Artelac, SDU, Eye drops solution

Product Information *

  • Company:

    Bausch Health Ireland Ltd.
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 04 May 2020

File name

leaflet clean_1588596046.pdf

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 04 May 2020

File name

spc clean_1588595553.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:Supply through pharmacy only

Updated on 22 June 2016

Reasons for updating

  • Change to date of revision
  • Change to packaging
  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to how the medicine works
  • Change to further information section

Updated on 22 June 2016

File name

PIL_15482_252.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 October 2015

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The implementation of the recommended text by the CHMP regarding risk or corneal calcification (SmPC section 4.8 –very rare 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 and  in PIL section 4 In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.) for  phosphate containing eye drops. Additional QRD update done.

Updated on 15 October 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 31 August 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 July 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided