NUROFEN JOINT & MUSCULAR PAIN RELIEF

Posology Adults or adolescents aged 16 years and over:

One dose is equal to one medicated plaster. The maximum dose for a single 24 hour period is one medicated plaster. The plaster can be applied at any time during the day or night, but should be removed and a new plaster re-applied at the same time on the following day.

The medicated plaster should be used for the shortest duration necessary to control symptoms. The treatment duration should not exceed 5 days. The therapeutic benefit of treatment longer than 5 days has not been established. If there is no improvement, during the recommended duration of treatment or a worsening of symptoms, a healthcare professional should be consulted.

Elderly patients:

No special dose adjustment is necessary.

Paediatric population:

The safety and efficacy of Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster in children or adolescents under 16 years of age has not yet been established. Method of administration For cutaneous use and short-term use only.

The medicated plaster should be used whole and not be cut. The medicated plaster should not be used together with an occlusive dressing. It is recommended to carefully wash and dry the area to be treated before applying the medicated plaster.

Apply to intact skin only. Tear or cut the sachet along the dotted line to remove a medicated plaster. First remove the central portion of the release liner used to protect the adhesive surface and apply this surface to the painful area, once securely in place remove the remaining release liner at the edges of the plaster.

The medicated plaster is flexible and conformable, and if necessary can be applied on or near a joint and will allow for normal movement. Avoid getting the medicated plaster wet.

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 events relates to those experienced with topical ibuprofen at OTC (dose maximum 500 mg per day), in short term use.

The following frequency conventions are used in the rating of undesirable effects:

Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); 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.

System Organ Class Frequency Adverse Events Immune System Disorders Not known Hypersensitivity 1 Gastrointestinal Disorders Not known Abdominal pain, dypepsia Renal and Urinary Disorders Not known Renal impairment 2 General Disorders and Administration Site conditions Not known Application site reaction 3 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 reported following treatment with oral ibuprofen.

These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactions comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) skin reactions, including rashes of various types, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme), and pruritus.

If symptoms persist for longer than 5 days or worsen, a healthcare professional should be consulted. Undesirable effects can be reduced by reducing the duration of treatment. Bronchospasm can occur in patients using ibuprofen who suffer or have previously suffered from bronchial asthma or allergies.

The treatment should be discontinued immediately if a skin rash develops after applying the medicated plaster. g. tanning lamps) during treatment and for one day after removal of the medicated plaster, in order to reduce the risk of photosensitivity.

Although the systemic availability of topically applied ibuprofen is significantly less than for oral dosage forms, complications may occur in rare cases. For these reasons, patients with: an impaired renal, cardiac or hepatic function; active or a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis should seek medical advice before using this medicinal product.

Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more likely to experience undesirable effects. 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, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid or other non-steriodal anti-inflammatory drugs (NSAIDs). • Application on broken or damaged skin • Third trimester of pregnancy.

• Use on the eyes, lips or the mucous membranes.