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Xalatan 50 micrograms/ml eye drops solution

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Latanoprost

    *Additional information is available within the SPC or upon request to the company

Updated on 28 November 2023

File name

Patient Information Leaflet - IE - Xalatan.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 28 November 2023

File name

Patient Information Leaflet - IE - Xalatan.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 28 November 2023

File name

Patient Information Leaflet - IE - Xalatan.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 July 2023

File name

Patient Information Leaflet - IE - Xalatan - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 02 June 2022

File name

Reg SPC XN 28_0 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 vomitting

Updated on 02 June 2022

File name

DEC202205975-V_Reg PIL XN 38_0 IE - clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 May 2021

File name

DEC202106341-V_Reg PIL XN 37_0 BFS 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 25 May 2021

File name

DEC202106341-V_Reg SPC XN 27_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 10 November 2020

File name

Reg PIL XN 36_0 BFS IE Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 12 October 2018

File name

Reg PIL XN 35_2 BFS IE Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • 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 12 October 2018

File name

Reg SPC XN 26_1 IE Clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.5 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC:

Section 1, 2,4.1, 4.2, 4.5, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.4, 6.5, 6.6 - QRD and other minor editorial updates  for clarity to these section.

 

Section 4.4-Excipient update inline with Excipient Guidelines.

Updated on 12 October 2018

File name

Reg SPC XN 26_1 IE Clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.5 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC:

Section 1, 2,4.1, 4.2, 4.5, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.4, 6.5, 6.6 - QRD and other minor editorial updates  for clarity to these section.

 

Section 4.4-Excipient update inline with Excipient Guidelines.

 

Updated on 30 August 2018

File name

Reg SPC XN 25_0 IE Clean.pdf

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

SPC: Update to section 6.5 of SmPC to remove information relevant to Preformed bottle container.

Updated on 23 April 2018

File name

Reg_SPC_XN_25_0_IE_Clean.docx

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

Update to section 6.5 of SmPC to remove information relevant to Preformed bottle container.

Updated on 07 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 April 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

The SPC is updated in section 1, 2, 3, 4.2, 4.3, 4.6, 4.8, 5.1, 6.1, 6.2, 6.4, 6.6, 9, 10 editorial and QRD updates

Updated on 06 April 2017

File name

PIL_8802_400.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 April 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 05 April 2016

Reasons for updating

  • Change to side-effects

Updated on 05 November 2015

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, Update to include HPRA details for reporting side effects.

Updated on 05 November 2015

Reasons for updating

  • Change to side-effects

Updated on 28 September 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 5 - Pharmacological properties

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 1:            Product name updated to Xalatan 50 micrograms/ml eye drops solution.

Section 5:            Strength of the product from a % w/v representation of the strength to a mass per ml format.

Updated on 25 September 2015

Reasons for updating

  • Change to product name

Updated on 19 March 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 4.6:         Updated in line with QRD

Section 4.8:         Update to:

·         frequency of ADR of photophobia

·         revision of adverse drug reaction term “aggravation of angina in patients with pre-existing disease” to match preferred term (PT) as per Medical Dictionary for Regulatory Activities version 16.0”.

Updated on 14 March 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 27 August 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

Update to section 4.8 (Undesirable effects) of the SPC to bring in line with the agreed core safety profile following the assessment of the PSUR.  

Updated on 21 August 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 01 August 2013

Reasons for updating

  • Change to storage instructions

Updated on 24 July 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 6.3 has been updated to change the shelf life from 3 year to 2 year
section 6.4 has been updated in relation to change in storage condition to Room temperature

Updated on 02 January 2013

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 information/data for Fertility and
section 4.8 has been updated with the addition of few rare and vary rare ocular side effects, section 10 has been updated to reflect the approval date

Updated on 01 March 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

Change of MAH from Pharmacia Ireland to Pfizer Healthcare Ireland and change to marketing authorisation number from PA 936/41/1 to PA 822/140/1

Updated on 01 March 2012

Reasons for updating

  • Change to marketing authorisation holder

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

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 27 April 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

Changes to Sections 4.4 and 4.8.

Updated on 20 April 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 24 January 2011

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC: Changes to Sections 4.1, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2

Updated on 20 January 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 09 July 2010

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Changes to Sections 4.7 and 4.8

Updated on 08 July 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 17 September 2009

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Changes have been made to the SPC

 to reflect the new prefilled bottle that has been introduced and the reduced shelf life of 2 years for this new bottle.

There will be two different shelf lives on the SPC: 3 years for the existing BFS bottle (unchanged) and 2 years for the new prefilled bottle.

 

Updated on 17 February 2009

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder address
  • Change due to user-testing of patient information
  • Change to improve clarity and readability

Updated on 12 November 2008

Reasons for updating

  • Change to marketing authorisation holder address

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to Section 7: Change in the MAH address

Updated on 12 November 2008

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 07 December 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 – Information regarding the change in eye colour. May change eyelashes and vellus hair in treated eye or the surrounding area.

4.8 –  Update of the section to include new adverse events including palpitation.

Section 4.5. Interaction with other medicinal products and other forms of interaction

Update regarding concomitant ophthalmic administration of prostaglandin analogues or derivatives.

Updated on 07 December 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to drug interactions

Updated on 23 August 2007

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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1. Name of the Medicinal Product

Re-wording/update

Section 2. Qualitative and Quantitative Composition

Update

Section 3. Pharmaceutical Form

Update

Section 4.4: Special Warnings and precautions for use

-  Update on information wrt the use of Xalatan in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema

-  Update of information on asthma

Section 4.8. Undesirable effects

Reformatting

Section 6.1. List of Excipients

Re-wording

Section 6.4. Special Precautions for Storage

Re-wording

Updated on 14 November 2006

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision
  • Change to further information section

Updated on 11 October 2006

Reasons for updating

  • 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:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section 4.2 (Poslogy and method of administration): Instruction on use of contact lenses added.

Section 4.3 (Contraindications): Removal of contact lens contraindication

Section 4.4 (Warnings and precautions for use): benzalkonium chloride warning

Updated on 02 August 2005

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision

Updated on 12 July 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 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 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)