IBUMOUSSE

Active substance: IBUPROFEN

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Ibumousse PIL UK GP12_13_2:1 04/06/2013 10:54 Page 1

PACKAGE LEAFLET Information for the user

IBUMOUSSE
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 IBUMOUSSE IS AND WHAT IT
IS USED FOR
• Ibumousse is an anti-inflammatory painkiller
applied to, and absorbed through, the skin.
• It is for the treatment of the following conditions
involving the musculoskeletal system:
• backache
• rheumatic or muscular pain
• sprains
• strains
• neuralgia.
• It is also for pain relief in common arthritic
conditions.
• Ibumousse 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.
• The active ingredient in this product is
ibuprofen. This is one of a group of medicines
known as non-steroidal anti-inflammatory
drugs (NSAIDs).
• Ibuprofen works by:
• relieving pain
• reducing swelling and inflammation.

2. BEFORE YOU USE IBUMOUSSE
Do not use Ibumousse:
• if you are allergic (hypersensitive)
to ibuprofen or any of the other ingredients
of Ibumousse listed in Section 6;
• 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;
• if you are pregnant or breast-feeding;
• on broken, damaged, infected or diseased skin.
Before applying this product for the first time,
make sure it is suitable for you to use:
Because Ibumousse 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. However, in rare cases you may
be at risk:
• if you have a stomach ulcer (also called
a peptic or gastric ulcer);
• if you have ever had kidney problems;

• if you have ever had asthma;
• 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:
• This product is flammable. Do not spray it near
flames or ignition sources.
• Use it only on the skin.
• Do not use it on children under 12 years old
unless advised by a doctor.
• Keep the mousse away from the eyes, nose
and mouth.
Using other medicines
• Interaction between Ibumousse and blood
pressure lowering drugs and anticoagulants
(medicines that stop blood clotting) is possible,
in theory, although very unlikely. If you would like
more advice about this, speak to your doctor
or pharmacist.
• If you are also taking aspirin or other NSAIDs by
mouth, discuss this beforehand with your
doctor or pharmacist because these may
increase the risk of undesirable effects.
• Please 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 Ibumousse if you are pregnant
or breast-feeding.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.
Important information about one of the
ingredients of Ibumousse
The product contains a small amount of propylene
glycol. This ingredient may cause skin irritation in a
small number of people who are intolerant to it. If
your doctor has told you that you have an
intolerance to propylene glycol, please talk
to your doctor before using this product.

3. HOW TO USE IBUMOUSSE
Do not spray near flames, burning cigarettes,
electric heaters or similar ignition sources.
Shake the container well before use.
For adults, the elderly and children over
12 years old:
• Use the mousse up to three to four times a day,
or as often as advised by your doctor.
• Hold the can upright, then press the nozzle to
dispense the mousse into the palm of your
hand.

GP12/13/2 201118

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

continued…

Prints: Pantone 293

Flat size: 160mm x 285mm

Ibumousse PIL UK GP12_13_2:1 04/06/2013 10:54 Page 2

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibumousse can cause side
effects, although not everybody gets them.
Occasionally, the temporary cooling effect of the
mousse may pale the skin temporarily. 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 Ibumousse that
are applied to the skin.
If you experience any of the following, stop
using Ibumousse immediately and tell your
doctor:
• Allergic reactions (particularly in people who
have a history of asthma or allergic problems),
such as:
• unexplained runny nose and watery eyes, or,
in more serious cases asthma or aggravated
asthma involving breathing difficulties,
wheezing or chest tightness;
• generalised allergic skin reactions involving
itch, swelling, inflammation, redness and
perhaps blistering and light sensitivity;
• other more serious generalised allergic
reactions possibly involving unexplained
nausea and vomiting, swollen eyes, face or
tongue, difficulty swallowing, dizziness or
light-headedness. Unconsciousness could
perhaps occur in the most serious cases.

• Kidney problems (particularly in people who
have a history of kidney disease), such as:
• decreased urine volume;
• loss of appetite / weight loss;
• swelling to abdomen.
• Problems with the digestive system
(particularly in people who have a history of
stomach ulcers etc), such as:
• stomach pain;
• heartburn / indigestion.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 IBUMOUSSE





Keep it out of the sight and reach of children.
Always replace the cap after use.
Do not store the product above 25°C.
Protect from sunlight and do not expose
pressurised container to temperatures higher
than 50°C.
• Do not use after the expiry date shown on the
base of the can and on the carton. The expiry
date refers to the last day of that month.
• Do not pierce or burn, even when empty.
• 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 ABOUT
IBUMOUSSE
What Ibumousse contains:
The active ingredient is ibuprofen (5% w/w).
The other ingredients are propylene glycol,
carbomer, phenoxyethanol, diethylamine and
purified water. The ozone-friendly aerosol propellant
is butane 40.
What Ibumousse looks like and contents of
the pack
• The product is a white, cutaneous foam that is
non-sticky, non-greasy and contains no
fragrance.
• The mousse is available in pressurised spray
cans containing 125g.
The Marketing Authorisation holder is Dermal
Laboratories, Tatmore Place, Gosmore, Hitchin,
Herts, SG4 7QR, UK.
The Manufacturer is Pharmasol Ltd, Andover,
Hants, SP10 5AZ, UK.
This leaflet was last revised in June 2013.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Ibumousse, 00173/0169.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

Prints: Pantone 293

GP12/13/2 201118

• Gently massage the mousse into the skin over
and around the painful area.
• The exact amount that you need to apply will
vary, depending on the extent and severity of
your condition, but normally 1 to 2g (1 to 2 golfball sized quantities of mousse dispensed into
the palm of your hand) should be enough.
• Wash hands after use, unless treating them.
• Carry on using the mousse 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).
• If your symptoms worsen or continue for more
than a few weeks, discuss this with your doctor
before continuing treatment.
If the mousse comes into contact with broken
skin or gets into the eyes, nose or mouth
• The 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 mousse is accidentally swallowed
• Symptoms may include headache, vomiting,
drowsiness and low blood pressure.
• If 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.

Flat size: 160mm x 285mm

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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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