Alliance Pharmaceuticals

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

Summary of Product Characteristics last updated on the eMC: 05/05/2011
SPC Occlusal

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

Updated on 05/05/2011 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   28-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Changes highlighted in red text:

 

 

4.3.      Contra-indications

 

Hypersensitivity to salicylic acid or to any of the excipients.

 

Thwart should not be used by diabetics or patients with impaired blood circulation.  Do not use if the wart or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.

 

4.4.      Special Warnings and Precautions for Use

 

Thwart is for external use only.  Do not permit contact with eyes or mucous membranes.  If contact occurs flush with water for 15 minutes.  Do not allow contact with normal skin around wart.  Avoid using on areas of broken or damaged skin.  Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.

 

4.5.      Interactions with other Medicaments and other forms of Interaction

 

There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Thwart and other topical medicines on the treated wart should therefore be avoided.

 

4.6.      Fertility, pregnancy and Lactation

 

Whilst there are no known contra-indications to the use of Thwart during pregnancy and lactation, the safety has not been established. Thwart should therefore be used with caution or following professional advice.

 

 

 

4.9.      Overdose

 

Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Thwart is used as indicated.

 

5.         Pharmacological Properties

 

5.1.      Pharmacodynamic Properties

 

Pharmacotherapeutic group: Wart and anticorn preparations

 

ATC code: D11AF

 

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product.  When applied externally it produces slow and painless destruction of the epithelium.  Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.

 

5.2.      Pharmacokinetic Properties

 

Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Thwart.

 

5.3.      Preclinical Safety Data

 

No other information relevant to the prescriber other than that already stated in other sections of the SPC.

Updated on 12/08/2010 and displayed until 05/05/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2005
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Changes hightlighted in red text:


10.       DATE OF REVISION OF TEXT

 

            June 2005

Updated on 07/07/2005 and displayed until 12/08/2010
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2004 and displayed until 07/07/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2004 and displayed until 30/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   salicylic acid