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BETADINE DRY POWDER SPRAY

Active substance(s): POVIDONE-IODINE

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Glyceryl Trinitrate Spray

400 micrograms per metered dose, Sublingual spray
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 Glyceryl Trinitrate Spray is & what it is used for
2. What you need to know before you use Glyceryl Trinitate Spray
3. How to use Glyceryl Trinitrate Spray
4. Possible side effects
5. How to store Glyceryl Trinitrate Spray
6. Contents of the pack and other information

Warnings and precautions
Talk to your doctor before using GTN Spray 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 GTN Spray
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 GTN Spray if you are taking or
1. WHAT GLYCERYL TRINITRATE SPRAY IS AND WHAT IT IS
have recently taken any of the following:
USED FOR
Your medicine is called Glyceryl Trinitrate Spray. It will be referred • Medicines treating blood pressure or heart problems, such
as vasodilators, antihypertensives, betablockers and calcium
to throughout this leaflet as GTN Spray.
channel blockers.
It is a sublingual (under the tongue) aerosol spray that contains the
active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a • Tricyclic anti-depressants or neuroleptics, used to treat mental
health conditions.
group of medicines called nitrates that relax the muscle walls of
• Diuretics (water tablets to increase amount of urine produced).
the blood vessels and reduce the workload of the heart.
• Dihydroergotamine, used to treat migraine headaches.
GTN Spray is used to treat angina at the onset of an attack. It is
• Heparin, a blood thinner used to prevent blood clots. Your doctor
also used for the prevention of angina, which can be brought on
will need to monitor you more closely.
from physical effort, emotional stress, and exposure to cold, etc.
• Organic nitrates (other acute angina treatments).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCERYL
GTN Spray with alcohol
TRINITATE SPRAY
Be careful about drinking alcohol as GTN Spray may affect you
Do not use GTN Spray and talk to your doctor:
more than usual. Both alcohol and GTN Spray may lower your
• If you are allergic to glyceryl trinitrate or any of the other
blood pressure and slow down your reactions.
ingredients of this medicine (listed in section 6).
Pregnancy and breast-feeding:
• If you have severe low blood pressure.
If you are, or think you might be pregnant, ask your doctor for
• If you have shock caused by low blood pressure.
advice before taking this medicine, GTN Spray should not be used
• If you have severe anaemia.
if you are breastfeeding.
• If you have constrictive pericarditis (a heart condition).
• If you have an extremely low heart rate.
• If you have glucose-6-phosphate-dehydrogenase deficiency Driving and using machines:
Your reactions may slow down. Therefore you should avoid driving
(an inherited enzyme deficiency, mainly affecting men).
• If you have a brain trauma or cerebral haemorrhage (brain or and using machinery whilst taking GTN Spray.
head injury, including bleeding).
GTN Spray contains ethanol
• If you have narrowing of the heart valves or arteries or
This product contains small amounts of ethanol (alcohol), less than
angina caused by a disease of the heart muscle.
100mg per spray.
• If you have circulatory collapse (a failure of blood circulation).
• If you have toxic pulmonary oedema (lung swelling/ fluid)
Continuous use warning:
• If you have cardiogenic shock (a serious heart condition
Continuous use of GTN Spray and other nitrates may reduce
caused by very low blood pressure, which may result in
effectiveness at relieving your symptoms, so high continuous
the following symptoms: dizziness and lightheadedness,
doses should be avoided.
fast pulse rate, white skin, sweating, restlessness or loss of
consciousness).
3. HOW TO USE GLYCERYL TRINITRATE SPRAY
Do not use if you are taking Sildenafil, tildenafil, vardenafil or
1. GTN Spray is not recommended for children.
similar phospho-diesterase inhibitors used to treat male erectile
2. Always use GTN Spray exactly as explained in this leaflet. You
dysfunction (impotence).
should check with your doctor or pharmacist if you are not sure.

Client:
AYRTON SAUNDERS
Product:
Glyceryl Trinitrate Spray
Date: 15.09.2015
Color: Black
Fonts and Size: Helvetica Neue LT Std (Condensed, Bold Condensed) 8 pt
Leading:
9 pt

3. Learn how to use GTN Spray 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 GTN Spray 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 GTN Spray, 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)

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
6. Before using GTN spray for the first time, check that the spray is side effects directly via the national reporting system listed in
working by pressing the pump button a few times until it produces Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By
a fi ne mist of liquid. Practice aiming the spray onto a tissue or
reporting side effects you can help provide more information on
similar item so that you will be able to aim it correctly under the
the safety of this medicine.
tongue when you need to use it. If you do not need to use GTN
5. HOW TO STORE GLYCERYL TRINITRATE SPRAY
spray very often, remember to check the spray regularly to see
that it still works properly.
• Keep this medicine out of the sight and reach of children.
7. At the onset of an attack, or to prevent an imminent attack:
• Do not use GTN Spray after the expiry date which is stated
• Sit down.
on the carton and the canister base after EXP. The expiry date
• Hold the canister upright and near your mouth.
refers to the last day of that month.
• Hold your breath.
• Do not store above 25°C. Do not refrigerate or freeze.
• Aim the spray under your tongue.
• GTN Spray is an aerosol spray and contains a pressurised liquid.
• Press down the button fi rmly, once only.
Do not expose to temperatures higher than 50°C, and do not
• Close your mouth immediately.
pierce the canister, even when empty.
• Do not inhale the spray.
• Do not throw away any medicines via wastewater or household
8. The usual dose is one or two sprays. No more than three doses
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
are recommended at any one time.
environment.
9. After using GTN Spray, rest for a while. When you stand up, rise
slowly, as you may feel faint.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
If you use more GTN Spray than you should:
What GTN Spray contains:
Special treatment is not normally required.

The active ingredient is glyceryl trinitrate. Each spray of product
Overdose symptoms are usually the same as the stated side effects.
contains 400 micrograms of glyceryl trinitrate.
Some people may experience a reaction similar to shock, with nausea,
• The other ingredients are peppermint oil, ethanol and 1,1,1,2
weakness and sweating. If you feel faint sit down and raise your legs.
tetrafluoroethane (the propellant).
Contact your doctor if your symptoms do not improve.
Rarely a bluish colour to lips/fi ngers may occur (cyanosis or
What GTN Spray looks like and contents of the pack:
methaemoglobinaemia). If this happens contact your doctor
• GTN Spray is a colourless spray presented in a printed aluminium
immediately.
canister, with a metered dose spray nozzle, and a cap.
• Each canister contains enough product for 200 sprays.
4. POSSIBLE SIDE EFFECTS
Like all medicines, as well as benefi ts, GTN Spray 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 GTN Spray 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:
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Leading:

Marketing Authorisation Holder and Manufacturer:
MA 16431/0018
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.
For information in large print, audio CD or braille please contact
the Marketing Authorisation Holder.
This leaflet was last revised in September 2015.
® Registered Trademark Ayrton Saunders Ltd.

AYRTON SAUNDERS
Glyceryl Trinitrate Spray
15.09.2015
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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