IBULEVE SPORTS

5 g gel (quantified by appropriate means) to the affected areas, up to three times daily, or as directed by the physician. Individual doses should be administered at least 4 hours apart. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed.

5 g of gel (quantified appropriately on the labelling) in any 24 hour period. Wash hands after use unless treating them. Do not use excessively. Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor.

The same dosage and dosage schedule applies to all age groups, although the gel is not normally recommended for children under 12 years, unless instructed by their doctor.

Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reaction Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis) Skin and subcutaneous tissue disorders Not known Photosensitivity reactions Skin rash Pruritus Skin irritation Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Immune System Disorders Not known Hypersensitivity 1 Renal and urinary disorders Not known Renal impairment 2 Gastrointestinal disorders Not known Abdominal pain Dyspepsia 1 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).

2 Renal: renal impairment can occur in patients with a history of kidney problems. 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.

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Keep away from the eyes and mucous membranes. 8). Most of these reactions occur 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).

Oral NSAID's, 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 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 asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the gel, as should patients already taking other painkillers. Patients should seek medical advice if symptoms worsen or persist.

Propylene glycol may cause skin irritation. Keep out of the sight and reach of children. For external use only. 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.

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 broken or damaged skin. Do not use during pregnancy or lactation.