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Iopidine 1% Eye Drops Solution *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Apraclonidine Hydrochloride

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

Updated on 29 September 2021

File name

Iopidine 1 REGPIL PF 20-0091 clean_1632919083.pdf

Reasons for updating

  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 03 September 2020

File name

REG_SPC_iopidine1_PF18-0168clean_1599137560.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 May 2020

File name

Iopidine 1pc REG PIL PF 19-0250 IPHA_1589360995.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 02 March 2020

File name

Iopidine REG 1 % PIL PF 19-0250 IPHA_1583151236.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 20 January 2020

File name

Iopidine 1 pc REG PIL 431205 IPHA_1579530872.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 20 January 2020

File name

Iopidine 1% REG PIL 431205 IPHA_1579530714.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 20 November 2019

File name

REG_SPC_iopidine1_PF18-0168clean_1574263962.pdf

Reasons for updating

  • Other

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

Updated on 16 September 2019

File name

REG_SPC_iopidine1%_PF18-0168clean_1568621131.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 25 March 2019

File name

IPHA431205_R92_p1_LFT_TBI jan 2019_1553525157.pdf

Reasons for updating

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

Updated on 06 September 2018

File name

REG_SPC_iopidine1%_PF8-0168clean_1536231052.pdf

Reasons for updating

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

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

Updated on 11 July 2018

File name

REG_SPC_iopidine1per_PF8-0168clean.docx

Reasons for updating

  • Addition of marketing authorisation holder

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

Updated on 09 July 2018

File name

REG_SPC_Iopidine_1p_PF18_0168_clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 09 July 2018

File name

REG_SPC_Iopidine 1%_PF18-0168_clean.docx

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

File name

SPCIopidine1EyeDropsSolutionV2.docx

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 07 June 2018

File name

Iopidine_Eye_Drops_Solution.pdf

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

Reasons for updating

  • New SPC for new product

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

Updated on 30 May 2017

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 18 May 2017

File name

PIL_12307_655.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 May 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

Updated on 07 July 2016

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 06 July 2016

Reasons for updating

  • Change to name of manufacturer

Updated on 13 May 2014

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 02 May 2014

Reasons for updating

  • Change to MA holder contact details

Updated on 18 December 2012

Reasons for updating

  • Improved electronic presentation

Updated on 13 August 2010

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

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 13 August 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 June 2003

Reasons for updating

  • New SPC for medicines.ie

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