Lotemax 0.5% Eye Drops, Suspension
*Company:
Bausch + Lomb Ireland Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 April 2021
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 January 2021
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2021
File name
ie-pil-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 06 May 2020
File name
m1-3-1-common-spc-clean ie.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 March 2020
File name
ie-pl-lotemax-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 October 2017
File name
PIL_15479_762.pdf
Reasons for updating
- New PIL for new product
Updated on 09 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 October 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 October 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 August 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 March 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To update section 4.5 (interactions) of the SmPC in line with the PRAC recommendations on signals, adopted at the 24-27 October 2016 PRAC meeting (EMA/PRAC/700146/2016) concerning
interaction of cobicistat - containing products with corticosteroids leading to adrenal suppression for all corticosteroids other than beclomethasone (excluding cutaneous formulations). Consequently, the PIL is updated.
Updated on 15 March 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - 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 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 April 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"The use of steroids after cataract surgery may delay healing and inc ease the incidence of bleb formation".
Updated on 31 August 2012
Reasons for updating
- New PIL for medicines.ie
- PIL - Product no longer marketed in Ireland
Updated on 31 July 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)