Artelac, SDU, Eye drops solution
- Name:
Artelac, SDU, Eye drops solution
- Company:
Bausch Health Ireland Ltd.
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/20

Summary of Product Characteristics last updated on medicines.ie: 4/5/2020
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Bausch Health Ireland Ltd.

Company Products
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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 4 May 2020 PIL
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 4 May 2020 SPC
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 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 15 October 2015 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 31 August 2012 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 30 July 2012 SPC
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