Liquifilm Tears
- Name:
Liquifilm Tears
- Company:
Allergan Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/05/09


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Allergan Ltd

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Medicine Name Ganfort SD | Active Ingredients Bimatoprost, Timolol Maleate |
Medicine Name Lacri-Lube | Active Ingredients No Active Ingredients |
Medicine Name Liquifilm Tears | Active Ingredients Polyvinyl Alcohol |
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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 SPC
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 |
A |
4.3 |
Contraindications |
Hypersensitivity to the active substance or to any of the excipients |
4.4 |
Special warnings and precautions for use |
Section expanded – safety update. All current text deleted and replaced as below.
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 intera |
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 |
4.8 |
Undesirable effects |
Text deleted and replaced with expanded section
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 SPC
Reasons for updating
- New SPC 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 SPC
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 |
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’ |
9 |
Date of first authorisation/renewal of the authorisation |
Text added - Date of first authorization: Date of last renewal:
|
10 |
Date of revision of text |
4th July 2008 replaced 22nd December 2004 |
Updated on 15 August 2005 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only