NITRONOX INHALATION GAS - patient leaflet, side effects, dosage

1 what nitronox is and what it is used for

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

Nitronox is exclusively for the relief of short-term and intermittent pain. It may be used to relieve pain during:

• labour in childbirth
• dental treatment
• wound cleaning, stitching or dressing
• acute trauma such as broken bones
• other medical conditions or surgical and investigative treatments where pain relief is required

"2j What you need to know before you use Nitronox

Nitronox is only prescribed to you by a healthcare professional. Ensure that your healthcare professional is aware of any medical conditions that you may have.

Do not use Nitronox if:

• you are allergic to nitrous oxide
• you have

• – air trapped in a part of your body due to a disease or injury, where it’s expansion may be dangerous, such as air lodged in an artery

• – decompression sickness (the bends) or if you have been deep diving within the previous 48 hours

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

• – lung disease or breathing difficulties such as emphysema

• – injuries to the face and jaw

• – head injuries

• – a severely bloated abdomen

• – 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.

Warnings and precautions

Frequent use or exposure to nitrous oxide may lead to addiction. Talk to your doctor or nurse before you are given Nitronox if you have a history of drug/medication abuse because there is a higher risk of developing dependence on nitrous oxide if you use it repeatedly. Your doctor will decide whether treatment with Nitronox is possible in your case.

Repeated or long-term use of nitrous oxide may increase the risk of Vitamin B12 deficiency, which may lead to damage of the bone marrow or the nervous system. When using Nitronox, your doctor will supervise you closely and you may have blood tests to monitor your blood cells and assess the consequences of possible Vitamin B12 deficiency.

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.

Care is needed in the handling and use of Nitronox gas cylinders – you must follow your healthcare professional’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.

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.

Other medicines and Nitronox

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Please tell your doctor before using Nitronox if:

• you are taking methotrexate (a medicine used in the treatment of arthritis and cancer). Using Nitronox with methotrexate may have an effect on your blood cell count.
• you are taking strong pain killers, or medicines to treat anxiety or help you sleep (e.g. diazepam, lorazepam). These medicines may increase the effect of Nitronox.
• you have been taking or have been prescribed bleomycin (to treat cancer), amiodarone (to treat an irregular heartbeat), or nitrofurantoin or similar antibiotics (to treat infection) as there is a possibility of toxic effects on the lungs.
• you are taking or have recently taken Vitamin B12.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Nitronox can be used for short-term pain relief during pregnancy. Ensure that you tell your healthcare professional that you are pregnant before using Nitronox as they will advise you on safe use.

Nitronox can be used by breast-feeding mothers, but should not be used while actually breast-feeding the baby.

Driving and using machines

If you have been given Nitronox for pain relief, your healthcare professional will advise you whether they consider it is safe for you to drive or use machines.

If you have used Nitronox on its own you must wait at least 30 minutes after use before driving or using any machines, and be sure that you feel competent to do so.

If you have also been given other medicines you may need to wait longer. Ask your doctor or pharmacist for advice.

^_| How to use Nitronox

Nitronox should only be given to you under the direct supervision of attendant and suitably trained medical personnel. They will ensure that your Nitronox supply is suitable for your use and that the equipment has been set up correctly.

To breathe your Nitronox you will be given a face mask or mouthpiece. The mask or mouthpiece is connected to a demand valve system which only delivers Nitronox to you as you breathe in. The valve closes when you stop breathing in or breathe out. You will hold the face mask or mouthpiece to your face with your hand and it should remain loose in your hand. Follow the healthcare professional’s in­structions.

Nitronox will begin to take effect immediately when you start to inhale the gas. The effects will quickly wear off once you stop breathing the gas. You will be able to control how much Nitronox you use, depending on the amount of pain you experience.

• If you are using Nitronox 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 Nitronox cylinder at home, you must: ensure that the cylinder is stood upright on a flat surface, away from heat and in a well-ventilated area, and supported so that it will not fall over. Small cylinders may be laid down if appropriate. You should use Nitronox in a well-ventilated area to prevent the build-up of exhaled gas.
• 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.

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.

• 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.

If a Nitronox cylinder has been stored below 0°C, then the contents of the cylinder must be re-mixed before use 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.

DO NOT SMOKE or have a naked flame near your Nitronox gas cylinder. The Nitronox will make a flame burn much more violently.

NEVER use oil-based moisturising creams with your equipment.

If using alcohol gels on your skin allow plenty of time for the alcohol gel to dry before handling your cylinder equipment. If using isopropyl alcohol (IPA) wipes ensure that all alcohol has fully evaporated before handling Nitronox cylinders or equipment.

Always use your Nitronox exactly as your healthcare professional has shown you. You should check with your healthcare professional if you are not sure.

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 frequently, or for prolonged periods, 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 continue to inhale Nitronox 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 Nitronox when used correctly.

If you deliberately try to use too much Nitronox it may eventually result in unconsciousness. If you become unconscious, your Nitronox 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 Nitronox 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 Nitronox 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 the use of this product, ask your healthcare professional.

Possible side effects

Like all medicines Nitronox can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following serious side effects stop using the medicine and /or seek urgent medical advice:

• generalised seizures
• difficulty with breathing
• interference with the way your body uses Vitamin B12, which may affect your blood cell count and have effects on nerve function including sensations of numbness and weakness, usually in the legs
• addiction

Other side effects

Common (may affect up to 1 in 10 people):

• dizziness
• light-headedness
• sickness
• tingling
• disorientation
• euphoria
• sense of intoxication

Uncommon (may affect up to 1 in 100 people):

• problems with the ear due to increased pressure inside the ear tiredness
• bowel enlargement due to trapped gas

Frequency not known (cannot be estimated form the available data)

• confusion

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5 how to store nitronox

Expiry date

Check the date given on the batch label attached to the cylinder. Do not use Nitronox after the expiry date which is stated on the label.

Nitronox cylinders should be used in strict rotation so that cylinders with the earliest expiry date are used first.

Cylinder storage

• 1. Keep Nitronox out of the sight and reach of children.

• 2. Nitronox cylinders should be stored securely in a well-ventilated place, under cover and kept clean and dry.

• 3. Store the cylinders so that they cannot fall over and cause injury.

• 4. 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. Store the cylinders away from flammable material.

• 5. Nitronox cylinders should not be stored where they might suffer extremes of heat or cold. Keep the cylinders 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 a cylinder has been stored below 0°C, follow the instructions in section

3. How to use Nitronox

above.

• 6. Nitronox cylinders must be stored separately from other medical gases and non-medical gases, with empty and full cylinders kept apart.

Handling cylinders

Always handle your Nitronox cylinders with care, only moving them using an appropriate trolley or handling device.

Return empty cylinders to Medical Gas Solutions.

6 contents of the pack and other information

What Nitronox contains

The active substances are nitrous oxide and oxygen. Nitronox contains 50% oxygen and 50% nitrous oxide. There are no other ingredients.

What Nitronox looks like and contents of the pack

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 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

Tel: 01352 736050

e-mail:

This leaflet was last revised in October 2021

The following information is intended for Healthcare Professionals only

Caution should be exercised in healthcare professionals with occupational exposure to Nitronox. Repeated administration or exposure to Nitronox may lead to addition.

It has been suggested that prolonged occupational exposure to high levels of nitrous oxide may affect a woman’s ability to become pregnant.