Goldshield Pharmaceuticals is pleased to announce the launch of
Mobigel Spray 4%. Mobigel Spray is the new diclofenac spray gel
which has been shown to be effective in the relief of mild to
moderate pain and inflammation following acute blunt trauma of
small and medium-sized joints and periarticular structures 1, 2.
Goldshield Group Limited is a Pharmaceutical and Consumer Health
company. The company markets and sells its products to more than 50 countries. Sales turnover for the last financial year (ending March 31, 2008
was GBP 85 million. For more information on the Goldshield Group Limited,
please visit:- www.goldshieldgroup.com

Prescribing Information for Mobigel® Spray 4% (diclofenac)
Name and Composition:
Mobigel® Spray 4%, each 1g of solution contains 40 mg of diclofenac sodium.

Indications:
For the local symptomatic relief of mild to moderate pain and
inflammation following acute blunt trauma of small and medium-
sized joints and periarticular structures.

Dosage and method of administration:
For cutaneous adminstration. In adults and elderly sufficient solution of spray gel should be sprayed onto the skin of the affected site and massaged gently. Hands should then be washed unless they are the site to be treated. Depending on the size of area to be treated 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times daily in regular intervals. A maximum single dose (1 g) should not be exceeded. The maximum daily dose is 15 pump strokes
(3.0 g of spray containing 120 mg of diclofenac sodium). Some minutes for drying should be allowed before dressing or binding the treated area. Treatment should not be continued beyond 7-8 days without review.

Children:
Not recommended for use in children below 15 years of age.

Contra-indications:
Hypersensitivity to the active substance or to any of the excipients, to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Patients with or without asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. The last trimester of pregnancy. Application to the breast area of nursing mothers

Warnings and precautions:
Contact with eyes and mucous membranes, oral use should be avoided. Should only be administered onto intact skin, not on open wounds or diseased skin or with occlusive dressings. Avoid excessive exposure to sunlight. Discontinue if rash develops. Possibility of systemic side-effects (hypersensitivity, asthmatic and renal adverse reactions) when applied to a large area of skin (more than 600 square centimetres of the body surface) and in long term treatment (more than 4 weeks). If such usage is envisaged, the data sheet on diclofenac oral dosage forms should be consulted. Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease. Should be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, bleeding diathesis or inflammatory bowel disease and while using oral NSAIDs concomitantly. Contains propylene glycol & peppermint oil which may cause skin irritation and allergic reactions respectively.

Pregnancy and lactation:
Not recommended.

Interactions:
Risk of interactions with other medicinal products is small as the systemic availability of diclofenac is very low in this pharmaceutical form. Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

Undesirable effects:
Application site reactions, rashes, pruritus and urticaria, drying, reddening, burning sensations, contact dermatitis. Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. There is a possibility of systemic adverse reactions during long term treatment (> three weeks) and/or when treating large areas (i.e. more than 600 square centimetres of the body surface). Abdominal pain, dyspepsia, gastric and renal disorders may occur. Asthma, generalised skin rash, hypersensitivity reactions (angioedema and photosensitivity reactions) have been reported.

Please refer Summary of Product Characteristics for detailed information.

Legal Category: POM
Basic NHS price: £5.38 for 25g bottle
Marketing Authorisation number: PL 12762/0402
Marketing Authorisation Holder: Goldshield Pharmaceuticals Ltd.,
NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT, UK
Date of preparation: September 2008

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Goldshield Medical Information
at 08700 703033 or via e-mail to medicalinformation@goldshieldgroup.com
MobPressRelease Corp Mar-09

1. Mobigel Spray 4% Summary of Product Characteristics
2. Data on file (53511), MIKA Pharma GmbH, February 2005