Xalacom eye drops, solution

  • Name:

    Xalacom eye drops, solution

  • Company:
    info
  • Active Ingredients:

    Latanoprost, Timolol Maleate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 26/9/2018

Click on this link to Download PDF directly

Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name Atorvastatin Pfizer 10 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 20 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 40 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 80 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
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 26 September 2018 SmPC

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 14 August 2017 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

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 3 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 August 2017 PIL

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 SmPC

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 PIL

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 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 section 6.5

Updated on 20 September 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

SPC: to add class labelling on the use of phosphates in eye drops to section 4.8:
“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 PIL

Reasons for updating

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

Updated on 6 September 2012 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 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 3 September 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Improved electronic presentation

Updated on 1 June 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

Section 7: Change of MAH from Pharmacia Ireland to Pfizer Healthcare Ireland
Section 8  Change to marketing authorisation number from PA 936/10/01 to PA 822/139/1

Updated on 30 May 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 26 January 2012 SmPC

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

Changes to Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 6.4.

Updated on 26 January 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 January 2012 PIL

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 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 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 3 August 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

SmPC: Changes to Sections 4.4 and 4.8.

Updated on 2 August 2011 PIL

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 November 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 November 2010 PIL

Reasons for updating

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

Updated on 22 November 2010 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

SmPC: Changes to Sections 4.8

Updated on 8 July 2010 SmPC

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 PIL

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 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 November 2008 SmPC

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 PIL

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 SmPC

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 PIL

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 SmPC

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.

6.5 – Reformatting.

Updated on 11 November 2005 SmPC

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 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision

Updated on 2 August 2005 PIL

Reasons for updating

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

Updated on 20 July 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 April 2004 SmPC

Reasons for updating

  • Improved electronic presentation

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

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 3 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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