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Opatanol 1mg/ml eye drops solution

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Pharmacy Only: Prescription

Updated on 01 July 2024

File name

Opatanol REG PIL L671252 02_R89_LFT_Removal of UK(NI) June 2024.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Removal of side effect reporting and local representative details for UK(NI)

Updated on 08 September 2022

File name

Opatanol_REG SPC_PF21-0157_23.08.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 20 October 2021

File name

Opatanol_REG PIL_PF21-0142_05.10.2021_clean_TBI 02 July 2022.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to MA holder contact details

Updated on 06 October 2021

File name

Opatanol REG PIL PF20-0259 november 2020 TBI 31 March 2021_format corrections 06.10.2021.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 August 2021

File name

Opatanol REG PIL PF20-0259 november 2020 TBI 31 March 2021.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Error message when opening previous PIL. 

Updated on 24 November 2020

File name

Opatanol REG PIL PF20-0259 november 2020 TBI 31 March 2021.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 24 November 2020

File name

Opatanol REG PIL PF20-0259 november 2020 TBI 31 March 2021.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 24 November 2020

File name

Opatanol REG SmPClean PF 20-0259 November 2020.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Updated on 12 October 2020

File name

Opatanol REG PIL 450057 clean site change PF 20 -0079 IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 December 2019

File name

Opatanol REG PIL 450057 TBI 08-02-2019 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 April 2019

File name

IPHA_450057_R92_p1_LFT_X-4.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 08 April 2019

File name

Opatanol-SmPC_EN-clean_IPHA.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 25 March 2019

File name

IPHA431205_R92_p1_LFT_TBI jan 2019.pdf

Reasons for updating

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

Updated on 25 May 2018

File name

Opatanol-SmPC_EN-clean.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 07 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 07 June 2017

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

- Update to SPC following approval of transfer of MAH from Alcon to Novartis.

Updated on 06 June 2017

File name

PIL_8946_369.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 June 2017

Reasons for updating

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

Updated on 15 April 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

- Update to ADR reporting information.

Updated on 13 April 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 03 February 2014

Reasons for updating

  • Improved electronic presentation

Updated on 17 January 2014

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 11 November 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • 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 1: Minor amendment to text "ml" to "mL"
  • Section 2: Minor amendment to text "ml" to "mL" and addition of "with known side effects"
  • Section 4.2: Revisied method of and added additional use in peadriatric population
  • Section 4.3: Minor amendment to text added "listed in section 6.1."
  • Section 4.4: Revised information on Benzalkonium chloride
  • Section 4.5: Minor amendment to text added "with other medicinal products"
  • Section 4.6: Revised existing pregnancy and lactation information with new info. Added Fertility information
  • Section 4.7: Added "Opatanol has no or negligible influence on the ability to drive and use machines."
  • Section 4.8: "Undesirable effects" changed to "adverse reactions" throughout. Adverse reactions converted into tabulated format. Added "Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas." Added national information on Reporting of suspected adverse reactions
  • Section 5.2: Added headiungs "Absorption" and "Elimination"
  • Section 5.3: Added "Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use. Olopatadine has been detected in the milk of nursing rats following oral administration."
  • Section 6.2: Added "In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products."
  • Section 6.3: Added heading "Shelf-life after first opening"
  • Section 9: Minor amendment to text "last" to "latest"
  • Section 10: Updated revision date

Updated on 08 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 14 August 2013

Reasons for updating

  • Improved electronic presentation

Updated on 16 July 2013

Reasons for updating

  • Change to MA holder contact details

Updated on 31 May 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH address update

Updated on 29 May 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 November 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 07 June 2011

Reasons for updating

  • 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

Date of revision of the text has been included. This was missing from previous version of the SPC.

Updated on 19 January 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 2 - Whole section amended

Section 3 - Whole section amended

Section 4.2 - 'Use in children and adolescents' paragraph removed, replaced with 'Paediatric patients'

Section 4.3 - Whole section amended

Section 4.5 - 'No clinical interaction studies were performed with Opatanol' has been changed to 'No interaction studies have been performed'

Section 4.8 - Whole section amended

Section 5.3 - The word 'preclinical' has been changed to 'Non-clinical'

Section 6.2 - 'None known' has been changed to 'Not applicable'

Section 6.4 - Whole section amended

Section 6.5 - Whole section amended

Section 9 - Date of last renewal added

Section 10 - Date added

Updated on 13 August 2007

Reasons for updating

  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

 
   4.3 Updates to section

Updated on 13 August 2007

Reasons for updating

  • Change of contraindications

Updated on 18 May 2005

Reasons for updating

  • Change to further information section

Updated on 29 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

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