Savlon Antiseptic Cream

  • Name:

    Savlon Antiseptic Cream

  • Company:
    info
  • Active Ingredients:

    Cetrimide, Chlorhexidine digluconate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/10/19

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2019

Click on this link to Download PDF directly

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Address: 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line: 1800 441 442

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1 - 0 of 54 items.Total: Infinity pages

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 3 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 21 August 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 25 January 2019 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 12 June 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 1 June 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 10 July 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

Change of ownership

Updated on 10 July 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 7 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 July 2017 PIL

Reasons for updating

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

Updated on 7 July 2017 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 27 October 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

In section 1 (Name of medicinal product) the name is updated to include the strength of the active.

Updated on 24 May 2016 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 16 May 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 May 2015 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

“gluconate” amended to “digluconate”

Section 4.2

“Apply to…” amended to “Apply the cream over…”

Section 4.3

“digluconate” inserted

Section 4.4

“If no improvement occurs…” amended to “If symptoms persist…”

“The product is incompatible with anionic substances (e.g. soap) added”

Section 4.5

“with the topical forms” removed

Section 4.6

“digluconate” inserted

Section 4.8

“blistering” amended to “blisters”

Reporting of suspected adverse reactions section added

Section 4.9

Additional information regarding symptoms added

Management section added

Section 5.1

“chlorhexidine, combinations” added into pharmacotherapeutic group

“digluconate” added

Section 5.2

“digluconate” added

Section 5.3

“digluconate” added

Section 10

Date of revision amended from 30 April 2014 to 13 May 2015

 

Updated on 13 January 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

Correction of typos in 4.3, 4.4 and 5.2.

Date of revision corrected from 14 April 2014 to 30 April 2014

Updated on 6 May 2014 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
  • 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

Savlon Antiseptic Cream – SPC Changes – 14 April 2014

 

Section 4.3

“Keep out of the eyes and ears.” replaced with ‘Hypersensitivity to chlorhexidine, cetrimide or to any of the excipient listed in section 6.1.”

 

Section 4.4

Added:

“Avoid contact with the eyes, ears, mouth or other muscose.”

 

“If accidentally splashed into the eye, the open eye should be irrigated for at least 10 minutes.”

 

“Savlon cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).”

 

Section 4.5

Replaced text with “No interaction studies have been performed with the topical forms.”

 

Section 4.6

Added subheadings “Breastfeeding” & “Fertility”

 

Replaced text with individual sections on pregnancy, breastfeeding and fertility.

 

Section 4.7

Replaced text with “Savlon has no influence on the ability to drive and use machines.”

 

Section 4.8

Replaced text with details of adverse drug reactions for the immune system, skin and subcutaneous tissue disorders and paediatric population.

 

Section 4.9

Added: “While accidental ingestion is unlikely to cause any systemic effects due to poor absorption of chlorhexidine or cetrimide, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed.”

 

“In case of overdose, seek medical attention or contact a poison control centre.”

 

Section 5.1

Added: “Chlorhexidine, combination – Pharmacotherapeutic group: Antiseptics and disinfectants, ATC Code: D08AC52.”

 

Section 5.2

Replaced text with “Clorhexidine and cetrimide are poorly absorbed from the gastro-intestinal tract and skin.”

 

Section 5.3

Replaced text with: “There is minimal systemic absorption of chlorhexidine and cetrimide following topical administration. Preclinical safety data do not show genotoxic risk for chlorhexidine. Reproductive studies with chlorhexidine gluconate in animals have not revealed any teratogenic potential or risk to the foetus. No additional information is available for cetrimide.”

 

Section 7

Change of the address to: “Trading as Novartis Consumer Health, Park View, Riverside Way

Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.

 

 

Section 10

Date of revision of the text changed from “30 July 2013” to “14 April 2014.”

 

Updated on 12 August 2013 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 6.1
Disodium edetate was added.

Updated on 23 November 2011 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 6.4

30 changed to 25.

 

 

Section 6.6

Deletion of words ‘of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’ after the words ‘Special precautions for disposal’.

 

 

Section 7

Addition of words ‘UK’.

 

 

Section 10

Change of date from September 2010 to 17 November 2011.

Updated on 7 October 2010 SmPC

Reasons for updating

  • 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 7 - Marketing authorisation holder
  • 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 6.5

Deletion of Polyethylene/aluminium/polyethylene laminate tube with screw cap.

Addition of Polyethylene/aluminium/polyethylene laminate tube with a multi-layer peel off tamper evident seal composed of lacquer, aluminium and internal ionomer, closed screw cap.

 

 

Section 6.6

Heading changed from Special precautions for disposal to Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

 

Section 7

Heading changed from Marketing Authorisation Holder to Name or style and permanent address or registered place of business of the holder of the marketing authorisation

 

UK deleted from the end of the address

 

 

Section 10

Date changed from 23 January 2009 to September 2010

Updated on 14 August 2009 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Section 2

Excipients listed which replaces ‘For excipients, see Section 6.1.

Section  3

Addition of : ‘Smooth, white, homogeneous cream with an antiseptic odour’.

Section  6.1

Addition of E numbers  to list of excipients:

Methyl parhydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216).

Section  6.4

‘Do not store above 30°C’ replaces ‘None’.

Section  6.5

Addition of ‘Not all pack sizes may be marketed’.

Section  9

Last renewal date changed from 26 June 2001 to 26 June 2006.

Section  10

Date of revision changed from 16 June 2008 to 23 January 2009.

 

NB delay in resolving a correction issue with IMB resulted in delay in loading onto medicines.ie.

Updated on 7 July 2008 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 Shelf life changed from 3 years to 24 months

 

Section 10 Date of revision changed from June 2006 to June 2008

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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