Xylocaine Spray 10mg

  • Name:

    Xylocaine Spray 10mg

  • Company:
    info
  • Active Ingredients:

    Lidocaine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/05/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/5/2017
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Aspen

Aspen

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When a pharmaceutical company changes any document, 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 29 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 6 - manufacturer

Updated on 16 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text

 

 

7. Marketing Authorisation holder

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublin 24

Ireland.

 

AstraZeneca UK Ltd.,

600 Capability Green,

Luton, LU1 3LU, UK.

 

 

8.Marketing authorisation number

1691/028/001

PA 970/54/4

10. Date of revision of the text

30th June 2016

April 2017

Updated on 11 May 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 12 July 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 2: Editorial changes to reflect the QRD template

Section 4.2 information on Paediatric population added.

Section 4.3 Editorial changes to reflect the QRD template

Section 4.4 Editorial changes to reflect the QRD template

Section 4.5 Editorial changes to reflect the QRD template

Section 4.6 Editorial changes to reflect the QRD template

Section 4.7 updated statement on influence on driving and using machines

Section 4.8 Editorial changes to reflect QRD template and addition of ADR reporting statement

Section 5.1 Editorial changes to reflect QRD template

Section 5.2 Editorial changes to reflect QRD template

Section 6.6 Editorial changes to refelect QRD template

Section 10 Revision date

Updated on 11 July 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 23 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision

Updated on 23 March 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Section 4.3

Paragraph amended to:

Known hypersensitivity to local anaesthetics of the amide type or to any of the excipients listed in section 6.1.


Section 6.5

Paragraph 1 amended to:

A 50 ml Type I Ph. Eur. neutral glass spray bottle with a metering spray pump. The package includes a single use PP spray nozzle approximately 120 mm long. Additional short spray nozzles are available separately.


Section 6.6

Paragraph 2 amended to:

The nozzle must not be shortened, as it will affect the spray function. Nozzles should not be reused and should be discarded immediately after use.


Section 10

Date of revision changed to: 20th March 2012.

Updated on 19 May 2011 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

Change of text first paragraph

4th paragraph is new text. i.e. “If the dose or site of administration is likely to result...”


Section 4.9

Change of text under the heading ‘Treatment of acute toxicity’


Section 10

Date of revision of text: 28th April 2011

Updated on 27 September 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 

update the table to MedRA format

Section 10
Revision date of text: 27 August 2010

Updated on 20 May 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC Changes – Xylocaine Spray

 

Section 2

 

Text now reads,

 

“Each depression of the valve delivers 10 mg of lidocaine.

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

For a full list of excipients see section 6.1.”

Updated on 10 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to Xylocaine Mucosal Spray

 

Section 1

Now reads,

“Xylocaine 10 mg/delivered dose Mucosal Spray”

 

Section 2

Now reads,

“Excipients: Each depression of the valve delivers 10 mg of lidocaine. Each depression also delivers 1 mg of propylene glycol (an excipient of the banana essence).

For a full list of excipients see section 6.1.”

 

Section 4.5

Small text change in first paragraph, now reads,

“Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g. antiarrhythmics, such as mexiletine, since the toxic effects are additive.”

Section 6.1

Now reads,

“Ethanol (96%)

Macrogol 400

Essence of Banana

Levomenthol

Saccharin

Water purified”

 

Section 6.2

Now reads,

“Not applicable.”

 

Section 6.5

First paragraph now reads,

“A 50 ml Type I Ph. Eur. Neutral glass spray bottle with a metered dose valve and an autoclavable PP spray nozzle applicator.”

 

Section 9

Now reads,

“Date of first authorisation: 1st April 1980
Date of last renewal: 1st April 2010”

 

Section 10

Now reads,

“9th April 2010”

Updated on 29 April 2010 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about driving or using machinery
  • Change to further information section

Updated on 4 September 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 June 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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
Change to date of revision to 27 May 2008

Updated on 11 June 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 6 December 2007 SmPC

Reasons for updating

  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5

New text added to end of section 4.5:

Drugs that reduce the clearance of lidocaine (e.g. cimetidine or beta-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. Xylocaine spray) at recommended doses.

 

 

Section 5.3

Following sentence deleted:

Lidocaine is a well established active ingredient.

 

And replaced with following new paragraph

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 6.6

Following new sentence added:

The spray nozzle is bent to ensure correct spray function. Do not try to alter the shape as this could affect its performance.

 

 

Section 10

Date changed to 14th June 2006

Updated on 12 April 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 April 2006 PIL

Reasons for updating

  • Change of active ingredient
  • Change to date of revision

Updated on 28 March 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 November 2004 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 July 2004 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 October 2003 SmPC

Reasons for 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)