RADIAN B ANTI-INFLAMMATORY IBUPROFEN

Strength 5% maximum Method of Administration For topical application to the skin Dosage Adults, the elderly and children over 14 years: Squeeze 5 to 10cm of the gel (containing 50 to 100mg of ibuprofen) from the tube and lightly rub into the affected area until absorbed.

The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period. Wash hands after each application. Do not exceed the stated dose. Unless recommended by a doctor advice should be sought about continued treatment if symptoms persist for more than 2 weeks.

Children under 14 years:

Do not use on children under 14 years of age except on the advice of a doctor.

Skin disorders are most frequently reported. Skin and subcutaneous tissue disorders Application site reactions, rashes, pruritis, and urticaria.

Very rare:

Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Frequency not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions. Gastro-intestinal: abdominal pain, dyspepsia. Respiratory: bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

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 of asthma, aggravated asthma, bronchospasm or dyspnoea, or c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Other adverse effects reported very rarely include renal failure. Reporting 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.

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Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive dressings. Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients.

Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with a history of kidney problems, an active peptic ulcer, asthma or intolerance to aspirin or ibuprofen should seek medical advice before using Radian B Ibuprofen 5% w/w Gel.

Avoid excessive sunlight exposure on the treated area as this may possibly lead to photosensitisation. Keep out of the sight and reach of children. Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it. 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

Ingredients with specified warnings This medicine contains 1% w/w Benzyl Alcohol which may cause mild local skin irritation (allergic reactions).

Hypersensitivity to ibuprofen or any of the excipients in the product. g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other NSAIDs. Patients suffering from renal failure. Third trimester of pregnancy.