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NITROMIN 400 MCG PER ACTUATION SUBLINGUAL SPRAY

Active substance(s): GLYCERYL TRINITRATE

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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 Nitromin Sublingual Spray (henceforth
Nitromin Spray) is and what it is used for
2. What you need to know before you use
Nitromin Spray
3. How to use Nitromin Spray
4. Possible side effects
5. How to store Nitromin Spray
6. Contents of the pack and other information
1. What Nitromin Spray is and what it is
used for

2. What you need to know before you use
Nitromin Spray








Pharmacode









Warnings and precautions
Talk to your doctor or pharmacist before using
Nitromin 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.

Glyceryl trinitrate



Package leaflet: Information for the user

Nitromin Sublingual Spray







Continued top of the next column

Other medicines and Nitromin Spray
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any 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:
Medicines 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.
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).
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.








Nitromin Spray with alcohol
Consumption of alcoholic beverages during
the use of the preparation 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 taking this medicine.
Nitromin 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.
Nitromin 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 0.04g
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.
3. How to use Nitromin Spray
Always use this medicine exactly as your
doctor or pharmacist have told you. Check with
your doctor or pharmacist if you are not sure.
You may be given Nitromin Spray in either
a transparent plastic or aluminium canister.
If you have a transparent plastic canister follow
the instructions below to take off the cap:
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 safety ring

Continued over page

Pharmacode

Do not use Nitromin Spray if you:
Are 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)
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 possible
raised pressure within your head including
that caused by an accident

Children
The use of Nitromin Spray is not recommended
for children.

Pharmacode

Pharmacode

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).

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.
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.

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).
If symptoms have not resolved after a total
of three doses (sprays), seek prompt medical
attention.
For the prevention of an attack use one or two
doses (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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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:
Allergic skin reactions or in some cases
hypersensitivity reactions and exfoliative
dermatitis (itchy, scaling skin rash) may
appear.
Worsened 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).
Cyanosis (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).
Methaemoglobinaemia (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).
Decreased blood flow to the brain (may
affect up to 1 in 10,000 people).







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 Nitromin Spray
Store below 25°C, in the original package
in order to protect from light.
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the expiry date
which is stated on the carton and on the base
of the aluminium canister or on the label
of plastic canister.
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.
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 to
protect the environment.
6. Contents of the pack and other
information
What Nitromin Spray contains
The active substance is glyceryl trinitrate
0.8% w/w (400 micrograms per spray)
The other ingredients are ethanol, propylene
glycol and a particle free solution in a CFC-free
spray.
What Nitromin Spray looks like
and contents of the pack
The aluminium or transparent plastic 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 or 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

Egis Item

Figure 3. – Snapping off
the cap without shirt
collar safety ring from
the aluminium canister

This leaflet was last revised in March, 2016
PL 18190/0010
Distributor Item

Continued top of the next column

P

This leaflet was
last revised in
March, 2016

Nitromin Sublingual Spray

If you have an aluminium canister follow
the instruction below to take off the cap:
When using the aluminium canister, you can
easily snap the cap off (see Figure 3.)




















Glyceryl trinitrate

Figure 2. – Snapping off
the cap

The following side effects have also been reported:
Very common (may affect more than
1 in 10 people)
Headache
Common (may affect up to 1 in 10 people)
Dizziness
Drowsiness
Fast heart beat
Decreased blood pressure*
Fall of blood pressure when standing up or
sitting up*
Weakness
Uncommon (may affect up to 1 in 100 people)
Syncope (loss of consciousness)
Slow heart beat
Facial flushing
Circulatory collapse (failure of the blood
circulation)
Nausea (feeling sick)
Vomiting (being sick)
Very rare (may affect up to 1 in 10,000 people)
Restlessness
Heartburn
Bad breath
Difficulty breathing
Skin rash
* 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.

Package leaflet: Information for the user

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

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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