Fucithalmic 10 mg/g Viscous eye drops, suspension *
Pharmacy Only: Prescription

  • Company:

    ADVANZ Pharma
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

Updated on 22 April 2022

File name

Fusidic Acid Eye drops 1 pct ww Fucithalmic Multi Dose_PIL_IE_1650616694.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 16 December 2021

File name

Fusidic Acid Eye drops 1 pct ww_PIL_IE_1639678199.pdf

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

update PIL and delete Medical Information phone number published in the PIL.

Updated on 12 October 2021

File name

FUCITH~1_1634041671.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 May 2021

File name

Fucithalmic 10mg-g Viscous Eye Drops_3g_PIL_1622186448.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 May 2021

File name

Fucithalmic 10mg-g Viscous Eye Drops_SPC_1622186387.pdf

Reasons for updating

  • Change due to harmonisation of SPC
  • Updated inline with QRD template and/or excipient guideline

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 24 October 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 October 2017

Reasons for updating

  • 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 4.7 - 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0Section 6.6 - Directions for use for administration updated$0Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1 and 6.5 in line with QRD template 

Updated on 11 August 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SPC was updated with the ADR statement

Updated on 03 August 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 03 February 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

in Section 6.5, additional pack size 3g, was added.

Updated on 17 February 2014

Reasons for updating

  • Improved electronic presentation

Updated on 14 February 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 February 2014

Reasons for updating

  • New PIL for new product