IBULEVE MAXIMUM STRENGTH

Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply 2 to 5 cm gel (50 to 125 mg ibuprofen) to the affected area, and gently massage well into the skin, until completely absorbed.

Wash hands after use unless treating them. Unless recommended by a doctor, medical advice should be sought about continued treatment if symptoms persist for more than 7 days. The same dosage and dosage schedule applies to all age groups, although the gel is not recommended for use on children under the age of 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 Skin and subcutaneous tissue disorders Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis) 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 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 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 an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using the gel. Patients should seek medical advice if symptoms worsen or persist.

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.

The label should include the following warnings: “Do not exceed the stated dose. Not recommended for children under 12 years. For external use only. Not to be used during pregnancy or breast-feeding. Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen or related painkillers (including when taken by mouth).

If symptoms persist consult your doctor or pharmacist. Keep out of the sight and reach 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 broken or damaged skin. Do not use during pregnancy or lactation.