PATIENT
INFORMATION LEAFLET
What you should know about
IBUMOUSSE™
( ibuprofen )
Read these instructions
carefully before use
About
your treatment
The name of
your treatment is Ibumousse.
It contains 5.0% of ibuprofen as the active ingredient.
It also contains the inactive ingredients propylene
glycol, carbomer, phenoxyethanol, diethylamine and
purified water. The ozone-friendly aerosol propellant is
butane 40. The container holds 125 g of Ibumousse. It is
a white, fragrance-free mousse which is non-sticky and
non-greasy.
Ibuprofen is
a proven non-steroidal
anti-inflammatory
drug (NSAID), which works
by relieving pain, reducing swelling and easing
inflammation. Ibumousse is designed to be rapidly
absorbed into the skin for effective relief at the point
of pain. The mousse also exerts a soothing and cooling
effect when applied to the affected area.
Your doctor
or pharmacist has recommended or supplied Ibumousse
because you are suffering from one or more of the
following conditions:
-
Backache
-
Rheumatic and Muscular Pain
-
Neuralgia
-
Common arthritic conditions
When NOT
to apply Ibumousse
-
DO NOT use if you are
sensitive to any of its ingredients (as listed
earlier).
-
DO NOT use if you have
experienced problems in the past with aspirin,
ibuprofen or related painkillers (including when
taken by mouth), especially where associated with a
history of asthma, allergic rhinitis (nasal allergy)
or urticaria (allergy of the skin associated with
weals).
-
DO NOT use if you are
pregnant or breast feeding.
- Keep
away from broken skin, the eyes, nose and mouth.
-
DO NOT use on infected or
diseased skin.
Before
you apply Ibumousse
Make sure it
is appropriate for you to use Ibumousse. Because the
mousse is applied to the skin, directly over the painful
area, there is less risk of the complications that
sometimes arise when ibuprofen (or similar
anti-inflammatory painkillers) are taken by mouth.
However, there are certain categories of patients who
may be at risk in rare cases.
Do not use
Ibumousse in any of the following cases without first
seeking medical advice from a doctor or a pharmacist:
- If
you have ever suffered from asthma.
- If
you have a stomach ulcer (also called a peptic or
gastric ulcer).
- If
you have ever suffered from kidney problems.
- If
you are already taking aspirin or other painkillers.
For
your safety
-
FLAMMABLE: Do not spray near flames, burning
cigarettes, electric heaters or similar objects.
-
Ibumousse is for external use only.
-
Ibumousse is not normally recommended for use on
children under the age of 12 years, unless
instructed by their doctor.
-
Interaction between Ibumousse and blood pressure
lowering drugs is possible, in theory, although
very unlikely.
-
Where aspirin or other NSAID tablets are taken
concurrently, it is important to bear in mind
that these may increase the incidence of
undesirable effects.
If you
would like more advice, speak to your doctor or a
pharmacist.
Any
overdose with ibuprofen applied to the skin is
extremely unlikely. In case of severe overdosage
(for example, if the mousse is accidentally
swallowed), symptoms include headache, vomiting,
drowsiness and low blood pressure, and the patient
should be taken to a doctor or hospital straight
away.
How to
apply Ibumousse
Ibumousse is for external use only.
Do not spray near flames, burning
cigarettes, electric heaters or similar objects.
Shake container well before use.
Hold container upright, then press nozzle to dispense
the mousse into the palm of your hand. Gently massage
the mousse into and around the affected area until
absorbed. The exact amount to be applied will vary,
depending on the extent and severity of the condition,
but it should normally be sufficient to apply 1 to 2 g
(1 to 2 golf-ball sized quantities of mousse dispensed
into the palm of the hand). This amount may be repeated
3 to 4 times daily unless otherwise directed by your
doctor. Wash hands after use, unless treating them. If
your symptoms persist for more than a few weeks, consult
your doctor or a pharmacist before continuing treatment.
During
your treatment
The
transient cooling effect of the mousse may cause the
skin to pale temporarily. Because the preparation is
applied to the skin, directly over the affected area,
there is less risk of the complications that can
sometimes arise when ibuprofen is taken by mouth.
However, undesirable effects can occur very
occasionally. Mostly these involve application site skin
rashes, itching or irritation. Very rarely, wheezing may
occur in people who already have a history of asthma or
allergic problems, or kidney problems may occur in
people with kidney disease. Abdominal pain or stomach
upset have been reported in rare instances, as have
non-specific allergic reactions. If you are in any doubt
about your treatment, or if you experience any of the
following, stop treatment immediately and tell your
doctor or pharmacist: unexplained
bruising, wheezing, shortness of breath, skin rash,
itching, facial swelling, or any other undesirable
effect.
How to
store Ibumousse
This product
should not be used after the expiry date shown on the
base of the container.
Always
replace the protective cap after use. Keep Ibumousse
upright in a safe place where children cannot see or
reach it.
Do not store
above 25°C. Protect from sunlight and do not expose
pressurised container to temperatures higher than 50°C.
Do not
pierce or burn container even when empty.