Mucodyne 375mg Capsules- Discontinued *

  • Company:

    Ipsen Pharmaceuticals Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 16 July 2020

File name

170602A ie-spc-clean-11_MUC375_1594910686.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Data correction to sections 5.2 and 5.3 of SmPC

Updated on 03 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 03 January 2018

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change of MAH from Sanofi Ireland to Ipsen Pharmaceuticals Ltd approved in June 2017. SPC added in December 2017 in line with first delivery of Ipsen labelled product.

Updated on 20 December 2017

File name

PIL_8386_910.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 December 2017

Reasons for updating

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

Updated on 25 February 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

.

Updated on 18 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 15 February 2016

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Name change

Updated on 12 February 2016

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 02 October 2015

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

 Side effects include;

Gastrointestinal disorders

 nausea, headache, gastrointestinal upset, vomiting,

 

Nervous system disorders

Headache

 

Skin and subcutaneous tissue disorders

Aallergic skin reactions and anaphylactic reactions, fixed drug eruption.

 

Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme.

 

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 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Updated on 01 September 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8             Undesirable effects

 

(additional sideeffects) Side effects include;

Gastrointestinal disorders
vomiting,

Nervous system disorders
Headache 
 
Skin and subcutaneous tissue disorders

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 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie 



Section 6:

Date leaflet was last revised.

 

Updated on 27 August 2015

Reasons for updating

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

Updated on 28 January 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 21 May 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8 updated to include 'Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme.'

Updated on 20 September 2012

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 updated to include 'T/A SANOFI'

Updated on 08 July 2009

Reasons for updating

  • Change to improve clarity and readability

Updated on 20 May 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 08 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Section
4.8 - additional undesirable effect
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 06 April 2005

Reasons for updating

  • Improved electronic presentation

Updated on 30 March 2005

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 31 July 2003

Reasons for updating

  • 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 be renewed (B)

Updated on 17 June 2003

Reasons for updating

  • New SPC for medicines.ie

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