BOOTS MAX STRENGTH IBUPROFEN

e. 8 to 2 inches) of gel (50mg to 125 mg ibuprofen) from the tube and lightly rub into the affected area until absorbed. Use up to four times daily with individual doses administered at least 4 hours apart. Patients should not apply more than 500mg ibuprofen (approximately 5g gel) in any 24 hour period.

Wash hands after each application. Review treatment after 2 weeks, especially if the symptoms worsen or persist.

Paediatric population:

Do not use on children 12 years of age, except on the advice of a doctor. Method of administration. For cutaneous use.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Uncommon (≥1/1,000 to <1/100) 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:- System Order Class Frequency Adverse effects Immune system disorders Uncommon Hypersentivity1 Gastrointestinal disorders Uncommon Abdominal pain Dyspepsis 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 Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Uncommon Renal impairment2 1Hypersensitivity reactions have been reported following treatment with ibuprofen.

These may consist of (a) non-specific allergic reaction and anaphylaxis (b) respiratory tract reactivity comprising of asthma, aggravated asthma, brochospasm 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).

2Renal 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Apply with gentle massage only. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive dressings. Keep away from the eyes and mucous membranes. 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). 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 as should patients already taking other painkillers.

The label should include the following warnings: • Do not apply more of this medicine than the label tells you to. • Not recommended for children under 12 years. • Use this medicine only on your skin. • Not to be used during pregnancy or breastfeeding.

• 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 do not get better after 2 weeks or if they worsen, consult your doctor or pharmacist.

• Keep out of the sight and reach of children. • Patients with asthma, an active peptic ulcer or history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers. Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.

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.

01mg/mg. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine contains less than 1 mmol sodium (23 mg) per 125mg, that is to say essentially ‘sodium-free’.

1. 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. Third trimester of pregnancy.