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Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR , UK
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
Summary of Product Characteristics last updated on medicines.ie: 14/02/2012
SPC Perinal Cutaneous Spray

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 14/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 10 (Date of revision of the text) the date has changed to "January 2012".
Updated on 02/12/2010 and displayed until 14/02/2012
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
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
In section 6.1 (List of excipients) there is a change of name from "cetomacrogol 1000" to "macrogol cetostearyl ether (cetomacrogol)"

In section 10 (date of revision of the text) the date has changed to "November 2010"
Updated on 19/01/2009 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In section 1 (Name of the Medicinal Product) : the name has changed to "Perinal Cutaneous Spray"
 
In section 10 (Date of Revision of the Text) : the date has changed to "December 2008"
Updated on 01/12/2008 and displayed until 19/01/2009
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 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In section 4.3 (Contraindications) the text has changed to:

Not to be used if sensitive to lidocaine or any other of the ingredients.  Not to be used on broken or infected skin.  Do not use on children under the age of 14 years without medical supervision.

 
In section 4.4 (Special warnings and precautions for use) the text has changed to:
 
Perinal Spray is intended for use for limited periods and so should not be used continuously for longer than 7 days without medical advice.  Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, if the stomach is distended or if they are losing weight.  Prompt medical treatment may be very important under such circumstances.

Not to be used internally (inside the anus), or anywhere other than the anal area.

Medical supervision is required if used in conjunction with other medicines containing steroids, owing to possible additive effects.

Perinal Spray should be kept away from the eyes, nose and mouth.
 
 
In section 10 (Date of revision of the text) the text has changed to:
 
October 2008.
Updated on 13/08/2007 and displayed until 01/12/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 01/08/2007 and displayed until 13/08/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update to section 4.6, pregnancy and lactation, in line with UK SPC.
 
Update to section 5.1, pharmacodynamic properties, to include ATC code.
 
Amends to sections 6.2, incompatibilities, and 6.6, special precautions.
 
Section 9 - renewal date changed to 5 June 2007.
Updated on 18/08/2006 and displayed until 01/08/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   11/2002
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Posology and method of administration:  Text "The spray will operate in any orientation" deleted.
 
Section 4.4 - Special warnings and precautions for use: Text "Keep all medicines out of the reach of children" deleted.
 
Section 5.1 - Pharmacodynamic properties: Text "On application, finger contact with the affected area can be avoided which makes for improved hygiene, and lessens the risk of infection" deleted.
 
Section 5.2 - Pharmacokinetic properties: Text "Because the preparation is a clear solution, it is entirely homogeneous, and the availability of the active ingredients is optimal" deleted.
 
 
Updated on 27/07/2005 and displayed until 18/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 13/06/2003 and displayed until 27/07/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydrocortisone
  Lidocaine Hydrochloride