DEEP RELIEF DUO JOINT PAIN

Posology For adults, the elderly and children over 12 years Method of administration Apply the gel over the affected area and massage gently until absorbed. Repeat as necessary, up to a maximum of three times a day. Not to be repeated more frequently than every four hours.

For each application use about 10 to 40mm (½ to 1½ inches), containing 50- 125mg Ibuprofen. If no improvement is seen after two weeks, consult your doctor. For external use only.

Skin disorders are most frequently reported:

Application site reactions such as rashes, pruritus and urticaria, drying, reddening, burning sensation, contact dermatitis. Application site burns have been reported for menthol-containing products. Frequency unknown. Photosensitivity reactions – frequency unknown.

Other systemic undesirable effects of NSAIDs depend on the quantity of gel applied, the treated area, the integrity of the skin, the duration of treatment, the use of occlusive dressings: although extremely uncommon when administered topically side effects such as abdominal pain, dyspepsia and renal impairment are possible.

Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of: (a) Non-specific allergic reactions and anaphylaxis. 3). (c) Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

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

Paediatric population Not recommended for children under 12 years of age. The gel should not be used on or near mucous membranes, nor near the eyes. Avoid contact with inflamed or broken skin. Discontinue use if rash or irritation develops.

Not for use with occlusive dressings. Always try on a small area first. As it is known that oral Ibuprofen may worsen an existing renal impairment, or aggravate an active peptic ulcer, patients with a history of renal problems or with an active peptic ulcer should seek medical advice before using topical Ibuprofen products.

The hands should be washed after applying the product, unless they are being treated. Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. If anyone swallows the gel he or she should contact his or her doctor or nearest casualty department.

If anyone experiences any unwanted effects, if there is no improvement, or the condition is aggravated, he or she should consult his or her doctor.

By extrapolation from other routes of administration:

Although this is less likely with NSAIDs intended for topical use compared to oral drugs, the use of this product, as with any drug known to inhibit cyclo- oxygenase/prostaglandin synthesis, may impair fertility. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of this product should be considered.

Keep all medicines out of the sight and reach of children. For external use only. Do not store above 25°C 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. 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 Those patients known to be hypersensitive to ibuprofen, levomenthol, or any of the ingredients or sensitive to aspirin, or other NSAIDS including when taken by mouth, or asthmatic patients in whom aspirin or non-steroidal anti- inflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria.

Use on broken skin or denuded skin. Simultaneous use on the same site with any other topical medicine. Use in the presence of local infection. Use in the last trimester of pregnancy.