Sofradex Eye/Ear Drops | Medicines.ie

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Sofradex Eye/Ear Drops

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Name:
Sofradex Eye/Ear Drops
Company:
SANOFI
Active Ingredients:
Dexamethasone sodium metasulphobenzoate, Framycetin sulfate, Gramicidin
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/05/19

(Click to Download)

XPIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

1. What Sofradex Drops are and what they are used for

2. Before you use Sofradex Drops

3. How to use Sofradex Drops

4. Possible side effects

5. How to store Sofradex Drops

6. Further information

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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 20 May 2019 PIL

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 - use in children and adolescents
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - pregnancy, breast feeding and fertility
Change to section 2 - driving and using machines
Change to section 2 - excipient warnings
Change to section 4 - possible side effects
Change to section 4 - how to report a side effect

Updated on 20 May 2019 SmPC

Reasons for updating

Change to section 4.3 - Contraindications
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects
Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.3 (addition of text eardrum perforation related to contraindication), 4.4 (addition of text related to warning about deafness) and 4.8 (eye disorders) of the SPC have been updated. (please email me if you wish to view the highlighted SPC).

Updated on 20 June 2017 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 June 2017 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
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: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IB C.1.3.z Variation to update the product information following PRAC updates - PSUSA procedure for budesonide (PSUSA/000449/201604): blurred vision and central serous chorioretinopathy (CSCR) and the CMDh decision to extend the warning to other corticosteroids.

Updated on 13 June 2017 PIL

Reasons for updating

New PIL for new product

Updated on 13 June 2017 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions
Change to section 4 - possible side effects
Change to section 4 - how to report a side effect
Change to section 6 - date of revision

Updated on 12 May 2016 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration
Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated on 29 April 2016 PIL

Reasons for updating

Change to warnings or special precautions for use
Change to date of revision

Updated on 11 August 2015 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration
Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.2 & 4.8 updated to remove unapproved information.

Updated on 19 August 2014 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type 1A B.II.d.1.z) Change in the specification parameters and/or limits of the finished product to more accurately describe the appearance of the drug product

Updated on 24 September 2012 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 updated to include 'T/A SANOFI'

Updated on 2 September 2009 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 24 August 2009 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of For a full list of excipients to Section 2.

Updated on 20 August 2009 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 25 July 2008 SmPC

Reasons for updating

Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 December 2006 PIL

Reasons for updating

Improved electronic presentation

Updated on 13 November 2006 PIL

Reasons for updating

Change of licence holder

Updated on 13 November 2006 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 7 - MAH changed to sanofi-aventis Ireland Ltd.

Update Section 10 - Change of revision date.

Updated on 31 July 2006 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Sections -

4.4 - addition of statement that treatment should not be longer than 7 days. Prolonged use may lead to skin sensitisation and emergence of resistant organisims

4.8 - addition of statement regarding prolonged use and formation of posterior subcapsular cataracts, thinning of globe leading to perforation.

Updated on 16 May 2005 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 12 October 2004 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 April 2004 SmPC

Reasons for updating

Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003 SmPC

Reasons for updating

Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)