Updated on 18 September 2023
File name
Lido_Spr_IE_S_10mg-dose_v2.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 6.6 - Special precautions for disposal and other handling
- 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)
Updated on 18 September 2023
File name
Lido_Spr_IE_P_10mg-dose_v7.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 18 September 2023
File name
Lido_Spr_IE_P_10mg-dose_v7.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 18 September 2023
File name
Lido_Spr_IE_P_10mg-dose_v7.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 18 September 2023
File name
Lido_Spr_IE_P_10mg-dose_v7.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 18 September 2023
File name
Lido_Spr_IE_P_10mg-dose_v7.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 03 August 2021
File name
Lido_Spr_IE_P_10mg-dose_v6_remove MDM as Mnfr & EU legal rep.pdf
Reasons for updating
- New PIL for new product
Updated on 09 December 2020
File name
Lido_Oromuc spray_IE_S_ 10mg-dose_Apr2017_v1.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 May 2020
File name
Lido_LiqSpr_UK_S_ 10mg_v2.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 May 2019
File name
Lido_Spr_IE_P_10mg-dose_v4.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 June 2018
File name
Lido_Spr_IE_P_10mg-dose_v3.pdf
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
File name
PIL_7681_648.pdf
Reasons for updating
- New PIL for new product
Updated on 20 October 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to section 6 - manufacturer
Updated on 16 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2017
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
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
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
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
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 23 March 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
Updated on 19 May 2011
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
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
update the table to MedRA format
Section 10
Revision date of text: 27 August 2010
Updated on 20 May 2010
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
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
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 04 September 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 11 June 2008
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
Xylocaine Spray is probably porphyrinogenic and should only be prescribed to
patients with acute porphyria on strong or urgent indications. Appropriate
Updated on 11 June 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 06 December 2007
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
Updated on 12 April 2007
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 April 2006
Reasons for updating
- Change of active ingredient
- Change to date of revision
Updated on 28 March 2006
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
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
Reasons for updating
- New PIL for medicines.ie
Updated on 06 July 2004
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
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 06 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)