Last Updated on eMC 31-08-2017 View medicine  | Aspen Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:25-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 0.1 mg fludrocortisone acetate.

 

Excipient(s) with known effect:

 

 

4.3       Contraindications

 

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

 

 

4.4       Special warnings and precautions for use

 

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC:27-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text

 

 


2          QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 0.1 mg fludrocortisone acetate.

 

Excipient(s) with known effect:

 

4.3          Contraindications

 

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

 

 

4.4          Special warnings and precautions for use

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

10           DATE OF REVISION OF THE TEXT

 

27/07/2017  Feb 2017

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:28-02-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text


4.5       Interaction with other medicinal products and other forms of interaction


CYP3A inhibitors: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

10      DATE OF REVISION OF THE TEXT

 

February 2017 December 2016

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
  • Product/presentation discontinued

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO