A.Menarini Pharma U.K. S.R.L.

Update to the following sections:

4.2 Posology and method of administration:
Powergel is approved now for prescription use only.

4.3 Contraindications
Contraindications updated and the following statements added:

History of any photosensitivity reaction.

Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or  urticaria to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs. 

History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.

Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation.

Hypersensitivity to any of the excipients of the product.

4.4 Special warnings and precautions

Warnings updated and the following statements added:

Hands should be washed thoroughly after each application of the product.

Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products.

It is recommended to avoid exposure of treated skin to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.

4.8 Undesirable effects. 
Introductory paragraph added highlighting the most common adverse reactions -   photosensitivity reactions and reports of localised skin reactions due to photosensitivity, including erythema, pruritis and burning sensations.  Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.

New side-effects from post-marketing experience added:

Secondary impetigo, eosinophilia, hypersensitivity, eyelid oedema, vasculitis, lip oedema, angioedema, burning sensation, dermatitis (allergic, bullous, exfoliative, vesicular), blister, photosensitivity allergic reaction, skin exfoliation, rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular),  skin oedema, application site burn, acute renal failure, pyrexia, wound complication. 

6.5       Nature and contents of container

Reference to the 'P' pack removed.

Section 5.1 Add Pharmacotherapeutic code and ATC code

Section 5.2 Add more details on pharmacokinetic properties

Section 5.3 Add more details on animal, preclinical and clinical trials 

Section 10 Amend date of revision of the text to 20 April 2010

Section 4.6 Pregnancy and lactation – rewritten and statement added: Powergel should not be used during pregnancy and lactation.

Section 4.8 Undesirable effects – rewritten and list of side-effects included in a table.

Section 10 – amend date of revision of the text to 29 September 2009

The following sections have been updated

1. NAME OF THE MEDICINAL PRODUCT - '2.5% gel' added after POWERGEL

2. QUALITATIVE AND QUANTITATIVE COMPOSITION - 'For a full list of excipients, see section 6.1.' added.

4.7. Effects on ability to drive and use machines - Statement amended to read - No effects on the ability to drive and use machinery have been reported.

6.1. List of excipients - 'triethanolamine' updated to 'trolamine'

6.5. Nature and contents of container - 'Not all pack sizes may be marketed.' added.

7. MARKETING AUTHORISATION HOLDER
 A Menarini Industrie Farmaceutiche Ruinite S.r.l. - 'srl' amended to 'S.r.l.'

• Section 4.3 – update hypersensitivity information to add reference to the excipients and to fenofibrate.  Take out sentence that severe bronchospasm might be precipitated in patients who are hypersensitive to ketoprofen or aspirin and in those suffering from, or with a history of, bronchial asthma or allergic disease.  The sentence stating ketoprofen gel should not be administered to patients in whom acetyl salicylic acid or other NSAIDs have caused asthma, rhinitis or urticaria remains.  Move warning not to apply to open wounds, skin lesions or near the eyes from 4.4 to 4.3. 
  
• Section 4.4 – update information to provide more details regarding use if skin rash develops, use in patients with serious kidney failure, prolonged use of topical products, hypersensitivity or photosensitivity.  Update warning to keep out of the reach and sight of children.
  
• Section 6.3 – extend shelf-life of dispenser packs from 24 to 60 months in line with tubes.
  
• Section 9 – update date of renewal to 1 May 2008
  
• Section 10 – amend date of revision of the text to May 2008