Nodolox 50%/50% medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nodolox 50%/50% medicinal compressed gas

Nitrous oxide/oxygen

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, 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.

Contents of the leaflet

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

1. What Nodolox is and what it is used for

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

This medicine can be used in adults and children older than 1 month. The safety and efficacy of Nodolox have not been established in children under 1 month of age.

Effects of Nodolox

Nitrous oxide constitutes 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 are due to the action of nitrous oxide on the substances transmitting signals in your nervous system.

The effect of this medicine is lower 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 Nodolox is and what it is used for

Nodolox should be used when rapid-onset and short-duration analgesic effects are desired, in cases of mild to moderate pain of limited duration. Nodolox produces analgesic effects after a few inhalations, and analgesic effects subside within minutes after discontinuation.

2. What you need to know before using Nodolox

Do not use Nodolox:

Before using this medicine, you must inform your doctor if you have any of the following signs/symptoms:

• Gas-filled cavities or gas bubbles: If, as a result of a disease or for any other reason, air is suspected to be present in the chest outside the lungs, or gas bubbles are present in the blood or in any other organ. For example, if you have been diving with scuba equipment and may have gas bubbles in the blood, or if you have received an injection of gas into the eye, for instance, for retinal detachment or similar. These gas bubbles may expand and therefore 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 potential risk of damage.
• Vitamin deficiencies: 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; in this case, Nodolox may further increase intestinal distension.

Warnings and precautions

Consult your doctor or pharmacist before using Nodolox:

If you need to use this medicine for more than 6 consecutive hours, healthcare professionals will perform routine blood tests to ensure that Nodolox has not affected your blood count or your body's ability to use vitamin B12.

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

• Ear discomfort: For example, ear inflammation, since this medicine may increase pressure in the middle ear.
• Vitamin deficiencies: If you suspect you have vitamin B12 deficiency or folic acid deficiency, since the use of nitrous oxide may worsen symptoms caused by vitamin B12 and folic acid deficiency.
• If you currently suffer from or have previously had drug addiction, since there is a high risk of developing dependence on nitrous oxide if administered repeatedly. Your doctor will decide whether treatment with nitrous oxide is appropriate in your case.

Prolonged or repeated use of nitrous oxide may increase the risk of vitamin B12 deficiency, which may lead to bone marrow or nervous system damage. The use of nitrous oxide should be accompanied by close clinical monitoring and hematological checks to assess the consequences of a possible vitamin B12 deficiency.

Your doctor will decide whether Nodolox is suitable for you.

Children

The success rate is lower in children under 3 years of age.

Nodolox can be used in children who are able to follow instructions on how to use the equipment. In treating younger children or other patients unable to follow instructions, administration should be performed with the assistance of a healthcare professional.

This medicine must not be used in children under 1 month of age.

Other medicines and Nodolox

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 drugs, you must inform your doctor. Nitrous oxide may enhance the effects of these medicines. Nodolox, in combination with other sedatives or other medicines affecting 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 treating heart conditions). Nodolox increases the adverse effects of these medicines.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Some data indicate that short-term use of nitrous oxide during pregnancy does not involve an increased risk of congenital malformations. In isolated cases, nitrous oxide may cause respiratory problems in newborns. Medicinal nitrous oxide should only be used during pregnancy when strictly necessary. Frequent or prolonged use should be avoided.

Lactation

It is unknown whether medicinal nitrous oxide is excreted in breast milk. It is not necessary to interrupt breastfeeding after a short period of administration.

Driving and use of machines

Do not drive or operate tools or machinery after receiving Nodolox, as this medicine may affect your reaction ability. Your doctor will advise you how long you should wait before driving or using machinery again.

3. How to use Nodolox

Nodolox will always be administered in the presence of personnel familiar with this type of medicine. The personnel will ensure that Nodolox can be used and that the equipment has been correctly installed. While you are receiving this medicine, you will be monitored to ensure it is administered safely. After completion of treatment with Nodolox, you must be monitored by competent personnel until you have fully recovered.

Always use this medicine exactly as your doctor has instructed. Your doctor must explain to you how to use Nodolox, how Nodolox works, and what effects to expect from its use. If in doubt, consult your doctor again.

Nodolox 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 is open only during inspiration. Nodolox may also be administered using a nasal mask.

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

After completing treatment with this medicine, you should rest and recover until you feel mentally restored.

Safety precautions

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

If you use more Nodolox than you should

It is highly 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 with normal breathing, you may feel clearly drowsy and notice a certain disconnection from your surroundings. In such a case, you must immediately inform the medical staff 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 (may affect up to 1 in 10 patients/people): Dizziness, mild dizziness, euphoria, nausea, and vomiting.

Uncommon (may affect up to 1 in 100 patients/people): Severe fatigue. Sensation of pressure in the middle ear, if Nodolox is used for a prolonged period.

This is due to the fact that Nodolox increases pressure in the middle ear.

Abdominal distension, due to Nodolox 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 vitamin B12 and folate metabolism, thereby inhibiting an enzyme: methionine synthetase.

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

Generalized seizures with unknown frequency.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may 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 Nodolox

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the batch label of the cylinder. 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.

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

Keep away from combustible materials.

Contact with combustible materials may cause fire. Do not smoke or light a flame near Nodolox.

Do not expose to intense heat.

If there is a risk of fire, move the cylinder to a safe location. Keep the cylinder clean, dry, and free from oil and grease.

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

Different types of gas must be stored separately from each other. Empty and full gas cylinders must be stored separately.

Store and transport with valves closed.

Ensure that the cylinder is not struck or dropped. Inhaling vapour may cause drowsiness and dizziness.

6. Contents of the container and other information

Composition of Nodolox

The active substances are:

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

This medicine does not contain any other active substances or excipients.

Appearance of the product and contents of the container

This medicine is a colourless, odourless, tasteless gas supplied in a gas cylinder with a valve to control gas flow. The cylinder may be made of steel or aluminium.

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

Container sizes in litres (170 bar): 0.75 L, 1 L, 1.4 L, 1.6 L, 2 L, 2.5 L, 2.75 L, 3 L, 3.5 L, 4 L, 4.55 L, 4.7 L, 5 L, 6.7 L, 7 L, 10 L, 10.7 L, 13 L, 13.4 L, 15 L, 20 L, 30 L, 40 L, 50 L, cylinder bundles of 600 L (12 x 50 L) and 900 L (18 x 50 L).

Only some container sizes may be marketed.

Marketing Authorization Holder

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer

OXIGEN SALUD, S. A.

Polígono Industrial, Callea A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Date of the most recent revision of this leaflet: May 2019

This information is intended for healthcare professionals only:

Safety instructions

Special precautions must be taken when working with nitrous oxide. Nitrous oxide must be administered according to local guidelines.

Repeated administration or exposure to nitrous oxide may lead to addiction. Caution should be exercised in healthcare professionals with occupational exposure to nitrous oxide.

Nodolox must 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 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 exposure periods.

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

• The valve must be opened slowly and carefully.
• Close the equipment in case of fire or when not in use.
• During use, the cylinder must be secured in an appropriate holder.
• Consider replacing the gas cylinder 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 cylinder, the valve must be closed.
• It is important to leave a small amount of pressure in the cylinder to prevent entry of contaminants.
• After use, the cylinder valve must be closed manually until tight.
• Depressurize the regulator or connection.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.