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DONOPA 50 %/50 % V/V MEDICINAL GAS COMPRESSED

Active substance(s): NITROUS OXIDE / OXYGEN

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Donopa

UK_DONOPA_P_2017-01

Package leaflet:
Information for the user

50%/50% v/v

Medicinal gas, compressed

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 signs of illness 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.
What is in this leaflet
1. What Donopa is and what it is used for
2. What you need to know before you use
Donopa
3. How to use Donopa
4. Possible side 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 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.

The following information is intended for
healthcare professionals only:

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 organ. 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
function.
• 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 harm.
• 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
deficiency.
• Ileus: If you have severe abdominal
discomfort: symptoms which may indicate
ileus, then Donopa may further increase the
dilation of the gut.
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: e.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 deficiency.
• The success rate is lower in children under
3 years.

By using a scavenging system and ensuring
good ventilation, high atmospheric
concentrations of laughing gas in ambient air
Safety directions
are
avoided. High concentrations of laughing
Special precautions should be taken when
working with nitrous oxide. Nitrous oxide should gas in ambient air may cause negative health
effects in personnel or other people in the
be administered according to local guidelines.
vicinity.
Donopa should only be used in areas that are
well ventilated and where there is special
equipment to evacuate excess gas.

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.

There are national guidelines for the
concentration of laughing gas that should not
be exceeded in ambient air, so-called “hygienic
limit values”, often expressed as TWA (time
weight average), the mean value over a working
day and STEL (short-term exposure limit), the
mean value during a shorter exposure.
These values should not be exceeded in order
to guarantee that personnel are not exposed to
risk.

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 place.
• Donopa is intended for medicinal use only.
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: N 2O) 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).
Pack sizes in litres
(135 bar)

2

2.7

5

10

15

20

Pack sizes in litres
(185 bar)

2

-

5

-

-

-

Not all pack sizes may be marketed.

• The valve should be opened slowly and
carefully.
• Turn off the equipment in the event of fire, or if
not in use.
• During use the cylinder must be fixed in a
suitable support.
• One should consider replacing the gas
cylinder when the pressure in the bottle has
dropped to a point where the indicator on the
valve is within the yellow field.

• When a small quantity of gas is left in the gas
cylinder, the cylinder valve must be closed. It is
important to leave a small amount of
pressure in the cylinder to avoid the entrance of
contaminants.
• After use the cylinder valve must be closed
hand-tight. Depressurise the regulator or
connection.

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
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Belgium: Antafil, 50%/50% v/v, gaz médicinal
comprimé
Germany: Donopa
Italy: Donopa
Luxemburg: Antafil
Netherlands: Donopa
UK: Donopa
This leaflet was last revised in 01/2017

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