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GLYTRIN SPRAY

Active substance(s): GLYCERYL TRINITRATE

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Glytrin

400 micrograms per metered dose, Sublingual spray
Glyceryl Trinitrate 400 micrograms per metered dose
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.
In this Leaflet:
1. What Glytrin is & what it is used for
2. What you need to know before you use Glytrin
3. How to use Glytrin
4. Possible side effects
5. How to store Glytrin
6. Contents of the pack and other information
1. WHAT GLYTRIN IS AND WHAT IT IS USED FOR
Your medicine is called Glytrin.
It is a sublingual (under the tongue) aerosol spray that contains the
active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a
group of medicines called nitrates that relax the muscle walls of
the blood vessels and reduce the workload of the heart.
Glytrin is used to treat angina at the onset of an attack. It is also
used for the prevention of angina, which can be brought on from
physical effort, emotional stress, and exposure to cold, etc.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYTRIN
Do not use Glytrin and talk to your doctor:
• If you are allergic to glyceryl trinitrate or any of the other
ingredients of this medicine (listed in section 6).
• If you have severe low blood pressure.
• If you have shock caused by low blood pressure.
• If you have severe anaemia.
• If you have constrictive pericarditis (a heart condition).
• If you have an extremely low heart rate.
• If you have glucose-6-phosphate-dehydrogenase deficiency
(an inherited enzyme deficiency, mainly affecting men).
• If you have a brain trauma or cerebral haemorrhage (brain or
head injury, including bleeding).
• If you have narrowing of the heart valves or arteries or
angina caused by a disease of the heart muscle.
• If you have circulatory collapse (a failure of blood circulation).
• If you have toxic pulmonary oedema (lung swelling/ fluid)
• If you have cardiogenic shock (a serious heart condition
caused by very low blood pressure, which may result in
the following symptoms: dizziness and lightheadedness,
fast pulse rate, white skin, sweating, restlessness or loss of
consciousness).
Do not use if you are taking Sildenafil, tildenafil, vardenafil or
similar phospho-diesterase inhibitors used to treat male erectile
dysfunction (impotence).

Warnings and precautions
Talk to your doctor before using Glytrin if any of the following apply
to you:
• Fluid around the heart (pericardial tamponade).
• Low filling pressures (e.g. acute myocardial infarction)
• Problems controlling your blood pressure.
• Any disease that increases pressure on the brain.
• Glaucoma (a condition in which the pressure in the eye may be high).
• Liver or kidney problems.
• An underactive thyroid gland.
Please consult your doctor, even if these statements were
applicable to you at any time in the past. You may need to be more
closely supervised during treatment.
Other medicines and Glytrin:
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Talk to your doctor before using Glytrin if you are taking or
have recently taken any of the following:
• Medicines treating blood pressure or heart problems, such
as vasodilators, antihypertensives, betablockers and calcium
channel blockers.
• Tricyclic anti-depressants or neuroleptics, used to treat mental
health conditions.
• Diuretics (water tablets to increase amount of urine produced).
• Dihydroergotamine, used to treat migraine headaches.
• Heparin, a blood thinner used to prevent blood clots. Your doctor
will need to monitor you more closely.
• Organic nitrates (other acute angina treatments).
Glytrin with alcohol:
Be careful about drinking alcohol as Glytrin may affect you more
than usual. Both alcohol and Glytrin may lower your blood pressure
and slow down your reactions.
Pregnancy and breast-feeding:
If you are, or think you might be pregnant, ask your doctor for
advice before taking this medicine, Glytrin should not be used if
you are breastfeeding.
Driving and using machines:
Your reactions may slow down. Therefore you should avoid driving
and using machinery whilst taking Glytrin.
Glytrin contains ethanol
This product contains small amounts of ethanol (alcohol), less than
100mg per spray.
Continuous use warning:
Continuous use of Glytrin and other nitrates may reduce
effectiveness at relieving your symptoms, so high continuous
doses should be avoided.
3. HOW TO USE GLYTRIN
1. Glytrin is not recommended for children.
2. Always use Glytrin exactly as explained in this leaflet. You
should check with your doctor or pharmacist if you are not sure.

Client:
AYRTON SAUNDERS
Product: Glytrin
Date: 14.04.2014
Color: Black
Fonts and Size: Helvetica Neue LT Std (Condensed, Bold Condensed) 8 pt
Leading:
9 pt

3. Learn how to use Glytrin before the onset of an angina attack, as you
may need to use it in a hurry, or in the dark. Familiarise yourself with
the spray button, which has a finger rest to help you direct the spray.
4. Keep a spare handy at all times as it can be diffi cult to tell how
many doses are left in the canister.
5. Do not use Glytrin if you are near a naked flame, e.g. a cigarette.

• Transient hypoxaemia (deprived oxygen supply).
• Patients with coronary heart disease may experience a
restriction in blood supply.
Continuous use may result in a tolerance to Glytrin, reducing
its effectiveness. If symptoms are not relieved, medical advice
should be sought immediately.
Other known side effects are:
Very common
(more than 1 in 10 patients)
Common
(less than 1 in 10 patients)
Uncommon
(less than 1 in 100 patients)
Rare
(less than 1 in 1000 patients)
Very rare
(less than 1 in 10000 patients)

6. Before using Glytrin for the first time, check that the spray
is working by pressing the pump button a few times until it
produces a fi ne 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 Glytrin very often, remember to check the spray
regularly to see that it still works properly.
7. At the onset of an attack, or to prevent an imminent attack:
• Sit down.
• Hold the canister upright and near your mouth.
• Hold your breath.
• Aim the spray under your tongue.
• Press down the button fi rmly, once only.
• Close your mouth immediately.
• Do not inhale the spray.
8. The usual dose is one or two sprays. No more than three
doses are recommended at any one time.
9. After using Glytrin, rest for a while. When you stand up, rise
slowly, as you may feel faint.
If you use more Glytrin than you should:
Special treatment is not normally required.
Overdose symptoms are usually the same as the stated side effects.
Some people may experience a reaction similar to shock, with
nausea, weakness and sweating. If you feel faint sit down and raise
your legs. Contact your doctor if your symptoms do not improve.
Rarely a bluish colour to lips/fi ngers may occur (cyanosis or
methaemoglobinaemia). If this happens contact your doctor
immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, as well as benefi ts, Glytrin can cause side
effects, although not everybody gets them.
If you experience one of the following rare serious side effects
(affecting less than 1 in 1000 patients unless specified), stop
taking Glytrin immediately and consult your doctor:
• An allergic skin reaction (with or without rash).
• Tongue blistering (less than 1 in 100 patients).
• Fainting due to a low heart rate and a severe fall in blood
pressure. This may be accompanied by a worsening of the
original angina symptoms.

Client:
Product:
Date:
Color:
Fonts and Size:
Leading:

Headache
Vertigo (spinning sensation),
dizziness, nausea, facial
flushing, weakness
Burning sensation, stinging
sensation
Severe fall in blood pressure,
heart rhythm change
Flaking or peeling skin

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet. You can also report
side effects directly via the national reporting system listed in
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 GLYTRIN
• Keep this medicine out of the sight and reach of children.
• Do not use Glytrin after the expiry date which is stated on the
carton and the canister base after EXP. The expiry date relates to
the last day of that month.
• Do not store above 25°C. Do not refrigerate or freeze.
• Glytrin is an aerosol spray and contains a pressurised liquid. Do
not expose to temperatures higher than 50°C, and do not pierce
the canister, even when empty.
• 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 Glytrin contains:
• The active ingredient is glyceryl trinitrate. Each spray of Glytrin
contains 400 micrograms of glyceryl trinitrate.
• The other ingredients are peppermint oil, ethanol and 1,1,1,2
tetrafluoroethane (the propellant).
What Glytrin looks like and contents of the pack:
• Glytrin is a colourless spray presented in a printed aluminium
canister, with a metered dose spray nozzle, and a cap.
• Each canister contains enough product for 200 sprays.
Marketing Authorisation Holder and Manufacturer:
MA 16431/0017
PA 501/4/1
Marketing Authorisation Holder: Ayrton Saunders Ltd.,
9 Arkwright Road, Astmoor Industrial Estate, Runcorn,
Cheshire, WA7 1NU, UK.
Manufacturer: Pharmasol Limited, North Way, Andover, SP10 5AZ, UK.
This leaflet was last revised in April 2014.
® Registered Trademark Ayrton Saunders Ltd.

AYRTON SAUNDERS
Glytrin
14.04.2014
Black
Helvetica Neue LT Std (Condensed, Bold Condensed) 8 pt
9 pt

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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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