Entonox

Leaflet attached to the packaging: information for the user

ENTONOX, 50% + 50%, compressed medical gas

Dinitrogen oxide+ Oxygen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is ENTONOX and what is it used for
• 2. Important information before using ENTONOX
• 3. How to use ENTONOX
• 4. Possible side effects
• 5. How to store ENTONOX
• 6. Contents of the packaging and other information

1. What is ENTONOX and what is it used for

ENTONOX contains a ready-made mixture of nitrous oxide (medical "laughing gas", N2O) and oxygen (medical oxygen, O2), each 50%, and is used by inhalation.

How ENTONOX works

Nitrous oxide makes up 50% of the gas mixture. Nitrous oxide has analgesic effects, reduces the sensation of pain, and increases the pain threshold. Nitrous oxide also has relaxing and slightly sedative effects. These effects are caused by the action of nitrous oxide on neurotransmitters in the nervous system.

What ENTONOX is used for

ENTONOX should be used when a rapid-onset and short-duration analgesic effect is needed, and when the pain being treated is mild to moderate and limited in time. ENTONOX has an analgesic effect after a few breaths. This effect disappears within a few minutes of stopping administration. ENTONOX can be used in adults and children from 1 month of age.

2. Important information before using ENTONOX

When not to use ENTONOX:

Before using ENTONOX, you should inform your doctor about any of the following conditions:

• Spaces filled with gas or gas bubbles: if it is suspected that there is air or gas in the pleural cavities outside the lungs, or in any other organ, or if there are gas bubbles in the blood (e.g., if the patient has been scuba diving), or if the patient has been injected with gas into the eye (e.g., due to retinal detachment or similar conditions). Such gas bubbles can expand and cause organ damage.
• Heart disease:If the patient has circulatory failure or significant impairment of heart function, the slight relaxing effect of nitrous oxide on the heart muscle may further worsen its function.
• Central nervous system damage:if intracranial pressure is increased, for example, due to a brain tumor or intracerebral hemorrhage, because nitrous oxide may further increase intracranial pressure and potentially cause damage.
• Vitamin deficiency:if a deficiency of vitamin B or folic acid has been diagnosed and not treated, the use of nitrous oxide may exacerbate the symptoms caused by the deficiency of vitamin B and folic acid.
• Bowel obstruction:if there is severe abdominal pain, a symptom that may indicate bowel obstruction, ENTONOX may exacerbate bowel distension.
• Facial and jaw injuries, which may make the use of a face mask difficult or risky.

Warnings and precautions

You should also inform your doctor about the following symptoms/disorders:

• Decreased level of consciousness or persistent confusion:You should inform your doctor if there are symptoms of malaise or a feeling of incomplete awakening due to injury or illness. This is important information, as the sedative effect of nitrous oxide in ENTONOX may increase the sedative effect and affect natural defense reflexes.
• Ear disorders:such as ear inflammation, as ENTONOX may increase the pressure in the middle ear.
• History of substance abuse/drug abusebecause the risk of dependence on nitrous oxide is higher in case of repeated use. The doctor will decide whether ENTONOX can be used in such a case.
• Vitamin deficiency:If a deficiency of vitamin B12 or folic acid is suspected, nitrous oxide may exacerbate the symptoms caused by the deficiency of vitamin B12 and folic acid.

The doctor will decide whether to use ENTONOX.

ENTONOX and other medicines

You should tell your doctor or nurse about all medicines you are taking, have recently taken, or plan to take.

• Methotrexate used to treat, for example, rheumatoid arthritis. Taking ENTONOX with methotrexate may affect the blood cell count.
• Other medicines that affect the brain or its functions, such as benzodiazepines (sedatives) and morphine-like medicines, you should inform your doctor about this. ENTONOX may enhance the effect of these medicines. ENTONOX in combination with other medicines affecting the central nervous system increases the risk of side effects.
• Bleomycin (used to treat cancer) or amiodarone (used to treat heart arrhythmias) before taking ENTONOX, as there is a possibility of toxic effects on the lungs due to high oxygen levels.
• Nitrofurantoin or antibiotics with similar effects (for the treatment of infections)

ENTONOX enhances the side effects of these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or nurse before taking this medicine.

Driving and using machines

You should be aware that after taking ENTONOX, you should rest. Nitrous oxide in ENTONOX is quickly eliminated from the body after short inhalation. The effect on cognitive abilities may persist for several hours. For safety reasons, you should avoid driving, operating machinery, and performing complex tasks until you have fully recovered (at least 30 minutes).

3. How to use ENTONOX

ENTONOX is always administered by trained personnel familiar with this form of the medicine. During administration, both the patient and the administration of the medicine should be monitored to ensure safe use. After administration, the patient will be under the supervision of competent personnel until they regain full consciousness.

Administration in children

In children who are unable to understand and follow instructions, ENTONOX may be administered under the supervision of competent medical personnel who can help maintain the mask in the correct position and actively control administration. In such cases, ENTONOX may be administered with a constant gas flow.

Precautions

• Smoking or using open fire in rooms where ENTONOX is being used is strictly prohibited.
• ENTONOX is intended for medical purposes only.

Also, check the instructions for storing and using the cylinder (5. How to store ENTONOX)

Use of a higher than recommended dose of ENTONOX

It is very unlikely that a patient will receive too much gas, as the patient controls the gas supply, and the gas mixture is constant (contains 50% nitrous oxide and 50% oxygen).

4. Possible side effects

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store ENTONOX

The medicine should be stored out of sight and reach of children.

What ENTONOX contains

• The active substances of the medicine are: nitrous oxide 50% (medical "laughing gas"; chemical formula: N2O) and oxygen 50% (medical oxygen; chemical formula: O2)
• ENTONOX does not contain other ingredients.

What ENTONOX looks like and what the packaging contains

ENTONOX is a colorless, odorless, tasteless gas that is supplied in gas cylinders with valves to control gas flow.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Linde Sverige AB
Rättarvägen 3
16968 Solna
Sweden

Manufacturer

Linde Gas AB
Baltzar von Platens gata 4-6
SE-749 47 Enköping
Sweden
Linde France
16 avenue de la Saudrune
Zone industrielle du Bois Vert
31 120 Portet sur Garonne
France
Linde Gaz Polska Sp. z o.o.
ul. Żwirowa 4
33-100 Tarnów
Poland
LINDE GAZ POLSKA Sp. z o. o.
Oddział w Warszawie
ul. Kasprowicza 132
01-949 Warszawa
Poland

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

Austria LIVOPAN

Belgium RELIVOPAN

Czech Republic ENTONOX

Cyprus ENTONOX

Denmark LIVOPAN

Finland LIVOPAN

Germany LIVOPAN

Greece ENTONOX

Hungary LIVOPAN

Iceland LIVOPAN

Italy LIVOPAN

Luxembourg RELIVOPAN

Netherlands RELIVOPAN

Norway LIVOPAN

Poland ENTONOX

Portugal LIVOPAN

Spain ENTONOX

Romania ENTONOX

Slovakia ENTONOX

Sweden LIVOPAN

Date of last revision of the leaflet:

February 2022

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. http://www.urpl.gov.pl

Information intended for healthcare professionals only:

Safety instructions

No adverse effects have been observed in fetuses of women professionally exposed to chronic inhalation of nitrous oxide during pregnancy, if an appropriate exhaust or ventilation system has been installed. Please refer to the Summary of Product Characteristics for more information.

• The valve should be opened slowly and carefully.
• The device should be turned off 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 if the pressure in the cylinder has dropped and the indicator on the valve is in the yellow zone.
• When there is little gas left in the cylinder, the cylinder valve should be closed. It is important to leave some pressure in the cylinder to prevent contamination.
• After use, the cylinder valve must be manually closed "to the stop". The pressure should be released from the regulator and connector.