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Evorel 50 micrograms per 24 hours Transdermal Patch

  • Name:

    Evorel 50 micrograms per 24 hours Transdermal Patch

  • Company:
    info
  • Active Ingredients:

    Estradiol Hemihydrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/04/19

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Summary of Product Characteristics last updated on medicines.ie: 8/4/2019

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Janssen Sciences Ireland

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1 - 0 of 55 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 8 April 2019 PIL

Reasons for updating

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

Updated on 8 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 July 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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 June 2016 SmPC

Reasons for 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

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 16 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2016 PIL

Reasons for updating

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

Updated on 23 December 2013 PIL

Reasons for updating

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

Updated on 23 December 2013 SmPC

Reasons for 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

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 4 April 2013 PIL

Reasons for updating

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

Updated on 4 April 2013 SmPC

Reasons for updating

  • 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 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 February 2013 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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 February 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to date of revision

Updated on 28 November 2012 SmPC

Reasons for 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

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 February 2012 SmPC

Reasons for 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

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 Cancer,  Coronary 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 13 February 2012 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to further information section
  • Change to date of revision

Updated on 27 May 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 April 2010 SmPC

Reasons for 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

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 20 April 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 22 May 2009 SmPC

Reasons for 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

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 21 May 2009 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 28 November 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 27 November 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 17 October 2008 SmPC

Reasons for updating

  • 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 not be renewed (A)

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 15 October 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 November 2005 PIL

Reasons for updating

  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use

Updated on 8 November 2005 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2004 SmPC

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 4.5 - 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 30 July 2004 SmPC

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 4.5 - 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2003 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)