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Iopidine 1% Eye Drops Solution

  • Name:

    Iopidine 1% Eye Drops Solution

  • Company:
    info
  • Active Ingredients:

    Apraclonidine Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/05/20

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2020

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Novartis Ireland Limited

Novartis Ireland Limited

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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 3 September 2020

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 May 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 2 March 2020 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 20 January 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 20 January 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 20 November 2019

Reasons for updating

  • Other

Updated on 16 September 2019

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 March 2019 PIL

Reasons for updating

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

Updated on 6 September 2018

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

Updated on 11 July 2018

Reasons for updating

  • Addition of marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 July 2018

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 July 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

MAH Transfer

Updated on 11 June 2018

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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated safety information

Updated on 7 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents

Updated on 30 May 2017 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Updated to sections 7,8 and 10 following approval of change of ownership from Alcon to Novartis.

Updated on 30 May 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 May 2017 PIL

Reasons for updating

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

Updated on 18 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 July 2016 SPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated with ''reporting of side effects''.

Updated on 6 July 2016 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 13 May 2014 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Change of MAH address and date of revision

Updated on 2 May 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 18 December 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 August 2010 SPC

Reasons for updating

  • 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
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5 - 'The risk of clinically relevant interactions appears low considering the plasma levels of apraclonidine given by the ocular route.' and 'caution is advised in patients taking tricyclic antidepressants which can affect metabolism and uptake of circulating amines' has been added.

Section 4.6 - Section amended to include there is no adequate data from the use of Iopidine in pregnant women, and caution should  be exercised when Iopidine is administered to nursing women.

Section 4.8 - Section updated to MEDRA coding.

Section 4.9 - Information on overdosage in a 2month old child has been added.

Section 6.1 - 'Preservative Free' removed.

Section 6.4 - 'In order to protect from light' removed.

Section 6.5 - Additional pack sizes included.

Section 10 - Date of revision changed to July 2006.

Updated on 12 August 2010 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 13 August 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)