NITRONOX INHALATION GAS

Active substance: OXYGEN

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PL 17872/0001- May 2012-revised

Nitronox Inhalation Gas - Patient Information Leaflet
Read all of this leaflet carefully because it contains important information for you. Keep this leaflet; you may need to read it
again. Ask your pharmacist or Doctor if you need more information or advice.

What is in this Leaflet
Page 1

1. What is Nitronox and what it is used for
2. Before you use Nitronox

Page 2

3. How to use Nitronox
4. Possible side effects
5. How to store Nitronox
6. Further information

1. What is Nitronox and what is it used for?
Nitronox is a breathed in (inhalation) gas. It is a colourless, odourless gas supplied under pressure in a cylinder with a valve
to control the flow. The cylinder contains equal amounts of nitrous oxide and oxygen. A variety of cylinder sizes are available.
What Nitronox is used for?
Nitronox is exclusively for the relief of short-term and intermittent pain. It may be used in the following circumstances:

at the dentist,

after an accident,

during normal child birth,

during the dressing of wounds and burns

2. Before you use Nitronox
Other medicines and Nitronox.
Tell your doctor if you are taking or have recently taken any other medicines– even those not prescribed.
Unless specially advised by your doctor to do so, do not use Nitronox if:

you are taking or have recently taken methotrexate (a medicine used in the treatment of rheumatoid arthritis and in
the treatment of tumours)

you are taking or have recently taken Vitamin B12
Take special care with Nitronox
Care is needed in the handling and use of Nitronox gas cylinders-You must follow your Doctor’s instructions.
Fire Risks:

do not smoke or allow those near you to smoke during treatment with Nitronox as it helps things burn.

do not allow naked flames in the area where you are using your Nitronox, since even the smallest spark can cause
violent ignition; electrical equipment capable of sparking (including toys which may produce sparks) must not be
used where you are using your Nitronox.
Do not use Nitronox.
If you suffer from any medical complaint where there is likely to be air entrapped within your body and it might be dangerous
for this air to expand such as:

following a recent dive,

decompression sickness ,

pneumothorax (air that is trapped next to a lung resulting in collapse of the lung)

or air embolism (when bubbles of air become trapped in the circulating blood).
Elderly persons and people with poor vegetarian diets or a history of anaemia should be checked for vitamin B12 deficiency.
Pregnancy
Nitronox can be used if you are pregnant, however, seek medical advice before taking any medicine
Driving and using machines.
You should not try to drive or use machinery up to twelve hours after breathing Nitronox.
Sportsmen and Sportswomen.
Nitronox will not affect the result of dope testing. Because of its effect on driving ability, it is probably best avoided for twelve
hours before an event.

PL 17872/0001- revised Nov 2011

3. How to use Nitronox
Nitronox should only be given to you under the direct supervision of attendant and suitably trained medical personnel.
Always follow the instructions given by your doctor.:

During use keep cylinders upright, away from heat and in a well ventilated area.

Connections for hoses, valves, etc must be clean and dry. If necessary clean only with plain water, do not use
solvents. Use clean, lint free cloths for cleaning and drying off or similar.

Nitronox is non flammable but strongly supports combustion (including some materials that do not normally burn in
the air). It is highly dangerous when in contact with oils, greases, tarry substances and many plastics.

If you use Nitronox frequently as advised by your doctor it is without any significant effects. However, if you are
exposed to Nitronox over a longer period it may have severe adverse effects, as may long term exposure to lower
levels (i.e. to Midwifes and Nurses who are exposed to it for long periods during their work).

You should use Nitronox in a well-ventilated area to prevent the build up of exhaled gas.
If the cylinders have been stored below 0°C, then the contents of the cylinder must be re-mixed using one of the following
methods:
1. Store the cylinder horizontally for 24 hours at or above 10°C;
2. Mix the contents by fully inverting the cylinder three times, after warming it at 10°C or more for at least two hours.
You will be given a face mask or mouth piece to use Nitronox. The mask or mouth piece is connected to a Nitronox supply
through a demand valve system. You will operate the demand valve by breathing in normally. The valve closes when you stop
breathing in or breathe out. You will hold the face mask or mouth piece to your face with your hand and it will remain loose in
your hand.
Your doctor may advise a modified method of administration for example using a mouth piece. Follow their instructions.
Your doctor will tell you how much Nitronox you should use per day and how long your treatment with Nitronox is likely to last.
Follow your Doctor's advice.
If you use Nitronox for more than twenty-four hours, or if you use the gas more frequently than every four days your doctor will
take blood tests to check your red and white blood cells. Your Doctor will advise when this is necessary.
If you use more Nitronox than you should:
If you may have used more Nitronox than you should, talk to a doctor or pharmacist as soon as possible. However, it is very
unlikely that an overdose will occur.

4. Possible side effects
Like all medicines Nitronox can cause side effects, although not everybody gets them
Do not overuse Nitronox as addiction to the gas mixture can occur.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

5. How to Store Nitronox
Check the date given on the batch label attached to the cylinder. Do not use Nitronox after the expiry date given on the label.
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5.

Keep Nitronox out of the sight and reach of children.
Nitronox should be stored securely in a well-ventilated place, under cover and kept clean and dry.
Nitronox helps things burn so there must be no smoking or naked flames where the cylinders are stored and
the cylinders must not come into contact with oil, grease or some plastics.
Nitronox cylinders should not be stored where they might suffer extremes of heat or cold, preferably between
10°C and 30°C. If the temperature falls below 0°C it is possible for the gases to separate into Nitrous Oxide and
Oxygen. If the cylinders have been stored below 0°C, then please see the instructions under How To Use
Nitronox above
Nitronox cylinders must be stored separately from other medical gases and non-medical gases

Return empty cylinders to Medical Gas Solutions

6 Further information
What Nitronox contains:.
The active substances are Nitrous Oxide Ph. Eur and Oxygen Ph. Eur., mixed 50:50 v/v.
There are no other ingredients.
Nitronox is supplied as a gas in cylinders. These contain compressed gas. The colour scheme for Nitronox cylinders is
changing from a blue body with blue and white quartered top to a white body white with a blue and white quartered top. Your
cylinder may be of either colour scheme. The cylinder label gives the amount of Nitronox provided by the cylinder when it is
used at normal atmospheric pressure. Always read the label.
Marketing Authorisation Holder and Manufacturer:
Medical Gas Solutions Ltd, Unit 19, Manor Industrial Estate, Bagillt, Flintshire, CH6 5UY.
For any other information about Nitronox, please contact Medical Gas Solutions
Date of last revision of leaflet: (May 2012)

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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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