Epiduo 0.1%/2.5% Gel *

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 27 August 2021

File name

ie-spc-clean_1630078633.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

​​​​​​4.4 Special warnings and precautions for use

This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4 %w/w, it may cause skin irritation.

This product contains propylene glycol (E1520) that may cause skin irritation.

4.8 Undesirable effects

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 directly via HPRA Pharmacovigilance, Website: www.hpra.ievia HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

10. DATE OF REVISION OF THE TEXT

August 2021

Updated on 27 August 2021

File name

(022609) P24569-13 EPIDUO GEL LEAFLET_1630078407.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

2. What you need to know before you use Epiduo

Epiduo contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4 %w/w, it may cause skin irritation.

 

Reporting of side effects

directly via HPRA Pharmacovigilance, Website: www.hpra.ie

 

This leaflet was last revised in April 2021

Updated on 14 July 2020

File name

ie-mockup-pil_1594723225.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 14 July 2020

File name

ie-spc-clean_1594722835.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 November 2018

File name

PLTASCP24569-6(4)+vCertification+1.0_1542188575.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 November 2018

File name

Epiduo IRE SPC V4_1541418199.pdf

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 be renewed (B)

Updated on 15 June 2018

File name

Epiduo 45g PIL UK & IRE (P24569-9) eMC.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 06 June 2018

File name

Epiduo_IRE__SPC_.docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 June 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Updated on 21 February 2018

File name

PIL_17316_268.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 February 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 02 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 February 2018

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 2: (E1520; 4.00%) has been added after 'excipient with known effect: propylene glycol'. This now reads: 'Excipient with known effect: Propylene glycol (E1520; 4.00%)
  • Section 4.1: The following has been added: Epiduo is indicated in adults, adolescents and children aged 9 years and over.
  • Section 4.5: Minor rewording. 'No interaction studies have been performed conducted with Epiduo.
  • Section 4.8: Minor rewording of table headings and the addition of '(cannot be estimated from the available data)*' to the frequency column for Eye disorders; Respiratory, thoracic and mediastinal disorders; and skin and subcutaneous disorders.
  • Section 5.1: Pharmacotherapeutic group changed. 'D10A' has been removed, and 'D10AD Retinoids for topical use in acne' has been added. Also a minor spelling change 'forth' to 'fourth'.
  • Section 6.1: Change of 'glycerin' to 'glycerol'
  • Section 10: Change of date to January 2018.

Updated on 29 September 2017

Reasons for updating

  • New PIL for new product

Updated on 29 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided