Liquifilm Tears

  • Name:

    Liquifilm Tears

  • Company:
    info
  • Active Ingredients:

    Polyvinyl Alcohol

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/05/09

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Summary of Product Characteristics last updated on medicines.ie: 13/5/2010
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Allergan Ltd

Allergan Ltd

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1 - 0 of 23 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 13 May 2010 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Summary of Changes to Liquifilm Tears® Irish Summary of Product Characteristics (SPC)

 

The current Liquifilm Tears® SPC is dated Jan 2009

This supersedes SPC dated July 2008

 

 

Section Number

Subject

Change

3

Pharmaceutical Form

AC clear, colourless solution with a pH of 6.0-7.5 and osmolality of 200-260 mOsm/kg.

 

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipientsits ingredients

4.4

Special warnings and precautions for use

Section expanded – safety update.  All current text deleted and replaced as below.

The dropper tip should not be allowed to touch any surface.

 

If the patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, use should be discontinued and the doctor should be consulted.

If irritation, pain, redness and changes in vision occur or worsen or persist for more than 72 hours, treatment should be discontinued and a new assessment considered.

 

To avoid contamination, the dropper tip should not be allowed to touch the eye or any other surface.

 

Contact lenses should be removed before each application and may be reinserted after 15 minutes.

 

Liquifilm Tears contain benzalkonium chloride which is irritant to the eye and could cause discolouration of soft lenses.  Avoid contact with soft contact lenses.  Remove contact lenses before Liquifilm Tears is used and wait for at least 15 minutes before reinsertion.

 

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Liquifilm Tears.

 

 

4.5

Interaction with other medicinal products and other forms of interaction

Text amended

No interat applicablection studies have been performed.

 

4.7

Effects on ability to drive and use machines

Section expanded

No studies on the effects on the ability to drive and use machines have been performed.

 

Based upon the information available, Liquifilm Tears has no or negligible influence on the ability to drive and use machines.  However, it Mmay cause transient blurring of vision.  Do not drive or use hazardous machinery unless vision is clear.

 

4.8

Undesirable effects

Text deleted and replaced with expanded section

May cause transient stinging or irritation on instillation.

The following undesirable effects have been reported since Liquifilm Tears was marketed.

 

Frequency:

Not known: the incidence cannot be determined from available information.

 

Eye disorders:

Not known: Eye irritation, eye pain, ocular hyperaemia, lacrimation increased, foreign body sensation, eye pruritus.

 

Immune system disorders:

Not known: hypersensitivity

 

 

4.9

Overdose

Text added

No case of overdose has been reported.

 

5.1

Pharmacodynamic properties

Text added (details of group)

Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01AX20.

 

9

Date of first authorization/renewal of the authorization

 

Date of last renewal amended from 1st November 2007 to 4th July 2008.

10

Date of revision of text

Amended from 4th July 2008 to 28th January 2009.

Updated on 13 May 2010 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 28 May 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 28 May 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 February 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 August 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Section Number

Subject

Change

2

Qualitative and quantitative composition

Added text in red

Polyvinyl alcohol 1.4% w/v

Excipient: Benzalkonium chloride 0.005% w/v

 For a full list of excipients, see section 6.1.

3

Pharmaceutical Form

Added the following text with a pH of 6.0-7.5 and osmolality of 200-260 mOsm/kg.

All

 

Removed trademark symbol (®)  throughout the document

6.1

List of excipients

Disodium edentate replaced Edetate disodium

Text ‘to adjust pH’ changed to ‘for pH adjustment’

6.6

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Heading ‘Instructions for use and handling’ changed to ‘Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’

 ‘No special requirements’ replaced ‘Not applicable’

9

Date of first authorisation/renewal of the authorisation

Text added - Date of first authorization:

                     Date of last renewal:
 
In Date of last renewal section - 1st November 2007 replaced 1st November 2002

10

Date of revision of text

4th July 2008 replaced 22nd December 2004

Updated on 15 August 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 27 August 2003 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only