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IBUSPRAY

Active substance(s): IBUPROFEN / IBUPROFEN

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PACKAGE LEAFLET Information for the user

IBUSPRAY
ibuprofen 5% w/w

Read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after a few weeks.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet
please tell your doctor or pharmacist.

1. WHAT IBUSPRAY IS AND WHAT IT IS
USED FOR
s )BUSPRAY IS AN ANTI INFLAMMATORY PAINKILLER
APPLIED TO AND ABSORBED THROUGH THE SKIN
s )T IS FOR THE TREATMENT OF THE FOLLOWING CONDITIONS
INVOLVING THE MUSCULOSKELETAL SYSTEM
s BACKACHE
s RHEUMATIC OR MUSCULAR PAIN
s SPRAINS
s STRAINS
s NEURALGIA
s )T IS ALSO FOR PAIN RELIEF IN COMMON ARTHRITIC
conditions.
s )BUSPRAY IS RECOMMENDED FOR USE BY adults,
the elderly and children over the age of
12 years. Children under the age of 12 may
also use it if recommended by their doctor.
s 4HE active ingredient in this product is
IBUPROFEN 4HIS IS ONE OF A GROUP OF MEDICINES
KNOWN AS nON steroidal aNTI inflammatory
drugs (NSAIDs).
s )BUPROFEN WORKS BY
s RELIEVING PAIN
s REDUCING SWELLING AND INFLAMMATION

2. BEFORE YOU USE IBUSPRAY
Do not use Ibuspray:
s IF YOU ARE allergic (hypersensitive) to
ibuprofen or any of the other ingredients of
Ibuspray listed in Section 6;
s IF YOU ARE asthmatic, or suffer from rhinitis
(allergic runny nose) or urticaria (hives) and
have ever had a bad reaction to aspirin,
ibuprofen or other NSAIDs in the past;
s IF YOU ARE pregnant or breast-feeding;
s ON BROKEN DAMAGED INFECTED OR DISEASED SKIN
Before applying this product for the first time,
MAKE SURE IT IS SUITABLE FOR YOU TO USE
"ECAUSE )BUSPRAY IS DELIVERED THROUGH THE SKIN
DIRECTLY OVER THE PAINFUL AREA THERE IS LESS RISK OF
the complications that sometimes occur when
IBUPROFEN OR A SIMILAR ANTI INFLAMMATORY PAINKILLER
IS TAKEN BY MOUTH (OWEVER IN RARE CASES YOU
MAY BE AT RISK
s IF YOU HAVE A STOMACH ULCER ALSO CALLED
a peptic or gastric ulcer);

s IF YOU HAVE EVER HAD KIDNEY PROBLEMS
s IF YOU HAVE EVER HAD ASTHMA
s IF YOU HAVE EVER HAD A BAD REACTION TO
ASPIRIN OR IBUPROFEN TAKEN BY MOUTH
If any of the above apply to you, only use
this product on advice from your doctor or
pharmacist.
Take special care WHEN USING THIS PRODUCT
s 4HIS PRODUCT IS flammable. Do not spray it near
flames or ignition sources.
s 5SE IT ONLY ON THE SKIN
s $O NOT USE IT ON CHILDREN UNDER  YEARS OLD
unless advised by a doctor.
s +EEP THE SPRAY AWAY FROM THE EYES NOSE AND
mouth.
Using other medicines
s )NTERACTION BETWEEN )BUSPRAY AND BLOOD
pressure lowering drugs and anticoagulants
(medicines that stop blood clotting) is possible,
IN THEORY ALTHOUGH VERY UNLIKELY )F YOU WOULD
LIKE MORE ADVICE ABOUT THIS SPEAK TO YOUR
doctor or pharmacist.
s )F YOU ARE ALSO TAKING ASPIRIN OR OTHER .3!)$S
by mouth, discuss this beforehand with your
doctor or pharmacist because these may
INCREASE THE RISK OF UNDESIRABLE EFFECTS
s 0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU
ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER
medicines including other medicines obtained
without prescription.
Pregnancy and breast-feeding
You should not use Ibuspray if you are pregnant or
BREAST FEEDING
Driving and using machinery
5SING THIS PRODUCT IS NOT KNOWN TO AFFECT YOUR
ability to drive or use machinery.

3. HOW TO USE IBUSPRAY
Do not spray near flames, burning cigarettes,
electric heaters or similar ignition sources.
For adults, the elderly and children over
12 years old:
s 5SE THE SPRAY UP TO THREE TO FOUR TIMES A DAY
or as often as advised by your doctor.
s (OLDING THE BOTTLE UPRIGHT OR UPSIDE DOWN
APPROXIMATELY  TO  INCHES AWAY FROM THE SKIN
spray over the affected area.
s %VERY  TO  SPRAYS GENTLY MASSAGE THE SPRAY
INTO THE SKIN OVER AND AROUND THE PAINFUL AREA
s 4HE EXACT AMOUNT THAT YOU NEED TO APPLY WILL
vary, depending on the extent and severity of
your condition, but normally 5 to 10 sprays
(1 to 2 ml) should be enough.
s 7ASH HANDS AFTER USE UNLESS TREATING THEM
continued…

YP10/15/1 201353

In this leaflet:
1. What Ibuspray is and what it is used for
2. Before you use Ibuspray
3. How to use Ibuspray
4. Possible side effects
5. How to store Ibuspray
6. Further information

4. POSSIBLE SIDE EFFECTS
,IKE ALL MEDICINES )BUSPRAY CAN CAUSE SIDE EFFECTS
although not everybody gets them.
Occasionally, MILD SKIN RASHES ITCHING OR IRRITATION
can sometimes occur at the site of application. If
this is unacceptable, or persists, stop using the
product and tell your doctor or pharmacist.
Very rarely, the following side effects can happen
with ibuprofen, although these are extremely
uncommon with products such as Ibuspray that
ARE APPLIED TO THE SKIN
If you experience any of the following, stop
using Ibuspray immediately and tell your
doctor:
s Allergic reactions (particularly in people who
have a history of asthma or allergic problems),
SUCH AS
s UNEXPLAINED RUNNY NOSE AND WATERY EYES OR
in more serious cases asthma or aggravated
asthma involving breathing difficulties,
wheezing or chest tightness;
s GENERALISED ALLERGIC SKIN REACTIONS INVOLVING
itch, swelling, inflammation, redness and
perhaps blistering and light sensitivity;
s OTHER MORE SERIOUS GENERALISED ALLERGIC
reactions possibly involving unexplained
nausea and vomiting, swollen eyes, face or
tongue, difficulty swallowing, dizziness or
LIGHT HEADEDNESS 5NCONSCIOUSNESS COULD
perhaps occur in the most serious cases.
s Kidney problems (particularly in people who
HAVE A HISTORY OF KIDNEY DISEASE SUCH AS
s DECREASED URINE VOLUME
s LOSS OF APPETITE  WEIGHT LOSS
s SWELLING TO ABDOMEN
s Problems with the digestive system
(particularly in people who have a history of
STOMACH ULCERS ETC SUCH AS
s STOMACH PAIN
s HEARTBURN  INDIGESTION

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR
PHARMACIST OR NURSE 4HIS INCLUDES ANY POSSIBLE
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
3CHEME AT WWWMHRAGOVUKYELLOWCARD
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE IBUSPRAY
s +EEP IT OUT OF THE REACH AND SIGHT OF CHILDREN
s !LWAYS REPLACE THE CAP AFTER USE
s 3TORE THE BOTTLE UPRIGHT IN A SAFE PLACE AWAY
from flames.
s $O NOT STORE THE PRODUCT ABOVE ª#
s $O NOT USE AFTER THE EXPIRY DATE SHOWN ON THE
BOTTLE LABEL AND ON THE CARTON 4HE EXPIRY DATE
refers to the last day of that month.
s -EDICINES SHOULD NOT BE DISPOSED OF VIA
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
pharmacist how to dispose of medicines no
LONGER REQUIRED 4HESE MEASURES WILL HELP TO
protect the environment.

6. FURTHER INFORMATION ABOUT
IBUSPRAY
What Ibuspray contains:
4HE active ingredient is ibuprofen  WW 
4HE other ingredients are industrial methylated
spirit, macrogol 300, macrogol cetostearyl ether
(cetomacrogol 1000) and purified water.
What Ibuspray looks like and contents of
the pack
s 4HE PRODUCT IS A CLEAR COLOURLESS SPRAY THAT
contains no fragrance.
s 4HE PRODUCT IS AVAILABLE IN A PUMP SPRAY BOTTLE
containing 100 ml.
The Marketing Authorisation holder is Dermal
,ABORATORIES 4ATMORE 0LACE 'OSMORE (ITCHIN
(ERTS 3' 12 5+
The Manufacturer is Fleet Laboratories Ltd,
 2ICKMANSWORTH 2OAD 7ATFORD (ERTS
7$ ** 5+
This leaflet was last revised in -AY 
4O LISTEN TO OR REQUEST A COPY OF THIS LEAFLET IN
Braille, large print or audio, please call free of
CHARGE    5+ ONLY 
0LEASE BE READY TO GIVE THE FOLLOWING INFORMATION
)BUSPRAY 
4HIS IS A SERVICE PROVIDED BY THE 2OYAL .ATIONAL
)NSTITUTE OF "LIND 0EOPLE 2.)" 

YP10/15/1 201353

s #ARRY ON USING THE SPRAY IN THIS WAY UNTIL YOUR
condition gets better (you may find you need
TO USE IT FOR A FEW WEEKS AND YOUR DOCTOR MAY
want you to continue using it for longer than
this).
s )F YOUR SYMPTOMS WORSEN OR CONTINUE FOR MORE
THAN A FEW WEEKS DISCUSS THIS WITH YOUR DOCTOR
before continuing treatment.
If the spray comes into contact with broken
skin or gets into the eyes, nose or mouth
s 4HE PRODUCT MAY CAUSE IRRITATION IF IT COMES
INTO CONTACT WITH BROKEN SKIN OR GETS INTO THE
eyes, nose or mouth. If this happens, rinse the
affected areas with plenty of water. If rinsing one
EYE TAKE CARE TO AVOID WASHING PRODUCT INTO THE
other eye. If irritation persists, tell your doctor or
pharmacist.
If the spray is accidentally swallowed
s 3YMPTOMS MAY INCLUDE HEADACHE VOMITING
drowsiness and low blood pressure.
s )F YOU EXPERIENCE ANY OF THESE SYMPTOMS
contact a doctor or hospital straight away.
If you forget to use this product
Do not worry if you occasionally forget to use this
product, just carry on using it when you remember.
If you have any further questions on the use of this
PRODUCT ASK YOUR DOCTOR OR PHARMACIST

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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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