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

In this leaflet:

1. What nitrous oxide (medical) is and what it is used for

2. Before you use nitrous oxide (medical)

3. How to take nitrous oxide (medical)

4. Possible side effects

5. Storing nitrous oxide (medical)

Trade Name:    Nitrous oxide (medical)

Composition:    Contains nitrous oxide Ph Eur (100 %v/v)

Who makes your medicine?

The product licence holder is:

Air Products Plc at 2 Millenium Gate, Westmere Drive, Crewe, Cheshire, CW1 6AP

The manufacturer of nitrous oxide (medical) is:

Air Products Plc at Weston Road, Crewe, Cheshire, CW1 6BT

Air Products Plc at Zone Industrielle de l’Epinoy, 59175 Templemars (Nord)

1. What is Nitrous oxide (medical) and what it is used for?

Nitrous oxide (medical) is a colourless, odourless, tasteless gas. It is supplied under pressure as a liquid in a cylinder with a valve to control the outflow of gas. A variety of sizes of cylinders are available containing different volumes of nitrous oxide.

It is categorised as an inhalation gas.

There are no other ingredients.

Nitrous oxide (medical) mixed with 30% oxygen is used in general anaesthesia. It may be used with a wide variety of other anaesthetic drugs allowing lower doses of the other anaesthetic drugs to be given.

Nitrous oxide (medical) mixed with 50% oxygen is used to reduce pain in a number of situations such as childbirth, dental work and other painful procedures such as the wound and burn dressing, the insertion of cannulae or needles into veins. It is occasionally used as an insufflating agent in laproscopy and as a refrigerant in cryosurgery.

2. Before you use Nitrous oxide (medical)

Unless specially advised by your doctor to do so.

Do not use nitrous oxide (medical) if:

You have:

o a head injury o a pneumothorax o decompression sickness o following air encephelography o severe bullous emphysema o during myringoplasty o occluded middle ear o renal cyst

Nitrous oxide should not be used as an analgesic or anaesthetic agent for more than 24 hours, unless your doctor monitors you carefully.

Take special care with nitrous oxide (medical)

Care is needed in the handling and use of nitrous oxide (medical) gas cylinders.

Do not smoke or allow those near you to smoke during treatment with nitrous oxide (medical).

Pregnancy.

Ask your doctor or pharmacist for advice before taking any medicines.

Nitrous oxide (medical) can be used if you are pregnant.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines.

Nitrous oxide (medical) can be used if you are breast-feeding.

Driving and using machines

It is recommended that you do not drive or operate machinery for 12 hours after the use of nitrous oxide (medical)

Taking / using other medicines

Nitrous oxide inactivates vitamin B12

Interactions with other medicines are unlikely when used as directed

It is important that you tell your doctor if you are taking, or have recently taken any other medicine - even those not prescribed.

3.    How to use Nitrous oxide (medical)

Nitrous oxide (medical) will be administered via inhalation and you will be given a facemask, mouthpiece or nasal prongs to use. The facemask or mouthpiece is connected to nitrous oxide (medical) via a suitable medical device. The device must be operated in the manner described by the manufacturer. These systems will only be used to give you nitrous oxide under the direct supervision of attendant and suitably trained medical personnel.

The concentration of nitrous oxide used in your treatment will depend on the condition it is being used to treat.

Your doctor will tell you how long the treatment will nitrous oxide (medical) will last. Follow the instructions given to you by your doctor.

During use the cylinder should be kept upright, away from heat in a well-ventilated area. Connections for hoses, valves etc. must be kept clean and dry. If necessary clean only with plain water. Do not use solvents. Use clean, lint free cloths for cleaning and drying off Use no oil or grease on valve or associated equipment. Do not allow naked flames near the cylinder.

If you use more nitrous oxide (medical) than you should:

If you may have used more nitrous oxide (medical) than you should, talk to a doctor or pharmacist as soon as possible.

Over dosage is rarely a problem.

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

4.    Possible side effects.

Like all medicines nitrous oxide (medical) can have side effects.

Nitrous oxide inactivates vitamin B12 and following prolonged use or exposure to nitrous oxide may result in megaloblastic bone marrow changes.

Nitrous oxide passes into all gas containing spaces in the body faster than nitrogen passes out. This may result in bowel distension, middle ear damage and rupture of the eardrums.

If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.

5. Storing Nitrous oxide (medical).

Keep Nitrous oxide (medical) out of the reach and sight of children.

Nitrous oxide (medical) should be stored in a well-ventilated place, under cover and kept clean and dry. Cylinders should be stored where they will not be exposed to extremes of temperature. They should preferably be stored between 10 C and 30 C. Full cylinders should be stored separately from empty cylinders and separately from non medical cylinders and from other medical cylinders containing different gases.

Use by date

Check the date given on the batch label attached to the cylinder. Do not use Nitrous oxide (medical) after the expiry date given on the label.

This leaflet was prepared for approval October 2005.