Artelac, Eye drops solution
*Company:
Bausch + Lomb Ireland Ltd.Status:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 October 2023
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Updated on 23 March 2022
File name
ie-spc-clean.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 23 March 2022
File name
ie-pil-clean.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 20 January 2022
File name
ie-spc-artelac-eye-drops-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Supply through pharmacy only
Updated on 20 January 2022
File name
ie-pil-artelac-eye-drops-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 28 July 2020
File name
leaflet-clean.pdf
Reasons for updating
- XPIL Created
Updated on 04 May 2020
File name
leaflet-clean.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.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Updated on 22 June 2016
File name
PIL_15483_260.pdf
Reasons for updating
- New PIL for new product
Updated on 22 June 2016
Reasons for updating
- Change to, or new use for medicine
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 15 October 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 15 October 2015
Reasons for updating
- 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
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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 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