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Emulsiderm Emollient Bath Additive/Cutaneous Emulsion

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Pharmacy Only: Non-prescription
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Updated on 29 August 2024

File name

HPRA EMDX -PIL.RP19-24-1.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Initial wording if possible to revise before section 1

Section 2, title"What you need to know before you use Emulsiderm Emollient"

Pregnancy and breast-feeding - revised wording

Section 4, reporting of side effects replace with Via the HPRA Pharmacovigilance website WWW.hpra.ie

Section 6 - Title amend to" Contents of the pack and other information"

Marketing authorisation, delete UK

last revised May 2024


Updated on 29 August 2024

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.6 Fertility, pregnancy and lactation (please add Fertility to title as a change)

 

Additional text added as noted in red:

 

“Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal. When breastfeeding, patients should note that if use on the breast and nipple area is necessary, the product should be applied sparingly and after feeds. Any remaining product should be gently wiped away before breast-feeding in order to avoid exposure by the infant to benzalkonium chloride during breast-feeding.

 

 

In Section 10 Date of revision of the text:

 

The date has changed to:

“August 2024”

Updated on 13 May 2024

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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 3 Pharmaceutical form to change product colour: the following text has been amended:

“ White oil-in water emulsion”

 

In Section 6.1 revision to List of excipients the following text has been deleted

 

To remove the excipient methylene blue (methylthionium chloride)

 

 In Section 10,  Date of revision of the text:

 The date has changed to:

May 2024

Updated on 13 May 2024

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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

3.1 Product colour change

6.1 remove excipient mythylene blue

10.0 date change

Updated on 10 May 2024

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 3 Pharmaceutical form to change product colour: the following text has been amended:

“ White oil-in water emulsion”

 

In Section 6.1 revision to List of excipients the following text has been deleted

 

To remove the excipient methylene blue (methylthionium chloride)

 

 

In Section 10,  Date of revision of the text:

 

The date has changed to:

May 2024

Updated on 18 March 2024

File name

EMDX-IPHA.PIL.RP16-23-2 Apk.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 18 March 2024

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 4.6 Fertility, pregnancy and lactation

 

The text “No known side effects” has been removed and the text below added:

 

“Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal. When breast-feeding, if use on the nipples is necessary, apply sparingly and after feeds. Genty wipe away any remaining product before feeding your baby.”

 

In Section 4.8 Undesirable effects – ADR reporting, Address details, telephone contact and email removed,

 

Via HPRA Pharmacovigilance. Website: ww.hpra.ie

 

 

In Section 10,  Date of revision of the text:

 

The date has changed to:

March 2024

Updated on 23 January 2023

File name

EMDX-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Updated on 17 December 2020

File name

EMDX-IPHA.SPC.pdf

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:Supply through pharmacy only

Updated on 08 June 2020

File name

EMDX-IPHA.PIL.RP16-20-1 Apk.pdf

Reasons for updating

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

Updated on 25 November 2019

File name

EMDX-IPHA.PIL.RP16-19-1.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

In section 2 Before you use Emulsiderm Emollient, the following text has been added under Warnings and precautions, "Do not smoke or go near naked flames - risk of severe burns.  Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.  Washing clothing and bedding may reduce product build-up but not totally remove it."

In section 6 Further Information, the date the leaflet was last revised has changed to "May 2019"

Updated on 25 November 2019

File name

EMDX-IPHA.SPC.pdf

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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 Special warnings and precautions for use, the following text has been added "Instruct patients not to smoke or go near naked flames - risk of severe burns.  Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.  Washing clothing and bedding may reduce product build-up but not totally remove it."

In section 10 Date of revision of the text, the date has changed to "November 2019"

Updated on 31 August 2018

File name

EMDX-IPHA.SPC.04.08.15.06.08.15.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 13 February 2018

File name

PIL_14293_66.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 February 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 28 April 2017

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 06 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 06 August 2015

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, in the HPRA address "IRL - Dublin" has been updated to "IRL - Dublin 2"

Updated on 22 April 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 10 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "February 2015"

Updated on 01 September 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 01 October 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 22 July 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 (Undesirable effects) the following text has been added: "Although the emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.  These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic/hypersensitive in nature.  Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area."

In section 10 (Date of revision of the text) the date has changed to: "June 2009"

Updated on 29 May 2009

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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 1 (Name of the medicinal product) : the name has changed from "Emulsiderm Emollient" to "Emulsiderm Emollient Bath Additive/Cutaneous Solution"

In section 9 (Renewal of the Authorisation) : the date has changed to "21 February 2009"

In section 10 (Date of revision of the text) : the date has changed to "April 2009"

Updated on 29 May 2009

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 August 2007

Reasons for updating

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

Section 4.4 - Special warnings and precautions for use: Text has changed from 'Keep out of the reach of children' to 'Keep out of the reach and sight of children'
 
Section 6.5 - Nature and contents of container: The text 'These are supplied as original packs (OP)' has been removed.

Updated on 28 April 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Product Notice

Safety Notice

Section 3, Change to product colour

Safety Notice

section 6.1 to remove excipient methylene blue

Safety Notice

10.0 revised date