Xalacom eye drops, solution
*Company:
Upjohn EESVStatus:
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 06 November 2023
File name
Patient Information Leaflet - IE - Xalacom.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 November 2023
File name
Patient Information Leaflet - IE - Xalacom.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 July 2023
File name
Patient Information Leaflet - IE - Xalacom.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 09 June 2022
File name
DEC202206682-V_Reg SPC XM 22_1 IE - clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.8 Undesirable effects – Addition of gastrointestinal disorders: nausea and vomiting
Updated on 09 June 2022
File name
DEC202206682-V_Reg PIL XM 18_1 IE - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 May 2021
File name
DEC202106339-V_Reg SPC XM 21_0 IE Clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 May 2021
File name
DEC202106339-V_Reg PIL XM 17_0 IE 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 05 June 2020
File name
DEC202037137_Reg SPC XM 20_1 IE Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2020
File name
DEC202037137_Reg PIL XM 16_1 IE Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 April 2020
File name
DEC202025520_Reg SPC XM 19_1 Clean IE.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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SPC: Section 6.3 is updated to increase the shelf life to 36 months.
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Updated on 21 April 2020
File name
DEC202025520_Reg SPC XM 19_1 Clean IE .pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details. |
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SPC: Section 6.3 is updated to increase the shelf life to 36 months. |
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Updated on 26 September 2018
File name
Reg SPC XM 17_2 IE Clean.pdf
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 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
SPC: update includes revisions to various sections of the product information in alignment with the current Quality Review of Documents (QRD) template including Falsified Medicines Directive (FMD) update and to incorporate recommendations from the Excipients Guidance (SANTE-2017-11668; EMA/CHMP/302620/2017 dated 9th October 2017).
Updated on 25 September 2018
File name
Reg PIL XM 15_2 IE Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 August 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The proposed update includes additions and/or revisions to Section 4.4 Special warnings and precautions for use and Section 4.8 Undesirable effects. In Section 4.8, 4 new Adverse Drug Reactions (ADRs) are proposed for addition (Angina, Eyelid oedema, Localized skin reaction on the eyelids and Pseudopemphigoid of the ocular conjunctiva). Additionally, some ADR terms have been revised to match the MedDRA version 18.1 hierarchy. These updates are intended to provide clarification regarding adverse reactions potentially observed with the use of latanoprost/timolol maleate.
Updated on 03 August 2017
File name
PIL_8801_121.pdf
Reasons for updating
- New PIL for new product
Updated on 03 August 2017
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 June 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
· Update to sections 2, 4.2, 4.3, 4.4, 4.5, 4.6 and section 6.5 to be compliant with the most recent QRD template (v9)
· Inclusion of “Reporting of suspected adverse reactions” (section 4.8)
· Correct other minor editorial discrepancies.
Updated on 18 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 18 November 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 September 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
“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.”
Updated on 18 September 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 September 2012
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Section 4.6 has been updated with the information regarding Fertility, section 4.8 updated with the addition of Ocular side effects, section 10 has been updated with date of revision of text.
Updated on 03 September 2012
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Improved electronic presentation
Updated on 01 June 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 8 Change to marketing authorisation number from PA 936/10/01 to PA 822/139/1
Updated on 30 May 2012
Reasons for updating
- Change to marketing authorisation holder
Updated on 26 January 2012
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- Change to section 4.3 - Contraindications
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 January 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 January 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 24 October 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 20 October 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 03 August 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 August 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 27 April 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 November 2010
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 November 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 November 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 July 2010
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
Update Section 4.4 of the SPC - Strengthen the existing language around patients with cardiovascular disease
Updated on 22 December 2009
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
Updated on 17 November 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 14 November 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Section 7 Change in the MAH address in Ireland
Updated on 29 November 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
- Change to side-effects
Updated on 26 November 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- XM_003
Section 4.2 & 4.4 - Update to contact lens wording for consistency with Xalatan label (MHRA request at renewal)
- XM_004
Section 4.8 - Removal of ADRs (SLE & Peyronie's disease) for timolol
(BfArM request at renewal)
- XM_005
Section 4.8 - Add palpitations as ADR for latanoprost
Updated on 26 September 2007
Reasons for updating
- Improved electronic presentation
- Change of contraindications
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 25 September 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2 – Reformatting
3 – Reformatting
4.3 – Reformatting
4.4 – Rewording of the warning concerning Beta-blockers and hypoglycaemia.
4.5 – Interactions with concomitant ophthalmic administrations of two prostaglandin analogues. Also interactions concerning concomitant treatment with oral beta-adrenergic blocking agent.
4.7 – Wording inserted that patients should not drive or use machines due to transient blurring of vision.
4.8 – Includes new adverse events.
6.4 – Reformatting.
Updated on 11 November 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 November 2005
Reasons for updating
- Change to dosage and administration
- Change to date of revision
Updated on 02 August 2005
Reasons for updating
- Change of manufacturer
- Change to side-effects
- Change to date of revision
Updated on 20 July 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 30 April 2004
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 April 2004
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)