Leaflet: information for the user

Serynox 50% / 50% medicinal compressed gas

nitrous oxide/oxygen

Read this leaflet carefully before starting to use this medicine, as 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, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1.What Serynox is and what it is used for

2.What you need to know before starting to use Serynox

3.How to use Serynox

4.Possible side effects

1. Storage of Serynox

6.Contents of the pack and additional information

Serynox contains a mixture of two medicinal gases:

• nitrous oxide at 50% («medical laughing gas»),
• oxygen at 50% (medical oxygen).

It is used by breathing the gas mixture. At this concentration, Serynox has no narcotic effect (anesthetic).

Serynox belongs to the group of nitrous oxide combinations.

Serynox can be used in adults, adolescents, and children over 1 month of age.

Serynox acts by reducing the sensation of pain and increasing patient relaxation during:

• short-term analgesia for procedures or situations with mild to moderate pain intensity and sedation during dental surgery, when rapid onset and termination analgesia is required.

No use Serynox

• If a gas has been applied to the eye during eye surgery, inform your doctor about it at all times to ensure that administration does not cause severe postoperative complications due to increased intraocular pressure;
• If your condition requires the administration of 100% oxygen;
• In case of excessive pressure in the head (intracranial hypertension);
• In case of altered consciousness (consciousness is not completely normal);
• In case of known untreated deficiency of vitamin B12 or folic acid;
• In case of recent unexplained neurological disorders;
• In patients with heart failure or cardiac dysfunction (e.g., after cardiac surgery).

When inhaling Serynox, gas bubbles and air-filled cavities can expand in the body and cause severe damage. Therefore, Serynox should not be used in the following cases:

• Head trauma;
• Face or jaw trauma;
• Air accumulation between the lungs and the thoracic cavity (pneumothorax);
• Pulmonary alveoli disease that causes respiratory problems (severe emphysema);
• Formation of air bubbles in the bloodstream (gas embolism);
• Deep-sea diving with a risk of decompression syndrome;
• Performing a cerebral radiograph;
• Ear or nasal sinus surgery;
• Presence of air in the abdomen causing intense abdominal pain;
• Having received spinal anesthesia to eliminate pain from the hips down (epidural anesthesia) during which air was injected;

Warnings and precautions

Consult your doctor before starting to use Serynox.

Serynox should be administered by trained personnel. However, self-administration under the supervision of a doctor is preferred to assess the patient's level of consciousness. Never manipulate the Serynox balloon.

The areas where Serynox is used should be well ventilated and/or equipped with an extraction device to keep the ambient concentration of nitrous oxide as low as possible.

Breathe normally when inhaling Serynox.

It is not recommended for use in newborns.

Monitor for possible adverse effects in newborns, especially respiratory depression, when Serynox is administered to the mother during delivery.

Prolonged or repeated administration of Serynox may cause abuse and dependence.

In cases of repeated or prolonged administration of Serynox, vitamin B12 may lose its effectiveness in the body. Your doctor may need to prescribe vitamin B12.

Consult your doctor in the following situations, as there is a risk of vitamin B12 deficiency:

- If you have anemia, a specific type of stomach mucosa inflammation (gastritis atrophica), or a brain disease;

- If you are a vegetarian;

- If you are an alcoholic.

If you or your children have an acute ear infection, inform your doctor.

Use of Serynox with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if:

• You have received an injection of an ocular gas during eye surgery, as there is a risk of postoperative complications if intraocular pressure becomes too high;
• You are taking medications that act on the central nervous system (such as morphine derivatives, benzodiazepines, and other psychotropic medications), as they may increase hypnotic effects;
• You are taking vitamin B12/folic acid, as vitamin B12 may lose its effectiveness due to Serynox.

Serynox may potentiate the toxicity of methotrexate by interfering with folate metabolism.

The pulmonary toxicity associated with active principles such as bleomycin, amiodarone, nitrofurantoin, and similar antibiotics may be exacerbated by inhaling high concentrations of oxygen.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Serynox can be used during pregnancy in cases where it is clinically indicated.

If used near delivery, monitor for possible adverse reactions in the child.

After a short-term administration of Serynox, it is not necessary to interrupt breastfeeding.

Driving and operating machinery

Serynox has effects on perception and behavior related to movement (cognitive and psychomotor functions).

After administration of Serynox, you will be monitored until all effects have disappeared and you have regained your normal level of alertness. After nitrous oxide administration, it is not recommended to drive and operate machinery or perform other activities that require psychomotor functions for a reasonable period after exposure.

Dosage

Serynox should only be administered by personnel familiar with this type of medication. Your doctor will explain how to use Serynox, how it works, and what effects its use produces. For certain interventions, you will be asked to hold the equipment for gas administration. This will allow you to dose yourself with the amount of gas.

Throughout the time you use Serynox, you and the medication administration will be monitored to confirm that it is administered safely.

Serynox administration should be discontinued if verbal contact is interrupted.

The maximum analgesic effect is achieved after at least 3minutes.

Administration method

Serynox is administered by inhalation.

Serynox is a mixture of two medicinal gases that you will inhale and will be administered through a mask placed on your face via an appropriate device.

During Serynox inhalation, you should breathe normally.

When you stop using Serynox, the mask will be removed and you should rest and recover until you consider yourself mentally recovered.

Duration of use

The use of Serynox depends on the duration of the intervention and is normally not to exceed one inhalation of 60minutes per day. Repeated administration of Serynox should not exceed 15days.

If you use more Serynox than you should

It is highly unlikely that you will receive too much gas, as you can control the amount of gas you inhale through the mask and are closely monitored.

If you breathe faster than normal and, therefore, receive more nitrous oxide than you normally would by breathing normally, you may feel notably tired and to some extent disconnected from your surroundings.

Under these circumstances, you should immediately inform the medical staff and interrupt the administration.

If your skin turns blue (cyanosis) during Serynox use, the medical staff will immediately stop treatment. If cyanosis does not rapidly decrease, you will be ventilated with air using a manual ventilation bag or oxygen.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you interrupt treatment with Serynox

The analgesic effect disappears immediately after the end of Serynox administration without irreversible effects.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects may occur during treatment and usually disappear a few minutes after stopping the inhalation of the mixture:

Frequent: may affect up to 1 in 10people

• dizziness
• fatigue
• nausea
• vomiting

Rare: may affect up to 1 in 100people

• tingling (paresthesia)
• deep sedation (somnolence)
• hallucinations
• anxiety
• agitation
• euphoria
• dreams

Unknown frequency: cannot be estimated from available data

• headache
• seizure
• increased intracranial pressure (see section2, Do not use Serynox)
• ear pain
• psychosis
• confusion
• disorientation
• respiratory depression (in newborns during delivery)
• severe visual impairment (caused by intraocular gas expansion, see section2, Do not use Serynox)

After prolonged and repeated use of Serynox

Unknown frequency: cannot be estimated from available data

After increased breathing during inhalation (hyperventilation) abnormal movements may occur.

Neurological disorders such as spinal cord diseases(myeloneuropathies).

Decreased red blood cell count, accompanied by a decrease in white blood cell count(megaloblastic anemia with leucopenia).

Abuse and dependence.

Vitamin B12 deficiency(see section2, Do not use Serynox, Warnings and precautions and Use of Serynox with other medicines).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the gas cartridge after CAD.

Storage of Gas Cartridges

Do not freeze.

The mixture is unstable below –5°C; if it cools below that temperature, a part of the nitrous oxide may liquefy, so that an unequal mixture of gases containing too much oxygen (a mixture with reduced analgesic activity) is administered at the beginning of treatment and too much nitrous oxide (a hypoxic mixture) at the end of treatment.

Never expose the cartridges to temperatures below 0°C.

Store the gas cartridges as follows:

Store full cartridges for at least 48hours in HORIZONTAL POSITION at a temperature above +10°C, in a transitional zone of the pharmacy or maintenance department.

In all other situations, the cartridges must be stored securely in VERTICAL POSITION (full cartridges in the gas storage area, full cartridges in use, full cartridges for transportation within healthcare centers and vehicles, storage of empty cartridges).

Different types of medical gases must be separated from each other. Full and empty gas cartridges must be stored separately.

Storage of Full Cartridges in a Gas Storage Area

Full cartridges must be stored in VERTICAL POSITION in a clean and well-ventilated area where there is no combustible material and that is protected from the elements. This room must be reserved for the storage of medical gases and locked.

Full and empty cartridges must be stored separately.

Full cartridges must be protected from impacts and falls and kept away from heat sources and ignition sources and flammable substances. They must also be protected from the elements and, in particular, from cold. Once delivered by the manufacturer, the cartridges must have an intact safety seal.

Storage of Full Cartridges 48hours before use

Full cartridges must be stored for at least 48hours in HORIZONTAL POSITION at a temperature above +10°C, in a transitional zone of the pharmacy or maintenance department before use.

The cartridges must be in a place where they are protected from impacts, heat sources or ignition sources and flammable materials.

The cartridges must be stored with the valves closed.

Transportation of Full Cartridges

In healthcare centers, full cartridges must be securely fastened in VERTICAL POSITION using the appropriate means (carts with chains, rings or bars) for transportation to protect them from impacts and falls. During transportation in vehicles, full cartridges must be securely fastened in VERTICAL POSITION. Emergency services must be warned that the cartridges must be protected from cold both in vehicles and during use outdoors. In the case of cartridges with pressure residual valves, special attention must be paid to the connection of the pressure regulator to avoid accidental damage.

Storage of Empty Cartridges
Empty cartridges must be stored securely in VERTICAL POSITION.

The valves must be closed.

Composition of Serynox

• The active principles are:

Nitrous oxide at 50% and oxygen at 50%

• Serynox does not contain any other component.

Appearance of the product and contents of the container

Serynox is an incolored medicinal compressed gas.

Aluminum and/or steel gas cylinders of 2 liters, 5 liters, 10 liters, 15 liters, and 20 liters (identification with blue and white tip and white body) filled to a pressure of 170 bar, equipped with a residual pressure valve and/or valves with an integrated pressure regulator and a specific outlet connection in both cases.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Messer Ibérica de Gases S.A.U.

Autovía Tarragona-Salou, km. 3.8

E-43480, Vilaseca (Tarragona)

Spain

Responsible manufacturer:

MESSER FRANCE

ZI Lafayette, 35 rue de l'Europe

38790 Saint-Georges-d'Espéranche

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria, Germany:Serynox 50% / 50% Gas zur medizinischen Anwendung, druckverdichtet

Belgium:Placynox 50% / 50% v/v medicinaal gas, samengeperst / gaz médicinal comprimé

Croatia:Serynox 50%/50% V/V medicinski plin, stlačen

Czech Republic:Serynox

Estonia, Latvia, Lithuania:Serynox

France:Placynox 50% / 50% gaz médicinal comprimé

Poland:Serynox

Romania:Serynox 50% / 50% Gaz medicinal comprimat

Slovenia:Serynox 50 %/50 % V/V medicinski plin, stisnjeni

Slovakia:Serynox 50% / 50% stlačený medicinálny plyn

Spain:Serynox 50% / 50% gas comprimido medicinal

Last review date of this leaflet:November 2020

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals

Serynox gas cylinders should only be used for medical purposes.

Rooms where Serynox is frequently used should be equipped with an adequate gas exhaust system or ventilation.

Different types of medicinal gases should be kept separate from each other. Gas cylinders filled and empty should be stored separately.

Never use oil or grease, even if the valve of the cylinder is rigid or difficult to connect the regulator. Handle the valves and accompanying equipment with clean, grease-free hands (hand cream, etc.).

Turn off the equipment in case of fire or if it is not in use. If there is a risk of fire, transfer the gas cylinder to a safe location.

Use only conventional equipment indicated for the nitrous oxide/oxygen gas mixture of 50% N2O and 50% O2.

Check that the gas cylinders are sealed before proceeding with their first use.

Smoking and open flames are strictly prohibited in rooms where Serynox treatment takes place.

When using the cylinder, it must be securely fastened to an appropriate support.

After use, the valve of the cylinder should be closed by hand. Remove the pressure from the regulator or connection.

Do not dispose of the empty gas cylinder. The supplier will collect the empty gas cylinders.