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GLYCERYL TRINITRATE SPRAY

Active substance: GLYCERYL TRINITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glyceryl Trinitrate Spray
Active substance: glyceryl trinitrate

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Glyceryl Trinitrate
Spray carefully to get the best results from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your symptoms
worsen or do not improve after taking the
product and resting for 10 to 15 minutes.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Glyceryl Trinitrate Spray is and what
it is used for
2 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 Further 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 BEFORE YOU USE GLYCERYL TRINITRATE
SPRAY
Do not use Glyceryl Trinitrate Spray if you:








Are allergic (hypersensitive) to glyceryl
trinitrate or any of the other ingredients
of the spray (see section 6)
Have marked hypotension (low blood
pressure with a systolic pressure below
90mmHg)
Have too little circulating blood (due to
blood loss or dehydration)
Suffer 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)
Have angina pectoris caused by
hypertrophic, obstructive cardiomyopathy
(abnormal heart growth)
Have constrictive pericarditis (an
inflammation of the smooth membrane that
surrounds the heart)

Continued top of the next column
L20278EIG-30









Have pericardial tamponade (an
accumulation of fluid in the sac that
surrounds the heart)
Have aortic and mitral stenosis (heart valve
disease)
Suffer from primary pulmonary hypertension
(an increased resistance to blood flow
through the lungs)
Have had a heart attack with low blood
supply to the heart
Are very anaemic
Take sildenafil, tadalafil or vardenafil (these
drugs are used for the treatment of male
impotence)
Suffer from any condition with raised
pressure within your head including that
caused by an accident

Take special care with Glyceryl Trinitrate
Spray and talk to your doctor





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 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).
If this medicine does not work it may be
an early sign of a myocardial infarction (heart
attack).
Please 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.
Taking other medicines
Never use Glyceryl Trinitrate Spray with:
• Sildenafil, vardenafil or tadalafil containing
erectile dysfunction preparations. The bloodpressure lowering effect of Glyceryl Trinitrate
Spray may be increased.
Take care when using Glyceryl Trinitrate Spray
with:
• Other vasodilators (medicines used to treat
hypertension, angina and heart failure, e.g.
ACE inhibitors or Calcium channel blockers),
antihypertensive agents (medicines which
help to lower blood pressure, e.g. Beta
blockers or Sympatholytics, Diuretics,
Renin-inhibitors) antipsychotics, sedatives,
sleeping pills, tricyclic and MAOI-type
antidepressants, baclofen (for the relief
of spasticity of muscles e.g. in multiple
sclerosis), levodopa (for Parkinsonism),
aldesleukin (for the treatment of kidney
cancer which has spread to other parts of the
body, as all of these drugs types may cause a
greater reduction of blood pressure
Continued over page



Dihydroergotamine containing preparations
for the treatment of abnormal bleeding from
the female reproductive system as the effect
of this drug can be increased by glyceryl
trinitrate
• Heparin containing blood-thinning
preparations (the effectiveness of heparin
may decrease)
Patients who have previously taken nitrates for
their condition (e.g. isosorbide mononitrate or
isosorbide dinitrate) may require higher doses
of this medicine (glyceryl trinitrate) to prevent
or relieve their symptoms.
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.
Using Glyceryl Trinitrate Spray with food and
drink
You should not drink alcohol while being treated
with Glyceryl Trinitrate Spray as some of the side
effects may be worse than usual (see section 4).
Pregnancy and breast-feeding
If you are pregnant, or think you may be
pregnant, or breast feeding, you should tell your
doctor before using this medicine. He/she can
then decide if you should use it.
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.
Important information about some of the
ingredients of Glyceryl Trinitrate Spray
This product contains 79.2 volume% of ethanol.
Each dose (2 sprays) contains up to 0.08g
of alcohol. This product may be harmful for
patients suffering from liver disease, alcoholism,
epilepsy, brain injury or disease.
3 HOW TO USE GLYCERYL TRINITRATE SPRAY
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 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.
Take off the plastic cap and hold the spray bottle
upright. 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.
Use one or two sprays (never more than three
within 15 minutes) and then immediately close
your mouth before breathing normally through
your nose again. Put the cap back on the spray
bottle.
If you are not sure how to use the spray, ask your
pharmacist to show you.

Some people are more sensitive to the effects
of glyceryl trinitrate than others.
• Rarely flushing and allergic skin reactions
or in some cases hypersensitivity reactions
and exfoliative dermatitis (itchy, scaling skin
rash) may appear. If you experience any
of these, stop using the spray and consult
your doctor immediately.
• Headache may occur at the beginning of the
treatment. Occasionally, 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.
• Application may cause a mild, temporary
burning sensation in the mouth.
• Rarely, nausea (feeling sick), vomiting (being
sick), heartburn may occur.
• Very rarely, in cases where there is a large fall
in blood pressure, this medicine may make
the symptoms of angina worse.
Sometimes the heart rate may slow and even
lead to feeling faint or actually fainting.
Usually these are mild and will stop after a few
minutes.
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5 HOW TO STORE GLYCERYL TRINITRATE
SPRAY
Keep out of the reach and sight of children.
Do not use Glyceryl Trinitrate Spray after the
expiry date which is stated on the carton and
on the base of the canister.
Do not store above 25°C (normal room
temperature).
Protect from sunlight.
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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
6 FURTHER INFORMATION
What Glyceryl Trinitrate Spray contains
The active substance is glyceryl trinitrate
0.8% w/w (400 micrograms per spray)
The other ingredients are ethanol and propylene
glycol.
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.
Marketing Authorisation Holder
EGIS Pharmaceuticals UK Ltd.
127 Shirland Road
London
W9 2EP
United Kingdom

If you use more Glyceryl Trinitrate Spray than
you should
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.

Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király út 65.
Körmend
H-9900
Hungary

4 POSSIBLE SIDE EFFECTS

Distributor
Actavis, Barnstaple, EX32 8NS, UK

Like all medicines, Glyceryl Trinitrate Spray can
cause side effects, although not everybody gets
them.
Continued top of the next column
L20278EIG-30

This leaflet was last approved in [05/2011].

Actavis, Barnstaple, EX32 8NS, UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glyceryl Trinitrate Spray
Active substance: glyceryl trinitrate

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Glyceryl Trinitrate
Spray carefully to get the best results from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your symptoms
worsen or do not improve after taking the
product and resting for 10 to 15 minutes.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Glyceryl Trinitrate Spray is and what
it is used for
2 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 Further 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 BEFORE YOU USE GLYCERYL TRINITRATE
SPRAY
Do not use Glyceryl Trinitrate Spray if you:








Are allergic (hypersensitive) to glyceryl
trinitrate or any of the other ingredients
of the spray (see section 6)
Have marked hypotension (low blood
pressure with a systolic pressure below
90mmHg)
Have too little circulating blood (due to
blood loss or dehydration)
Suffer 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)
Have angina pectoris caused by
hypertrophic, obstructive cardiomyopathy
(abnormal heart growth)
Have constrictive pericarditis (an
inflammation of the smooth membrane that
surrounds the heart)

Continued top of the next column
L20279EIG-30









Have pericardial tamponade (an
accumulation of fluid in the sac that
surrounds the heart)
Have aortic and mitral stenosis (heart valve
disease)
Suffer from primary pulmonary hypertension
(an increased resistance to blood flow
through the lungs)
Have had a heart attack with low blood
supply to the heart
Are very anaemic
Take sildenafil, tadalafil or vardenafil (these
drugs are used for the treatment of male
impotence)
Suffer from any condition with raised
pressure within your head including that
caused by an accident

Take special care with Glyceryl Trinitrate
Spray and talk to your doctor





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 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).
If this medicine does not work it may be
an early sign of a myocardial infarction (heart
attack).
Please 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.
Taking other medicines
Never use Glyceryl Trinitrate Spray with:
• Sildenafil, vardenafil or tadalafil containing
erectile dysfunction preparations. The bloodpressure lowering effect of Glyceryl Trinitrate
Spray may be increased.
Take care when using Glyceryl Trinitrate Spray
with:
• Other vasodilators (medicines used to treat
hypertension, angina and heart failure, e.g.
ACE inhibitors or Calcium channel blockers),
antihypertensive agents (medicines which
help to lower blood pressure, e.g. Beta
blockers or Sympatholytics, Diuretics,
Renin-inhibitors) antipsychotics, sedatives,
sleeping pills, tricyclic and MAOI-type
antidepressants, baclofen (for the relief
of spasticity of muscles e.g. in multiple
sclerosis), levodopa (for Parkinsonism),
aldesleukin (for the treatment of kidney
cancer which has spread to other parts of the
body, as all of these drugs types may cause a
greater reduction of blood pressure
Continued over page



Dihydroergotamine containing preparations
for the treatment of abnormal bleeding from
the female reproductive system as the effect
of this drug can be increased by glyceryl
trinitrate
• Heparin containing blood-thinning
preparations (the effectiveness of heparin
may decrease)
Patients who have previously taken nitrates for
their condition (e.g. isosorbide mononitrate or
isosorbide dinitrate) may require higher doses
of this medicine (glyceryl trinitrate) to prevent
or relieve their symptoms.
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.
Using Glyceryl Trinitrate Spray with food and
drink
You should not drink alcohol while being treated
with Glyceryl Trinitrate Spray as some of the side
effects may be worse than usual (see section 4).
Pregnancy and breast-feeding
If you are pregnant, or think you may be
pregnant, or breast feeding, you should tell your
doctor before using this medicine. He/she can
then decide if you should use it.
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.
Important information about some of the
ingredients of Glyceryl Trinitrate Spray
This product contains 79.2 volume% of ethanol.
Each dose (2 sprays) contains up to 0.08g
of alcohol. This product may be harmful for
patients suffering from liver disease, alcoholism,
epilepsy, brain injury or disease.
3 HOW TO USE GLYCERYL TRINITRATE SPRAY
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 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.
Take off the plastic cap and hold the spray bottle
upright. 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.
Use one or two sprays (never more than three
within 15 minutes) and then immediately close
your mouth before breathing normally through
your nose again. Put the cap back on the spray
bottle.
If you are not sure how to use the spray, ask your
pharmacist to show you.

Some people are more sensitive to the effects
of glyceryl trinitrate than others.
• Rarely flushing and allergic skin reactions
or in some cases hypersensitivity reactions
and exfoliative dermatitis (itchy, scaling skin
rash) may appear. If you experience any
of these, stop using the spray and consult
your doctor immediately.
• Headache may occur at the beginning of the
treatment. Occasionally, 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.
• Application may cause a mild, temporary
burning sensation in the mouth.
• Rarely, nausea (feeling sick), vomiting (being
sick), heartburn may occur.
• Very rarely, in cases where there is a large fall
in blood pressure, this medicine may make
the symptoms of angina worse.
Sometimes the heart rate may slow and even
lead to feeling faint or actually fainting.
Usually these are mild and will stop after a few
minutes.
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5 HOW TO STORE GLYCERYL TRINITRATE
SPRAY
Keep out of the reach and sight of children.
Do not use Glyceryl Trinitrate Spray after the
expiry date which is stated on the carton and
on the base of the canister.
Do not store above 25°C (normal room
temperature).
Protect from sunlight.
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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
6 FURTHER INFORMATION
What Glyceryl Trinitrate Spray contains
The active substance is glyceryl trinitrate
0.8% w/w (400 micrograms per spray)
The other ingredients are ethanol and propylene
glycol.
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.
Marketing Authorisation Holder
EGIS Pharmaceuticals UK Ltd.
127 Shirland Road
London
W9 2EP
United Kingdom

If you use more Glyceryl Trinitrate Spray than
you should
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.

Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király út 65.
Körmend
H-9900
Hungary

4 POSSIBLE SIDE EFFECTS

Distributor
Actavis, Barnstaple, EX32 8NS, UK

Like all medicines, Glyceryl Trinitrate Spray can
cause side effects, although not everybody gets
them.
Continued top of the next column
L20279EIG-30

This leaflet was last approved in [05/2011].

Actavis, Barnstaple, EX32 8NS, UK

Expand view ⇕

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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