Prospect: information for the user

Donopa 50%/50% medicinal compressed gas

Nitrous oxide / Oxygen

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

• Keep this prospect, as you may need to read it again.
• If you have any other questions, ask your doctor or pharmacist.

• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possible adverse effect that does not appear in this prospect. See section 4.

1.What is Donopa and for what it is used

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

3.How to use Donopa

4.Possible adverse effects

5.Donopa storage

6.Contents of the package and additional information

Donopa contains a prepared mixture of nitrous oxide (N2O) and oxygen (medical oxygen, O2), with each constituting 50%, and must be used by breathing the gas mixture.

Donopa can be used in adults and children over 1 month old.

Effects of Donopa

The nitrous oxide constitutes 50 % of the gas mixture. Nitrous oxide has an analgesic effect, reduces the sensation of pain, and increases the pain threshold. Nitrous oxide also presents a relaxing and slightly calming effect. These effects are generated by the action of nitrous oxide on signaling substances present in the nervous system

The effect of Donopa is less in children under three years old.

The oxygen concentration at 50 %, which is approximately double that of the ambient air, guarantees a safe oxygen content in the inspired gas.

Donopa should be used

• When analgesic effects that start and end quickly are desired, and the treated pain is of mild to moderate intensity and limited duration. Donopa produces analgesic effects after a few inhalations, and these effects persist for several minutes after use is discontinued.

For dental care, in the case of patients who suffer from anxiety.

No use Donopa:

Before using Donopa, you should inform your doctor if you present any of the following symptoms or signs:

• Gas-filled cavities or gas bubbles:If, as a result of a disease or for any other reason, there is suspected accumulation of gas in your chest outside the lungs, or gas bubbles in your blood or in any other organ. For example, if you have dived with scuba gear and may have gas bubbles in your blood, or if you have received a gas injection in your eyes, for example, to treat a retinal detachment or similar. Such gas bubbles may expand and, therefore, cause damage.
• Heart diseases:If you have heart failure or severely damaged heart function, since the slightly relaxing effect of nitrous oxide on the heart muscle may further affect heart function.
• Central nervous system injuries:If you present high pressure in the brain, for example, as a result of a brain tumor or cerebral hemorrhage, since nitrous oxide would further increase brain pressure, with the potential risk of damaging it.
• Vitamin deficiencies:If you have been diagnosed with a deficiency of vitamin B12or folic acid but have not received treatment, including the first months of pregnancy, since the use of nitrous oxide may worsen the symptoms caused by a deficiency of vitamin B12and folic acid.

• Intestinal ileus (intestinal obstruction):If you have severe abdominal discomfort symptoms that may indicate the presence of an intestinal obstruction, since Donopa may increase intestinal dilation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Donopaif:

• You consume or have consumed excessive amounts of medications, as there is a higher risk of developing nitrous oxide dependence if you consume it repeatedly. Your doctor will decide if it is advisable to continue treatment with Donopa in your case.

Prolonged or repeated use of nitrous oxide may increase the risk of vitamin B12 deficiency, which may cause damage to the bone marrow or nervous system. Your doctor may perform blood tests before and after treatment to assess the consequences of a possible vitamin B12 deficiency.

You should also inform your doctor if you present any of the following symptoms or signs:

• Ear discomfort:For example, ear inflammation, since Donopa may increase middle ear pressure.
• Vitamin deficiencies:Ifit is suspectedthat you have a deficiency of vitamin B12or folic acid, since the use of nitrous oxide may worsen the symptoms caused by a deficiency of vitamin B12and folic acid.
• The success rate is lower in children under 3 years old.

You should breathe normally during inhalation.

Your doctor will decide if Donopa is suitable for you.

Use of Donopa with other medications

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

If you are taking more medications that affect the brain or cerebral function, such as benzodiazepines (tranquilizers) or medications of the type of morphine, you should inform your doctor, since Donopa may increase the effects of these medications. In combination with other sedatives or other medications that affect the central nervous system, Donopa increases the risk of adverse effects.

You should also inform your doctor if you are taking medications that contain methotrexate (for example, for rheumatoid arthritis), bleomycin (to treat cancer), nitrofurantoin or similar antibiotics (to treat infections), or amiodarone (to treat heart diseases), since Donopa increases the adverse effects of these medications.

Pregnancy, breastfeeding, and fertility

Donopa can be used during pregnancy if it is clinically necessary.

If Donopa is administered for a short period, it is not necessary to interrupt breastfeeding.

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

Driving and operating machinery

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

Do not forget to ask your healthcare professional if it is safe for you to drive.

Donopa will always be administered in the presence of personnel familiar with this type of medication. The personnel will ensure that the Donopa supply is suitable for use and that the equipment is properly configured. While using Donopa, you will be monitored to ensure that you are taking the medication safely. Once you have finished using Donopa, you will continue to be monitored by competent personnel until you have recovered.

Follow exactly the medication administration instructions indicated by your doctor.

Your doctor will explain how to use Donopa, how it works, and what effects its use may cause. In case of doubt, ask your doctor.

Donopa is normally inhaled through a face mask connected to a special valve, which means that you will have full control of the gas flow according to your own breathing. The valve will only be open during breathing. Donopa can also be administered through a nasal mask.

Regardless of the mask you use, you must breathe at a normal intensity through the mask.

Once you have finished using Donopa, you must rest and wait until you feel mentally recovered.

Safety Precautions

• It is strictly forbidden to smoke and the presence of open flames in rooms where a treatment with Donopa is being performed.
• Donopa is designed exclusively for medicinal use.

If you use more Donopa than you should

It is highly unlikely that you will receive an excessive gas supply, since you yourself control the gas flow and the mixture is fixed (it contains 50% nitrous oxide and 50% oxygen).

If you breathe faster than normal and, therefore, receive more nitrous oxide flow than you should with normal breathing, you may feel considerably tired and, to some extent, disoriented. In that case, you must immediately inform the medical personnel and interrupt the medication administration.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent(may affect up to 1 in 10 people)

Dizziness, mild headache, euphoria, nausea, and vomiting.

Infrequent(may affect up to 1 in 100 people)

Intense fatigue. Sensation of pressure in the middle ear, if you use Donopa for a prolonged period. This is due to Donopa increasing pressure in the middle ear.

Abdominal swelling, due to Donopa slowly increasing the volume of gas in the intestines.

Unknown Frequency(available data do not allow for estimation of frequency)

Effects on the bone marrow that may cause anemia.

Effects on nervous functions, numbness, and weakness, usually in the legs.

This is due to nitrous oxide affecting the metabolism of vitamin B12and folic acid, thus inhibiting an enzyme: methionine synthase.

Abnormal movements that generally occur after hyperventilation (increase in respiratory rate during inhalation).

Depressed respiration. You may also experience headaches.

Psychiatric effects such as psychosis, confusion, anxiety, or addiction.

Generalized seizures.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date (Exp) that appears on the cartridge label. The expiration date is the last day of the month indicated.

Store between 0 °C and 50 °C. Do not freeze.

If Donopa has been stored at temperatures that are too low, the cartridges must be stored in a horizontal position at a temperature above +10?°C for at least 48 hours before use.

Keep away from flammable products.

Contact with flammable products may cause a fire.

Do not smoke or use open flames near Donopa.

Do not expose the product to intense heat.

If there is a risk of fire, move the cartridge to a safe location.

Keep the cartridge clean, dry, and free of oils and greases.

Keep the cartridge in a closed storage area reserved for medical gases.

Store and transport with valves closed.

Ensure the cartridge has not suffered impacts or falls.

Inhalation of vapors may cause drowsiness and dizziness.

Composition of Donopa

• The active principles are:
  Nitrous oxide 50% (v/v) (chemical symbol: N2O) and oxygen 50% (v/v) = medicinal oxygen (chemical symbol: O2).
• Donopa does not contain other ingredients.

Appearance of Donopa and contents of the container

Donopa is an colourless, odourless and tasteless gas that is administered in a gas cartridge with a valve to control the flow of gas. The cartridges can be made of steel or aluminium.

Pharmaceutical form: compressed medicinal gas.

The top of the gas cartridge is marked in white and blue (oxygen/nitrous oxide). The body of the gas cartridge is white (medicinal gas).

Only some sizes of packaging may be commercially available.

Marketing authorisation holder:

SOL FRANCE SUCURSAL EN ESPAÑA

Calle Yeso, num. 2

28500 Arganda del Rey - (Madrid)

Spain

Manufacturer

SOL France

ZI des Béthunes

8 Rue du Compas

95310 Saint Ouen l’Aumone

France

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

Bélgica: Antafil

Alemania: Donopa

Austria : Donopa

Bulgaria: ??????

Croacia: Donopa
Eslovenia: Donopa

España: Donopa
Grecia: Donopa
Hungría: Donopa
Irlanda: Donopa
Italy: Donopa

Luxemburgo: Antafil

Países Bajos: Donopa

Reino Unido: Donopa

Date of the last review of this leaflet: 11/ 2022

--------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:

Safety instructions

The administration or repeated exposure to nitrous oxide may cause addiction. Precautions should be taken in the case of healthcare professionals who, due to their work, are exposed to nitrous oxide.

Nitrous oxide should be administered in accordance with local guidelines.

Donopa should only be used in well-ventilated areas and where special equipment is available for evacuating excess gas. High atmospheric concentrations of nitrous oxide can be avoided by using a gas extraction system and ensuring good ventilation. High concentrations of nitrous oxide in the atmosphere can cause adverse health effects in healthcare personnel or other people present in the vicinity. National guidelines exist regarding the concentration of nitrous oxide in the atmosphere, which indicate that these so-called "health-based exposure limits" should not be exceeded, expressed as TWA (time weight averageor average weighted concentration in time), which is the average concentration during a working day, and STEL (short-term exposure limitor short-term exposure limit), which is the average concentration during a shorter exposure period.

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

• The valve should be opened slowly and carefully.
• Switch off the equipment in case of fire or when not in use.
• During use, the cartridge should be secured in an appropriate holder.
• Consider replacing the gas cartridge when the pressure in the bottle has decreased to the point where the indicator on the valve is in the yellow field.
• When a small amount of gas remains in the cartridge, the cartridge valve should be closed. It is essential to leave a small amount of pressure in the gas cartridge to prevent the entry of contaminants.

After use, the cartridge valve should be closed firmly. The regulator or connection should be depressurised.