the
product into a naked flame or onto a hot surface.
Do not pierce or burn the canister after use.

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

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some people are more sensitive to the effects of glyceryl
trinitrate than others.
If you experience one of the following side effects, stop
using the spray and consult your doctor immediately:
•A
 llergic skin reactions or in some cases hypersensitivity
reactions and exfoliative dermatitis (itchy, scaling skin
rash) may appear.
•W
 orsened angina pectoris symptoms (increase of chest
pain). In cases where there is a large fall in blood pressure,
this medicine may make the symptoms of angina worse
(may affect up to 1 in 100 people).
•C
 yanosis (blue or purple coloration of the skin or mucous
membranes due to the tissues near the skin surface being
low on oxygen) (may affect up to 1 in 100 people).
•M
 ethaemoglobinaemia (a blood disorder where oxygen
cannot be released effectively to parts of your body)
causes bluish skin colouring, headache, tiredness and lack
of energy or shortness of breath (may affect up to 1 in
10,000 people).
•D
 ecreased blood flow to the brain (may affect up to 1 in
10,000 people).
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)
•H
 eadache
Common (may affect up to 1 in 10 people)
•D
 izziness
•D
 rowsiness
• F ast heart beat
•D
 ecreased blood pressure*
• F all of blood pressure when standing up or sitting up*
•W
 eakness

6 Contents of the pack and other information

What Glyceryl Trinitrate Spray contains

The active substance is 400 micrograms glyceryl trinitrate
per spray.
The other ingredients are ethanol and propylene glycol and
a particle-free solution in a CFC-free spray.

What Glyceryl Trinitrate Spray looks like and
contents of the pack

The aluminium canister is equipped with a metered dose
valve and a protective cap. Each canister containing 10g of
solution is designed to deliver at least 180 doses.
Appearance: Colourless or almost colourless, clear solution,
free from sediments.
Marketing Authorisation Holder
EGIS Pharmaceuticals UK Ltd.
127 Shirland Road
London
W9 2EP
United Kingdom
Manufacturer
EGIS Pharmaceuticals PLC
Mátyás Király út 65.
Körmend
H-9900
Hungary
Distributor
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in October 2016
PL 18190/0013

Actavis, Barnstaple, EX32 8NS, UK

Continued top of the next column
BBBA0055

Glyceryl Trinitrate Spray 400mcg 180 Dose PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0055

Originator:
Origination Date: 30.09.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
30.09.16
Date received:

Dimensions:
165 x 300
Min Body Text Size: 8pts
Supplier:
Egis

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Package leaflet: Information for the user

Glyceryl Trinitrate Spray
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
1 What Glyceryl Trinitrate Spray is and what it
is used for
2 What you need to know before you use
Glyceryl Trinitrate Spray
3 How to use Glyceryl Trinitrate Spray
4 Possible side effects
5 How to store Glyceryl Trinitrate Spray
6 Contents of the pack and other information
1 What Glyceryl Trinitrate Spray is and what it

is used for

Glyceryl Trinitrate Spray is a smooth muscle relaxant. The
walls of many of the body’s veins and arteries are made of
smooth muscle, and so glyceryl trinitrate helps to widen
these vessels.
When you spray Glyceryl Trinitrate Spray under your tongue
it is quickly absorbed in the bloodstream. The action of
Glyceryl Trinitrate Spray allows blood to flow more quickly
and more easily. This means that your heart does not need
to work so hard. The greater blood flow through the heart
also means that the heart works more efficiently. These
actions of glyceryl trinitrate bring relief in an attack of
angina and can prevent an attack coming on.
Glyceryl Trinitrate Spray is for the relief and prevention of
angina attacks (chest pains).
2 What you need to know before you use

Glyceryl Trinitrate Spray

Do not use Glyceryl Trinitrate Spray if you:
•A
 re allergic to glyceryl trinitrate, to other nitrates, or any of
the other ingredients of this medicine (listed in section 6)
(you have previously had swelling of the face, extremities,
lips, inside of the mouth, tongue, glottis and/or larynx
while using any of the nitrate preparations)
•H
 ave marked hypotension (low blood pressure with a
systolic pressure below 90mmHg)
•H
 ave too little circulating blood (due to blood loss or
dehydration)
• S uffer from conditions where your heart is unable to
supply enough oxygenated blood to the rest of your body
(cardiac shock or left sided heart failure)
•H
 ave angina pectoris caused by hypertrophic, obstructive
cardiomyopathy (abnormal heart growth)
•H
 ave constrictive pericarditis (an inflammation of the
smooth membrane that surrounds the heart)
•H
 ave pericardial tamponade (an accumulation of fluid in
the sac that surrounds the heart)
•H
 ave aortic and mitral stenosis (heart valve disease)
• S uffer from primary pulmonary hypertension (an
increased resistance to blood flow through the lungs)
•H
 ave had a heart attack with low blood supply to the heart
•A
 re very anaemic
• T ake sildenafil, tadalafil or vardenafil (these drugs are used
for the treatment of male impotence)
• S uffer from any condition with possible raised pressure
within your head including that caused by an accident.

Warnings and precautions

Talk to your doctor or pharmacist before using Glyceryl
Trinitrate Spray.
• If you are prone to postural hypotension (low blood
pressure) which can lead to dizziness and/or fainting on
sitting up or standing up

• If you suffer from narrow angle glaucoma (increased
pressure in the eye), or migraine
• If you suffer from liver disease, alcoholism, epilepsy,
cerebral trauma and other nervous system diseases (the
spray contains small amounts of alcohol and may be
harmful to patients with the above conditions)
• If you suffer from a disease of the blood vessels supplying
the brain (cerebrovascular disease)
• If you suffer from lung disease or lung disease related
heart disease
• If you had a recent heart attack (myocardial infarction).
If your dose is increased, you may become tolerant to this
medicine (where you need to use higher doses to prevent
or relieve the symptoms of an angina attack) or to other
medicines containing nitrates.
If this medicine does not work it may be an early sign of
a myocardial infarction (heart attack). If this occurs, you
should see your doctor immediately or go to the casualty
department.
Tell your doctor or nurse that you are using this medicine
if you are having blood or urine tests, as it may affect the
results.

Children

The use of Glyceryl Trinitrate Spray is not recommended for
children.

Other medicines and Glyceryl Trinitrate Spray
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Never use Glyceryl Trinitrate Spray with:
• S ildenafil, vardenafil or tadalafil containing erectile
dysfunction medicines. The blood-pressure lowering effect
of Glyceryl Trinitrate Spray may be increased, possibly
resulting in collapse, unconsciousness and even death.
Take care when using Glyceryl Trinitrate Spray with:
•M
 edicines with blood pressure lowering effect, such
as vasodilators and other antihypertensive agents,
neuroleptics (used to treat mental illness), drugs used to
treat depression (e.g. tricyclic antidepressants), sapropterin
(used to treat phenylketonuria) and N-acetylcysteine
(amino acid supplement). Any one of these medicines
could increase the blood pressure lowering effect of
glyceryl trinitrate.
•D
 ihydroergotamine containing medicines for the
treatment of abnormal bleeding from the female
reproductive system as the effect of this drug can be
increased by glyceryl trinitrate.
•H
 eparin containing blood-thinning medicines (the
effectiveness of heparin may decrease).
You may need a higher dose of glyceryl trinitrate if you
have been previously treated with long-acting nitrates (e.g.
isosorbide-dinitrate, isosorbide mononitrate).
If your doctor has prescribed tablets to be placed under the
tongue for your angina, you should not use your spray for
the same attack.

Glyceryl Trinitrate Spray with alcohol

Consumption of alcoholic beverages during the use of this
medicine is strictly forbidden as some of the side effects
may be worse than usual (see section 4).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
Glyceryl Trinitrate Spray should only be used in women
during pregnancy or breast-feeding, if the doctor considers
that the benefit for the mother exceeds any possible risk to
the baby.

Driving and using machines

It is not recommended to drive or use machinery when you
start using this product as the hypotensive (blood pressure
lowering) effect may lead to dizziness and/or feeling faint or
unwell. After you have got used to the spray, it may be that
you have no problems and are able to drive safely.

Continued top of the next column
BBBA0058

Continued over page

Glyceryl Trinitrate Spray 400mcg 200 Dose PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0058

Originator:
Origination Date: 30.09.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
30.09.16
Date received:

Dimensions:
165 x 300
Min Body Text Size: 8pts
Supplier:
Egis Pharma

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Glyceryl Trinitrate Spray contains small amounts
of ethanol (alcohol) and propylene glycol
This product contains 79.2 volume% of ethanol (alcohol).
Each dose (spray) contains up to 0.04 g of alcohol. This
product may be harmful for patients suffering from liver
disease, alcoholism, epilepsy, brain injury or disease.
Propylene glycol may cause skin irritation.

Uncommon (may affect up to 1 in 100 people)
• S yncope (loss of consciousness)
• S low heart beat
• F acial flushing
•C
 irculatory collapse (failure of the blood circulation)
•N
 ausea (feeling sick)
•V
 omiting (being sick)
Very rare (may affect up to 1 in 10,000 people)
•R
 estlessness
•H
 eartburn
•B
 ad breath
•D
 ifficulty breathing
• S kin rash

3 How to use Glyceryl Trinitrate Spray
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Before using the spray for the first time, check that the
pump is working by pressing the pump button a few times
until it produces a fine mist of liquid. Practice aiming the
spray onto a tissue or similar item so that you will be able
to aim it correctly under the tongue (sublingual use) when
you need to use it. If you do not need to use the spray very
often, remember to check the pump regularly to see that it
still works properly.
If possible, sit down before using your spray. Rest or sit
quietly, as you may feel faint or dizzy otherwise, particularly
if you are elderly. Take off the plastic cap and hold the spray
bottle upright. There is no need to shake the canister before
dosing.
The spray outlet should then be placed close to the mouth.
Hold your breath for a moment to avoid breathing in the
spray, then open your mouth and spray a dose under
your tongue by pressing down on the pump button then
letting go. The mouth should be closed immediately after
each dose (spray). The spray should not be breathed in. It is
useful to become aware of the position of the spray outlet
so that its using at night can be easily achieved.
At the onset of an attack use one or two doses (sprays)
under your tongue, and then immediately close your
mouth before breathing normally through your nose again.
If symptoms do not resolve, this dose may be repeated at
five minute intervals for a total of three doses (sprays).

*Particularly upon initiation of therapy and following an
increase in dose. The first dose, or the first higher dose, may
cause a blood pressure drop and/or postural hypotension
(fainting or feeling faint when standing up or getting out
of bed), tachycardia (your heart may seem to speed up),
dizziness and weakness.
The following side effects may also occur in approximately
30-40% of patients: taste disturbance (metallic taste), mild
burning or stinging sensation in the mouth or tongue, and
palpitations (feeling your heartbeat). These are usually mild
and disappear within a few minutes.
Headache may occur at the beginning of the treatment.
Sometimes the heart rate may slow and even lead to
feeling faint or actually fainting.

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 via the Yellow
Card Scheme (Website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.
5 How to store Glyceryl Trinitrate Spray

If symptoms have not resolved after a total of three doses
(sprays), seek prompt medical attention.

Store below 25ºC, in the original package in order to protect
from light and radiant heat!

For the prevention of an attack use one or two doses
(sprays) immediately before the event.

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

Put the cap back on the spray bottle.
If you are not sure how to use the spray, ask your
pharmacist to show you.

If you use more Glyceryl Trinitrate Spray than you
should

Do not use this medicine after the expiry date which is
stated on the carton and on the base of the canister.
This medicinal product is flammable, explosive. Storage
and application near open fire and while smoking are
forbidden.

If you use too many sprays some of the side effects (see
below) may be worse than usual.
In this case you should see your doctor immediately.

Do not use it near to anyone that is smoking; or spray the
product into a naked flame or onto a hot surface.
Do not pierce or burn the canister after use.

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

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some people are more sensitive to the effects of glyceryl
trinitrate than others.
If you experience one of the following side effects, stop
using the spray and consult your doctor immediately:
•A
 llergic skin reactions or in some cases hypersensitivity
reactions and exfoliative dermatitis (itchy, scaling skin
rash) may appear.
•W
 orsened angina pectoris symptoms (increase of chest
pain). In cases where there is a large fall in blood pressure,
this medicine may make the symptoms of angina worse
(may affect up to 1 in 100 people).
•C
 yanosis (blue or purple coloration of the skin or mucous
membranes due to the tissues near the skin surface being
low on oxygen) (may affect up to 1 in 100 people).
•M
 ethaemoglobinaemia (a blood disorder where oxygen
cannot be released effectively to parts of your body)
causes bluish skin colouring, headache, tiredness and lack
of energy or shortness of breath (may affect up to 1 in
10,000 people).
•D
 ecreased blood flow to the brain (may affect up to 1 in
10,000 people).
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)
•H
 eadache
Common (may affect up to 1 in 10 people)
•D
 izziness
•D
 rowsiness
• F ast heart beat
•D
 ecreased blood pressure*
• F all of blood pressure when standing up or sitting up*
•W
 eakness

6 Contents of the pack and other information

What Glyceryl Trinitrate Spray contains

The active substance is 400 micrograms glyceryl trinitrate
per spray.
The other ingredients are ethanol and propylene glycol and
a particle-free solution in a CFC-free spray.

What Glyceryl Trinitrate Spray looks like and
contents of the pack

The aluminium canister is equipped with a metered dose
valve and a protective cap. Each canister containing 11g of
solution is designed to deliver at least 200 doses.
Appearance: Colourless or almost colourless, clear solution,
free from sediments.
Marketing Authorisation Holder
EGIS Pharmaceuticals UK Ltd.
127 Shirland Road
London
W9 2EP
United Kingdom
Manufacturer
EGIS Pharmaceuticals PLC
Mátyás Király út 65.
Körmend
H-9900
Hungary
Distributor
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in October 2016
PL 18190/0013

Actavis, Barnstaple, EX32 8NS, UK

Continued top of the next column
BBBA0058

Glyceryl Trinitrate Spray 400mcg 200 Dose PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0058

Originator:
Origination Date: 30.09.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
30.09.16
Date received:

Dimensions:
165 x 300
Min Body Text Size: 8pts
Supplier:
Egis Pharma

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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