Donopa 50%/50% medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donopa 50%/50% medicinal compressed gas

Nitrous oxide / Oxygen

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Donopa is and what it is used for

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

Donopa can be used in adults and children older than 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 mildly sedative effect. These effects are produced by the action of nitrous oxide on signaling substances present in the nervous system.

The effect of Donopa is lower in children under three years of age.

The 50% oxygen concentration, which is approximately twice that found in ambient air, ensures a safe oxygen content in the inspired gas.

Donopa should be used

• When rapid onset and offset of analgesic effects are desired, and when the pain being treated is of mild to moderate intensity and of limited duration. Donopa produces analgesic effects after a few inhalations, and these effects persist for several minutes after discontinuation.

For dental procedures, in patients who suffer from anxiety.

2. What you need to know before using Donopa

Do not use Donopa:

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

• Gas-filled cavities or gas bubbles: if, due to illness or for any other reason, gas accumulation outside the lungs in your chest or gas bubbles in your blood or any other organ is suspected. For example, if you have been diving with scuba equipment and may have gas bubbles in your blood, or if you have received a treatment involving a gas injection into the eyes, for instance, to treat retinal detachment or similar. Such gas bubbles may expand and thus cause damage.

• Heart disease: if you have heart failure or severely impaired cardiac function, since the slightly depressant effect of nitrous oxide on heart muscle may further affect cardiac function.

• Central nervous system disorders: if you have increased pressure in the brain, for example, as a result of a brain tumor or cerebral hemorrhage, since nitrous oxide could further increase intracranial pressure, potentially causing brain damage.

• Vitamin deficiency: if you have been diagnosed with vitamin B12 or folic acid deficiency but have not received treatment, including during the first months of pregnancy, since the use of nitrous oxide may worsen symptoms caused by vitamin B12 and folic acid deficiency.

• Ileus (intestinal obstruction): if you have symptoms of severe abdominal discomfort that may indicate intestinal obstruction, since Donopa may increase intestinal distension.

Warnings and precautions

Talk to your doctor or pharmacist before using Donopa if:

• you consume or have consumed excessive amounts of drugs/medication, as there is an increased risk of developing dependence on nitrous oxide if used repeatedly. Your doctor will decide whether continuing treatment with Donopa is appropriate for you.

Repeated or long-term use of nitrous oxide may 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 potential consequences of vitamin B12 deficiency.

You should also inform your doctor if you have any of the following symptoms or conditions:

• Ear discomfort: e.g., ear inflammation, since Donopa may increase pressure in the middle ear.
• Vitamin deficiency: if vitamin B12 or folic acid deficiency is suspected, since the use of nitrous oxide may worsen symptoms caused by vitamin B12 and folic acid deficiency.
• Success rates are lower in children under 3 years of age.

You must breathe normally during inhalation.

Your doctor will decide whether Donopa is suitable for you.

Use of Donopa with other medicines

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

If you are taking other medications that affect the brain or brain function, such as benzodiazepines (tranquilizers) or morphine-like drugs, you must inform your doctor, since Donopa may enhance the effects of these medicines. In combination with other sedatives or other medicines affecting the central nervous system, Donopa increases the risk of adverse effects.

You should also inform your doctor if you are taking medications containing methotrexate (e.g., for rheumatoid arthritis), bleomycin (for cancer treatment), nitrofurantoin or similar antibiotics (for infections), or amiodarone (for heart conditions), since Donopa increases the adverse effects of these medicines.

Pregnancy, lactation and fertility

Donopa may be used during pregnancy if 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

If Donopa has been administered 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 whether it is safe for you to drive.

3. How to use Donopa

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

Follow exactly the instructions for administering the medicine given by your doctor.

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

Normally, Donopa is inhaled through a face mask attached to a special valve, meaning that you will have full control over the gas flow according to your own breathing. The valve opens only during inhalation. Donopa may also be administered through a nasal mask.

Regardless of the type of mask used, you must breathe normally into the mask.

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

Safety precautions

• Smoking and the presence of open flames are strictly prohibited in rooms where Donopa treatment is being administered.
• 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 gas mixture is fixed (containing 50% nitrous oxide and 50% oxygen).

If you breathe faster than normal and therefore receive more nitrous oxide than intended with normal breathing, you may feel considerably drowsy and somewhat disoriented. In this case, you must immediately inform the medical staff and stop administration of the medicine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Severe 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 bloating, due to Donopa slowly increasing gas volume in the intestines.

Frequency not known (available data do not allow estimation of frequency)

Effects on bone marrow that may cause anaemia.

Effects on nerve function, sensations of numbness and weakness, usually in the legs.

This is due to nitrous oxide affecting vitamin B12 and folic acid metabolism, thereby inhibiting an enzyme: methionine synthetase.

Abnormal movements, which usually occur following hyperventilation (increased respiratory rate during inhalation).

Respiratory depression. You may also experience headache.

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

Generalized seizures.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse 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) stated on the label of the gas cylinder. The expiry date refers to 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 excessively low temperatures, the gas cylinders must be stored horizontally at a temperature above +10 °C for at least 48 hours prior to use.

Keep away from flammable materials.

Contact with flammable materials may cause fire.

Do not smoke or use open flames near Donopa.

Do not expose the product to intense heat.

In case of fire risk, move the gas cylinder to a safe location.

Keep the gas cylinder clean, dry, and free from oils and greases.

Store the gas cylinder in a closed, designated area intended for medicinal gases.

Store and transport with valves closed.

Ensure that the gas cylinder has not been subjected to impacts or falls.

Inhalation of vapors may cause drowsiness and dizziness.

6. Contents of the container and other information

Composition of Donopa

• The active ingredients are: nitrous oxide 50% (v/v) (chemical symbol: N2O) and oxygen 50% (v/v) = medicinal oxygen (chemical symbol: O2).
• Donopa contains no other ingredients.

Appearance of Donopa and contents of the container

Donopa is a colourless, odourless and tasteless gas supplied in a gas cylinder equipped with a valve to control gas flow. Cylinders may be made of steel or aluminium.

Pharmaceutical form: compressed medicinal gas.

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

Some pack sizes may not 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 medicinal product is authorized in the European Economic Area member states 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 the most recent review of this leaflet: 11/2022

The following information is intended exclusively for healthcare professionals:

Safety instructions

Repeated administration or exposure to nitrous oxide may lead to dependence. Precautions must be taken for healthcare professionals who are occupationally exposed to nitrous oxide.

Nitrous oxide must be administered in accordance with local guidelines.

Donopa should only be used in well-ventilated areas equipped with special devices for evacuating excess gas. High atmospheric concentrations of nitrous oxide in ambient air can be prevented by using an extraction system and ensuring adequate ventilation. High concentrations of nitrous oxide in the ambient air may cause adverse health effects in healthcare personnel or other individuals nearby. National guidelines exist regarding permissible nitrous oxide concentrations in the air, specifying maximum allowable levels known as "occupational exposure limits," often expressed as TWA (time-weighted average), which represents the average concentration over a working day, and STEL (short-term exposure limit), which represents the average concentration during a short-term exposure period.

These limits must not be exceeded to ensure personnel are not exposed to health risks.

• The valve must be opened slowly and carefully.
• Deactivate the equipment in case of fire or when not in use.
• During use, the cartridge must be securely held in an appropriate holder.
• Consider replacing the gas cartridge when the cylinder pressure has dropped to the point where the valve indicator enters the yellow zone.
• When only a small amount of gas remains in the cartridge, close the cartridge valve. It is important to leave a small residual pressure in the gas cartridge to prevent the entry of contaminants.

After use, firmly close the cartridge valve. Depressurize the regulator or connection.