Xalatan 50 micrograms/ml eye drops solution

  • Name:

    Xalatan 50 micrograms/ml eye drops solution

  • Company:
    info
  • Active Ingredients:

    Latanoprost

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/10/18

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Summary of Product Characteristics last updated on medicines.ie: 12/10/2018

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 231 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 October 2018 PIL

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 7 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 April 2017 SmPC

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 6 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 April 2017 PIL

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 5 April 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 November 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 November 2015 SmPC

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 28 September 2015 SmPC

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 PIL

Reasons for updating

  • Change to product name

Updated on 19 March 2014 SmPC

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 PIL

Reasons for updating

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

Updated on 27 August 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 1 August 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 24 July 2013 SmPC

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 2 January 2013 SmPC

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 1 March 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 1 March 2012 SmPC

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 24 October 2011 SmPC

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 PIL

Reasons for updating

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

Updated on 27 April 2011 SmPC

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 PIL

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 SmPC

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 PIL

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 9 July 2010 SmPC

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 8 July 2010 PIL

Reasons for updating

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

Updated on 17 September 2009 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 7 December 2007 SmPC

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 7 December 2007 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 11 October 2006 SmPC

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 2 August 2005 PIL

Reasons for updating

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

Updated on 12 July 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 April 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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