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DIOMED SUNBURN LOTION

Active substance(s): IBUPROFEN / ISOPROPYL MYRISTATE

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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 disorders, facial
swelling, or any other undesirable effect.
Tanning and peeling of the skin are normal
reactions to sunburn, and may occur 4 to 7 days
after being burnt.

How to store Diomed Sunburn Lotion
This product should not be used after the expiry
date shown on the label. Always replace the cap
tightly and return the bottle to the carton after use.
Discard following a single course of treatment or
after one week. Do not store above 25ºC. Always
keep Diomed Sunburn Lotion in a safe place, out of
the reach and sight of children.

Responsible behaviour in the sun
Your skin may have been sun- damaged before you
realised it. The pain and redness of sunburn have
a delayed onset and are likely to worsen after being
first noticed. This may happen even after taking
corrective measures, such as keeping out of the
sun and treating the sunburn, because the signs
and symptoms take several hours (up to a day)
to develop fully.
Excessive exposure to the sun damages and
ages the skin. Prolonged, unprotected exposure
to the sun is also linked to skin cancer, which
may take more than 20 years to appear. Children
and people with fair skin who burn easily are
especially vulnerable to the harmful effects
of the sun. It is, therefore, very important to protect
the skin against sun damage.
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Many things can be done to minimise sun damage.
Always use a sun protection product on sun-exposed
skin. The higher the SPF (sun protection factor),
the better.
High SPF sun ‘blockers’ may be appropriate
for children. Sunlight penetrates loosely woven fabric,
so clothes made from fabrics like linen and cotton,
which are closely woven, offer more protection. Clothes
should cover easily burnt areas such as the shoulders
and upper arms. The face and scalp also burn readily,
so wear a hat with a brim. The sun is most dangerous
around noon, when the sun is high in the sky. If your
shadow is shorter than you (as is likely between 11 am
and 3 pm), try to stay in the shade.
There are many situations where you can get burnt
without realising it. This often happens because
clouds, water, wind or parasols reduce the sensation
of heat, but have only a limited effect on the amount
of harmful UV rays reaching the skin, leaving you
with a false sense of security. Be careful...
on overcast or cloudy days – the sun’s damaging
UV rays do penetrate through clouds, even though
the sun’s warmth does not;
under a parasol on the beach – up to 20% of the
sun’s UV rays are reflected off dry sand;
in a boat – a flat water surface can double your
exposure to the sun by reflecting UV rays and the
wind may make you feel deceptively cool;
in the water – over 75% of UV rays penetrate
water.
If you do get burnt, avoid further exposure to the
sun until the signs and symptoms have subsided
completely. This may take two to three days.

What you should know about
Diomed Sunburn™ Lotion
Read these instructions carefully before use
and keep for future reference. This medicine
has been prescribed for a particular individual
and should not be shared with others. It may
harm them even if their symptoms
are the same as yours.

About Diomed Sunburn Lotion
The name of this treatment is Diomed Sunburn
Lotion. Each 5 ml of cutaneous emulsion contains
50 mg ibuprofen and 500 mg isopropyl myristate.
It also contains the inactive ingredients coconut oil,
carbomers, sorbitan laurate, 2-diethylaminoethanol,
phenoxyethanol and purified water. This bottle
contains 200 ml of Diomed Sunburn Lotion.
Ibuprofen is a non-steroidal anti-inflammatory
(NSAID) analgesic, which works by relieving the
pain and redness (inflammation) of sunburn.
Isopropyl myristate is an established emollient
(moisturiser).
(DIOMED SUNBURN LOTION IS MADE FOR THE MARKETING

Date last revised: September 2007

AUTHORISATION HOLDER, DIOMED DEVELOPMENTS LTD,

Distributed by DDD Ltd, 94 Rickmansworth Road,
Watford, Herts, WD18 7JJ, UK on behalf of
Diomed Sunburn Lotion Trademark and Product
Licence Holder Diomed Developments Ltd, Hitchin,
Herts, SG4 7QR, UK.

HITCHIN, HERTS, SG4 7QR, UK, AT FLEET LABORATORIES LTD,

Your doctor has recommended or supplied Diomed
Sunburn Lotion for the relief of pain associated with
mild to moderate sunburn.

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WATFORD, HERTS, WD18 7JJ, UK.)

Before applying Diomed Sunburn Lotion
When NOT to apply Diomed Sunburn Lotion
Not to be used by patients who are allergic to any
of the ingredients (as listed earlier).
Not to be used by patients who have experienced
problems in the past with aspirin, ibuprofen or
related painkillers (including when taken by
mouth). This is especially important if problems
with painkillers have been linked to asthma or
allergies such as rhinitis (allergic runny nose) or
urticaria (sometimes referred to as nettle rash).
Not to be used on areas of skin which are cut or
grazed, or in cases of any unrelated skin condition
where the skin is broken.
Not to be used on children under the age of
12 years.
Take special care with Diomed Sunburn Lotion
Diomed Sunburn Lotion is not a sunscreen or
sunblock and must not be used for this purpose.
Avoid further sun exposure of the affected area(s)
until it is completely better.
Because Diomed Sunburn Lotion is applied to the
skin, there is less risk of the complications that
sometimes arise when ibuprofen (or similar antiinflammatory painkillers) are taken by mouth.
However, there are certain categories of patients
who may be at risk in rare cases. Do not use
Diomed Sunburn Lotion in any of the following cases
without first seeking medical advice from a doctor or
pharmacist:If the patient has ever suffered from asthma.
If the patient has a stomach ulcer (also called a
peptic, gastric or duodenal ulcer).
If the patient has ever suffered from kidney
problems.
If the patient is already taking aspirin or other
painkillers.
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Diomed Sunburn Lotion should not be used
for cases of severe sunburn, or where a large
proportion of the body surface is involved. Signs
and symptoms of severe sunburn include obviously
blistered skin, intense pain, intolerance of any
contact with clothing, fever, chills, feeling sick and
extreme exhaustion or lack of energy. Regarding
the area of involvement, as a general guide, if more
than one tenth (1/10) of a child’s body surface
(e.g. more than the equivalent area of the forehead,
plus shoulders and tops of both arms), or if more
than one fifth (1/5) of an adult’s body surface (e.g.
more than the equivalent area of both thighs and
knees, plus shoulders and tops of both arms) has
been burned, seek medical advice.
Excessive exposure to sunlight in a hot and/or
humid environment can also cause heat stroke.
If the patient develops a high temperature, is
confused or weak, or has convulsions, consult a
doctor immediately.
Take care to keep Diomed Sunburn Lotion away
from eyes and mouth.
Diomed Sunburn Lotion is for external use only.
Taking or using other medicines
Interaction between Diomed Sunburn Lotion and
blood pressure lowering drugs and anticoagulants
is possible, in theory, although very unlikely.
Where aspirin or other orally administered
NSAIDs 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 pharmacist.
Pregnancy and breast feeding
Not to be used by patients who are pregnant or
breast feeding.

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How to use Diomed Sunburn Lotion
Do not use Diomed Sunburn Lotion on children
under 12 years.
Commencing as soon as possible after the first
sign of any sunburn, lightly apply the lotion to
the affected areas and massage gently into the
skin.
The lotion is designed to resist being washed off
whilst swimming or bathing.
Repeat as required, at regular intervals, several
times per day. Do not apply more than once
every two hours, and not more than eight times
per day. You will find that the lotion spreads very
easily (i.e. a little goes a long way) and you will
not need to apply very much. In any event, do
not apply more than 15 ml at a time, or more
than 120 ml a day. As a guide the cap holds
approximately 12 ml.
Wash hands after use, unless treating them.
Treatment should be continued for two to three
days, by which time the symptoms should have
subsided.
In cases where children are to be treated, the
lotion should always be applied by an adult.
If the symptoms persist, consult a doctor or
pharmacist.
Seek medical advice if someone accidentally
swallows Diomed Sunburn Lotion.

During treatment
The initial application of Diomed Sunburn Lotion
or other preparations to sunburned skin may
occasionally be associated with a temporary sensation
of tingling or stinging, but this should subside after
a few minutes. Because the preparation is applied to
the skin, directly to 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.
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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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