Summary of Product Characteristics
last updated on the eMC:
23/12/2009
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 23/12/2009 and displayed until Current
|
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:
|
|
|
|
Updated on 06/09/1999 and displayed until 01/08/2000
|
Reasons for adding or updating:
|
|
|
|