Last Updated on eMC 07-09-2017 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 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

Date of revision of text on the SPC:02-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 4.4 (special warnings and precautions for use), the following text has been added:

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.

 

In section 4.8 (undesirable effects), the following text has been added:

Eye disorders

Vision, blurred (see also section 4.4)

 

In section 10 (date of revision of the text)

The date has been changed from 23/03/2017 to 02/08/2017

 

 

 

 

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
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:23-02-2017

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

 

4.4       Special warnings and precautions for use

A patient information leaflet should be supplied with this product.

In post-marketing experience tumour lysis syndrome (TLS) has been reported very rarely in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions taken.

 

 

 

4.5       Interaction with other medicinal products and other forms of interaction

Rifampicin, rifabutin, carbamazepine, phenobartital, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.

Dexamethasone is a moderate inducer of CYP 3A4. Co-administration of dexamethasone with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentrations.

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.

4.8       Undesirable effects

Ophthalmic

Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exacerbation of opthalmic viral or fungal diseases, chorioretinopathy

 

10      DATE OF REVISION OF THE TEXT

               18/08/2016 23/02/2017

 

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC:18-08-2016

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

 

 

3        PHARMACEUTICAL FORM

Tablet

White, round and flat tablets with bevelled edges and a diameter of 6 mm, coded XC above, and 8 below on one side and plain on the other side.

 

6.3       Shelf life

 

3 years - when stored in polyethylene tampertainers 3 years - when stored in polystyrene bottle.

 

6.5     Nature and contents of container

 

Polyethylene tampertainers with child resistant closures containing 50 and 100 tablets.

                              Polyethylene tampertainers with closures containing 500 tablets.

                              Polystyrene bottles containing 50 tablets.

 

              

               White, cylindrical wide mouth containers with screw caps made of high density polyethylene (HDPE) with a child resistant polypropylene screw cap, containing 50, 100 or 500 tablets.

Not all pack sizes may be marketed

 

 

 

9        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/03/1990 March 1990 (Review licence) / 17/06 June /2010

10      DATE OF REVISION OF THE TEXT

            07/06/201618/08/2016

 

Reasons for adding or updating:

  • 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
  • Correction of spelling/typing errors

Date of revision of text on the SPC:07-06-2016

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

Dexamethasone is a moderate inducer of CYP 3A4. Co-administration of dexamethasone with other drugs that are metabolized by CYP 3A4 (e.g., indinavir,  erythromycin) may increase their clearance, resulting in decreased plasma concentrations.

 

4.8       Undesirable effects

Reporting of suspected adverse reactions

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.


 

10      DATE OF REVISION OF THE TEXT

May 201407/06/2016

 

 

 

 

 

 

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Date of revision on the primary section in the database amended to 22May2014 from 30May2014.

Reasons for adding or updating:

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

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

Legal Category:POM

Black Triangle (CHM): NO