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NITROLINGUAL 400 MICROGRAMPUMPSPRAY

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Package leaflet: Information for the user

NITROLINGUAL 400 MICROGRAM PUMPSPRAY
/ GLYCERYL TRINITRATE 400 MICROGRAM
PUMPSPRAY
(glyceryl trinitrate)

Your medication is available using one of the above names
but will be referred to as Nitrolingual throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

Always take this medicine exactly as described in this leaflet
or as your doctor or pharmacist or nurse has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or
advice.

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Nitrolingual is and what it is used for
What you need to know before you take Nitrolingual
How to take Nitrolingual
Possible side effects
How to store Nitrolingual
Contents of the pack and other information

1. What Nitrolingual is and what it is used for
Nitrolingual is a sublingual spray which means that you use it
under your tongue. The active ingredient is called glyceryl
trinitrate or GTN for short. GTN is one of a group of medicines
called ‘nitrates’. These relax the muscles around the blood
vessels and make it easier for the heart to do its work.
Nitrolingual helps stop the pain of angina (pain in your chest,
arms or neck especially when you exert yourself). You can
also use the medicine immediately before doing things which
you know will cause you angina pain.

2. What you need to know before you take
Nitrolingual
Do not take Nitrolingual




if you are allergic (hypersensitive) to nitrates or any
of the other ingredients of Nitrolingual (listed in
Section 6). An allergic reaction may include rash,
itching, difficulty breathing or swelling of the face, lips,
throat or tongue.
if you are very ill because of very low blood
pressure, severe blood loss, acute stroke, bleeding
in the brain, a severe head injury or severe
anaemia.

if you have certain unusual heart conditions (such as
acute circulatory shock (where there is insufficient blood
flow reaching the body’s tissues), this can include
hypovolaemic shock (as a result of low blood volume)
and uncontrolled cardiogenic shock (as a result of
decreased output from the heart), severe mitral stenosis
(a narrowing of the opening to the heart mitral valve) or
obstructive cardiomyopathy (a disease of the heart
muscle causing obstruction of blood flow)), which your
doctor will have told you about.

if you are taking Viagra (sildenafil) or similar products
(e.g., vardenafil, tadalafil) for the treatment of erectile
dysfunction or hypertension of arterial lung vessels. If
you take these products and Nitrolingual, a severe and
possibly dangerous fall in blood pressure can occur. This
would result in collapse, unconsciousness and could be
fatal.
Nitrolingual Pump Spray is not intended for use in
children.


Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Nitrolingual

if you are in the early stages of an eye condition called
glaucoma (where there is raised pressure within the
eye)

while taking Nitrolingual, tell your doctor if the spray
does not stop the pain; or if the spray usually works, but
this time the pain lasts longer (half an hour or more), or
feels different or worse than usual.

if you have aortic and/or mitral stenosis (a narrowing of
the opening to the heart aortic or mitral valve)

if you feel dizzy when you sit or stand upright suddenly

if you have cerebrovascular disease (brain disorders
relating to disease of the blood vessels supplying the
brain)

if you have pericardial tamponade (compression of the
heart caused by blood or fluid accumulation in the space
between the heart muscle and the outer covering of the
heart)

if you have constrictive pericarditis (inflammation and
swelling of the covering of the heart)

low blood oxygen in lung disease or pulmonary heart
disease (enlargement of the right ventricle of the heart)

if you have had a heart attack

if you have left ventricular hypertrophy (thickening of
the muscle of the left ventricle of the heart) associated
with aortic stenosis (narrowing of the opening of the
aortic heart valve)

if you have moderate to severe valvular aortic stenosis
(narrowing of the opening of the aortic heart valve)

Page 1 of 2

Other medicines and Nitrolingual

Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines. This is
important as using more than one medicine at the same time
can strengthen or weaken the effect of the medicines. Your
doctor may need to take special care or change the dose. This
is especially important for:

medicines for the treatment of erectile dysfunction or
hypertension of arterial lung vessels (see ‘Do not take
Nitrolingual’)

other medicines which can lower blood pressure, such as
beta-blockers, calcium channel blockers and
neuroleptics, vasodilators, anti-hypertensives, diuretics,
tricyclic antidepressants, sapropterin

anti-blood-clotting drugs such as heparin

N-acetyl-cysteine
If you use Nitrolingual very often or if you regularly use other
nitrates, the pain relief you receive may be less. During use
with dihydroergotamine (DHE) (used to treat migraines),
Nitrolingual may lead to an increase in DHE levels, thereby
increasing blood pressure.

Nitrolingual with alcohol

If you drink alcohol before using Nitrolingual, you may feel
dizzy or faint due to low blood pressure.

Pregnancy, breast-feeding and fertility

Tell your doctor if you become pregnant while you are taking
Nitrolingual. You should use Nitrolingual only after discussing
with your doctor the potential benefits to you versus any
potential risks to your unborn child. It is not known whether
glyceryl trinitrate passes into human breast milk. You should
ask your doctor for advice if you are breast-feeding. There is
no sign of a harmful effect with respect to fertility.

Driving and using machines

You should wait at least five minutes after using the spray
before driving or using machinery. If you feel faint, dizzy or
unwell, wait until you feel better. You should be particularly
careful if you have just started using Nitrolingual, if you have
changed your dosage or if you drink alcohol.

Nitrolingual contains ethanol

This medicinal product contains small amounts of ethanol
(alcohol); less than 10mg per metered dose (puff).

3. How to take Nitrolingual
Dosage

Always take this medicine exactly as described in this leaflet
or as your doctor, pharmacist or nurse has told you. Check
with your doctor, pharmacist or nurse if you are not sure. The
spray is meant for use under your tongue and is not meant to
be inhaled.
The recommended dose is one or two puffs under your
tongue. If symptoms do not resolve, you can repeat this at 5
minute intervals for a maximum of two more times, for a
total of three doses. If, after that, your symptoms have still
not resolved, please seek immediate medical attention. The
spray should work quickly and last about half an hour.

Method of administration

Before you use a new bottle of
Nitrolingual, spray the first puff into
the air to get the pump working
properly. You must also do this if
you have not used the pump for a
week or more. Get used to the feel
of the grooved button in case you
need to use the pump in the dark.
1. Rest or sit quietly, as you may
feel faint or dizzy otherwise,
particularly if you are elderly.
2. Hold the bottle upright with
your finger on the button. You
don’t need to shake the bottle.
3. Open your mouth and put the
bottle next to your chin (see
picture).
4. Press the button firmly so that
the puff of medicine goes under
your tongue (see picture).
Close your mouth.
5. Do not breathe in while you are taking the puff of
medicine.
Keep the spray with you at all times. Through the side of the
bottle you can see how much spray you have left. Make sure
that you get a new spray before the old one runs out. Always
keep a spare.
Talk with your doctor about how long you should keep taking
Nitrolingual.

If you take more Nitrolingual than you should

If you take too many puffs you may notice more severe and
pronounced side effects (see section 4), for example, you
may get a bad headache, blurred vision, feel flushed or feel
that your heart is beating more slowly. You may also feel
faint, sweaty, breathless, weak, restless and feel sick or be
sick, or notice a bluish tinge to your lips or a bluish
colouration of the skin. In very rare cases you may develop
methaemoglobinaemia (a disorder of the red blood
cells). If any of these effects persist contact your doctor or
pharmacist.

If you forget to take Nitrolingual

Do not take a double dose to make up for a forgotten dose.

If you stop taking Nitrolingual

Do not stop taking Nitrolingual without the advice of your
doctor.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The frequency of side effects is classified into the following
categories:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the
available data

The following side effects have been reported:
Very common: headache

Common: decreased blood pressure, which can also occur
on standing up; weakness; dizziness; drowsiness; increased
heart rate
Uncommon: fainting; worsened angina symptoms; slowing
of the heart rate; bluish colouration of the skin; facial
flushing; circulatory collapse (failure of the blood circulation);
nausea; vomiting; allergic skin rash; hypersensitivity.
Very rare: cerebral ischaemia (decreased blood flow to the

brain); methaemoglobinaemia (a disorder of the red blood
cells); restlessness; difficulty breathing; skin rash

Not known: tongue swelling (due to an allergic reaction);
tongue blistering
Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Page 2 of 2

5. How to store Nitrolingual
Do not use the spray after the ‘expiry date’ which is printed
on all packs. The expiry date refers to the last day of that
month.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.

6. Contents of the pack and other
information
What Nitrolingual contains

The active ingredient is called glyceryl trinitrate or GTN for
short. Your medicine also contains
medium-chain triglycerides-miglyol 812, ethanol,
medium-chain partial glycerides-imwitor 742 and
peppermint oil.

What Nitrolingual looks like and contents of the
pack
Each metered dose contains 400 micrograms glyceryl
trinitrate.

The spray comes in sizes of 75, 200 and 250 doses. The 75
and 250 dose sizes are available together as a ‘Duo pack’.
The Duo pack provides a convenient small size 75 dose bottle
fitted with a metering pump containing a clear colourless
aromatic solution for use as an oromucosal spray which is
easier to carry with you, as well as the larger size bottle for
more regular home use. The contents of the bottles are
identical and they should be used in exactly the same way.

Manufacturer:

This product is manufactured by:
G. Pohl-Boskamp GmbH & Co, D-25551 Hohenlockstedt,
Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No:

04423/0358

P

Leaflet revision and issue date (Ref): 29.06.16

+ 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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