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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 Have pericardial tamponade (an
contains important information for you. accumulation of fluid in the sac that
This medicine is available without prescription. surrounds the heart)
However, you still need to use Glyceryl Trinitrate Have aortic and mitral stenosis (heart valve
Spray carefully to get the best results from it. disease)
Keep this leaflet. You may need to read it Suffer from primary pulmonary hypertension
again. (an increased resistance to blood flow
Ask your pharmacist if you need more through the lungs)
information or advice. Have had a heart attack with low blood
You must contact a doctor if your symptoms supply to the heart
worsen or do not improve after taking the Are very anaemic
product and resting for 10 to 15 minutes. Take sildenafil, tadalafil or vardenafil (these
If any of the side effects gets serious, or if drugs are used for the treatment of male
you notice any side effects not listed in this impotence)
leaflet, please tell your doctor or pharmacist. Suffer from any condition with raised
pressure within your head including that
In this leaflet: caused by an accident
1 What Glyceryl Trinitrate Spray is and what Take special care with Glyceryl Trinitrate
it is used for Spray and talk to your doctor
2 Before you use Glyceryl Trinitrate Spray If you are prone to postural hypotension
3 How to use Glyceryl Trinitrate Spray (low blood pressure) which can lead to
4 Possible side effects dizziness and/or fainting on sitting up or
5 How to store Glyceryl Trinitrate Spray standing up
6 Further information If you suffer from narrow angle glaucoma
(increased pressure in the eye), or migraine
1 WHAT GLYCERYL TRINITRATE SPRAY IS If you suffer from liver disease, alcoholism,
AND WHAT IT IS USED FOR epilepsy, cerebral trauma and other nervous
system diseases (the spray contains small
Glyceryl Trinitrate Spray is a smooth muscle amounts of alcohol and may be harmful to
relaxant. The walls of many of the bodys veins patients with the above conditions)
and arteries are made of smooth muscle, and so
glyceryl trinitrate helps to widen these vessels. If your dose is increased, you may become
When you spray Glyceryl Trinitrate Spray under tolerant to this medicine (where you need to use
your tongue it is quickly absorbed in the higher doses to prevent or relieve the symptoms
bloodstream. The action of Glyceryl Trinitrate of an angina attack).
Spray allows blood to flow more quickly and If this medicine does not work it may be
more easily. This means that your heart does not anearly sign of a myocardial infarction (heart
need to work so hard. The greater blood flow attack).
through the heart also means that the heart
works more efficiently. These actions of glyceryl Please tell your doctor or nurse that you are
trinitrate bring relief in an attack of angina and using this medicine if you are having blood or
can prevent an attack coming on. urine tests, as it may affect the results.
Glyceryl Trinitrate Spray is for the relief and Taking other medicines
prevention of angina attacks (chest pains).
Never use Glyceryl Trinitrate Spray with:
2 BEFORE YOU USE GLYCERYL TRINITRATE Sildenafil, vardenafil or tadalafil containing
SPRAY erectile dysfunction preparations. The blood-
pressure lowering effect of Glyceryl Trinitrate
Do not use Glyceryl Trinitrate Spray if you: Spray may be increased.
Are allergic (hypersensitive) to glyceryl Take care when using Glyceryl Trinitrate Spray
trinitrate or any of the other ingredients with:
ofthe spray (see section 6) Other vasodilators (medicines used to treat
Have marked hypotension (low blood hypertension, angina and heart failure, e.g.
pressure with a systolic pressure below ACE inhibitors or Calcium channel blockers),
90mmHg) antihypertensive agents (medicines which
Have too little circulating blood (due to help to lower blood pressure, e.g. Beta
blood loss or dehydration) blockers or Sympatholytics, Diuretics,
Suffer from conditions where your heart is Renin-inhibitors) antipsychotics, sedatives,
unable to supply enough oxygenated blood sleeping pills, tricyclic and MAOI-type
to the rest of your body (cardiac shock or left antidepressants, baclofen (for the relief
sided heart failure) of spasticity of muscles e.g. in multiple
Have angina pectoris caused by sclerosis), levodopa (for Parkinsonism),
hypertrophic, obstructive cardiomyopathy aldesleukin (for the treatment of kidney
(abnormal heart growth) cancer which has spread to other parts of the
Have constrictive pericarditis (an body, as all of these drugs types may cause a
inflammation of the smooth membrane that greater reduction of blood pressure
surrounds the heart)

Continued top of the next column Continued over page


L20278EIG-30
Dihydroergotamine containing preparations Some people are more sensitive to the effects
for the treatment of abnormal bleeding from ofglyceryl trinitrate than others.
the female reproductive system as the effect Rarely flushing and allergic skin reactions
of this drug can be increased by glyceryl orin some cases hypersensitivity reactions
trinitrate and exfoliative dermatitis (itchy, scaling skin
Heparin containing blood-thinning rash) may appear. If you experience any
preparations (the effectiveness of heparin ofthese, stop using the spray and consult
may decrease) your doctor immediately.
Patients who have previously taken nitrates for Headache may occur at the beginning of the
their condition (e.g. isosorbide mononitrate or treatment. Occasionally, the first dose, or the
isosorbide dinitrate) may require higher doses first higher dose, may cause a blood pressure
ofthis medicine (glyceryl trinitrate) to prevent drop and/or postural hypotension (fainting
or relieve their symptoms. or feeling faint when standing up or getting
out of bed), tachycardia (your heart may
If your doctor has prescribed tablets to be seem to speed up), dizziness and weakness.
placed under the tongue for your angina, you Application may cause a mild, temporary
should not use your spray for the same attack. burning sensation in the mouth.
Using Glyceryl Trinitrate Spray with food and Rarely, nausea (feeling sick), vomiting (being
drink sick), heartburn may occur.
Very rarely, in cases where there is a large fall
You should not drink alcohol while being treated in blood pressure, this medicine may make
with Glyceryl Trinitrate Spray as some of the side the symptoms of angina worse.
effects may be worse than usual (see section 4). Sometimes the heart rate may slow and even
Pregnancy and breast-feeding lead to feeling faint or actually fainting.
Usually these are mild and will stop after a few
If you are pregnant, or think you may be minutes.
pregnant, or breast feeding, you should tell your If any of the side effects become serious, or
doctor before using this medicine. He/she can if you notice any side effects not listed in this
then decide if you should use it. leaflet, please tell your doctor or pharmacist.
Driving and using machines
5 HOW TO STORE GLYCERYL TRINITRATE
It is not recommended to drive or use SPRAY
machinery when you start using this product
as the hypotensive (blood pressure lowering) Keep out of the reach and sight of children.
effect may lead to dizziness and/or feeling faint Do not use Glyceryl Trinitrate Spray after the
or unwell. After you have got used to the spray, expiry date which is stated on the carton and
it may be that you have no problems and are onthe base of the canister.
able to drive safely. Do not store above 25C (normal room
temperature).
Important information about some of the Protect from sunlight.
ingredients of Glyceryl Trinitrate Spray Do not use it near to anyone that is smoking;
This product contains 79.2 volume% of ethanol. orspray the product into a naked flame or onto
Each dose (2 sprays) contains up to 0.08g a hot surface.
of alcohol. This product may be harmful for Do not pierce or burn the canister after use.
patients suffering from liver disease, alcoholism, Medicines should not be disposed of via
epilepsy, brain injury or disease. wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
3 HOW TO USE GLYCERYL TRINITRATE SPRAY longer required. These measures will help
toprotect the environment.
Before using the spray for the first time, check
that the pump is working by pressing the pump 6 FURTHER INFORMATION
button a few times until it produces a fine mist
of liquid. Practice aiming the spray onto a tissue What Glyceryl Trinitrate Spray contains
or similar item so that you will be able to aim it The active substance is glyceryl trinitrate
correctly under the tongue when you need to 0.8%w/w (400 micrograms per spray)
use it. If you do not need to use the spray very The other ingredients are ethanol and propylene
often, remember to check the pump regularly to glycol.
see that it still works properly.
If possible, sit down before using your spray. What Glyceryl Trinitrate Spray looks like and
Take off the plastic cap and hold the spray bottle contents of the pack
upright. Hold your breath for a moment to avoid The aluminium canister is equipped with
breathing in the spray, then open your mouth ametered dose valve and a protective cap. Each
and spray a dose under your tongue by pressing canister containing 10g of solution is designed
down on the pump button then letting go. to deliver at least 180 doses.
Use one or two sprays (never more than three
within 15 minutes) and then immediately close Marketing Authorisation Holder
your mouth before breathing normally through EGIS Pharmaceuticals UK Ltd.
your nose again. Put the cap back on the spray 127 Shirland Road
bottle. London
If you are not sure how to use the spray, ask your W9 2EP
pharmacist to show you. United Kingdom
If you use more Glyceryl Trinitrate Spray than Manufacturer
you should EGIS Pharmaceuticals PLC
If you use too many sprays some of the side Mtys kirly t 65.
effects (see below) may be worse than usual. Krmend
In this case you should see your doctor H-9900
immediately. Hungary
Distributor
4 POSSIBLE SIDE EFFECTS Actavis, Barnstaple, EX32 8NS, UK
Like all medicines, Glyceryl Trinitrate Spray can This leaflet was last approved in [05/2011].
cause side effects, although not everybody gets
them.
Continued top of the next column
L20278EIG-30 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 Have pericardial tamponade (an
contains important information for you. accumulation of fluid in the sac that
This medicine is available without prescription. surrounds the heart)
However, you still need to use Glyceryl Trinitrate Have aortic and mitral stenosis (heart valve
Spray carefully to get the best results from it. disease)
Keep this leaflet. You may need to read it Suffer from primary pulmonary hypertension
again. (an increased resistance to blood flow
Ask your pharmacist if you need more through the lungs)
information or advice. Have had a heart attack with low blood
You must contact a doctor if your symptoms supply to the heart
worsen or do not improve after taking the Are very anaemic
product and resting for 10 to 15 minutes. Take sildenafil, tadalafil or vardenafil (these
If any of the side effects gets serious, or if drugs are used for the treatment of male
you notice any side effects not listed in this impotence)
leaflet, please tell your doctor or pharmacist. Suffer from any condition with raised
pressure within your head including that
In this leaflet: caused by an accident
1 What Glyceryl Trinitrate Spray is and what Take special care with Glyceryl Trinitrate
it is used for Spray and talk to your doctor
2 Before you use Glyceryl Trinitrate Spray If you are prone to postural hypotension
3 How to use Glyceryl Trinitrate Spray (low blood pressure) which can lead to
4 Possible side effects dizziness and/or fainting on sitting up or
5 How to store Glyceryl Trinitrate Spray standing up
6 Further information If you suffer from narrow angle glaucoma
(increased pressure in the eye), or migraine
1 WHAT GLYCERYL TRINITRATE SPRAY IS If you suffer from liver disease, alcoholism,
AND WHAT IT IS USED FOR epilepsy, cerebral trauma and other nervous
system diseases (the spray contains small
Glyceryl Trinitrate Spray is a smooth muscle amounts of alcohol and may be harmful to
relaxant. The walls of many of the bodys veins patients with the above conditions)
and arteries are made of smooth muscle, and so
glyceryl trinitrate helps to widen these vessels. If your dose is increased, you may become
When you spray Glyceryl Trinitrate Spray under tolerant to this medicine (where you need to use
your tongue it is quickly absorbed in the higher doses to prevent or relieve the symptoms
bloodstream. The action of Glyceryl Trinitrate of an angina attack).
Spray allows blood to flow more quickly and If this medicine does not work it may be
more easily. This means that your heart does not anearly sign of a myocardial infarction (heart
need to work so hard. The greater blood flow attack).
through the heart also means that the heart
works more efficiently. These actions of glyceryl Please tell your doctor or nurse that you are
trinitrate bring relief in an attack of angina and using this medicine if you are having blood or
can prevent an attack coming on. urine tests, as it may affect the results.
Glyceryl Trinitrate Spray is for the relief and Taking other medicines
prevention of angina attacks (chest pains).
Never use Glyceryl Trinitrate Spray with:
2 BEFORE YOU USE GLYCERYL TRINITRATE Sildenafil, vardenafil or tadalafil containing
SPRAY erectile dysfunction preparations. The blood-
pressure lowering effect of Glyceryl Trinitrate
Do not use Glyceryl Trinitrate Spray if you: Spray may be increased.
Are allergic (hypersensitive) to glyceryl Take care when using Glyceryl Trinitrate Spray
trinitrate or any of the other ingredients with:
ofthe spray (see section 6) Other vasodilators (medicines used to treat
Have marked hypotension (low blood hypertension, angina and heart failure, e.g.
pressure with a systolic pressure below ACE inhibitors or Calcium channel blockers),
90mmHg) antihypertensive agents (medicines which
Have too little circulating blood (due to help to lower blood pressure, e.g. Beta
blood loss or dehydration) blockers or Sympatholytics, Diuretics,
Suffer from conditions where your heart is Renin-inhibitors) antipsychotics, sedatives,
unable to supply enough oxygenated blood sleeping pills, tricyclic and MAOI-type
to the rest of your body (cardiac shock or left antidepressants, baclofen (for the relief
sided heart failure) of spasticity of muscles e.g. in multiple
Have angina pectoris caused by sclerosis), levodopa (for Parkinsonism),
hypertrophic, obstructive cardiomyopathy aldesleukin (for the treatment of kidney
(abnormal heart growth) cancer which has spread to other parts of the
Have constrictive pericarditis (an body, as all of these drugs types may cause a
inflammation of the smooth membrane that greater reduction ofblood pressure
surrounds the heart)

Continued top of the next column Continued over page


L20279EIG-30
Dihydroergotamine containing preparations Some people are more sensitive to the effects
for the treatment of abnormal bleeding from ofglyceryl trinitrate than others.
the female reproductive system as the effect Rarely flushing and allergic skin reactions
of this drug can be increased by glyceryl orin some cases hypersensitivity reactions
trinitrate and exfoliative dermatitis (itchy, scaling skin
Heparin containing blood-thinning rash) may appear. If you experience any
preparations (the effectiveness of heparin ofthese, stop using the spray and consult
may decrease) your doctor immediately.
Patients who have previously taken nitrates for Headache may occur at the beginning of the
their condition (e.g. isosorbide mononitrate or treatment. Occasionally, the first dose, or the
isosorbide dinitrate) may require higher doses first higher dose, may cause a blood pressure
ofthis medicine (glyceryl trinitrate) to prevent drop and/or postural hypotension (fainting
or relieve their symptoms. or feeling faint when standing up or getting
out of bed), tachycardia (your heart may
If your doctor has prescribed tablets to be seem to speed up), dizziness and weakness.
placed under the tongue for your angina, you Application may cause a mild, temporary
should not use your spray for the same attack. burning sensation in the mouth.
Using Glyceryl Trinitrate Spray with food and Rarely, nausea (feeling sick), vomiting (being
drink sick), heartburn may occur.
Very rarely, in cases where there is a large fall
You should not drink alcohol while being treated in blood pressure, this medicine may make
with Glyceryl Trinitrate Spray as some of the side the symptoms of angina worse.
effects may be worse than usual (see section 4). Sometimes the heart rate may slow and even
Pregnancy and breast-feeding lead to feeling faint or actually fainting.
Usually these are mild and will stop after a few
If you are pregnant, or think you may be minutes.
pregnant, or breast feeding, you should tell your If any of the side effects become serious, or
doctor before using this medicine. He/she can if you notice any side effects not listed in this
then decide if you should use it. leaflet, please tell your doctor or pharmacist.
Driving and using machines
5 HOW TO STORE GLYCERYL TRINITRATE
It is not recommended to drive or use SPRAY
machinery when you start using this product
as the hypotensive (blood pressure lowering) Keep out of the reach and sight of children.
effect may lead to dizziness and/or feeling faint Do not use Glyceryl Trinitrate Spray after the
or unwell. After you have got used to the spray, expiry date which is stated on the carton and
it may be that you have no problems and are onthe base of the canister.
able to drive safely. Do not store above 25C (normal room
temperature).
Important information about some of the Protect from sunlight.
ingredients of Glyceryl Trinitrate Spray Do not use it near to anyone that is smoking;
This product contains 79.2 volume% of ethanol. orspray the product into a naked flame or onto
Each dose (2 sprays) contains up to 0.08g a hot surface.
of alcohol. This product may be harmful for Do not pierce or burn the canister after use.
patients suffering from liver disease, alcoholism, Medicines should not be disposed of via
epilepsy, brain injury or disease. wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
3 HOW TO USE GLYCERYL TRINITRATE SPRAY longer required. These measures will help
toprotect the environment.
Before using the spray for the first time, check
that the pump is working by pressing the pump 6 FURTHER INFORMATION
button a few times until it produces a fine mist
of liquid. Practice aiming the spray onto a tissue What Glyceryl Trinitrate Spray contains
or similar item so that you will be able to aim it The active substance is glyceryl trinitrate
correctly under the tongue when you need to 0.8%w/w (400 micrograms per spray)
use it. If you do not need to use the spray very The other ingredients are ethanol and propylene
often, remember to check the pump regularly to glycol.
see that it still works properly.
If possible, sit down before using your spray. What Glyceryl Trinitrate Spray looks like and
Take off the plastic cap and hold the spray bottle contents of the pack
upright. Hold your breath for a moment to avoid The aluminium canister is equipped with
breathing in the spray, then open your mouth ametered dose valve and a protective cap. Each
and spray a dose under your tongue by pressing canister containing 11g of solution is designed
down on the pump button then letting go. to deliver at least 200 doses.
Use one or two sprays (never more than three
within 15 minutes) and then immediately close Marketing Authorisation Holder
your mouth before breathing normally through EGIS Pharmaceuticals UK Ltd.
your nose again. Put the cap back on the spray 127 Shirland Road
bottle. London
If you are not sure how to use the spray, ask your W9 2EP
pharmacist to show you. United Kingdom
If you use more Glyceryl Trinitrate Spray than Manufacturer
you should EGIS Pharmaceuticals PLC
If you use too many sprays some of the side Mtys kirly t 65.
effects (see below) may be worse than usual. Krmend
In this case you should see your doctor H-9900
immediately. Hungary
Distributor
4 POSSIBLE SIDE EFFECTS Actavis, Barnstaple, EX32 8NS, UK
Like all medicines, Glyceryl Trinitrate Spray can This leaflet was last approved in [05/2011].
cause side effects, although not everybody gets
them.
Continued top of the next column
L20279EIG-30 Actavis, Barnstaple, EX32 8NS, UK