Medicinal gas Donopa – Information for the user

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

Keep this You may need to read it again.
If you have any further questions, ask your doctor or
This medicine has been prescribed for you Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

What Donopa is and what it is used for
What you need to know before you use Donopa
How to use Donopa
Possible side effects
How to store Donopa
Contents of the pack and other information

1. WHAT DONOPA IS AND WHAT IT IS USED FOR

Donopa contains a ready mixture of nitrous oxide (medicinal “laughing gas”, N₂O) and oxygen (medicinal oxygen, O₂), 50% of each, and should be used by breathing in the gas mixture.

Donopa can be used in adults and children older than 1 month.

The effects of Donopa

The nitrous oxide constitutes 50% of the gas mixture. Nitrous oxide has a painkilling effect, reduces the sensation of pain, and raises the pain threshold. Nitrous oxide also has a relaxing and slightly calming effect. These effects are produced by the effects of nitrous oxide on signal substances in your nervous system.

The effect of Donopa is lower in children who are less than three years old.

The 50-percent concentration of oxygen, around double that in ambient air, guarantees a safe oxygen content in the inspired gas.

Donopa should be used

When painkilling effects that start quickly and stop quickly are wanted and when the treated pain state is of mild to moderate intensity and of limited duration. Donopa produces painkilling effects after just a few breaths and the painkilling effects subside within minutes after use is ceased.

For dental care, in anxious patients.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DONOPA

Do not use Donopa:

Before you use Donopa you should inform your doctor if you have any of the following signs/ symptoms:

Gas-filled cavities or gas bubbles: if as a result of illness, or for any other reason it may be suspected that there is air in your chest outside the lungs, or gas bubbles in your blood or any other E.g. if you have dived with diving equipment and may have gas bubbles in your blood, or if you have been treated with an injection of gas into the eye, e.g. for a retinal detachment or similar. These gas bubbles may expand and thereby cause harm.
Heart disease: if you have heart failure or severely impaired heart function, since the slightly relaxing effect of nitrous oxide on the heart muscle can further impair cardiac
Central nervous system injury: If you have increased pressure in the brain, e.g. resulting from a brain tumour or bleed in the brain, since nitrous oxide can further increase the pressure in the brain with potential risk of
Vitamin deficiency: If you have been diagnosed with vitamin B₁₂ deficiency or folic acid deficiency but have not been treated for this, since use of nitrous oxide can worsen the symptoms caused by vitamin B₁₂ and folic acid
Ileus: If you have severe abdominal discomfort: symptoms which may indicate ileus, then Donopa may further increase the dilation of the

Warnings and precautions

Talk to your doctor or pharmacist before using Donopa:

If you need to use Donopa for more than

6 hours at a time your healthcare professional will take routine blood tests to ensure that Donopa has not affected your blood cell count or the way your body uses Vitamin B12.

Also inform your doctor if you have any of the

following signs/symptoms:

Ear discomfort: g. ear inflammation, since Donopa may increase the pressure in the middle ear.
Vitamin deficiency: If you are suspected of having vitamin B₁₂ deficiency or folic acid deficiency, since use of nitrous oxide can worsen the symptoms caused by vitamin B₁₂ and folic acid
The success rate is lower in children under 3

You must breathe normally during inhalation. Your doctor will decide whether Donopa is suitable for use.

Other medicines and Donopa

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

If you are taking other medicines which affects the brain or brain function, e.g. benzodiazepines (tranquillising) or morphine like medicines, you should inform your doctor of this. Donopa can increase the effects of these medicines. Donopa in combination with other sedatives, or other medicines affecting the central nervous system, increases the risk of side effects.

You should also inform your doctor if you are taking medicine containing methotrexate (e.g. for rheumatoid arthritis), bleomycin

(to treat cancer), furadantin or similar antibiotics (to treat infection) or amiodarone (to treat heart disease). Donopa increases the side effects of these medicines.

Pregnancy, breast-feeding and fertility Donopa can be used during pregnancy if clinically needed.

After a short-term administration of Donopa, interruption of breast-feeding is not necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you have been given Donopa , without any other painkilling/sedative drug, for safety reasons, you should avoid driving, using machines or carrying out complicated tasks until you are fully recovered (at least

30 minutes).

Ensure that your healthcare professional advises you whether it is safe for you to drive.

3. HOW TO USE DONOPA

Donopa will always be given to you in the presence of personnel who are familiar with this form of medicine. They will ensure that your Donopa supply is suitable for use and that the equipment has been set up correctly. While you are using Donopa you will be monitored to ensure that you take it safely. After you stop using Donopa you will be monitored by competent personnel until you have recovered. Always use this medicine exactly as your doctor has told you.

Your doctor should explain to you how to use Donopa, how Donopa works, and what effects arise from use. Check with your doctor if you are not sure.

You normally breathe in Donopa through a facemask attached to a special valve, which means that you have full control of the flow of gas by virtue of your own breathing. The valve is only open while you are breathing in. Donopa can also be administered via a so-called nasal mask.

Irrespective of which mask you use, you should breathe normally with normal breaths in the mask.

After you stop using Donopa you should rest and recover until you feel you have recovered mentally.

Safety precautions

Smoking and open flames are strictly forbidden in rooms where treatment with Donopa is taking
Donopa is intended for medicinal use

If you use more Donopa than you should You are very unlikely to receive too much gas, since you govern supply of gas and the gas mixture is fixed (contains 50% nitrous oxide and 50% oxygen).

If you breathe quicker than normal and thereby receive more nitrous oxide than you would with normal breathing, you may feel noticeably tired and may to some extent feel out of touch with your surroundings. In such circumstances you should immediately inform the medical staff and stop the administration.

If you have any further questions on the use of this product, 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, light headedness, euphoria, nausea and vomiting.

Uncommon (may affect up to 1 in 100 people) Severe fatigue. Feeling of pressure in the middle ear, if you use Donopa over a prolonged period.

This is because Donopa increases the pressure in the middle ear. Abdominal bloating, because Donopa slowly increases the volume of gas in the intestines.

Not known (frequency cannot be estimated from available data).

Effects on bone marrow, which can result in anaemia.

Effects on nerve function, sensations of numbness and weakness, usually in the legs. This is because nitrous oxide affects vitamin B12 and folate metabolism and thereby inhibits an enzyme: methionine synthetase.

Abnormal movements generally occurring after hyperventilation (increase in breathing rate during inhalation).

Breathing depression. You can also experience headache.

Psychiatric effects, such as psychosis,

confusion, anxiety, addiction.

Reporting of side effects

If you get 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 via the Yellow Card Scheme (website: www.mhra.gov.uk/ yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DONOPA

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

Do not use this medicine after the expiry date which is stated on the cylinder batch label. The expiry date refers to the last day of that month. Store between 0°C and 50°C. Do not freeze.

On suspicion that Donopa has been stored in too cold conditions, the cylinders should be stored in horizontal position at a temperature above +10°C for at least 48 hours before use. Keep away from combustible material.

Contact with combustible material may cause fire.

No smoking or naked flames near Donopa. Must not be exposed to strong heat.

If at risk of fire – move the cylinder to a safe place.

Keep the cylinder clean, dry and free from oil and grease.

Keep the cylinder in locked storage reserved for medicinal gases.

Store and transport with valves closed. Make sure the cylinder is not knocked or dropped.

Inhaling vapour may cause drowsiness and dizziness.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Donopa contains

The active substances are:

nitrous oxide 50% (v/v) = medicinal laughing

gas (chemical term: N₂O) and oxygen 50% (v/v)

= medicinal oxygen (chemical term: O₂)

Donopa contains no other ingredients

What Donopa looks like and contents of the pack

Donopa is a colourless, odourless gas without taste, which is supplied in a gas cylinder with a valve to control the gas flow.

The cylinder can either be made of steel or aluminium.

Pharmaceutical dosage form: medicinal gas, compressed

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

The body of the gas cylinder is white (medicinal gas).

Marketing authorisation holder

SOL SpA via Borgazzi, 27 20900 Monza (Italy)

Manufacturer

SOL France

ZI des Béthunes

8 Rue du Compas

95310 Saint Ouen l’Aumone France