Celluvisc 0.5% *
Pharmacy Only: Non-prescription

  • Company:

    Allergan Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Supply through pharmacy only
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 04 March 2020

File name

Celluvisc 0.5 PIL IE V4_1583330304.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 16 February 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 16 February 2015

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

To update Irish Medicines Board (IMB) name to Health Products Regulatory Authority (HPRA) in sec. 4.8 of the SPC

Updated on 12 February 2015

File name

PIL_11674_282.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 February 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 04 June 2014

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 4.6 - 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

Changed to update the SPC in line with the CCDS

Updated on 30 May 2014

Reasons for updating

  • Changes to therapeutic indications
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 10 March 2011

Reasons for updating

  • 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

Summary of Changes to Celluvisc® 0.5% Irish Summary of Product Characteristics (SPC)

 

The current Celluvisc® SPC is dated 17th December 2010

This supersedes SPC dated 10th November 2006

 

Section Number

Subject

Change

4.8

Undesirable effects

Added Text:

The frequency of adverse reactions documented during clinical trials is given.  The frequency is defined as follows: Very Common (³ 1/10); Common (³1/100, <1/10); Uncommon (³1/1,000, <1/100); Rare (³1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).

 

Eye disorders:

 

Common: Eye Irritation

 

The following other adverse reactions have reported since Cellufluid has been marketed:

Eye pain, vision blurred, lacrimation increased, ocular hyperaemia.

 

Deleted Text:

Temporary burning may occur.

 

 

10

Date of Revision of Text

Text added:

 

17th December 2010

 

 

 

Key:

Unchanged text appears as follows: eg sodium hydroxide

Added text appears as follows: eg Celluvisc

Deleted text appears as follows: eg Not applicable

 

Updated on 09 March 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 21 February 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 24 November 2006

Reasons for updating

  • New PIL for new product

Updated on 24 November 2006

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only