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OROEZE 0.15% W/V OROMUCOSAL SPRAY

Active substance(s): BENZYDAMINE HYDROCHLORIDE

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2. Before you use Oroeze Spray

Oroeze ® Spray 0.15% w/v
Oromucosal Spray
Benzydamine Hydrochloride

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use it carefully to
get the best results from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor or dentist if your
symptoms worsen or do not improve after 7
days.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor, dentist or
pharmacist.
In this leaflet:
1. What Oroeze Spray is and what it is used for
2. Before you use Oroeze Spray
3. How to use Oroeze Spray
4. Possible side effects
5. How to store Oroeze Spray
6. Further information

1. What Oroeze Spray is and
what it is used for

Oroeze Spray is used for treating pain and
inflammation (redness, swelling and a feeling of
heat) in the throat or mouth. Oroeze Spray
contains benzydamine hydrochloride, one of a
group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
What this medicine does
O r o e z e S p r a y is used to treat many painful
conditions affecting the throat or mouth
including:
• Sore throat
• Sore tongue or gums
• Mouth ulcers
• Discomfort caused by dentures
• Pain after dental surgery
Oroeze Spray works in the throat or mouth to help
stop pain and inflammation (redness, swelling
and a feeling of heat). It does this by stopping
the formation of prostaglandins.
Prostaglandins are natural substances made by
the body when it is injured or has an
infection. They cause an increase in the
blood supply to the area of injury or
infection.
This results in pain, redness,
swelling and a feeling of heat in that area.
Stopping the formation of prostaglandins
reduces these effects.

Do not use Oroeze Spray
If you are allergic (hypersensitive) to
benzydamine or any of the other ingredients of
Oroeze Spray (see section 6, ‘What Oroeze
Spray contains’).
Take special care with Oroeze Spray
Do not use this spray near your eyes. If you get
it in your eyes accidentally, wash them
immediately with cold water.
Using other medicines
Tell your doctor, dentist or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
If you are pregnant, thinking of becoming
pregnant or breast-feeding ask your doctor,
dentist or pharmacist for advice before using
Oroeze Spray.
Important information about some of the
non-active ingredients in Oroeze Spray
Some of the non-active ingredients in your
medicine may cause side effects:
• Methyl parahydroxybenzoate - this may
cause allergic reactions (possibly delayed)
• Propylene glycol – this may cause skin irritation

3. How to use Oroeze Spray

Unless your doctor or dentist has advised
otherwise, always use Oroeze Spray as
described in this leaflet. Check with your doctor,
dentist or pharmacist if you are not sure.
Oroeze Spray is for use in the throat or mouth. It
should be sprayed onto the sore area of the
mouth or throat according to the following
instructions:
Adults including the elderly
• Use 4 to 8 sprays every 11/2 to 3 hours.
Children aged 6 to 12 years
• Use 4 sprays every 11/2 to 3 hours.
• Children over 12 should use the adult dose.
Children under 6 years of age
• The dose is based on how much the child
weighs.
• Do not use more than 4 sprays at any one time.
• Use one spray for each 4 kilograms that the
child weighs but do not use more than 4
sprays at any one time.
• This dose should be used every 11/2 to 3 hours.
How to use the spray
1. Always use the spray in the upright position.
2. Turn the spray arm, in either direction, until it is
at right angles (90 degrees) to the body of the
spray container as shown in picture 1. Do not
use the spray arm in any other position, as the
medicine may not come out properly.

Picture 1

3. The first time you use
the spray, point the
spray arm away from
you and anyone else.
Then press the white
plunger down firmly
several times until a
Picture 2
fine spray appears
out of the end of
the spray arm as
shown in picture 2.
Your spray is now ready to use.
4. Point the spray arm at the sore part of your throat
or mouth and press the white plunger down
firmly. One press releases one spray of medicine.
5. Apply the correct number of sprays
according to the instructions above. Then
wipe the end of the spray arm with a clean
tissue. This helps to prevent your spray blocking.
6. Turn the spray arm down into the
closed position as shown in picture 3.
This stops any more sprays of your
medicine being released accidentally.
7. If your spray blocks or stops
working properly, return it to your
pharmacist. Do not push anything
into the end of the spray arm to try
to clear a blockage.
Picture 3

If you use more Oroeze Spray than you should
If you use too many sprays of Oroeze Spray, contact
your doctor, dentist or pharmacist for advice.
If you forget to use Oroeze Spray
• If you forget to use your spray, do not worry.
Apply the correct number of sprays as soon as
you remember and then carry on using the
spray every 11/2 to 3 hours as before.
• Do not use double the amount of sprays to
make up for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor, dentist or pharmacist.

4. Possible side effects

Like all medicines, Oroeze Spray can cause side
effects, although not everybody gets them. Side
effects are generally minor.
If you have any of the following side effects while
taking your medicine tell your doctor
immediately or go to hospital straight away:
• Severe allergic reaction which may include a
red and lumpy skin rash, difficulty breathing,
swelling of face, mouth, lips or eyelids,
unexplained high temperature (fever) and
feeling faint. If the swelling affects your throat
and makes breathing and swallowing difficult,
go to hospital straight away.
• Itchy rash, sometimes with pale, raised areas
of skin with red edges (urticaria).
• Your skin becoming more sensitive to sunlight
than normal causing an itchy, red, scaly rash,
sometimes with blisters.
• Tightening of the throat or chest making it
difficult to breathe.
Uncommon (may affect up to 1 in 100 people):
• A feeling of numbness in your mouth
• A stinging feeling in your mouth:
- this stinging usually disappears as you
continue to use the spray
- if the stinging does not go away stop using the spray
and talk to your doctor, dentist or pharmacist

See section 2 (Important information about some
of the non-active ingredients in Oroeze Spray) for
side effects that may be caused by some of the
non-active ingredients in your medicine.
Reporting of side effects
If you get any side effects, talk to your doctor,
dentist 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 at: 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 Oroeze Spray

Keep out of the reach and sight of children.
Do not use after the expiry date stated on the
carton and the base of the can. The expiry date
refers to the last day of that month.
Do not store above 25ºC. Keep the spray in the
outer carton.
Once you have started using the spray, do not
keep it for more than 6 months.
Do not use if you notice any damage to
the spray container or spray arm. Return it to
your pharmacist.
Medicines should not be disposed of via
wastewater or household waste.
Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information

What Oroeze Spray contains
• The active substance is benzydamine hydrochloride.
Each spray from the spray arm contains 262.5
micrograms of benzydamine hydrochloride.
• The other ingredients are glycerol, polysorbate 20,
saccharin
sodium,
ethanol
96%,
methyl
parahydroxybenzoate, aniseed flavour (contains
ethanol 95%), peppermint flavour (contains propylene
glycol), water. (See section 2 for important information
about some of these non-active ingredients.)
What Oroeze Spray looks like and contents of
the pack
Oroeze Spray is an oromucosal spray (a spray for
use in the throat or mouth). It is a clear solution
with a smell of peppermint. It is contained in a
spray container fitted with a metering pump (a
pump that delivers a measured amount of
medicine) and nozzle (spray arm).
Each spray container holds 30ml of medicine.
Marketing Authorisation Holder
Focus
Pharmaceuticals
Limited,
Unit
5,
Faraday
Court, First Avenue, Centrum 100,
Burton upon Trent, Staffordshire DE14 2WX
Tel: 01283 495 280 Fax: 01283 495 290
Email: medinfo@focuspharma.co.uk
Manufacturer
PPF Hasco-Lek S.A, ul. Eugeniusza
Kwiatkowskiego 9, 55-011 Siechnice, Poland.
For any information about this medicinal
product, please contact the Marketing
Authorisation Holder, details provided above.

For information in large print, audio CD or
Braille please telephone 01283 495 280 or
email medinfo@focuspharma.co.uk.

This leaflet was last revised in 11/2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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