NUROFEN MUSCULAR PAIN RELIEF

For cutaneous use.

Adults, the elderly and children over 12 years:

Squeeze 50 to 125 mg (4 to 10 cm) of the gel 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 every application.

Do not exceed the stated dose. Review treatment after 7 days, especially if the symptoms worsen or persist.

Children under 12 years:

Do not use on children under 12 years of age except on the advice of a doctor.

Systemic availability of topical ibuprofen is very low compared to orally administered NSAIDs. Adverse events, particularly those affecting the gastrointestinal tract, are less common with the use of topical ibuprofen. The list of the following adverse effects relates to those experienced with topical ibuprofen at OTC doses (maximum 500 mg per day), in short-term use.

In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. Adverse events which have been associated with ibuprofen are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Table of Adverse Events System Organ Class Frequency Adverse Event Immune System Disorders Not known Hypersensitivity 1 Gastrointestinal Disorders Not known Abdominal pain, dyspepsia Renal and Urinary Disorders Not known Renal impairment 2 General Disorders and Administration Site Conditions Not known Application site reaction3 Skin and subcutaneous tissue disorders Very Rare Not known Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis) Photosensitivity reactions Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Description of Selected Adverse Reactions 1 Hypersensitivity reactions have been rarely reported following treatment with oral and topical Ibuprofen.

These may consist of (a) non-specific allergic reaction 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, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme).

) 3 The most common undesirable effects are application site reactions. 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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If symptoms persist for more than 7 days, or worsen at any time, consult your doctor or pharmacist. Bronchospasm can occur in patients using ibuprofen who suffer or have previously suffered from bronchial asthma or allergic disease.

Discontinue immediately if rash develops. Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Hands should be washed immediately after use. Not for use with occlusive dressings.

The label will state:

Do not exceed the stated dose. Keep out of the reach and sight of children. For external use only. If symptoms persist, consult your doctor or pharmacist. Do not use if you are allergic to ibuprofen or any of the ingredients, aspirin or any other painkillers.

Speak to a pharmacist or doctor before using this product if:

You are taking aspirin or any other pain relieving medication. You are pregnant. You have asthma. Not to be used in children under 12 years, except on medical advice. 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 an active peptic ulcer, impaired hepatic function, a history of kidney problems or asthma should seek medical advice before using Ibuprofen gel as should patients already taking other painkillers.

For external use only. Apply with gentle massage only. 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. 25 mg benzyl alcohol in each dose.

Benzyl alcohol may cause allergic reactions and mild local irritation. 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).

1. g. asthma, rhinitis or urticaria) in response to ibuprofen, acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in third trimester of pregnancy. Not to be used on broken or damaged skin.