Oilatum Cream

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/11/16

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Summary of Product Characteristics last updated on medicines.ie: 7/11/2016
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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Medicine Name Oilatum Cream Active Ingredients Light Liquid Paraffin, White Soft Paraffin
Medicine Name Oilatum Emollient 63.4% w/w Bath Additive Active Ingredients Light Liquid Paraffin
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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 7 November 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 7 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 7 November 2016 SmPC

Reasons for updating

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

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Error in Section 10 corrected

Updated on 7 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 October 2015 SmPC

Reasons for updating

  • Change to MA holder contact details

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

The Irish Office has relocated;

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 general sale

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 PIL

Reasons for updating

  • Change of licence holder

Updated on 17 September 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4 - addition of the following text:
Oilatum Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin or to any of the excipients in the preparation.

Section 4.6 -current content replaced with the following text:

Fertility

There are no data on the use of topical Oilatum Cream on human fertility.

 

Pregnancy

There are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to white soft paraffin-light liquid paraffin is low.

 

Lactation

It is not known if Oilatum Cream is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low.

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breastfeeding.

Section 4.8 - addition of the following text:

Adverse drug reactions (ADRs) are listed below by MedDRA system organ and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

 

Post-marketing data

Skin and subcutaneous tissue disorders
Rare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation.      

 

Immune system disorders

Rare: Application site hypersensitivity reactions including application site dermatitis.


Section 4.9 - current content replaced with the following text: 
 

Symptoms and signs

The product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Excessive topical application should cause no untoward effects other than greasy skin.

 

Treatment

In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.

 

Updated on 31 January 2013 SmPC

Reasons for updating

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

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

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

In section 8 - PA 1077/124/1 is changed to PA 678/112/001

In section 10 - January 2012 is changed to January 2013

Updated on 22 May 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Additional pack sizes to section 6.5

Updated on 18 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 general sale

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 19 November 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 general sale

Free text change information supplied by the pharmaceutical company

Section 7: Change to the address of the MAH

Section 10: date updated.

Updated on 17 August 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through general sale

Updated on 16 August 2005 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale