Minims Phenylephrine Hydrochloride 2.5%, Eye drops solution
*Company:
Bausch + Lomb Ireland Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 July 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:Product subject to medical prescription which may be renewed (B)
Updated on 15 July 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 10 June 2021
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- 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
Edittorial changes and updates for the 10% strength not authorised in Ireland.
Updated on 05 June 2020
File name
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:Product subject to medical prescription which may be renewed (B)
Updated on 05 June 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 03 February 2020
File name
PIL_12388_149.pdf
Reasons for updating
- New PIL for new product
Updated on 08 August 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 20 June 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 June 2016
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 April 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 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
Updated on 29 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 July 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 30 August 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 July 2012
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
All SPCs on Medicines.ie have been updated for Bausch + Lomb following personnel changes to ensure accuracy of information.
Updated on 24 July 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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
Section 9 and 10 : update of renewal and revision dates
Updated on 27 August 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 04 September 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
Section 1: TRADE NAME OF THE MEDICINAL PRODUCT
Changed to Minims Phenylephrine Hydrochloride 2.5% Eye Drops, Solution
Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Changed to Phenylephrine Hydrochloride 2.5% w/v. Each ml contains 25mg phenylephrine hydrochloride.
For full list of excipients, see section 6.1
Section 3. PHARMACEUTICAL FORM
Section 6.4. Special Precautions for Storage
Changed to July 2006
Updated on 18 May 2005
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)