ENTONOX Package Leaflet Information for Users Rev V2 Aug 2013

Entonox® Medicinal gas, compressed Package Leaflet: Information for the User

Do not use Entonox if you have: • air trapped in a part of the body where it’s expansion may be dangerous, such as air lodged in an artery • a collapsed lung • decompression sickness (the bends) or if you have been deep diving within 48 hours • lung disease or breathing difficulties such as emphysema • injuries to the face and jaw • head injuries • a severely bloated stomach • suspected or known increased pressure on the brain. Tell your healthcare professional if you have recently had any surgery on your eyes or ears where injections of gas have been used. Take special care with Entonox If you need to use Entonox for more than 24 hours at a time or more frequently than once every 4 days, your healthcare professional will take routine blood tests to ensure the Entonox has not affected your blood cell count or the way your body uses Vitamin B12. Tell your healthcare professional if you know you have Vitamin B12 Deficiency. Inform your healthcare professional if you have accidentally taken Paraquat (a type of weed killer), as there is a possibility of toxic effects to the lungs combined with the high concentration of Oxygen. Taking other medicines Please tell your healthcare professional if: • you are taking Methotrexate for treating arthritis or cancer. Taking Entonox with Methotrexate may have an affect on your blood cell count

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• you are taking medicines to treat anxiety or help you sleep such as diazepam or lorazepam. These drugs may increase the effect of Entonox • you have been taking or prescribed Bleomycin (to treat cancer), Amiodarone (to treat an irregular heartbeat) or Nitrofurantoin and similar antibiotics (to treat infection), advise your healthcare professional before using Entonox, before using Entonox, as there is a possibility of toxic effects to the lungs. Tell your healthcare professional, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Entonox can be used for short term pain relief during pregnancy. Ensure that you tell your healthcare professional that you are pregnant before taking Entonox as they will advise you on the safe use of Entonox. Entonox can be used when breast-feeding. Driving and using machines ­If you have been given Entonox on its own for pain relief, you must wait at least 30 minutes after use before driving or using any machines. Ensure that your healthcare professional advises you whether it is safe for you to drive.

3. HOW TO USE ENTONOX Instructions for use In a hospital or clinic Entonox will be given to you by a healthcare professional. They will ensure that

Entonox® Medicinal gas, compressed Package Leaflet: Information for the User

your Entonox supply is suitable for your use and that the equipment has been set up correctly. To breathe your Entonox you will either be given a face mask or mouthpiece. The mask or mouthpiece is connected to a demand valve system which only delivers Entonox to you as you breathe in. Entonox will begin to take effect immediately when you start to inhale the gas. The effects of Entonox will quickly wear off once you stop breathing the gas. You will be able to control how much Entonox you use, depending on the amount of pain you experience. If you are using Entonox at home you will be given full training on the use of the cylinder and equipment when you receive your first supply. When using your Entonox cylinder at home, you must: • ensure that the cylinder is stood upright on a flat surface and supported so that it will not fall over. Small cylinders may be laid down if appropriate • check the contents gauge on the cylinder or the regulator before you start to make sure there is enough gas available for your use • check that the tubing is correctly fitted to the gas outlet • ensure that all equipment is kept free from oil and grease • open the cylinder valve slowly • turn the cylinder valve ‘OFF’ with moderate force only when the cylinder is not in use • if a leak occurs, this will be evident by a hissing noise. Close the cylinder valve and check the equipment • close the valve with moderate force only when the cylinder is empty.

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Always use your Entonox exactly as your healthcare professional has shown you. You should check with your healthcare professional if you are not sure. DO NOT SMOKE or have a naked flame near your Entonox gas cylinder. The Entonox will make a flame burn much more violently. NEVER use oil based moisturising creams with your cylinder equipment. If you use more Entonox than you should If you continue to inhale Entonox for too long, you will become very drowsy and the mask or mouthpiece will fall away as you relax and hence there is little risk of an overdose with Entonox when used correctly If you deliberately, try to use too much Entonox it may eventually result in unconsciousness. If you become unconscious, your Entonox supply should be turned off and you should be taken to an area where you can breathe fresh air. If your breathing has stopped your healthcare professional will provide the appropriate care, mouth to mouth resuscitation or use an oxygen resuscitator if available. If you are using Entonox at home, have someone with you to ensure that you have no difficulties with using the gas. If you take an overdose, you need to stop breathing the Entonox and start breathing fresh air. If you do not recover, your helper should call an ambulance and give mouth to mouth resuscitation if your breathing has stopped. If you have any further questions on how this product is used, ask your healthcare professional.

Entonox® Medicinal gas, compressed Package Leaflet: Information for the User

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE ENTONOX CYLINDERS

Like all medicines, Entonox may cause side effects, although not everybody will get them.

Expiry Date Do not use Entonox after the expiry date which is stated on the cylinder batch label.

Common side effects that may occur if you use Entonox are: • dizziness • light-headedness • sickness • tingling • disorientation. Less common side effects that may occur if you use Entonox are: • problems with the ear due to increased pressure inside the ear • tiredness • bowel enlargement due to trapped gas. Rare side effects that may occur if you use Entonox are: • interference with the way your body uses Vitamin B12, which may affect your blood cell count • effects on nerve function including sensations of numbness and weakness • difficulty with breathing • addiction. If you experience any of these side effects, or if you notice any other side effects not mentioned in this leaflet, during or after administration of Entonox, contact your healthcare professional immediately.

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Entonox cylinders should be used in strict rotation so that cylinders with the earliest filling date are used first. Cylinder Storage Store your Entonox cylinders: • at a temperature of at least 10ºC for at least 24 hours before use. If this is not possible, EA, D and ED size cylinders should be inverted before use to ensure the gas is completely mixed • so that they can not fall over and cause injury • in clean, well ventilated and dry conditions, not exposed to extremes of heat or cold • away from oil, grease and flammable material in a designated area, where they can be kept separate from other medical and non-medical cylinders, with empty and full cylinders kept apart • out of sight and reach of children Handling cylinders Always handle your Entonox cylinders with care, only moving them using an appropriate trolley or handling device.

Entonox® Medicinal gas, compressed Package Leaflet: Information for the User

6. FURTHER INFORMATION What Entonox contains Your Entonox cylinder contains 50% Oxygen and 50% Nitrous Oxide. There are no other ingredients. Entonox cylinders Entonox is supplied in the following size cylinders: Cylinder Size

Cylinder Contents (Litres)

Cylinder Size

Cylinder Contents (Litres)

EA D(*) ED

350 500 700

F(*) EX G(*)

2000 3500 5000

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The D, F and G size cylinders need to have a regulator attached to the cylinder valve before the gas can be used. The other cylinders are supplied with an integral pressure regulator built into the cylinder valve. Marketing Authorisation Holder and Manufacturer BOC Ltd The Priestley Centre 10 Priestley Road The Surrey Research Park Guildford Surrey GU2 7XY Tel 0800 111333 This leaflet was last approved in 06/2013

The colour coding of the shoulder of Entonox cylinders is blue and white. The body is colour coded white apart from the cylinders marked (*) in the table above which for a limited period may have a blue body.

Shoulder of cylinders viewed from above

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HLC/505550_ENT(REV2)/UKS/0813

Body of cylinder types viewed from the side