SOLEVE SUNBURN RELIEF

For adults, the elderly and children over the age of 12 years:

Commencing as soon as possible after the first sign of any sunburn, apply the lotion to the affected area(s) 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. Wash hands after use, unless treating them. In cases where children are to be treated, the lotion should always be applied by an adult.

The lotion spreads easily, and a small amount goes a long way. 5cm in diameter (2 to 4ml) will be sufficient. Individual doses should not exceed 12ml (one capful of the 200ml pack or one and a half capfuls of the 100ml pack), and the maximum daily dose should not exceed 100ml.

Soleve is not recommended for children under the age of 12 years.

The initial application of Soleve or other liquid preparations to sunburned skin may occasionally be associated with a temporary sensation of tingling or stinging, but this should subside after a few minutes. Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically.

If they occur, treatment should be discontinued:- Hypersensitivity: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a ) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Renal: renal impairment can occur in patients with a history of kidney problems. Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported. Peeling and tanning of the skin are normal reactions to sunburn, and may occur 4 – 7 days after being burnt.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Soleve is not a sunscreen or sunblock, and will not protect skin from the sun. Care should be taken to prevent further exposure to the sun's harmful rays until the signs and symptoms of the sunburn have completely resolved. Patients should be advised to stay in the shade and keep the affected area(s) completely covered up.

This is especially important when the effect of the sun is most intense (between 11 am and 3 pm). The pain and redness of sunburn have a delayed onset and are likely to worsen after being first noticed. Patients should be reminded that 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.

Cases of severe or extensive sunburn (involving more than 10% of a child's body surface area, or more than 20% of an adult's body surface area) and cases involving obviously blistered skin, may require more comprehensive medical intervention, and such patients should therefore be encouraged to 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, they should consult a doctor immediately. Medical advice should be obtained if a baby or small child has been sunburnt.

Keep away from the eyes and mucous membranes. 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.

Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity. Patients should be encouraged to seek medical advice if symptoms persist or worsen. Keep out of the reach and sight of children.

Not to be used if allergic to any of the ingredients, or in cases of hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis or urticaria.

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 concurrently with any other product containing ibuprofen or any other NSAID.