SUNBURN RELIEF CUTANEOUS EMULSION POM to P Training Guide for Pharmacists and Pharmacy Assistants A Diomed Product Distributed by DDD Ltd., 94 Rickmansworth Road, Watford, Herts, WD18 7JJ, UK on behalf of SOLEVE TM Trademark and Product Licence holder, Diomed Developments Ltd., Hitchin, Herts, SG4 7QR, UK. A A
Introduction & Contents Introduction to managing sunburn in pharmacy Welcome to the Pharmacy Training Guide for Soleve Sunburn Relief, a new pharmacy medicine for the treatment of mild to moderate sunburn. This guide is designed to help you manage the safe and appropriate supply of Soleve Sunburn Relief. Page Continuing Professional Development (CPD)... 4 Overview of Sunburn... 7 Soleve Sunburn Relief... 9 Pharmacy Supply of Soleve Sunburn Relief...10 Case Studies...18 Multiple Choice Questions (MCQ)... 21 SPF 30 2 3
Continuing Professional Development (CPD) Guidance CPD Learning objectives To gain an overview of the nature, causes and development of sunburn. To understand how Soleve Sunburn Relief works. To understand the circumstances when it may be appropriate to supply Soleve Sunburn Relief. To understand the circumstances when customers with sunburn should be referred for medical attention. To learn appropriate sunburn prevention and treatment advice to give to customers. CPD competencies G1a: Using expert knowledge and skills to benefit patients. G1c: Giving informed and accurate pharmaceutical advice. G2o: Responding to requests for advice and information. C1a: Assessing the medication needs of patients. C1f: Providing advice and counselling. C2a: Providing information to promote public health and prevent disease. CPD Record Sheet CPD... Record Sheet... Name of entry... Date learning need identified... Reflection What do you want to learn to do? Planning Please explain how you have identified this learning objective. Please indicate the method(s) used to identify this learning objective (tick boxes). Critical incidents Audit Appraisal Feedback from users of services/products Peer review/talking to colleagues Reading Personal Interest Other (please specify) To which areas of competence does this learning objective relate? Urgency: by when you will need to meet this learning objective?... Importance: what will be the impact of your learning?... What activities could you undertake to meet this objective?... The training content of this guide has been approved by the National Pharmacy Association (NPA). The NPA in no way endorses any product or product range(s) listed in this training material. Description Advantages/Disadvantages of proposed activities Irresponsible behaviour in the sun leads to sunburn. 4 5
CPD (continued) Overview of Sunburn Action Description Date completed and time taken What have you learnt as a result?...... Evaluation Has your learning objective been met? Fully Partly t at all If your learning objective has been fully or partly met: please describe an example of how you have applied what you have learnt. If your learning objective has been fully or partly met: please describe any feedback you have had. If your learning objective has been partly met: please describe what part of your learning objective you did not achieve. If your learning objective was partly met or not at all: explain the reasons why your learning objective was not fully met or not met at all. What are you going to do next? thing, the objective is no longer relevant. thing, the objective is sufficiently met. Review my options for activities to meet the objective. Start a new cycle by redefining the objective. In order for any training record to be counted towards official CPD, it must be recorded in a General Pharmaceutical Council approved CPD format. What is sunburn? When skin is exposed to sunlight, it speeds up its production of a pigment called melanin. Melanin helps protect the skin against UV rays and the increased melanin production results in darker-looking skin 1. Sunburn is defined as inflammation of the skin caused by overexposure of unprotected skin to sunlight. It is caused by excessive UV radiation and not by the sun s heat. Consequently, skin can burn even on breezy or cloudy and cold days, and can also be caused by the use of sunlamps or sunbeds. Sunburn ranges in severity from mild and painless redness of the skin to very painful red skin associated with blistering and swelling 2. Unfortunately the signs and symptoms of sunburn are not immediately apparent as they have a delayed onset and are likely to worsen after being first noticed. It usually takes approximately 4 hours for the first signs of sunburn to appear. Mild to moderate sunburn is characterised by red, warm and tender skin. The skin can be warm to the touch even after attempts to cool it with water or by moving into shade. The condition can worsen in the subsequent 24 to 48 hour period. Mild to moderate sunburn usually take 3 to 4 days to resolve. More serious sunburn results in very painful and swollen skin that may blister. Severe sunburn can be associated with dehydration and/or heat stroke, which may be accompanied by other symptoms, such as fever, nausea, vomiting, headache, skin rash, confusion, weakness or even convulsions; these symptoms require immediate medical attention. It usually takes several weeks for severe sunburn to resolve. Although the signs and symptoms of sunburn will eventually disappear, some permanent skin damage can occur, leading to premature skin ageing (such as wrinkles and age spots) and an increased risk of skin cancer. These effects are cumulative, so it is especially important to avoid sunburn in childhood. Skin cancer from sun overexposure is a serious health problem in the UK, affecting over 100,000 people in 2007 3. Rates of malignant melanoma (a type of skin cancer that is responsible for most deaths due to skin cancer) in Britain have risen faster than any other common cancer. 6 7
Soleve Sunburn Relief It is important to note however that limited exposure to the sun is considered beneficial. It increases people s sense of wellbeing, enables the synthesis of vitamin D and provides opportunities for physical activity 4. Who is at risk? Almost everyone has or will become sunburned at some point in their lifetime. However, certain people are at more risk than others. Fair-skinned individuals have a higher chance of getting sunburn as their skin produces less melanin. However, even darker complexions can burn under strong sunlight exposure. Sunburn can develop after very short exposure periods, it can occur within minutes in strong sunlight. Also, some medicines, such as certain types of antibiotics, are known to make the skin more sensitive to the sun (e.g. doxycycline). Treatment Treatment of sunburn is largely to relieve symptoms: Painkillers can be taken to ease pain and inflammation associated with sunburn. Soothing emollient lotions, creams and gels are used to ease the dryness and feeling of skin tightness. Cool compresses on the burned area may also provide some comfort do not apply ice directly to the skin as this can cause further damage. Drinking plenty of fluids (avoid alcohol) to cool down and replace water that is lost through sweating. Oral corticosteroids may be prescribed by GPs to reduce inflammation in severe cases. What is Soleve Sunburn Relief? Soleve Sunburn Relief (containing ibuprofen and isopropyl myristate) is a licensed medicine which is now available without a prescription; it is the only treatment of its type specifically developed to relieve pain associated with mild to moderate sunburn. The product is appropriate for the treatment of mild to moderate sunburnt skin that is red, warm and tender. Soleve is an emulsion containing two active ingredients, 1% w/w ibuprofen and 10% w/w isopropyl myristate. How Soleve Sunburn Relief works Ibuprofen is a n Steroidal Anti-inflammatory Drug (NSAID). This active ingredient has been approved for many years as an OTC medicine for topical use (applied directly on the skin). Ibuprofen possesses analgesic (reduces pain), anti-inflammatory (reduces inflammation) and antipyretic (reduces fever) activity by inhibiting prostaglandin production. Prostaglandins are chemicals produced in the body that contribute to inflammation. Soleve is specifically designed to deliver therapeutic levels of ibuprofen directly into the sunburnt skin - in contrast to other topical ibuprofen products which are designed to optimise ibuprofen delivery through the skin into the underlying soft tissue and muscle where it has its effect. Soleve is formulated at a lower concentration of ibuprofen (1%) than these other topical products (5% and 10%) and so can be used over a wider area without exceeding the recommended ibuprofen dose. Consequently, these higher ibuprofen strength preparations are inappropriate for the treatment of sunburnt skin. Isopropyl myristate is the second active ingredient included in the Soleve formulation. It is an emollient which effectively soothes and moisturises the skin. It works by trapping water in the skin. Rehydration of sunburnt skin relieves the symptoms of irritation and permits the normal healing process to proceed. Furthermore, isopropyl myristate can make the sunburnt skin feel more comfortable by reducing the skin tightness which is often associated with sun damaged skin. Isopropyl myristate can also help reduce frictional trauma between clothing, such as a T-shirt or swimwear, and sunburnt skin. 8 9
Pharmacy Supply of Soleve Sunburn Relief Who is Soleve Sunburn Relief indicated for? 1. People presenting with mild to moderate sunburn. Soleve is indicated for the relief of pain associated with mild to moderate sunburn in adults and children over the age of 12 years. Mild to moderate sunburnt skin is red and painful. It is warm to touch even after moving into shade or cooling. If the sunburnt area exceeds 20% of the total body surface area in adults, or exceeds 10% of the total body surface area in children, the sunburn is more serious and Soleve should not be used; instead the customer should be referred to their doctor. In addition, there must be no blistering as that would indicate severe sunburn. Adult: Face, shoulders and arms = 20% of the body 2. Cases where a large proportion of the body surface is involved. As a general guide, if more than 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 20% 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, more comprehensive medical treatment may be required. 3. Babies or children under 12 years with any type of sunburn. 4. Patients whose signs and symptoms have worsened or persisted for more than 2 to 3 days. 5. Patients with severe dehydration and/or heat stroke. If the patient has a high temperature, is confused or weak, or has convulsions, they require urgent medical attention. rmal skin 2. People going on holiday. Moderate sunburn Severe sunburn Customers going away on holiday may want to purchase Soleve as part of their first aid kit. This may be appropriate, although it is important that the advice on page 13 is given to these customers at the point of supply in order to ensure safe and appropriate use. Who should NOT use Soleve Sunburn Relief, and should instead be referred to a GP or hospital? 1. People suffering from severe sunburn. Severe sunburn is characterised by blistered and sometimes broken skin and may be accompanied by intense pain, headache, fever, chills, nausea or even rash. Adult: Front or back of torso = 20% of the body Adult: Front or back of legs = 20% of the body Other factors to take into consideration 1. Soleve should not be used by people who are allergic to any of the ingredients. The same applies if they have had problems in the past with aspirin, ibuprofen or related painkillers (even when taken orally), and especially if they have a history of asthma, rhinitis (allergic runny nose) or urticaria (hives). 2. Because Soleve is applied directly to the skin, 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, patients who currently have or have previously had a stomach ulcer (also called a peptic or gastric ulcer), kidney problems or asthma, may be at risk. 3. Soleve should be avoided during pregnancy. Theoretically, the onset of labour may be delayed and the duration of labour increased. Soleve should not be used by breast-feeding mothers. Child: Forehead, shoulders and tops of both arms = 10% of the body 10 11
When should pharmacy assistants refer the customer to the pharmacist? If the sunburn is severe (see page 10). If the sunburn area exceeds 20% of the total body surface area in adults or 10% of the total body surface area in children. If in addition to the red and painful sunburn, the customer suffers from any other symptoms such as blistering of the skin, rash, intense pain, headache, fever, chills, nausea. If the customer requests a second bottle of Soleve. If the customer is on any medication. If the symptoms have lasted for more than 2-3 days. If the customer is allergic to any medication or medicine ingredients (in particular, asprin, ibroprofen or any other NSAID). If the patient suffers from any medical conditions (in particular, stomach ulcer, kidney problems, or asthma). How is Soleve Sunburn Relief used? Treatment with Soleve should start as soon as possible after the first sign of sunburn (this is usually skin redness). The lotion should be applied to the affected area and massaged gently into the skin. The application can be repeated as required, if necessary up to 8 times daily, but leaving intervals of at least 2 hours. Treatment should be continued for a maximum of 2 to 3 days, by which time the symptoms should have subsided. When used by children over 12 years, application of the lotion should be performed by (or at least supervised by) an adult. The emulsion spreads easily, and a small amount goes a long way - so it will not be necessary to apply very much. The amount required depends on the surface area of the sunburn, but generally an amount ranging from the size of a 1 penny piece to a 2 penny piece will be sufficient. Individual doses should not exceed 12 ml (one capful), and the total amount applied in any one day should not exceed 100ml. A single 200ml bottle of Soleve is sufficient for the full 2 to 3 day treatment course. If a patient uses up one bottle, another bottle may be supplied to complete the maximum 3 days of treatment, provided their sunburn is improving. What advice should the pharmacist give when supplying Soleve Sunburn Relief? Soleve helps to soothe and alleviate pain and tenderness of mild to moderate sunburn. Remind the customer to read the Patient Information Leaflet (PIL) carefully before using Soleve, particularly to make sure it is suitable for the particular case of sunburn and for the particular individual concerned. Soleve is not a sunscreen or sunblock, and will not protect skin from the sun. Care should be taken to prevent further sun exposure until the signs and symptoms have gone away. Customers should be advised to stay in the shade and keep the sunburn area(s) completely covered. This is especially important when the sun is most intense (between 11am and 3pm). The skin may have been sun-damaged before the patient has 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. Soleve is designed for short-term use (2 to 3 days) because this is normally long enough to treat mild to moderate sunburn. If no improvement is felt during treatment, or if it gets worse, this may suggest that the sunburn is more severe and requires medical referral. Soleve should not be used as a general purpose after-sun lotion. Soleve is not to be applied to cut, grazed, broken or diseased skin. The patient should be reminded not to use more Soleve than the PIL tells them to. Soleve should not be used at the same time as any other oral or topical ibuprofen or NSAID product. 12 13
Does Soleve Sunburn Relief interact with any other medicines? Ibuprofen is a type of NSAID, and this class of medicine can interact with antihypertensive (blood pressure) drugs, and may possibly enhance the effects of anticoagulant (blood thinning) drugs, although the chance of either of these occurring with topically administered Soleve is small. Soleve should not be used at the same time as any other oral or topical ibuprofen or NSAID product. If the customer is on any medication, the pharmacist should refer to the current Summary of Product Characteristics (SPC) and/or PIL to check for medicines interactions. Are there any undesirable effects? Peeling and tanning of the skin are normal reactions to sunburn, and may occur 4 to 7 days after being burnt. Occasionally, because sunburnt skin is tender, the initial application of Soleve to sunburned skin may be associated with a temporary sensation of tingling or stinging, but should subside after a few minutes. Stop the treatment if tingling or stinging persists. Very rarely, ibuprofen has been associated with hypersensitivity (allergic reaction), renal (kidney) impairment and gastrointestinal side effects such as abdominal (stomach) pain and dyspepsia (heartburn). The pharmacists should refer to the current SPC and/or PIL for a list of undesirable effects. Soleve recommendation process for pharmacists and pharmacy assistants Customer presents with sunburn Is the person with sunburn under 12 years old? Does the sunburn affect: More than 10% of a child s (ages 12-18) body surface area? More than 20% of adult s body surface area? Is the sunburn severe i.e. blistering or broken skin or accompanied by any of the following symptoms: Intense pain? Headache? Fever? Chills? Nausea? Rash? Have the symptoms worsened, or persisted more than 2-3 days? Refer to the Pharmacist immediately, who can provide general advice on the management of burns and may refer the person to a GP or A&E. Provide the following counselling advice: Responsible behaviour in the sun. Soleve TM is not a sunscreen or sunblock. Customer wants a product for sunburn to keep in their first aid kit Is the person allergic to asprin, ibuprofen or any other NSAID (oral or topical), or any ingredients in Soleve TM? Does the person have A current history of stomach (peptic) ulcers? Asthma? Kidney problems? Pregnant? Only use Soleve TM on mild to moderate sunburn. Breastfeeding? Does the person take any other aspirin, ibuprofen or NSAID product? Recommend Soleve TM. Soleve TM is suitable for adults and children over 12 years old. Soleve TM should only be used for 2-3 days. If symptoms do not improve, or get worse, see your doctor. Remind customer to read the PIL. Soleve recommendation process for pharmacists Consider referring the person to a GP or A&E. Customer wants to buy a second bottle of Soleve TM Has the person seen any improvement after using the first bottle? Has the person already used Soleve for 3 days? Has the person used Soleve TM correctly? Is the person allergic to asprin, ibuprofen or any other NSAID (oral or topical), or any ingredients in Soleve TM? Does the person have: A current history of stomach (peptic) ulcers? Asthma? Kidney problems? Pregnant? Breastfeeding? Does the person take any other aspirin, ibuprofen or NSAID product? Provide general advice on the management of burns. Recommend Soleve TM. Is the burn still mild to moderate? Provide the following counselling advice: Responsible behaviour in the sun. Soleve TM is not a sunscreen or sunblock. Only use Soleve TM on mild to moderate sunburn. Soleve TM is suitable for adults and children over 12 years old. Soleve TM should only be used for 2-3 days. If symptoms do not improve, or get worse, see your doctor. Remind customer to read the PIL. 14 15
What other help can the pharmacist give to patients with sunburn or those taking Soleve Sunburn Relief away with them on holiday? The pharmacist should advise customers on responsible behaviour in the sun. Yellow Card reporting Pharmacists should report all incidences of suspected adverse reaction to Soleve Sunburn Relief using the Yellow Card. This can be found in the BNF or can be completed on the website www.yellowcard.gov.uk. See the BNF or the MHRA website (www.mhra.gov.uk) for additional advice. Excessive exposure to the sun damages and ages the skin. The damage is cumulative, and prolonged or repeated, inadequately protected exposure to the sun is linked to skin cancer. 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 avoid getting sunburnt. Precautions to minimise sun damage An effective sun protection product should always be used on sun exposed skin. Pharmacists should ensure customers understand the differences between the various sun protection products available on the market, and provide advice on the most suitable. Customers should be told that the sun protection product should be applied at least 30 minutes before going out into the sun. It should have a Sun Protection Factor (SPF) of 30 or more, and should protect against both UVA and UVB rays. If a sunscreen with SPF 30 is used, it will take the person 30 times longer to burn than they usually do, i.e. if they burn in 10 minutes, it will take 300 minutes (or 5 hours) for them to burn using the sunscreen correctly. It is important for customers to understand this so they select the correct sunscreen for their skin type. Higher SPF sun protection products are recommended for children as their skin is more delicate. These products should be reapplied regularly, especially after swimming, even if they are waterproof. In order to protect the eyes, sunglasses with UV filters should be worn. 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 customers should be advised to wear hats with a brim. The sun is most dangerous between 11am and 3pm, when it is high in the sky. Special precautions must be taken during this time of the day. There are many situations where people can get burnt without realising it. Clouds, wind and parasols reduce the sensation of heat, but have only a limited effect on the amount of harmful UV rays reaching the skin. Also, the skin is prone to getting burnt while on or in the water. Irresponsible behaviour in the sun leads to sunburn. 16 17
Case Studies Consider the following case studies. What additional information do you need to obtain and what course of action would you take? Case Study. 1 Mrs AW is your regular customer. She is a mother of three children, aged 14, 11 and 7. She walks into your pharmacy and informs you that next week she is taking her family on holiday to Spain for a fortnight. She needs some first aid medicines in case her family get sick. One of the things she requests is a new product she has heard about for treating sunburn. Advice and Action: The product is being requested on a just in case basis. sunburn has actually occurred yet. Consider the ages of the children. Stress that this product is not suitable for children under 12 years of age. Ensure no family member suffers from conditions that require GP referral (pages 10-11). If any member of the family is on any medication, ensure there is no potential medicines interaction (page 14). Impress upon her that she must read the PIL carefully before use, to make sure it is suitable for the particular case of sunburn and for the particular individual concerned (pages 10-11) and that the appropriate application procedure is followed (page 12). Emphasise to her that Soleve is not a sunscreen and will not prevent sunburn. Remind Mrs AW that by buying Soleve this does not mean that she and her family can be any less careful regarding avoiding any overexposure to the sun. Advise her on responsible behaviour in the sun. Case Study. 2 Mr PR is a young student who walks into your pharmacy and asks for a product for sunburn. He and his friends spent most of yesterday playing football in the local park. It was a sunny day, and his face and arms show signs of sunburn. His skin looks red and he complains that it feels sore. He says he is not taking any medication and is relatively fit and healthy. Advice and Action: Make sure his sunburn is mild to moderate, and NOT severe (page 10). Also take into consideration the surface area of affected skin, because if it is extensive he may need to see a doctor (page 11). Tell Mr PR that he must keep the sunburnt areas covered up, despite using Soleve. Remind him that Soleve is not a sunscreen and will not prevent further sunburn. Explore whether he may benefit from receiving some general advice on responsible behaviour in the sun. Recommend Soleve and advise him on the dosage regimen. Case Study. 3 Ms JG has previously visited your pharmacy with moderate sunburn on her face and shoulders. At that time, you supplied her with a bottle of Soleve Sunburn Relief. She returns 3 days later however, complaining that she has finished the bottle and the pain has not improved. She wants another bottle. Continued over page... Supply Soleve. 18 19
Multiple Choice Question (MCQ) Assessment Questions Advice and Action: 3 days treatment using Soleve is normally sufficient to relieve the symptoms. If it hasn t worked in this time, this may suggest that Ms JG s sunburn is more serious than originally thought. Consider referring her to her GP or local A&E. Please answer or to the following statements: 1. The active ingredients in Soleve are ibuprofen 10% and isopropyl myristate 1%. Another supply of Soleve would not be appropriate in this case. 2. An immediate referral to GP or A&E is needed if a person with sunburn presents with headache, nausea, fever. Case study. 4 3. Soleve can be used on skin that has blisters. Mrs KK is 55 years old, regularly uses sunbeds and feels at her best when her skin is tanned. She has heard about a new treatment for sunburn, and would like to buy some for the occasional skin tenderness that she experiences from time to time. 4. Soleve can be supplied to people as a first aid treatment to take away on holiday just in case. 5. If sunburn symptoms have shown no improvement Advice and Action: within 2 to 3 days, the patient should be referred to a GP. It would appear that Mrs KK has an irresponsible attitude towards overexposure to harmful UV rays. 6. Soleve can be used if the sunburnt area exceeds 20% of the total body surface area. She seems to be contemplating using Soleve to allow her to use her sunbed guilt-free. A supply of Soleve is not appropriate in this case. 7. If patients experience initial tingling (that resolves quickly) after applying Soleve, the treatment should be stopped immediately. She needs to be told that Soleve must not be used in this way. Excessive use of sunbeds can cause skin cancer. The skin tenderness she referred to means that she is not being careful enough, and Soleve is no substitute for her taking the necessary precautions. She should be warned about the risks involved not just in relation to her use of sunbeds, but also in relation to conventional sunbathing (page 16). 8. Oral ibuprofen should not be taken at the same time as Soleve. 9. Prolonged, unprotected exposure to the sun is linked to skin cancer. 10. The pharmacist should advise people to read the PIL carefully again before use, particularly if giving it to another family member. Answers: F,T,F,T,T,F,F,T,T,T 20 21
References Full Prescribing Information SOLEVE Trademark and Product Licence held by Diomed Developments Limited, Hitchin, Herts, SG4 7QR, UK. 1. Potts, J.E., Sunlight, sunburn and sunscreens, Postgraduate Medicine, 1990;87:52-63. 2. Lane-Brown M., New Concepts on Prevention and Treatment of Sunburn Drugs, 1977;13:366-372. 3. Cancer Research UK 2010. Skin cancer statistics Key Facts. Available from http://info.cancerresearchuk.org/cancerstats/ types/skin. 4. NICE public health guidance 32: Skin cancer: prevention using public information, sun protection resources and changes to the environment, January 2011. Indications: For the relief of pain associated with mild to moderate sunburn in adults and children over the age of 12 years. Directions: Apply the lotion to the affected area(s) as soon as possible after the first sign of any sunburn, and massage gently into the skin. Repeat as required, if necessary up to 8 times daily, but leaving at least 2 hours between applications. Treatment should be continued for a maximum of two to three days, by which time the symptoms should have subsided. Contraindications: t to be used in cases of sensitivity to any of the ingredients, particularly if asthmatic or suffering from allergic disease, and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers. t to be used on broken skin. t to be used during pregnancy or lactation. t to be used concurrently with any other product containing ibuprofen or any other NSAID. Precautions: Soleve is not a sunscreen or sunblock, and will not protect skin from the sun. t recommended for use on children under the age of 12 years. Seek medical advice if symptoms worsen or persist, or if sunburn is severe. Although systemic absorption of topically applied ibuprofen is less than for oral dosage forms, patients with asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the lotion. Keep away from the eyes and mucous membranes. For external use only. Side effects: The initial application of Soleve to sunburned skin may occasionally be associated with a temporary sensation of tingling or stinging. In normal use, systemic side effects are very rare, but may occasionally include hypersensitivity reactions and, in susceptible individuals, renal and/or gastrointestinal side effects. Legal category: P Pack size: 200ml PL 0173/0167 Revision date: July 2011 Abbreviated Prescribing Information: SOLEVE Trademark and Product Licence held by Diomed Developments Limited. Indications: For the relief of pain associated with mild to moderate sunburn in adults and children over the age of 12 years. Legal category: P Further information is available from Diomed Developments Limited, at the address above. Irresponsible behaviour in the sun leads to sunburn. 22 22 23