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Rythmodan Retard Tablets

  • Name:

    Rythmodan Retard Tablets

  • Company:
    info
  • Active Ingredients:

    disopyramide phosphate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 3/5/2017
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1 - 0 of 178 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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 3 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 May 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

 

  • Section 4.4 is updated with regard to glaucoma and paralytic ileus
  • Section 4.5 is updated to include the appropriate cross reference to section 4.4 & 4.8
  • Section 4.8 is updated to include adverse event Agranulocytosis
  • Section 4.9 updated to include reference to paralytic ileus

Updated on 12 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 December 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 14 February 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 November 2012 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Audit activity update

Updated on 7 July 2011 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Improved presentation

Updated on 6 July 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 February 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

update to section 2 & 4.4 to include relevant information regarding the sucrose and glucose excipients

Updated on 19 January 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 August 2010 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

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

Free text change information supplied by the pharmaceutical company

Type II  to update SPC with regard to:

  • Sections  4.4 & 4.8 were updated with regard to cognitive disorders in the elderly
  • Section 4.6 was updated to be more consistent with the guideline on risk assessment of medicinal products on human reproduction and lactation.

Updated on 22 October 2009 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Update section 4.2, 4.3, 4.4, 4.5, 4.6, 4.8
Additional warnings on heart disease, renal impairment, arrhythmias 

Updated on 16 October 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 October 2009 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change to tablet description
pack size, contents of container (60 tablets)
shelf-life (18 months)

Updated on 31 August 2009 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Change to improve clarity and readability

Updated on 15 September 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 September 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 1 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 August 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 December 2006 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: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section
7 - Change MAH to sanofi-aventis Ireland Ltd.
8 - Change MA number
10 - Change Date of Revision of text

Updated on 14 August 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Update to Section -
 
1 - addition of pharmaceutical form to name.
2 & 3- administrative
4.5 - Addition of Phosphodiesterase Type 5 Inhibitors to Interactions.
 

Updated on 21 March 2006 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

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

Updated on 28 July 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 17 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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