Label: information for the user

Medicinal nitrous oxide Solgroup 100 % v/v, medicinal liquefied gas

Nitrous oxide

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult yourdoctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

The Medicinal Nitrous Oxide Solgroup is an odorless, colorless inhalation gas (prepared for inhalation). The active substance is nitrous oxide, also known as "laughing gas". It belongs to the group of general anesthetics (narcotic agents).

The Medicinal Nitrous Oxide Solgroup is used in adults and in children aged 1 month:

• combined with oxygen (50% nitrous oxide and 50% oxygen) to relieve mild to moderate pain, on a short-term and intermittent basis.
• mixed with a minimum of 21% oxygen as a basic anesthetic, in combination with other anesthetics.

No useÓxidonitroso medicinal Solgroup:

• If you inhale medical oxygen 100% regularly or constantly
• If you have air trapped in a part of your body where a possible expansion of the air could have very serious consequences, such as a collapsed lung (pneumothorax), breathing difficulties like emphysema or decompression sickness (decompression sickness)
• If you have undergone coronary bypass surgery with or without a heart-lung machine

• In patients with heart disease (for example, heart failure or heart dysfunction)

• If you have facial injuries or a jaw disorder
• In case of head injuries with consciousness disorders
• In case of severe gastric distension
• If you suspect or observe an increase in intracranial pressure

• After an injection of gas (for example, SF6, C3F8) in the eye, it may cause an increase in the volume of the eye and the possibility of causing blindness. (The doctor should not use medical nitrous oxide until a sufficient time has passed).
• If you have been diagnosed with vitamin B12deficiency or folate acid deficiency (even in the early stages of pregnancy), but have not followed any treatment for this, as the use of nitrous oxide may worsen the symptoms caused by vitamin B12and folate deficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Medical Nitrous Oxide Solgroup:

• If you have or have had a tendency to abuse drugs/medicines, as there is a higher risk of developing dependence on nitrous oxide if it is administered repeatedly. Your doctor will decide if the treatment with Medical Nitrous Oxide Solgroup is suitable for you.
• The repeated or prolonged use of nitrous oxide may increase the risk of developing vitamin B12deficiency, which could affect the bone marrow or nervous system. Your doctor may prescribe blood tests before and after treatment to assess the consequences of a possible vitamin B12deficiency.

-If you have vitamin B12 deficiency, as occurs in people with pernicious anemia (a malignant form of anemia) or Crohn's disease (a chronic intestinal disease) or in vegetarians.

-If you have heart failure (if your heart does not function properly).

-If you have severe hypotension as a result of a concussion or cardiac arrest.

-If you have sickle cell anemia (a specific blood disease in which red blood cells have an abnormal shape).

-If analgesia containing opium was administered during childbirth (the combination of this type of medication with Medical Nitrous Oxide Solgroup may cause loss of consciousness).

-After an injection in the eye (with another agent), a sufficient time should have passed before administering Medical Nitrous Oxide Solgroup, as otherwise there is a risk of eye problems (including blindness).

• Due to its content of nitrous oxide, Medical Nitrous Oxide Solgroup may increase pressure in the middle ear and other air-filled cavities.

-When benzodiazepines are administered at the same time (a group of specific medications with tranquilizing, soporific, and/or muscle-relaxing properties), as it may cause loss of consciousness.

-If you have received treatment with bleomycin (a medication used in cancer treatment).

Children and adolescents

Do not administer this medication to newborns (full-term or premature).

Use of Medical Nitrous Oxide Solgroup with other medications

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

NOTE: The following warnings also apply to the use of medications before or after using Medical Nitrous Oxide Solgroup.

-Narcotic medications potentiate the activity of Medical Nitrous Oxide.

-Morphine-containing medications increase the analgesic and sedative effects of Medical Nitrous Oxide.

-Benzodiazepines and barbiturates (a group of specific medications with tranquilizing, soporific, and/or muscle-relaxing properties) increase the effect of Medical Nitrous Oxide and the combination of these medications with Medical Nitrous Oxide may cause loss of consciousness.

-The action of certain muscle relaxants (such as pancuronium, vecuronium) increases with Medical Nitrous Oxide.

-The damage caused by sodium nitroprusside (a medication used in the treatment of high blood pressure) and methotrexate (a medication used in cancer treatment) increases because the action of vitamin B12 predominates by Medical Nitrous Oxide.

-The damage caused by bleomycin (a medication used in cancer treatment) in the lungs may be increased if oxygen administration is increased (as occurs in treatment with Medical Nitrous Oxide).

Use of Medical Nitrous Oxide Solgroup with food, drinks, and alcohol

If Medical Nitrous Oxide Solgroup is used as a component of a general anesthetic, do not eat or drink anything in the 6 hours before the anesthetic, as Medical Nitrous Oxide Solgroup may cause nausea or vomiting (see section 4 "Possible side effects").

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Some data have indicated that short-term use of Medical Nitrous Oxide Solgroup does not pose a higher risk of congenital malformations. In isolated cases, nitrous oxide may cause respiratory problems in newborns. Medical Nitrous Oxide Solgroup should only be used during pregnancy in strictly necessary cases. Its frequent or prolonged use should be avoided.

Breastfeeding

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

Fertility

There are no relevant data in humans regarding the effects of nitrous oxide on fertility. Animal studies indicate that female and male fertility may be affected by exposure to low concentrations (≤1%).

Driving and operating machinery

-Do not drive or use any tools or machines in the 24 hours after administration of Medical Nitrous Oxide Solgroup combined with anesthetic medications, as nitrous oxide has a significant effect on the ability to drive and operate machines.

-Be careful after short-term administration of nitrous oxide for pain relief. Do not drive or use machines until the side effects have disappeared and you have regained the level of alertness you had before treatment.

Inhalation use.

The doctor will administer theMedical Nitrous Oxide Solgroupand establish the correct dose.

For short-term use for pain relief

When administered for pain relief, theMedical Nitrous Oxide Solgroupis only used in combinationwith the same proportion of oxygen(50% nitrous oxide and 50% oxygen).

The analgesic effectis produced after4-5 inhalations, producing maximum pain relief within 2-3 minutes. The administration of Medical Nitrous Oxide Solgroup should continue throughout the painful procedure, or for the duration desired for analgesic effect.

After suspension of administration/inhalation, the effects disappear rapidly in a few minutes.

The maximum administration period should not exceed 1 hour per day.

This treatment should not be repeated for more than 15 consecutive days.

Depending on the individual patient's pain relief reaction, additional analgesics may be required.

For use in combination with anesthetic medications

When used in combination with anesthetic medications, the Medical Nitrous Oxide Solgroupwill only be administered mixed with a minimum of 21% oxygen. Medical Nitrous Oxide Solgroupalone cannot cause anesthesia. Combining anesthetic medications with Medical Nitrous Oxide Solgrouprequires a lower amount of other anesthetic medications. Generally, the effect is observed in 2 to 5 minutes.

Instructions for use of Medical Nitrous Oxide Solgroup

Thenitrous oxide (medical)will be administered by inhalation and shouldbe used with a facial mask, a mouthpiece or nasal cannulas.The mask or mouthpiece is connected tonitrous oxide (medical) via a suitable medical device.The device should be handled as described by the manufacturer. These systems will only be used to administer nitrous oxide under the direct supervision and attention of medical personnel with the necessary trainingin well-ventilated areas, to prevent Medical Nitrous Oxide Solgroupexhaled into the ambient air.

If you use more Medical Nitrous Oxide Solgroup than you should

The consequences of a nitrous oxide overdosecause an acute lack of oxygen. In case of overdose, the administration of nitrous oxidemust be stopped immediately and the patient should be ventilated with air or oxygen until the oxygen concentration in the blood returns to normal levels.

If you interrupt treatment with Medical Nitrous Oxide Solgroup

If you interrupt the use of nitrous oxideand oxygen medicinal, it may cause a lack of oxygen. To prevent this, temporarily the patient can be ventilated with 100% oxygen.

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

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

The following side effects have been classified by organs. There is little data on the frequency of side effects, but they occur more frequently with a higher dose and/or a longer administration period. Nausea and vomiting are the most common side effects.

Blood and lymphatic system disorders

• Megaloblastic anemia (a type of anemia caused by a deficiency of vitamin B12due to nitrous oxide)

• Granulocytopenia (complete deficiency of a type of blood cell)

Mental health disorders

• Psychosis (serious mental illnesses in which behavior control is altered and actions are decreased), confusion, and headache, although it also causes reduced anxiety and improved mood.
• Dependence (frequency unknown).

Nervous system disorders

• Decreased cerebral circulation and decreased cerebral glucose consumption.
• May produce psychedelic effects, even without administering another anesthetic drug.
• Neurological effects: spinal cord disorders, neuropathy, paresthesias (sensations like pinpricks and muscle cramps) throughout the body, myeloneuropathy, epilepsy, generalized seizures (frequency unknown), sedation, dizziness, increased intracranial pressure, symptoms of leg paralysis with muscle cramps.
• Effects on nervous functions, numbness and weakness, especially in the legs (frequency unknown).
• Intense decrease and/or increase in body temperature.

Eye disorders

Slowed eye movements.

Temporary increase in intraocular pressure and/or volume if medicinal nitrous oxide is administered after injection of a gas-producing drug in the eye.

Vestibular and ear disorders

Middle ear damage and eardrum rupture.

Cardiac disorders

• Cardiac arrhythmia
• Heart failure
• Pulmonary hypertension
• Systemic hypotension

Respiratory, thoracic, and mediastinal disorders

• Respiratory depression
• Air in the thoracic cavity
• Subcutaneous emphysema and symptoms similar to a respiratory infection.

Gastrointestinal disorders

• Nausea
• Vomiting
• Temporary increase in intra-abdominal pressure and/or volume.

Hepatobiliary and pancreatic disorders

• Icterus
• Increased concentration of liver enzymes.

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 prospectus. You can also report them directly through the Spanish System for the 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.

Qualified personnel will be responsible for storing the Medicinal Nitrous Oxide Solgroup in accordance with the manufacturer's instructions and current regulations.

Do not use this medication after the expiration date shown on the label, after {CAD.}. The expiration date is the last day of the month indicated.

See complete information on special storage conditions at the end of the leaflet: Information intended solely for healthcare professionals.

Composition of the Medicinal Nitrous Oxide Solgroup

-The active principle is nitrous oxide (dinitrogen monoxide).

-The medicinal nitrous oxide Solgroup does not contain any other components.

Appearance of the product and contents of the package

-The medicinal nitrous oxide Solgroup is an inhalation gas (prepared for inhalation) and is packaged in liquid form in pressurized gas cartridges. The cartridges are coded with colors: the body is pure white (RAL 9010) and the shoulder is gentian blue (RAL 5010).

-The following table shows the contents of various gas cartridges (in liters) and the respective amount of kilograms of nitrous oxide gas at a pressure of 45 bar (at 15°C).

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

SOL FRANCE SUCURSAL EN ESPAÑA

Calle Yeso, num. 2

28500 Arganda del Rey - (Madrid)

Spain

Responsible for manufacturing:

SOL Nederland B.V.

Swaardvenstraat 11

5048 AV Tilburg

Netherlands

or

SOL B S.r.l.

Zoning Ouest 15

7860 Lessines

Belgium

or

SOL S.p.A.

Via Acquaviva 4

26100 Cremona

Italy

or

SOL France S.A.S.

ZI des Béthunes

8 Rue du Compas

95310 Saint Ouen L'Aumone

France

or

SOL Hellas S.A.

Thesi Stefani,ASPROPYRGOS ATTIKI,

GR-193 00Greece

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

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

Belgium:Protoxyde d’azote Médicinal SOL100% v/v, gaz médicinal liquéfié

Bulgaria:?????????? ???????? ????? SOL 100 % v/v, ??????? ??????????

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Luxembourg:Protoxyde d’azote Médicinal SOL100% v/v, gaz médicinal liquéfié

Slovenia:Medicinski didušikov oksid SOL100 % medicinski plin, utekocinjen

Slovakia:Medicinálny oxid dusný SOL100%, medicinálny plyn skvapalnený

Spain:Óxido nitroso medicinal SOLGROUP, 100% v/v, gas licuado medicinal

Greece:Φαρμακευτικ?Πρωτοξε?διοτουΑζ?τουSOL, 100% v/v,Ιατρικ?α?ριο,υγροποιημ?νο

Hungary:SOL Orvosi Dinitrogén-oxid, 100% v/v,Cseppfolyósított orvosi gáz

Ireland:Nitrous oxide medicinal SOL, 100%v/v, medicinal gas, liquefied

Netherlands:Distikstofoxide Medicinaal SOL, medicinaal gas, vloeibaar gemaakt 100% v/v

Czech Republic:Medicinální oxid dusný SOL 100%, medicinální plyn, zkapalnený

Romania:Protoxid de azot SOL 100% gaz medicinal lichefiat
United Kingdom:Nitrous oxide 100%v/v medicinal gas, liquefied

Last review date of this leaflet:

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The following information is intended only for healthcare professionals:

Safety guidelines

The administration or repeated exposure to nitrous oxide may cause addiction. Healthcare professionals with occupational exposure to nitrous oxide should take the necessary precautions.

Precautions and special storage conditions

-Store the gas cartridges at a temperature between –20°C and +65°C.

-Store the gas cartridges in a well-ventilated area suitable for storing medical gases.

-Keep the gas cartridges away from flammable products.

-Avoid any contact with oil, grease, or similar substances.

-Keep the gas cartridges upright, except for those with convex bases, which should be stored on their side or in a container.

-Protect the gas cartridges from falls and impacts by securing them in place or storing them in a cage.

-Store gas cartridges containing a different type of gas or composition separately.

-Store full and empty gas cartridges separately.

-Do not store gas cartridges near a heat source.

-Store gas cartridges covered and protected from atmospheric conditions.

-The valves of the nitrous oxide gas cartridges are adjusted with a rupture disc to prevent the cylinder from bursting if the internal pressure is too high. The rupture disc may fail if the temperature is too high. All the contents of the cartridge will be released. In this case, do not enter the storage area and ventilate it until it is clear for use by a professional.

Instructions for use, processing, and disposal

Follow the instructions of your supplier, and in particular the following:

• The nitrous oxide should only be administered after the corresponding pressure and flow regulation between the cartridge and the patient has been performed.
• Before opening the cartridge valve, the cartridge must be in an upright position and maintained in this position during administration.
• Nitrous oxide administration should be performed together with oxygen administration through a safe mixer; the pressure of nitrous oxide in the lines must always be less than the pressure of oxygen.
• If a variable mixer is used, it is recommended to monitor it with an oxygen analyzer.
• The gas cartridge should not be used if visible damage is observed or if there is suspicion of possible damage or exposure to high temperatures.
• Avoid any contact with oil, grease, or similar substances.
• Only use equipment suitable for the type of gas and specific cartridge.
• Do not use pliers, forceps, or other instruments to open or close the cartridge valve to avoid damaging it.
• Do not modify the type of packaging.
• In case of loss, close the cartridge valve immediately if it can be manipulated safely. If it cannot be closed, take the cartridge to a safe outdoor location and allow it to empty.
• Close the valves of the empty gas cartridges.
• It is not permitted to extract the compressed gas with a siphon.
• The installations used, with central storage, distribution networks, piping systems, terminal units, and connections must comply with the current regulations.
• Nitrous oxide can cause immediate ignition of flammable materials or with a flame, so smoking or approaching a flame near the gas cartridge is prohibited.
• Nitrous oxide is a non-toxic, non-flammable gas, resistant to air, and can cause fire. It can form explosive mixtures in combination with anesthetic gas or vapor, even in the absence of oxygen.
• Once empty, return the cartridges to the supplier.