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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: 19/04/2011
SPC Xylocaine 10mg Spray

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 19/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4


Changed text in first paragraph and additional text as follows:


If the dose or site of administration is likely to result in high blood levels, lidocaine, in common with other local anaesthetics, should be used with caution in the following patients who will require special attention to prevent potentially dangerous side effects:

Patients with epilepsy.

Patients with cardiovascular disease and heart failure.

Patients with impaired cardiac conduction or bradycardia.

Patients with severe renal dysfunction.

Patients with impaired hepatic function.

Patients in severe shock.

The elderly and patients in poor general health.

Section 4.9


Changed text under the heading “Treatment of acute toxicity”.

Section 10

Date of revision of text: 5th April 2011

Updated on 16/02/2011 and displayed until 19/04/2011
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:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.3

Additional information regarding genotoxicity and carcinogenicity:


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.

Genotoxicity tests with lidocaine showed no evidence of mutagenic potential. A metabolite of lidocaine, 2,6-dimethylaniline, showed weak evidence of activity in some genotoxicity tests. The metabolite 2,6-dimethylaniline 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 16/02/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   07-Dec-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1

Change of name to include 10mg:

Xylocaine 10 mg Spray

 

Section 2

Additional information:

Each depression also delivers 1 mg of propylene glycol (an excipient of the banana essence).


Section 6.1

Additional information:

Essence of Banana (contains propylene glycol)


Section 10

Date of revision of text: 7th December 2009
Updated on 11/06/2008 and displayed until 23/12/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   26-Mar-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SECTION 4.4

Addition of last paragraph to read: Xylocaine Spray is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Section 10

Date of revision of text to 26 March 2008
Updated on 28/03/2006 and displayed until 11/06/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/11/2004 and displayed until 28/03/2006
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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 25/03/2004 and displayed until 26/11/2004
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 25/03/2004 and displayed until 25/03/2004
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 13/11/2003 and displayed until 25/03/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
Updated on 11/11/2003 and displayed until 13/11/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
Updated on 31/05/2002 and displayed until 11/11/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/04/2002 and displayed until 31/05/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 03/04/2002 and displayed until 11/04/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 16/08/2001 and displayed until 03/04/2002
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 06/09/1999 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lidocaine