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A.Menarini Pharmaceuticals Ltd
2nd Floor, Castlecourt, Monkstown, Monkstown, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045
Summary of Product Characteristics last updated on medicines.ie: 24/06/2011
SPC Fastum gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   21-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update to the following sections:

4.2 Posology and method of administration:
Product is now approved 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 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.
Sentence added: Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
2 new side-effects added: hypersensitivity reaction and burning sensation.
Updated on 06/11/2007 and displayed until 24/06/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.3 - hypersensitivity warning amended

Section 4.4 - updated warning to keep out of the reach and sight of children

Section 4.8 - section updated and adverse reactions tabulated

Section 5.1 - section updated

Section 5.2 - section updated

Section 10 - date of revision updated
Updated on 18/09/2007 and displayed until 06/11/2007
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 9: Date of last renewal
Updated on 23/11/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.5 New pack size. 
Updated on 25/05/2005 and displayed until 23/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 04/08/2004 and displayed until 25/05/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Ketoprofen