Mydrilate 0.5% w/v Eye Drops

  • Name:

    Mydrilate 0.5% w/v Eye Drops

  • Company:
    info
  • Active Ingredients:

    Cyclopentolate Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/01/20

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Summary of Product Characteristics last updated on medicines.ie: 1/1/2020

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Intrapharm Laboratories Limited

Intrapharm Laboratories Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Lactulose 10 g / 15 ml Oral Solution Sachets Active Ingredients Lactulose
Medicine Name Mydrilate 0.5% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Mydrilate 1.0% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray Active Ingredients Glyceryl Trinitrate
Medicine Name Prialt solution for infusion Active Ingredients Ziconotide acetate
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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 1 January 2020

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

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 1 January 2020 PIL

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 PIL

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

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

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 PIL

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 5 June 2018

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 5 June 2018 PIL

Reasons for updating

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

Updated on 4 April 2018 SPC

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 4 April 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 29 December 2017 SPC

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 29 December 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 28 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 December 2017 PIL

Reasons for updating

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

Updated on 9 August 2015 SPC

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 5 August 2015 PIL

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 SPC

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 8 November 2013 PIL

Reasons for updating

  • New PIL for new product