Oxynox - 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.

In this Leaflet

Page 1    1. What is Oxynox and what it is used for    Page 2

2.    Before you use Oxynox

3.    How to use Oxynox

1.    What is Oxynox and what is it used for

Oxynox is a breathed in (inhalation) gas. It is colourless, odourless and tasteless. It is supplied under pressure in a cylinder with a valve to control the flow of gas. The cylinder contains equal amounts of nitrous oxide and oxygen. A variety of cylinders sizes are available.

What is Oxynox used for?

Oxynox is used exclusively as an analgesic (a medicine that alleviates pain without causing loss of consciousness). It is for the relief of shortterm and intermittent pain. It is often used during normal child birth, by ambulance staff after an accident, at the dentist or during the dressing of wounds and burns.

2.    Before you use Oxynox

Do not use Oxynox if any of the following apply

You should not use Oxynox if there is likely to be air entrapped within your body 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).

You should not give Oxynox to new-born or premature infants due to its high oxygen content.

Individuals who should avoid exposure to Oxynox:

Unless specially advised by your Doctor to do so, do not use Oxynox if you have: a head injury    following air encephalography (a type of brain scan)

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

occluded (blocked) middle ear    during myringoplasty (surgery to close holes in the eardrum)

renal cysts (swelling in the kidneys)    severe bullous emphysema (a lung disease)

Elderly persons and people with poor or vegetarian diets or a history of anaemia should be checked for vitamin B12 deficiency.

Interactions with other Medicines

Nitrous oxide, which is one of the two components of Oxynox may increase the effects of methotrexate (a medicine used in the treatment of rheumatoid arthritis and in the treatment of tumours)

Fire Risks:

Do not smoke or allow those near you to smoke during treatment with Oxynox.

Do not allow naked flames in the area where you are using your Oxynox, 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 Oxynox

Special Circumstances:

Driving and/or Operating Machinery

You should not try to drive or use machinery up to twelve hours after breathing Oxynox.

Sportsmen and Sportswomen

Oxynox 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.

Pregnancy and Childbirth

Extensive experience has indicated no significant hazard to the baby when administered to the mother in labour.

3.    How to use Oxynox

If the cylinders have been stored below freezing point (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.

Oxynox should only be given to you under the direct supervision of attendant and suitably trained medical personnel. You will be given a face mask or mouth piece to use Oxynox. The mask or mouth piece is connected to an Oxynox 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.

You should not give Oxynox to new-born or premature infants due to its high oxygen content.

Frequency and Duration of Administration

Your Doctor will advise you of the length of treatment needed. Follow your Doctor's advice. You should not use Oxynox for more than twenty-four hours, without blood samples being examined in the laboratory. Your Doctor will advise when this is necessary.

Use of Oxynox more frequently than every 4 days should be accompanied by routine blood cell counts. Your Doctor will advise on this.

If you use more Oxynox than you should:

If you may have used more Oxynox than you should, talk to a Doctor or pharmacist as soon as possible. However, it is very unlikely that an overdose will occur.

Inappropriate, unwitting or deliberate inhalation of nitrous oxide will ultimately result in unconsciousness, passing through stages of increasing light headiness and intoxication and if there is an absence of oxygen, death from asphyxiation will occur. The treatment is removal to fresh air, mouth to mouth resuscitation and if necessary the administration of oxygen Addiction to nitrous oxide may occur.

Withdrawal

Addiction to nitrous oxide (a component of Oxynox) may occur.

There are no additional side-effects from withdrawal of Oxynox.

4.    Possible side effects

Common side effects are euphoria (feeling high), confusion, feeling sleepy, feeling sick or being sick, dizziness or generalised tingling sensations. These effects are usually mild and get better after you stop taking Oxynox.

With prolonged use, less common side effects that may occur due to trapping of nitrous oxide gas in the body are problems with the ear including rupture of the ear drum, and swelling of the intestines.

Rarely, and mostly with prolonged or frequent use, nitrous oxide can interfere with the way your body uses vitamin B12, which may cause anaemia and other changes in your blood cell count.

This may show as excessive tiredness or looking pale, fever and other signs of infection, and unusual bleeding or bruising. The effect on vitamin B12 can also lead to problems with nerve function,

including loss of sensation and muscle weakness. If you experience any of these more serious effects or experience any other effects not mentioned in this leaflet, then contact your healthcare professional immediately.

5.    Storing Oxynox

-    check the date given on the batch label attached to the cylinder

-    do not use Oxynox after the expiry date given on the label

Oxynox should be stored securely in a well-ventilated place, under cover and kept clean and dry. Oxynox 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, greases, tarry substances and many plastics.

Oxynox cylinders should not be stored where they might suffer extremes of heat or cold. They should preferably be stored between 10°C and 30°C. If the temperature falls below 0°C it is possible for Oxynox 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 Your Medicine above

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 using a clean, lint free cloth. Do not use solvents

Keep out of reach of children

Do not allow naked flames near the container.

Do not smoke when using Oxynox.

Care is needed in the handling and use of Oxynox gas cylinders

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

You should use Oxynox in a well-ventilated area to prevent the build up of exhaled gas.

Oxynox cylinders must be stored separately from non-medical cylinders.

6.    Further information

The name of your medicine is Oxynox.

The active substances are Nitrous Oxide Ph. Eur and Oxygen Ph. Eur., mixed 50:50 v/v.

There are no additives to the oxygen and nitrous oxide used in Oxynox.

Contents of the containers

Cylinder sizes. These contained compressed gas. The sizes quoted are the amount of Oxynox provided by the cylinder, when it is used at normal atmospheric pressure. Some cylinders are only available for specific uses.

Commonly used sizes    342.5, 1292 and 3233 litres.    Other sizes    274, 685, 1071, 1370, 2740 and 6439 litres.

The Marketing Authorisation Holder and Manufacturer is:

Air Products PLC, 2 Millennium Gate, Westmere Drive, Crewe, Cheshire, CW1 6AP

Oxynox Marketing Authorisation No. 06183/0013    Oxynox Patient Information Leaflet Version 4, Jan 2009