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Rosemont Pharmaceuticals Limited

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire , LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 297 7812
Customer Care direct line: +44 (0)800 919 312
Medical Information Facsimile: +44 (0)113 297 7812
Summary of Product Characteristics last updated on medicines.ie: 11/01/2018
SPC Dexsol 2mg/5ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, 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 11/01/2018 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Jan-2018
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.4: updates to add visual disturbances and tumour lysis syndrome

In section 4.5: updates to add co-treatment with CYP3A inhibitors

In section 4.8: blurred vision and chorioretinopathy added

In section 10: approval date added

Updated on 24/10/2017 and displayed until 11/01/2018
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Oct-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 2: section updated in line with the QRD

In section 4.2: addition of suitability of administration via NG and PEG tube

In section 4.6: section updated in line with the QRD

In section 4.8: Reporting of suspected adverse reactions paragraph added

In section 5.1: section updated in line with the QRD

In section 6.6: instruction for administration via NG and PEG tube added

In section 10: approval date added

Updated on 11/07/2016 and displayed until 24/10/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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
Date of revision of text on the SPC:   30-Apr-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 2 Excipent list added.

In Section 4.1 Childhood croup added.

 

In section 4.2 childhood croup section added.

In section 4.4 significant changes to section

In section 4.5 Changes to section made.

 

In section 4.6 (Use during pregnancy and lactation) more information about administration of corticosterioids in pregnant animals added.

In section 4.8 (undesirable effects) Number of change made.

In section 5.3 (Preclinical safety data) Content amended.

In section 6.4 Light sensitivity information added.

In section 6.5 bottle size amended.

In section 10 date of text revision amended

Updated on 14/07/2011 and displayed until 11/07/2016
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Dexamethasone Sodium Phosphate