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Alliance Pharmaceuticals Ireland

Alliance Pharmaceuticals Ireland
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 44 (0)1249 466966
Fax: +44 (0)1249 466 977
Medical Information e-mail: medinfo@alliancepharma.co.uk
Summary of Product Characteristics last updated on medicines.ie: 09/11/2010
SPC Thwart 26%w/w cutaneous solution

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 09/11/2010 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:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.3         Contraindications

 

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         Interaction with other medicinal products 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

 

Pharmacotherapeutical group: Wart and anticorn preparations

 

ATC code: D11FA

 

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.


 

6.3         Shelf life

 

3 years.

Updated on 14/01/2009 and displayed until 09/11/2010
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Salicylic Acid

Versions

 
09/11/2010 to Current
14/01/2009 to 09/11/2010
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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