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Estradot Transdermal Patches *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Estradiol Hemihydrate

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2022

File name

62b17bd31f8de.pdf

Reasons for 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

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

Updated on 21 June 2022

File name

62b17b01b6d37.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 05 January 2022

File name

Estradot_REG PIL_PF 21-0246_clean_1641374910.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 October 2021

File name

Estradot_REG PIL_PF 21-0113_Clean_updated pictures_1634224422.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 02 September 2021

File name

Estradot_REG PIL_PF 21-0113_Clean_IPHA_1630593549.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 30 November 2020

File name

Estradot_REG PIL_PF 20-0153_Clean_IPHA_1606755536.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 30 November 2020

File name

Estradot_REG SmPC_PF 20-0153_November 2020_IPHA_1606755409.pdf

Reasons for updating

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

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

Updated on 21 May 2020

File name

Estradot REG PIL PF 19-0271 IPHA_1590064966.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 29 August 2019

File name

Estradot REG PIL_PF 18-0285_August 2019_IPHA_1567086041.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents

Updated on 29 August 2019

File name

Estradot REG SmPC_PF18-0285_August 2019_Clean_IPHA_1567086310.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Updated on 08 April 2019

File name

Estradot REG SmPC (combined)_PF 18-0193_IPHA_1554714466.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 27 October 2018

File name

REG PIL_Estradot Family_101990_9_IE_p2_LFT_X-4_IPHA_1540566762.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 13 July 2018

File name

Estradot REG SmPC (combined)_PF 18-0193_clean.docx

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 June 2016

File name

PIL_8502_597.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 June 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of special precautions for disposal

Updated on 06 June 2016

Reasons for updating

  • New SPC for new product

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

Updated on 06 June 2016

Reasons for updating

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

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: deleted "Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8)." and added "

Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping." under the Ovarian cancer heading.

Section 4.8: deleted " In the Million Women Study 5 years of HRT resulted in 1 extra case per 2,500 users." and added "

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."


Updated on 15 April 2016

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 6.6 - Replaced "No special requirements" with "Used transdermal patches should be folded in half with the adhesive side inwards, and discarded safely and out of the reach and sight of children. Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy, preferably in the original packaging."

Updated on 01 May 2015

Reasons for updating

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

Updated on 13 April 2015

Reasons for 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 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 - revised to include information on Severe anaphylactic/anaphylactoid reactions and a warning for patients with angioedema.
Section 4.5 - updated to include the following sentence: Estradiol is predominantly metabolized by CYP3A4, hence concomitant administration of inhibitors of CYP3A4 such as ketoconazole, erythromycin may result in increase in the exposure of estradiol.
Section 4.8 - additional ADRs included in table as well as information for reporting of suspected adverse reactions.
Section 5.1 - spelling of vertebral corrected.
Section 5.2 - heading changed to Biotransformation/Metabolism.
 

 

Updated on 21 May 2012

Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

SmPC has been revised to bring it in line the with the European Core Data Sheet for HRT products.

Updated on 21 May 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects

Updated on 16 November 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 July 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 12 April 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Additional Information in 1, 2, 4.1, 4.2, 4.3

Updated on 07 March 2006

Reasons for updating

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

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

Updated on 22 November 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Improved electronic presentation

Updated on 09 September 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 24 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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