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 25°C. 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.

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 LTV rays do penetrate through clouds, even though the sun’s warmth does not;

0 under a parasol on the beach - up to 20% of the sun’s LTV rays are reflected off dry sand;

0 in a boat - a flat water surface can double your exposure to the sun by reflecting LTV rays and the wind may make you feel deceptively cool;

Tj^in the water - over 75% of LTV 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.

Date last revised: September 2007

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.

DIOMED™

SUNBURN

LOTION

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 AUTHORISATION HOLDER, DIOMED DEVELOPMENTS LTD, HITCHIN, HERTS, SG4 7QR, UK, AT FLEET LABORATORIES LTD, WATFORD, HERTS, WD18 7JJ, UK.)

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

Before applying Diomed Sunburn Lotion

When NOT to apply Diomed Sunburn Lotion

0 Not to be used by patients who are allergic to any of the ingredients (as listed earlier).

0 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).

0 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.

0 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 ^ armacist:-^ If the patient has ever suffered from asthma.

If the patient has a stomach ulcer (also called a ■0 peptic, gastric or duodenal ulcer).

If the patient has ever suffered from kidney 0 problems.

If the patient is already taking aspirin or other painkillers.

0- 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.

41 Diomed Sunburn Lotion is for external use only.

Taking or using other medicines

41 Interaction between Diomed Sunburn Lotion and

blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely.

41 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

41 Not to be used by patients who are pregnant or breast feeding.

How to use Diomed Sunburn Lotion

41 Do not use Diomed Sunburn Lotion on children under 12 years.

41 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.

0 The lotion is designed to resist being washed off whilst swimming or bathing.

0 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.

4l 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.

Continued overleaf

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