DONOPA 50%/50% MEDICINAL COMPRESSED GAS

Introduction

Package Leaflet: Information for the User

Donopa 50%/50% Medical 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Donopa and what is it used for

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

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

Effects of Donopa

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 has 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.

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

Donopa should be used

• When analgesic effects that start and end quickly are desired and when the pain being treated 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 interrupted.

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

2. What you need to know before you use Donopa

Do not use Donopa:

Before using Donopa, you should inform your doctor if you have 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, it is suspected that there are gas accumulations in your chest outside of the lungs, or gas bubbles in your blood or in any other organ. For example, if you have dived with diving equipment and may have gas bubbles in your blood, or if you have received treatment with a gas injection in the eyes, for example, to treat a retinal detachment or similar. Such gas bubbles can expand and 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 can further affect heart function.
• Central nervous system injuries:if you have high pressure in the brain, for example, as a result of a brain tumor or brain hemorrhage, since nitrous oxide would increase the pressure in the brain, with the potential risk of damage.
• Vitamin deficiencies:if you have been diagnosed with a vitamin B12 or folic acid deficiency but have not received treatment, including the first months of pregnancy, since the use of nitrous oxide can worsen the symptoms caused by a vitamin B12 and folic acid deficiency.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Donopa if:

• You consume or have consumed an excessive amount of medication, since there is a greater risk of developing dependence on nitrous oxide if it is consumed repeatedly. Your doctor will decide whether it is advisable to continue treatment with Donopa in your case.

Repeated or long-term use of nitrous oxide can increase the risk of vitamin B12 deficiency, which can 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 have any of the following symptoms or signs:

• Ear discomfort:for example, inflammation in the ear, since Donopa can increase the pressure in the middle ear.
• Vitamin deficiencies:if it is suspected that you have a vitamin B12 or folic acid deficiency, since the use of nitrous oxide can worsen the symptoms caused by a vitamin B12 and folic acid deficiency.
• The success rate is lower in children under 3 years.

You should breathe normally during inhalation.

Your doctor will decide if Donopa is suitable for you.

Using Donopa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are taking other medicines that affect the brain or brain function, such as benzodiazepines (tranquilizers) or morphine-type medications, you should inform your doctor, since Donopa can increase the effects of these medicines. In combination with other sedatives or medications that affect the central nervous system, Donopa increases the risk of side 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, Breast-feeding, 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 breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and Using Machines

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.

3. How to Use Donopa

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 correctly configured. While using Donopa, you will be supervised to ensure that you are taking the medication safely. Once you finish using Donopa, you will continue to be supervised by competent personnel until you have recovered.

Follow the administration instructions of the medication indicated by your doctor exactly.

Your doctor will explain how to use Donopa, how it works, and what effects it may cause. If you are in doubt, ask your doctor.

Normally, Donopa is inhaled through a facial mask connected to a special valve, which means you will have full control over the gas flow based on your own breathing. The valve will only be open during breathing. Donopa can also be administered through a nasal mask.

Regardless of the mask used, you should breathe with normal intensity in the mask.

Once you finish using Donopa, you should rest and wait until you feel mentally recovered.

Safety Precautions

• It is strictly forbidden to smoke and have open flames in rooms where treatment with Donopa is being performed.
• Donopa is designed exclusively for medical use.

If you use more Donopa than you should

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

If you breathe more quickly 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 should immediately inform the medical personnel and interrupt the administration of the medication.

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

4. Possible Side Effects

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

Intense fatigue. Feeling of pressure in the middle ear, if Donopa is used for a prolonged period. This is because Donopa increases the pressure in the middle ear.

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

Frequency not known(available data do not allow an estimate of frequency)

Effects on the bone marrow that can cause anemia.

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

This is because nitrous oxide affects the metabolism of vitamin B12 and folic acid, thereby inhibiting an enzyme: methionine synthase.

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

Respiratory depression. You may also experience headache.

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

Generalized convulsions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donopa

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

Do not use this medicine after the expiry date (Exp) that appears on the gas cylinder label. The expiry date is the last day of the month indicated.

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

If it is suspected that Donopa has been stored at too low temperatures, the gas cylinders should be stored horizontally at a temperature above +10°C for at least 48 hours before use.

Keep away from flammable products.

Contact with flammable products can 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 gas cylinder to a safe place.

Keep the gas cylinder clean, dry, and free of oils and fats.

Keep the gas cylinder in a closed and reserved storage area for medical gases.

Store and transport with the valves closed.

Make sure the gas cylinder has not been damaged or dropped.

Inhaling vapors can cause drowsiness and dizziness.

6. Contents of the Pack and Other Information

Composition of Donopa

• The active substances 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 Pack

Donopa is a colorless, odorless, and tasteless gas that is administered in a gas cylinder with a valve to control the gas flow. The cylinders can be made of steel or aluminum.

Pharmaceutical form: compressed medicinal gas.

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

Not all pack sizes may be marketed.

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Antafil

Germany: Donopa

Austria: Donopa

Bulgaria: ??????

Croatia: Donopa

Slovenia: Donopa

Spain: Donopa

Greece: Donopa

Hungary: Donopa

Ireland: Donopa

Italy: Donopa

Luxembourg: Antafil

Netherlands: Donopa

United Kingdom: Donopa

Date of last revision of this leaflet: 11/2022

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

The following information is intended exclusively for healthcare professionals:

Safety Instructions

Administration or repeated exposure to nitrous oxide can 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 according to local guidelines.

Donopa should only be used in well-ventilated areas and in areas equipped with special equipment to evacuate excess gas. The formation of high atmospheric concentrations of nitrous oxide can be avoided by using an extraction system and ensuring good ventilation. High concentrations of nitrous oxide in the ambient air can cause adverse health effects in healthcare personnel or other individuals present in the vicinity. There are national guidelines regarding the concentration of nitrous oxide in the air that should not be exceeded, the so-called "health limit values", often expressed as TWA (time-weighted averageor time-weighted average concentration), which is the average value during a working day, and STEL (short-term exposure limitor short-term exposure limit), which is the average value during a shorter exposure.

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

• The valve should be opened slowly and carefully.
• Deactivate the equipment in case of fire or when not in use.
• During use, the cylinder should be held in an adequate support.
• Consider replacing the gas cylinder when the cylinder pressure has been reduced to the point where the valve indicator is in the yellow field.
• When a reduced amount of gas remains in the cylinder, the cylinder valve should be closed. It is important to leave a small amount of pressure in the gas cylinder to prevent the entry of contaminants.

After use, the cylinder valve should be firmly closed. Depressurize the regulator or connection.