Mydrilate 0.5% w/v Eye Drops *

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 11 December 2020

File name

20201203-ie-mockup-leaflet_1607645149.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

On 3Dec2020 HPRA approved a Type IB variation to update the Mydrilate SmPCs and package leaflet according to QRD and excipient guidelines, and also align the leaflet with that for the corresponding Mydrilate products in the UK.

Of note, the leaflet changes include addition of a side effect description for the ADR ‘partial seizures’, which was not covered in the previous version.

Also, although submitted and approved very recently, HPRA has accepted June 2020 as date of leaflet revision, which aligns with the date on the UK leaflet.

Updated on 10 December 2020

File name

20201203-ie-spc-mydrilate-0-5pc_1607644632.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

On 3Dec2020 HPRA approved a Type IB variation to update the Mydrilate SmPCs and package leaflet according to QRD and excipient guidelines, and also align the leaflet with that for the corresponding Mydrilate products in the UK.

Of note, the leaflet changes include addition of a side effect description for the ADR ‘partial seizures’, which was not covered in the previous version.

Also, although submitted and approved very recently, HPRA has accepted June 2020 as date of leaflet revision, which aligns with the date on the UK leaflet.

Updated on 01 January 2020

File name

20191217-mydrilate-0-5-spc-clean_1577901221.pdf

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

SmPC updated in section 4 to reflect Type II safety variation approved 17Dec2019 by HPRA.

Updated on 01 January 2020

File name

20191211-mydrilate-pil-uk-ie-mockup-approved-hpra-20191217_1577900702.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL updated in section 4 to reflect Type II safety variation approved 17Dec2019 by HPRA.

Updated on 21 October 2019

File name

Mydrilate-ie-mockup-1-05-10-PIL_1571693901.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Irish MA transferred to RIEMSER Pharma GmbH on 12Apr2019.

Updated on 21 October 2019

File name

Mydrilate-ie-spc-05 - 20190412_1571693544.pdf

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

Irish MA transferred to RIEMSER Pharma GmbH on 12th April 2019.

Updated on 31 July 2018

File name

ie-mockup-leaflet_1532990279.pdf

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 05 June 2018

File name

20180500-mydrilate-0-5-spc-ireland.docx

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

SmPC updated to reflect HPRA approval issued 17May2018 for the grouped Type IB national variation to re-align the shelf life after opening and the storage recommendations in Ireland with those approved in the UK.

Scope:

1) To reduce the shelf-life after first opening from 30 days to 28 days (ref. SmPC section 6.3).

2) To revise the storage conditions in order to provide greater clarity (ref. SmPC section 6.4).

Consequential changes made to the cartons, labelling and leaflet (ref. PIL section 5. How to store Mydrilate Eye Drops).

Updated on 05 June 2018

File name

20180425-mydrilate-pil-ie-text-clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 04 April 2018

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

In SmPC section 4.2 'Paediatric poulation' has been corrected to '...population'.

Updated on 04 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 29 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 29 December 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Irish SmPC, labelling and PIL amended to reflect Type IB national variation (HPRA approved 20Dec2017) to register in-use storage instructions and a change to the registered in-use shelf-life from 28 to 30 days.

Updated on 28 December 2017

File name

PIL_15880_806.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 December 2017

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 09 August 2015

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

SmPC revisions reflect 29May2015 HPRA approval for Type II safety variation (n.b. PIL also impacted).

Updated on 05 August 2015

Reasons for updating

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

Updated on 12 November 2013

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 08 November 2013

Reasons for updating

  • New PIL for new product