Femoston 2/10mg film-coated tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 March 2022
File name
ie-pl-femoston-2mg10mg-TIA-CoreHRT-clean.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
- Change to section 4 - how to report a side effect
Updated on 21 March 2022
File name
ie-spc-femoston-2mg10mg-TIA-CoreHRT-clean.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
- 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)
Updated on 28 April 2021
File name
ie-spc-femoston-2mg10mg-TIB-WS006-ERA-clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- 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 17 September 2020
File name
ie-spc-femoston-2mg10mg-tiain-prac-clean.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 not be renewed (A)
Updated on 17 September 2020
File name
ie-pl-femoston-2mg10mg-tiain-prac-clean.pdf
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
File name
IE-SmPC-Femoston 2-10mg-05 Apr 2018-CRN2197090-clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 May 2019
File name
IE-MT-PIL-Femoston 2mg-10mg-add MT-30May2019-emc.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 06 June 2018
File name
IE-SmPC-Femoston 2-10mg-05 Apr 2018-CRN2197090-clean.docx
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
File name
IE-PIL-Femoston 2-10mg-05 Apr 2018-CRN2197090-eMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 04 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2017
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
File name
PIL_9645_825.pdf
Reasons for updating
- New PIL for new product
Updated on 30 June 2017
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
Reasons for updating
- Change to further information section
Updated on 26 February 2016
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 4.3 - 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
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 08 April 2015
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
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
Reasons for updating
- Change to marketing authorisation holder
Updated on 23 June 2014
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
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
Reasons for updating
- Change to MA holder contact details
Updated on 07 January 2014
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 6.1 - Expansion of tablet composition
Updated on 04 January 2014
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 02 January 2014
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 4.2: 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
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 05 September 2011
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
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
Reasons for updating
- Change to appearance of the medicine
Updated on 03 March 2011
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 02 March 2011
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 22 April 2010
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 03 April 2007
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, 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
Updated on 03 April 2007
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
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
Updated on 13 September 2006
Reasons for updating
- Improved electronic presentation
Updated on 01 September 2006
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
Updated on 03 August 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2005
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
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)