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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 28/06/2011
SPC Xyloproct 5%/0.275% Ointment

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 28/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.9
change of text to most of section.

Section 10
Revision date of text: 20 May 2011
Updated on 15/02/2011 and displayed until 28/06/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.3

Additional information regarding genotoxicity and carcinogenicity:

Genotoxicity tests with lidocaine showed no evidence of mutagenic potential. A metabolite of lidocaine, 2,6-xylidine, showed weak evidence of activity in some genotoxicity tests. The metabolite 2,6-xylidine has been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use.

Section 10

Date of revision of text: 31st January 2011
Updated on 23/12/2009 and displayed until 15/02/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1
Change of name from Xyloproct Ointment to Xyloproct 5%/0.275% Ointment

Section 10
Date of revision of text: 14 December 2009
Updated on 20/06/2008 and displayed until 23/12/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   05-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2
Composition for: 100 g:

Lidocaine 5 g

Hydrocortisone Acetate micro Ph. Eur. 0.275 g

Section 3

Ointment.

Section 4.3
Known hypersensitivity to local anaesthetics of the amide type or any of the other ingredients. Use on atrophic skin. Xyloproct Ointment should not be used in patients with untreated infections of bacterial, viral, pathogenic fungal or parasitic origin. Xyloproct should not be used by patients being treated with a class III anti-arrhythmic drug outside of hospital (see sections 4.4 and 4.5).

Section 4.4
Hospitalised patients treated with anti-arrhythmic drugs class III (e.g. amiodarone or sotalol) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive (see sections 4.3 and 4.5).

 

Xyloproct ointment is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken for vulnerable patients.

Section 4.5
Lidocaine should be used with caution in patients receiving anti-arrhythmic drugs, local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are additive (see sections 4.3 and 4.4).

Section 10
Date changed to 5th June 2008
Updated on 30/11/2007 and displayed until 20/06/2008
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 5.3

Following new text added:

In animal studies the toxicity noted after high doses of lidocaine consisted of effects on the central nervous and cardiovascular systems.  No drug-related adverse effects were seen in reproduction toxicity studies, neither did lidocaine show a mutagenic potential in either in vitro or in vivo mutagenicity tests.  Cancer studies have not been performed with lidocaine, due to the area and duration of therapeutic use for this drug.

 

 

Section 10

Date changed to 6th August 2007
Updated on 07/11/2007 and displayed until 30/11/2007
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4

Following new text added:

Patients treated with anti-arrhythmic drugs class III (eg amiodarone) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

 

Section 4.5       

Following new text added (in bold)

Lidocaine should be used with caution in patients receiving antiarrhythmic drugs, other local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are additive.

 

 

 

Section 5.3

Following new text added:

In animal studies the toxicity noted after high doses of lidocaine consisted of effects on the central nervous and cardiovascular systems.  No drug-related adverse effects were seen in reproduction toxicity studies, neither did lidocaine show a mutagenic potential in either in vitro or in vivo mutagenicity tests.  Cancer studies have not been performed with lidocaine, due to the area and duration of therapeutic use for this drug.

 

 

Section 10

Date changed to 6th August 2007
Updated on 13/02/2004 and displayed until 07/11/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Updated on 22/04/2003 and displayed until 13/02/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 20/12/2002 and displayed until 22/04/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 08/04/2002 and displayed until 20/12/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
Updated on 21/08/2001 and displayed until 08/04/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 01/08/2000 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 01/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lidocaine
  hydrocortisone acetate