Travocort *
Pharmacy Only: Prescription

Updated on 29 April 2022

File name

ie-ins-travocort-segrate zip code cl_1651226788.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 6 - change to manufacturer zip code only

Updated on 20 January 2020

File name

ie-pl-travocort-009JXB-20200115-design_change-cl_1579525303.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 07 January 2020

File name

spc-Travocort-CRN008YXV-20191220-CoA-cl_1578402682.pdf

Reasons for updating

  • Addition of marketing authorisation holder

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

Updated on 07 January 2020

File name

ie-pl-Travocort-CRN008YXV-20191220-CoA-cl_1578402643.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 August 2019

File name

19040_PL_CC_20190808_1565261730.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 May 2019

File name

17212_PL_CC_TRA_20190507_1558449420.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 21 May 2019

File name

17212_SPC_CC_TRA_20190503_1558449228.pdf

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated SPC due to new PRAC guidance regarding vision

Section 4.4- 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.

Section 4.8

Eye disorders

Blurred vision may occur, however the frequency is not known (see section 4.4)

Updated on 07 January 2016

File name

PIL_7935_181.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 January 2016

Reasons for updating

  • Improved electronic presentation

Updated on 23 November 2015

Reasons for updating

  • New SPC for new product

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

Updated on 23 November 2015

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

- In section 4.2, details have been added on the administration in children aged 2 years or older and adolescents.  
- In section 4.4, special warnings and precautions for use, details have been added on the physician advising patients on hygenic measures during treatment and precautions to be taken,  if Travocort is applied to the genital regions.
- In section 4.6, fertility, pregnancy and lactation, details have been added in relation to the use of the product.
- In section 4.8, undesirable effects, adverse events have been categorised according to the MEDRA frequency convention and local adverse reactions have been listed. Also reporting details for suspected adverse reactions has been included.
-In section 5.1, the experience of Travocort in the paediatric  population has been outlined in tabular format.
- In section 5.2, additional detail on the absorption of the active Isoconazole has been added.

Updated on 19 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change of special precautions for disposal
  • Addition of information on reporting a side effect.

Updated on 07 February 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 20 January 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Change of MA holder.
Change of PA number.
Change of revision date of SPC.

Updated on 15 January 2014

Reasons for updating

  • Change of licence holder
  • Change to MA holder contact details

Updated on 03 March 2011

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 05 November 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and special precautions for use

Addition of the paragraphs;
"Extensive application of topical corticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects." 

 

"This medicinal product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)." 

 

In the first sentence in the second paragraph the word “corticosteroid” was changed to “corticoid”.

 

4.8 Undesirable Effects

The side effect “skin discoloration” was added to the third paragraph.

 

5.2 Pharmacokinetic properties

Subheading: Isoconazole nitrate:

The second sentence was changed from

Isoconazole penetrates rapidly into human skin from Travocort cream and maximum drug levels ...” to

Isoconazole penetrates rapidly into human skin from Travocort cream and reaches maximum drug levels ...”.

 

 

In the fourth paragraph, the text “H-labelled isoconazole nitrate” was changed to “3H-labelled isoconazole nitrate”.

 

In the eight paragraph, the word was changed from “feces” to “faeces”.

Updated on 01 November 2007

Reasons for updating

  • Change to improve clarity and readability
  • Change to date of revision

Updated on 24 October 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 16 June 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 1 - Name of medicinal product
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Update to the SMPC following Marketing Authorisation renewal.
 
Main changes are:
Section 1 Name updated to include strength of each active ingredient: Travocort 0.1 + 1 % w/w Cream
Section 4.4 Warning added regarding the excipient Cetostearyl alcohol

Updated on 16 June 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 08 February 2006

Reasons for updating

  • Change of manufacturer
  • Change to marketing authorisation holder

Updated on 26 October 2005

Reasons for updating

  • Improved electronic presentation

Updated on 15 August 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 15 August 2005

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to drug interactions
  • Change to dosage and administration
  • Change to instructions about overdose
  • Change to side-effects

Updated on 05 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 April 2004

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 07 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 02 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 06 June 2003

Reasons for updating

  • New SPC for medicines.ie

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