Actynox 50%/50% medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Actynox 50%/50% medicinal compressed gas

Nitrous oxide/oxygen

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Actynox is and what it is used for
2. What you need to know before using Actynox
3. How to use Actynox
4. Possible adverse effects
5. How to store Actynox
6. Contents of the pack and other information

1. What Actynox is and what it is used for

Actynox contains a prepared mixture of nitrous oxide (N2O) and oxygen (O2), 50% of each, and should be used by inhaling the gas mixture.

Actynox can be used in adults and children over 1 month of age. The safety and efficacy of Actynox have not been established in children under 1 month of age.

Effects of Actynox

Nitrous oxide makes up 50% of the gas mixture. Nitrous oxide has an analgesic effect, reduces the sensation of pain, and raises the pain threshold. Nitrous oxide also has a relaxing and mildly sedative effect. These effects occur due to the action of nitrous oxide on substances that transmit signals in your nervous system.

The effect of Actynox is reduced in children under three years of age.

The 50% oxygen concentration, approximately double that found in ambient air, ensures a safe oxygen content in the inspired gas.

What Actynox is and what it is used for

Actynox should be used when rapid-onset and rapidly reversible analgesic effects are desired, for the treatment of mild to moderate pain of limited duration. Actynox produces analgesic effects after a few inhalations, and analgesic effects subside within minutes after discontinuation.

2. What you need to know before using Actynox

Do not use Actynox:

Before using Actynox, you should inform your doctor if you have any of the following signs/symptoms:

• Gas-filled cavities or gas bubbles: If, due to illness or for any other reason, there is suspicion of air in the chest outside the lungs, or gas bubbles in the blood or in any other organ. For example, if you have been scuba diving and may have gas bubbles in your blood, or if you have received a gas injection into the eye, for instance, for retinal detachment or similar. These gas bubbles may expand and thus cause harm.
• Heart disease: If you have heart failure or severe impairment of cardiac function, since the mild relaxing effect of nitrous oxide on the heart muscle may further impair cardiac function.
• Central nervous system injury: If you have increased pressure in the brain, for example, due to a brain tumor or cerebral hemorrhage, since nitrous oxide may further increase intracranial pressure, with a possible risk of damage.
• Vitamin deficiency: If you have been diagnosed with vitamin B12 deficiency or folic acid deficiency, but have not received treatment for it, since the use of nitrous oxide may worsen symptoms caused by vitamin B12 and folic acid deficiency.
• Ileus: If you have severe abdominal discomfort: symptoms that may indicate ileus, as Actynox may further increase intestinal dilation.

Warnings and precautions

Consult your doctor or pharmacist before using Actynox:

If you need to use Actynox for longer than 6 consecutive hours, your healthcare professional will perform routine blood tests to ensure that Actynox has not affected your blood count or your body's use of vitamin B12.

Also inform your doctor if you have any of the following signs/symptoms:

• Ear discomfort: for example, ear inflammation, as Actynox may increase pressure in the middle ear.
• Vitamin deficiencies: if you suspect you have vitamin B12 deficiency or folic acid deficiency, as nitrous oxide use may worsen symptoms caused by vitamin B12 and folic acid deficiencies.
• The success rate is lower in children under 3 years of age.

Your doctor will decide whether Actynox is suitable for you to use.

Use of Actynox with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking other medicines that affect the brain or brain function, for example, benzodiazepines (tranquilizers) or morphine-like medicines, you must inform your doctor. Actynox may increase the effects of these medicines. Actynox, when used in combination with other sedatives or medicines that affect the central nervous system, increases the risk of adverse effects.

You should also inform your doctor if you are taking medicines containing methotrexate (e.g., for rheumatoid arthritis), bleomycin (for cancer treatment), nitrofurantoin or similar antibiotics (for treating infections), or amiodarone (for heart conditions). Actynox increases the adverse effects of these medicines.

Pregnancy, lactation and fertility

Actynox may be used during pregnancy when clinically indicated.

After short-term administration of Actynox, interruption of breastfeeding is not necessary.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

If you have received Actynox without any other analgesic/sedative medication, for safety reasons, you should avoid driving, operating machinery, or performing complex tasks until you are fully recovered (at least 30 minutes).

Make sure your healthcare professional advises you whether it is safe for you to drive.

3. How to use Actynox

Actynox will always be administered in the presence of personnel familiar with this form of medication. They will ensure that your supply of Actynox is suitable for use and that the equipment has been correctly installed. While you are receiving Actynox, you will be monitored to ensure it is administered safely. After completion of Actynox treatment, you must be supervised by competent personnel until you have fully recovered.

Always use this medicine exactly as your doctor has told you.

Your doctor must explain to you how to use Actynox, how Actynox works, and what effects may result from its use. If in doubt, consult your doctor again.

Actynox is usually inhaled through a face mask connected to a special valve, meaning that you have full control over the gas flow through your own breathing. The valve opens only during inspiration. Actynox can also be administered using a nasal mask.

Regardless of the type of mask used, you must breathe normally with regular breaths while wearing the mask.

After completing Actynox treatment, you should rest and recover until you feel mentally alert again.

Safety precautions

• Smoking and exposure to open flames are strictly prohibited in rooms where Actynox treatment is administered.
• Actynox is intended for medical use only.

If you use more Actynox than you should

It is very unlikely that you will receive an overdose of gas, as you regulate the gas supply yourself and the gas mixture is fixed (containing 50% nitrous oxide and 50% oxygen).

If you breathe faster than normal and therefore receive more nitrous oxide than during normal breathing, you may feel clearly drowsy and notice a certain disconnection from your surroundings. In such a case, you must inform medical personnel immediately and stop administration.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent (affects 1 to 10 users in every 100):

Dizziness, mild dizziness, euphoria, nausea and vomiting.

Uncommon (affects 1 to 10 users in every 1,000):

Severe fatigue. Sensation of pressure in the middle ear, if you use Actynox for a prolonged period. This is because Actynox increases pressure in the middle ear.

Abdominal distension, due to Actynox slowly increasing the volume of gas in the intestines.

Frequency not known (cannot be estimated from available data):

Effects on the bone marrow, which may cause anaemia.

Effects on nerve function, sensations of numbness and weakness, usually in the legs.

This is because nitrous oxide affects the metabolism of vitamin B12 and folate, and therefore inhibits an enzyme: methionine synthetase.

Respiratory depression. You may also experience headache. Psychiatric effects, such as psychosis, confusion, anxiety, addiction.

Generalized seizures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Actynox

Keep out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the batch label of the cylinders. The expiry date refers to the last day of the month indicated.

Store at a temperature between 0 °C and 50 °C. Do not freeze.

Full cylinders must be stored HORIZONTALLY at temperatures between 10 °C and 30 °C for at least 48 hours prior to use, with valves closed.

Protect from impact, falls, sources of heat or ignition, adverse weather conditions, and particularly from low temperatures.

If it is suspected that Actynox has been stored under excessively cold conditions, the cylinders must be kept horizontally at a temperature above +10 °C for at least 48 hours before use.

Keep the cylinder in a closed, designated storage area for medical gases.

Different types of gas must be kept separated from each other.

Empty and full gas cylinders must be stored separately.

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Inhaling vapour may cause drowsiness and dizziness.

6. Contents of the pack and other information

What Actynox contains

• The active substances are:

nitrous oxide 50% (v/v) = medicinal laughing gas (chemical term: N2O) and oxygen 50% (v/v) = medicinal oxygen (chemical term: O2)

• Actynox does not contain any other active substances.

Appearance of Actynox and contents of the pack

Actynox is a colourless, odourless, tasteless gas supplied in a gas cylinder fitted with a valve to control gas flow. The cylinder may be made of steel or aluminium. Pharmaceutical form: compressed medicinal gas.

The shoulder of the gas cylinder is marked white and blue (oxygen/nitrous oxide). The body of the gas cylinder is white (medicinal gas).

Steel or aluminium containers, filling pressure 185 bar:

2, 5, 10, 15 or 50 litre container sizes with shut-off valve, with or without integrated pressure regulator, and standard connector.

Cylinders filled at 185 bar contain approximately X cubic metres of gas at atmospheric pressure and 15°C according to the table below:

Some package sizes may not be marketed.

Marketing Authorization Holder

S.E. Carburos Metálicos, S.A.

Avda de la Fama, 1

08940 – Cornella de Llobregat

Spain

Manufacturer

Laboratoires SOL France

8 rue du Compas

ZI les Bethunes

Rue du Compas

95310 Saint-Ouen-l’Aumône

France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Actynox, 50%/50% v/v medicinal gas, compressed

Belgium: Actynox, 50%/50% v/v, medicinal gas, compressed

Portugal: Actynox, 50%/50% v/v

Spain: Actynox, 50%/50% v/v, compressed medicinal gas

Czech Republic: Actynox 50%/50% v/v medicinal compressed gas

Slovak Republic: Actynox 50% / 50% v/v compressed medicinal gas

Date of the most recent review of this leaflet: September 2019.

This information is intended exclusively for healthcare professionals: DOES NOT MATCH THE APPROVED TEXT

Safety Instructions

Special precautions must be taken when handling nitrous oxide. Nitrous oxide must be administered in accordance with local guidelines.

Actynox should only be used in well-ventilated areas and where special equipment is available to extract excess gas. If an extraction system is used and adequate ventilation is ensured, high atmospheric concentrations of nitrous oxide (laughing gas) in ambient air can be avoided. High concentrations of laughing gas in the air may cause adverse health effects in personnel and nearby individuals. National guidelines exist for the maximum allowable concentration of laughing gas in ambient air, known as "hygienic limit values," often expressed as TWA (time-weighted average), the average value over a working day, and STEL (short-term exposure limit) for shorter exposures.

These values must not be exceeded to ensure personnel are not exposed to risks.

• The valve must be opened slowly and carefully.
• Close the cylinder in case of fire or when not in use.
• During use, the cartridge must be secured in an appropriate holder.
• Consider replacing the gas cartridge when the pressure has dropped to the point where the valve indicator enters the yellow zone.
• When only a small amount of gas remains in the cartridge, the valve must be closed.

It is important to leave a small amount of pressure in the cartridge to prevent the entry of contaminants.

• After use, the cartridge valve must be manually closed tightly. Depressurize the regulator or connection.

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es

Equimolar medicinal gas mixtures of nitrous oxide – oxygen in cylinders are exclusively intended for medical use.

WHAT YOU SHOULD KNOW BEFORE USING ACTYNOX

• Personnel handling cylinders must be trained in gas handling procedures.
• Do not use any cylinder that has been exposed to negative temperatures.
• If signs of freezing appear on the cylinder, do not use it and return it to the pharmacy department.
• Do not handle any cylinder if the valve is not protected.
• Never use a cylinder that is leaking.
• Never attempt to repair a damaged cylinder.
• Secure cylinders properly (using chains, etc.) to keep them in a HORIZONTAL POSITION and prevent accidental falls.
• Never apply excessive force when fitting a cylinder into a holder.

PRECAUTIONS FOR THE OPERATOR AND THE PATIENT

• Never stand in front of the outlet valve; position yourself on the side opposite the pressure regulator, at a safe distance behind the cylinder. Never expose the patient to direct gas flow.
• Connect equipment with clean, grease-free hands (without gloves and without using pliers).
• Do not use sprays (hair sprays, deodorants, etc.) or solvents (alcohol, gasoline, etc.) on or near the equipment.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patient’s face.

ATTENTION

• Do not lubricate.
• Do not smoke.
• Do not place near flames.

And in particular:

1. Never introduce the gas into a device that may have contained flammable materials, especially greasy substances.
2. Never clean gas-containing equipment, taps, seals, or closure devices with flammable products, especially greasy substances.

• In case of leakage, close the faulty valve, ventilate the room, and evacuate.
• In case of fire, the risk of toxicity increases due to the formation of nitrous fumes.

INSTRUCTIONS FOR USE AND HANDLING OF CYLINDERS

The following rules must be observed to prevent accidents:

Connection:

• For cylinders equipped with a valve:
• Open the valve slowly before connecting the pressure regulator to blow out any dirt particles or foreign material from the valve outlet. Always keep the interface between the cylinder and pressure regulator clean.
• Ensure the pressure regulation equipment is compatible with this mixture and that the pressure regulator seal is in good condition.
• Use pressure regulators specifically designed for equimolar mixtures of nitrous oxide – oxygen at 185 bar (two-stage pressure regulators equipped with special connectors according to standard regulations).
• Use a pressure regulator with a flow meter capable of reading pressures at least 1.5 times the cylinder’s maximum working pressure.
• For cylinders equipped with an integrated pressure regulator:
• For safety reasons, these cylinders may only be used with a hose connected to a specific connector with a blue-and-white locking control, and connected to a demand valve or a flow meter equipped with a specific blue-and-white locking control connector.
• A specific connector for medicinal nitrous oxide – oxygen mixtures complying with national standards must be used.
• Never tighten the pressure regulator with pliers, as this may damage the seal.
• Do not use a connector adapter to join two devices that do not normally fit together.
• If signs of freezing appear on the pressure regulator, check whether gas is flowing (e.g., by inflating a balloon), as the regulator may be blocked.
• Ventilate the area (room, vehicle, etc.) after prolonged use and ensure gas is evacuated in case of accident or accidental leakage.

Opening the cylinder after connection:

• Follow the instructions on the cylinder cap label.
• Never use force to open the valve or open it fully.
• Always open the valve slowly and gradually to prevent cooling, which could lead to mixture separation.
• Never pressurize the pressure regulator suddenly.
• Do not transfer pressurized gas from one cylinder to another.

After use:

• Close the cylinder valve after use, allow the pressure gauge reading to drop by leaving the regulator open, then close the pressure regulator and unscrew the regulator thread.
• Never completely empty the cylinder; always leave a minimum pressure of 10 bar.
• Store empty cylinders in an UPRIGHT position with valves closed (to prevent corrosion due to moisture).