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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Evorel 50 micrograms per 24 hours Transdermal Patch

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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Jul-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


  • Movement of text to make use of progestogen prominent
  • Introduction of additional information regarding application of the patch
Updated on 20/06/2016 and displayed until 13/07/2017
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 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:   15-Jun-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Update to section 4.4

 

 Ovarian cancer

Ovarian cancer is much rarer than breast cancer.  Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. Some other studies, including the WHI trial, suggest that the use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).

  Update to section 4.8

 

Ovarian cancer

 

Use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).

A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.

 

 

 Update to ADR reporting statement

 

 

 

Updated on 23/12/2013 and displayed until 20/06/2016
Reasons for adding or 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 - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Dec-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Alignment with core saftey profile CMDh HRT core SPC 2012,

Update to risk factors for breast cancer, DVT, Sttroke and endometrial cancer
Updated on 04/04/2013 and displayed until 23/12/2013
Reasons for adding or updating:
  • 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:   27-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.8

addition of : hypersensitivity, epilepsy, depressed mood, migraing, dizziness, headache, cereborvascular accident, diarrhoea , flatulance, abdomina; distension, pruritus, breat enlargementm dysmenorrhoea, oedema, generalised oedema, peripheral

Updated on 20/02/2013 and displayed until 04/04/2013
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Feb-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

correction of typing errors
Updated on 15/02/2013 and displayed until 20/02/2013
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Feb-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 6.3 Shelf life

      3 2 years
Updated on 28/11/2012 and displayed until 15/02/2013
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   16-Nov-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4  Special Warnings and Precautions for Use

Conditions which need supervision

-           

-                 Hereditary angioedema

Other conditions

 

Chloasma may occasionally occur, especially in women with a history of chloasma exposure to the sun or ultraviolet radiation whilst taking HRT.gravidarum. Women with a tendency to chloasma should minimise


Section 4.9 Overdose

By virtue of the mode of administration of Evorel, overdosage is unlikely, but effects can if necessary be reversed by removal of the patch. The most commonly observed symptoms of overdose with oestrogen therapy are breast pain or tenderness, nausea, vomiting and break-through bleeding abdominal cramps or bloating.  There is no specific antidote and treatment should be symptomatic.

Updated on 14/02/2012 and displayed until 28/11/2012
Reasons for adding or updating:
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Feb-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.2, administration changes~ wording a updated in line with the comapny core data sheet.

Section 4.3 deletion of 'severe renal disease' as a contraindication. Addition of ; Pregnancy or Lactation,

Known thrombophilic conditions and pre-malignant tumours (e.g. untreated atypical endometrial hyperplasia)

Section 4
addition of bullet list with 'Conditions that require monitoring'.  Update to information under the headings Endometrial hyperplasia, Breast cancer,  Ovarian CancerCoronary artery disease, Stroke and Dementia information 

Section 4.6
Not indicatied
deleted replaced with contraindicated

Section 4.9

 pain,   abdominal cramps a and bloating added as symptoms of overdose

Updated on 27/04/2010 and displayed until 14/02/2012
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



1.

Trade Name of the Medicinal Product

Evorel® 50 Transdermal PatchEvorel 50 micrograms per 24 hours Transdermal Patch

 

2.

Qualitative and Quantitative Composition

3.2 mg estradiol hemihydrate per patch, releasing a nominal 50 micrograms (µg) estradiol per 24 hours.

 

For a full list of excipients, see Section 6.1.

 

6.2

Incompatibilities

None knownNot applicable

 

9.

Date of First Authorisation/Renewal of Authorisation

Date of first authorisation: 10 June 1999

Date of last renewal: 10 June 2009

10.

DATE OF REVISION OF THE TEXT

 

Changed to 9th April 2010

 

Updated on 22/05/2009 and displayed until 27/04/2010
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:   30-Apr-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update to section 4.5 - Addition of interaction with bosentan and  lamotrigine
Update to section 10 - Changed to 30th April 2009
Updated on 28/11/2008 and displayed until 22/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 7 - Change of MAH address to:
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
 
Change to section 10 - Changed to 24th November 2008
Updated on 17/10/2008 and displayed until 28/11/2008
Reasons for adding or updating:
  • 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:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.8

Undesirable effects

Addition of adverse events.

10.

DATE OF REVISION OF THE TEXT

 

Changed from 21st July 2005  to 8th October 2008

 

Updated on 08/11/2005 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 09/08/2005 and displayed until 08/11/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 27/08/2004 and displayed until 09/08/2005
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Updated on 30/07/2004 and displayed until 27/08/2004
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Updated on 26/08/2003 and displayed until 30/07/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - 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 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 26/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Estradiol Hemihydrate