Femoston 2/10mg film-coated tablets

  • Name:

    Femoston 2/10mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Dydrogesterone, 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: 17/09/20

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Summary of Product Characteristics last updated on medicines.ie: 17/9/2020

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 17 September 2020

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

Updated on 17 September 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 14 June 2019

Reasons for updating

  • Change to improve clarity and readability

Updated on 31 May 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 6 June 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • 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)

Updated on 23 April 2018 PIL

Reasons for updating

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

Updated on 4 July 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 4 July 2017 SPC

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)

Free text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/12/2 2007/8/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017 PIL

Reasons for updating

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

Updated on 29 July 2016 PIL

Reasons for updating

  • Change to further information section

Updated on 26 February 2016 SPC

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 6.1 - List of excipients

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 - Addition of "For oral use"
Section 4.3 - minor editorial updates
Section 4.4 - Addition of "meningioma" to conditions which need supervision, update text for ovarian cancer risk.
Section 4.6 - Deletion of text regarding studies in animals, addition of "Fertility" section
Section 4.8 - Comprehensive update of entire section including addition and deletion of side effects and changes of frequency of side effects. Update of Reporting of Suspencted Adverse Reactions text.
Section 4.9 - Deletion of "No cases of overdode have been reported.." Update list of symptoms of overdose.
Section 5.1 - minor editorial update
Section 5.2 - Update of pharmacokinetic parameters tables for estradiol and dydrogesterone. Update to distribution text for estradiol. Change "metabolism" to "biotransformation" 
Section 5.3 - minor editorial updates
Section 6.1 - minot editorial update

Updated on 26 February 2016 PIL

Reasons for updating

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

Updated on 8 April 2015 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 7:
Change of MA Holder from Abbott Healthcare Products Limited to BGP Products Ltd

Section 8:
Change of PA number from PA 108/21/1 to PA 2007/8/2

Updated on 30 March 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 June 2014 SPC

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

MA Holder address in Section 7 changed

from: Abbott Healthcare Products Ltd
Mansbridge Road
West End
Southampton
SO18 3JD
UK


to: Abbott Healthcare Products Limited,
Abbott House
Vanwall Business Park
Vanwall road
Maidenhead SL6 4XE
United Kingdom

Updated on 17 June 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 7 January 2014 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

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 "Reporting of suspected adverse reactions" paragraph
Section 6.1 - Expansion of tablet composition 

Updated on 4 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 2 January 2014 SPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.1: Addition of "at least 6 months since the last menses"

Section 4.2: Addition of "Treatment commences with one brick red tablet containing estradiol taken daily"

Section 4.3: Deletion of "Known or suspected progesterone dependent neoplasms
                   Addition of "Known thrombophilic disorders (e.g. protein S or antithrombin deficiency"
                   Deletion of "Known or suspected pregnancy"

Section 4.4: Comprehensive changes to Section

Section 4.5:  Deletion of "2B6, 3A4, 3A5, 3A7" and "CYP450, 3A4, A5, A7"
                   Deletion of "Estrogens might interfere with the metabolism of other drugs:  Estrogens per se may inhibit CYP450 drug metabolising enzymes via competitive inhibition.  This is in particular to be considered for substrates with a narrow therapeutic index, such as tacrolimus and cyclosporine A (CYP450, 3A4, 3A3), fentanyl (CYP450, 3A4), theophylline (CYP450 1A2).
Femoston 2/10 can be administered irrespective of food intake"

Section 4.6:  Deletion of "Clinically, data based on a large number of exposed pregancies indicate no adverse effects of dydrogesterone on the foetus"
                    Addition of" There are no adequate data from the use of estradiol/dydrogesterone in pregnant women.  Studies in animals have shown reproductive toxicity.  The potential risk for humans is unknown"

Section 4.8:  Comprehensive changes to Section

Section 5.1:  Comprehensive changes to Section

Section 5.2:  Comprehensive changes to Section

Updated on 14 June 2013 SPC

Reasons for updating

  • 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

10.       DATE OF REVISION OF THE TEXT

 

September 2011

Updated on 5 September 2011 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 3: Pharmaceutical form

The Solvay 'S' logo embossing has been removed from both the estradiol film-coated tablets and the estradiol/dydrogesterone film coated tablets

Updated on 31 August 2011 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 3 March 2011 SPC

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



The Abbott Corporation has recently taken over the pharmaceutical business of the Solvay Company. As a result the names of the former Solvay affiliate companies are being changed.

Updated on 2 March 2011 PIL

Reasons for updating

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

Updated on 22 April 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 3 April 2007 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • 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

4.2        Posology and method of administration

Added statement:

Femoston 2/10 is not recommended for the use in children below the age of 18 due to insufficient data on safety and efficacy.

 

 

4.3               Contraindications

Added statement:

Known hypersensitivity to the active substances or to any of the excipients;

 

·         Known or suspected progesterone dependant neoplasma;

·         Known or suspected pregnancy.

 

            Deleted statement:

·         Known hypersensitivity to the active substances or to any of the excipients;

 

 

4.5        Interaction with other medicinal products and other forms of interaction

Added statement:

 

No interaction studies have been performed.

 

Femoston 2/10 can be administrated irrespective of food intake.

 

 

4.7               Effect on ability to drive and use machines

 

Amended from: Femoston does not affect the ability to drive or use machines.

Amended to: Femoston has no or negiligible influence on the ability to drive and use machines.

 

 

4.8               Undesirable Effects

 

            Added asterix in Vascular disorder

 

Vascular disorders

 

Hypertension,
Peripheral vascular disease,
Varicose vein,

Venous thromboembolism*

 

Stroke

            * see below for further information

 

           

Other adverse reactions have been reported in association with estrogen/progestagen treatment:

     

      Added:

-          Increase in size of pregestogen dependant neoplasma (e.g. meningioma), (see section 4.3)

 

Double Asterix added:

-          Estrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer.**

 

 

 

4.9        Overdose

Added:

No case of overdose has been reported for Femoston 2/10.

 

 

5.3        Preclinical safety data

Deleted:

 

Supraphysiologically high doses (prolonged overdoses) of estradiol have been associated with the induction of tumours in estrogen‑dependent target organs for all rodent species tested. The changes observed with dydrogesterone in animal toxicity studies are characteristic for progesterone‑like compounds. In-vitro and in-vivo data gave no indications of mutagenic effects of dydrogesterone. In long-term studies, doses administered to rats and mice were sufficient to produce hormone-mediated changes, but did not provide tumorogenic potential.

 

Added:

There are no preclinical safety data which could be relevant to the presciber and shich are not already included in other relevant sections of the SPC.

Updated on 3 April 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of separate PILs covering individual presentations

Updated on 20 December 2006 SPC

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use
 
Added section under Conditions which need supervision
 
Progestogen dependant neoplasms, e.g. Meningioma

Updated on 13 September 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 1 September 2006 SPC

Reasons for updating

  • 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 4.8 Undesirable effects
 
Added: Immune System Disorders - very rare - Hypersensitivity reactions
 
 
 

Updated on 3 August 2005 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 May 2005 PIL

Reasons for updating

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

Updated on 25 November 2004 SPC

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 4.6 - 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 4.9 - 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 10 - Date of revision of the text

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

Updated on 27 June 2003 SPC

Reasons for updating

  • New SPC for new product

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