Celluvisc 1.0% w/v Eye drops, solution
- Name:
Celluvisc 1.0% w/v Eye drops, solution
- Company:
Allergan Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/05/20

XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Celluvisc is and what it is used for
1. What Celluvisc is and what it is used for
2. What you need to know before you use Celluvisc
2. What you need to know before you use Celluvisc
3. How to use Celluvisc
3. How to use Celluvisc
4. Possible side effects
4. Possible side effects
5. How to store Celluvisc
5. How to store Celluvisc
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Allergan Ltd

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Medicine Name BOTOX 50 Units | Active Ingredients Botulinum Toxin Type A |
Medicine Name Celluvisc 0.5% | Active Ingredients Carmellose sodium |
Medicine Name Celluvisc 1.0% w/v Eye drops, solution | Active Ingredients Carmellose sodium |
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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 29 May 2020 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 May 2020 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
In section 6.4 (special precautions for storage), storage precautions updated including storage of pouch.
In section 6.5 (nature and contents of container), pack sizes have been updated.
In section 10 (date of the revision of the text), the revision date is updated to May 2020.
Updated on 16 February 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 16 February 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Updated on 12 February 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 12 February 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 July 2014 SPC
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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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
Updated on 17 July 2014 PIL
Reasons for updating
- Change of contraindications
- Change to instructions about missed dose
- Change to storage instructions
- Change to side-effects
- Change to date of revision
Updated on 4 March 2009 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Summary of Changes to Celluvisc 1% Irish Summary of Product Characteristics (SPC)
The current Celluvisc SPC is dated 13th February 2009
This supersedes SPC dated 28th March 2008
Section Number |
Subject |
Change |
1 |
Name of the medicinal product |
Amended from Celluvisc 1.0% to read Celluvisc 1% |
4.5 |
Interaction with other medicinal products and other forms of interaction |
Section title amended to read: Interaction with other medicinal products and other forms of interaction |
7 |
Marketing Authorisation Holder |
Amendment to address (format only): Word |
9 |
Date of first authorisation /renewal of authorisation |
Date of last renewal amended from 29th September 2003 to 3rd October 2008. |
10 |
Date of revision of text |
New Text: 13th February 2009. Replaces: 28th March 2008. |
Updated on 4 March 2009 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 1 September 2008 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 28 August 2008 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 22 August 2008 SPC
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 4.7 - 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 6.5 - Nature and contents of container
- 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
Summary of Changes to Celluvisc® 1% Irish Summary of Product Characteristics (SPC)
The current Celluvisc® SPC is dated 28th March 2008
This supersedes SPC dated 31st January 2007
Section Number |
Subject |
Change |
2 |
Qualitative and quantitative composition |
Word Inserted: For a full list of excipients, see section 6.1. |
4.2 |
Posology and method of administration |
New Text: Instil one or two drops in the affected eye/s as needed. Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening. To avoid contamination do not touch the tip to the eye or any other surface. Replaces:
|
4.3 |
Contraindications |
Words Inserted: Hypersensitivity to the active substance or to any of the excipients. |
4.4 |
Special warnings and precautions for use |
New text: Discard open single dose container after use. Replaces: Discard open ampoule after use. |
4.5 |
Interaction with other medicinal products and other forms of interaction |
Text added: No interaction studies have been performed |
4.7 |
Effects on ability to drive and use machines |
New text: Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision. Replaces:
|
4.8 |
Undesirable effects |
New text: The frequency of undesirable effects is defined as follows:
Eye disorders: Not known: eye irritation, eye pain, vision blurred, lacrimation increased. Replaces:
|
4.9 |
Overdose |
Word change: Accidental overdose will present no hazard. Replaces: Accidental |
5.1 |
Pharmacodynamic properties |
New text: Pharmacotherapeutic group: Other ophthalmologicals ATC code: S01XA20 Carmellose sodium has no pharmacological effect. Carmellose sodium has a high viscosity resulting in an increased retention time on the eye. Replaces:
|
5.2 |
Pharmacokinetic properties |
New text: Due to the high molecular weight (approx. 90,000 Replaces: Carmellose sodium has a large molecular weight and is unlikely to penetrate the cornea. The period of retention on the cornea is approximately 22 minutes in healthy eyes. |
6.5 |
Nature and contents of container |
Words deleted: Pack sizes |
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 change: Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Replaces: Instructions for use and handling Word change: Ensure that the single dose container is intact before use. Replaces: Ensure that |
9 |
Date of first authorization /renewal of authorization |
New text: Date of first authorisation: 23rd April 1997 Date of last renewal: 29th September 2003 Replaces:
|
10 |
Date of revision of text |
New Text: 28th March Replaces: 31st January 2007 |
Updated on 12 March 2007 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 9 March 2007 PIL
Reasons for updating
- Addition of marketing authorisation holder
- Change to date of revision
- Change of active ingredient
Updated on 1 September 2006 PIL
Reasons for updating
- Change of inactive ingredient
- Change to appearance of the medicine
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 15 August 2005 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Updated on 9 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 6 August 2004 SPC
Reasons for updating
- Correction of spelling/typing errors
- Change to section 1 - Name of medicinal product
Legal category: Supply through pharmacy only
Updated on 27 August 2003 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Updated on 13 June 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only