Oilatum Shower Gel 70% w/w Gel

  • Name:

    Oilatum Shower Gel 70% w/w Gel

  • Company:
    info
  • Active Ingredients:

    Light Liquid Paraffin

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/16

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Summary of Product Characteristics last updated on medicines.ie: 10/7/2015
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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1 - 0 of 53 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 1 November 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 1 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 April 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 10 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 22 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 Addition of HPRA reporting statement

Updated on 21 May 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 July 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Correction to 4.4 following previous approval - removal of warning regarding hypersensitivity

Updated on 11 April 2014 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 'For cutaneous use only' added.  Addition of recommendation to use instead of soap.
Section 4.3 previously none stated
Section 4.4 Warning re: sensitivity added
Section 4.6 Reformatted into seperate sections on fertility, pregnancy and lactation
Section 4.8 Previously none stated
Section 4.8 Previously n/a
Section 6.1 617A removed from polyethylene.  Correction of typo in sorbitol

Updated on 10 April 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 January 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 7 - GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland Trading as Steifel was changed to GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland

In section 8 - PA 1077/125/002 was changed to PA 678/113/003

Updated on 18 April 2012 PIL

Reasons for updating

  • Change of manufacturer

Updated on 16 March 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The new SPC includes changes to section ‘6.5 Nature and Contents of Container’ where a new pack size range of laminate tubes has been added as a result of product transfer from Sligo to Barnard Castle.

Updated on 3 November 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company


 


1.         NAME OF THE MEDICINAL PRODUCT

 

Oilatum Shower Gel 70% w/w Gel

4.1       Therapeutic Indications

 

Oilatum Shower Gel is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions.

 

4.2       Posology and Method of Administration

 

Oilatum Shower Gel may be used as frequently as necessary.  Oilatum Shower Gel should always be applied to wet skin, normally as a shower gel.

 

Shower as usual.  Apply Oilatum Shower Gel liberally to wet skin and massage gently.  Rinse briefly and lightly pat the skin dry.

4.4       Special Warnings and Precautions for Use

 

Use care to avoid slipping in the shower.  Oilatum Shower Gel should not be used on

4.6       Fertility, pregnancy and Lactation

 

There is no evidence to confirm the safety of Oilatum Shower Gel in human pregnancy and lactation; however, topical preparations containing light liquid paraffin have been in widespread use for many years without apparent ill effects.

Updated on 3 November 2011 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 19 August 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).

Updated on 15 August 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 7, the address of the Marketing Authorisation Holder has been changed.

In section10, the date of approval has been updated.

Updated on 29 October 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2
Change from 'Light Liquid Paraffin BP 70.00% w/w' to 'Each gram of gel contains 700mg light liquid paraffin equivalent to 70% w/w. For full list of excipients, see section 6.1.'
 
Section 3
From 'A Shower gel for topical application to wet skin' to 'Gel. White, translucent, oily gel with an odour of perfume'.
 
Section 6.1
Change of excipients
 
Section 6.2
From 'None' to 'Not applicable'
 
Section 6.3
From 'Three' to '3'
 
Section 6.4
From 'Do not store above 25degreesC' to 'Store below 25degreesC'

Section 6.5
Addition of 'Not all pack sizes may be marketed'
 
Section 6.6
From 'There are no special instructions for use or handling of Oilatum Gel' to 'No special requirements'
 
Section 9
Change of date
 
Section 10
Addition of date

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition - format updated to Light Liquid Paraffin BP 70.00% w/w
 
Section 4.6 Pregnancy and lactation - wording updated to say 'ill effects' not 'ill consequence'.
 
Section 7 Address of MA holder is UK, not England.

Updated on 16 August 2005 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only