NITROMIN 400 MCG PER ACTUATION SUBLINGUAL SPRAY

Active substance: GLYCERYL TRINITRATE

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Transcript
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 Nitromin 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 Nitromin Spray is and what
it is used for
2. Before you use Nitromin Spray
3. How to use Nitromin Spray
4. Possible side effects
5. How to store Nitromin Spray
6. Further information

1. WHAT NITROMIN SPRAY IS
AND WHAT IT IS USED FOR
Nitromin 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 Nitromin Spray under
your tongue it is quickly absorbed in the
bloodstream. The action of Nitromin
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.
Nitromin Spray is for the relief
and prevention of angina attacks
(chest pains).

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not use Nitromin 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)
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

Active substance: glyceryl trinitrate

Nitromin 400 micrograms per actuation sublingual spray

2. BEFORE YOU USE NITROMIN
SPRAY

Take special care with Nitromin 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)
Continued top of the next column

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).
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 Nitromin Spray with:
Sildenafil, vardenafil or tadalafil
containing erectile dysfunction
preparations. The blood-pressure
lowering effect of Nitromin Spray
may be increased, possibly resulting
in collapse, unconsciousness and even
death.
Take care when using Nitromin 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, Renininhibitors) 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
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 Nitromin Spray with food and
drink
You should not drink alcohol while being
treated with Nitromin 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.

Continued over page

165 x 400 mm
1:1
UK
180D
IVAX
Article No.:
Pantone 2768
Pantone 137 (10, 50, 100%)
Zombor Cs./2012.12.12.

Font style: Bliss
Font size:
body text – 9,5pt
section headers – 11pt

You may be given Nitromin spray in either
a transparent plastic or aluminium canister.
If you have a transparent plastic canister,
when using for the first time, you need
to take off a shirt collar safety ring.
(see Figure 1.)
Figure 1. – Taking
off shirt collar like
safety ring

Then taking the transparent plastic
canister in one hand, you can easily snap
the cap off sideways with the other hand.
(see Figure 2.)
Figure 2. – Snapping
off the cap

When using the aluminium canister, you
can easily snap the cap off (see Figure 3.)
Figure 3. – Snapping
off the cap without
shirt collar safety
ring from the
aluminium canister
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.
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. A short pause of about
30 seconds should be used between
each dose where several doses are
administered. 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
sprays (never more than three within
15 minutes) and then immediately close
your mouth before breathing normally
through your nose again.
For the prevention of an attack use one or
two sprays immediately before the event.
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 Nitromin 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.

Some people are more sensitive to the
effects of glyceryl trinitrate than others.
Rarely 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. 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.
Agitation may occur.
Rarely, nausea (feeling sick), vomiting
(being sick), or 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 NITROMIN
SPRAY
Keep out of the reach and sight of
children.
Do not use Nitromin Spray after the
expiry date which is stated on the carton
and on the base of the aluminium
canister or on the label of plastic 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 Nitromin 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 Nitromin Spray looks like and
contents of the pack
The aluminium or transparent plastic
canister are 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
Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király út 65., Körmend, H-9900
Hungary

Article No.

Attention!

The following side effects occur in
approximately 30-40% of patients:
taste disturbance (metallic taste), mild
burning or stinging sensation in the
mouth or tongue, headache, postural
hypotension (fainting or feeling faint
when standing up or getting out of bed),
flushing, and palpitations. These are
usually mild and disappear within a few
minutes.

Continued top of the next column

This leaflet was
last approved in
{November/2012}

P

Nitromin 400 micrograms per actuation sublingual spray

Method of use

Like all medicines, Nitromin Spray
can cause side effects, although not
everybody gets them.

Active substance: glyceryl trinitrate

3. HOW TO USE NITROMIN SPRAY

4. POSSIBLE SIDE EFFECTS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some
of the ingredients of Nitromin 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.

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 Nitromin 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 Nitromin Spray is and what
it is used for
2. Before you use Nitromin Spray
3. How to use Nitromin Spray
4. Possible side effects
5. How to store Nitromin Spray
6. Further information

1. WHAT NITROMIN SPRAY IS
AND WHAT IT IS USED FOR
Nitromin 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 Nitromin Spray under
your tongue it is quickly absorbed in the
bloodstream. The action of Nitromin
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.
Nitromin Spray is for the relief
and prevention of angina attacks
(chest pains).

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not use Nitromin 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)
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

Active substance: glyceryl trinitrate

Nitromin 400 micrograms per actuation sublingual spray

2. BEFORE YOU USE NITROMIN
SPRAY

Take special care with Nitromin 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)
Continued top of the next column

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).
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 Nitromin Spray with:
Sildenafil, vardenafil or tadalafil
containing erectile dysfunction
preparations. The blood-pressure
lowering effect of Nitromin Spray
may be increased, possibly resulting
in collapse, unconsciousness and even
death.
Take care when using Nitromin 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, Renininhibitors) 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
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 Nitromin Spray with food and
drink
You should not drink alcohol while being
treated with Nitromin 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.

Continued over page

165 x 400 mm
1:1
UK
200D
IVAX
Article No.:
Pantone 2768
Pantone 137 (10, 50, 100%)
Zombor Cs./2012.12.12.

Font style: Bliss
Font size:
body text – 9,5pt
section headers – 11pt

You may be given Nitromin spray in either
a transparent plastic or aluminium canister.
If you have a transparent plastic canister,
when using for the first time, you need
to take off a shirt collar safety ring.
(see Figure 1.)
Figure 1. – Taking
off shirt collar like
safety ring

Then taking the transparent plastic
canister in one hand, you can easily snap
the cap off sideways with the other hand.
(see Figure 2.)
Figure 2. – Snapping
off the cap

When using the aluminium canister, you
can easily snap the cap off (see Figure 3.)
Figure 3. – Snapping
off the cap without
shirt collar safety
ring from the
aluminium canister
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.
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. A short pause of about
30 seconds should be used between
each dose where several doses are
administered. 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
sprays (never more than three within
15 minutes) and then immediately close
your mouth before breathing normally
through your nose again.
For the prevention of an attack use one or
two sprays immediately before the event.
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 Nitromin 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.

Some people are more sensitive to the
effects of glyceryl trinitrate than others.
Rarely 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. 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.
Agitation may occur.
Rarely, nausea (feeling sick), vomiting
(being sick), or 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 NITROMIN
SPRAY
Keep out of the reach and sight of
children.
Do not use Nitromin Spray after the
expiry date which is stated on the carton
and on the base of the aluminium
canister or on the label of plastic 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 Nitromin 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 Nitromin Spray looks like and
contents of the pack
The aluminium or transparent plastic
canister are 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
Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király út 65., Körmend, H-9900
Hungary

Article No.

Attention!

The following side effects occur in
approximately 30-40% of patients:
taste disturbance (metallic taste), mild
burning or stinging sensation in the
mouth or tongue, headache, postural
hypotension (fainting or feeling faint
when standing up or getting out of bed),
flushing, and palpitations. These are
usually mild and disappear within a few
minutes.

Continued top of the next column

This leaflet was
last approved in
{November/2012}

P

Nitromin 400 micrograms per actuation sublingual spray

Method of use

Like all medicines, Nitromin Spray
can cause side effects, although not
everybody gets them.

Active substance: glyceryl trinitrate

3. HOW TO USE NITROMIN SPRAY

4. POSSIBLE SIDE EFFECTS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some
of the ingredients of Nitromin 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.

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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