Femoston-conti 1mg/5mg film-coated tablets
- Name:
Femoston-conti 1mg/5mg film-coated tablets
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/11/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 16/11/2020
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Mylan IRE Healthcare Limited
Company Products
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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 16 November 2020 SPC
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 16 November 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 20 March 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Free text change information supplied by the pharmaceutical company
Change the name of the medicinal product in Spain
Updated on 25 October 2019 SPC
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 2 September 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Updated on 13 August 2019 PIL
Reasons for updating
- Change to further information section
Updated on 12 August 2019 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 12 August 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 July 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 4 July 2017 SPC
Reasons for updating
- New SPC 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 2010/12/4 2007/8/4
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 22 September 2016 PIL
Reasons for updating
- Change of distributor details
Updated on 15 March 2016 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.4 - Update text for 'Ovarian cancer' section
In section 4.6 - Update 'Lactation' to 'Beast-feeding'
In section 4.7 - Minor editorial update
In section 4.8 - Update text for 'Ovarian cancer' section, correction of spelling/editorial errors in adverse events table, addition of details for reporting of suspected adverse reactions
In section 4.9 - Minor editorial update
In section 5.2 - Update 'metabolism' to 'biotransformation'
In section 6.3 - Minor editorial update
In section 6.4 - Update storage conditions to "This medicine does not require any special storage conditions'
In section 4.6 - Update 'Lactation' to 'Beast-feeding'
In section 4.7 - Minor editorial update
In section 4.8 - Update text for 'Ovarian cancer' section, correction of spelling/editorial errors in adverse events table, addition of details for reporting of suspected adverse reactions
In section 4.9 - Minor editorial update
In section 5.2 - Update 'metabolism' to 'biotransformation'
In section 6.3 - Minor editorial update
In section 6.4 - Update storage conditions to "This medicine does not require any special storage conditions'
Updated on 15 March 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to further information section
- Addition of information on reporting a side effect.
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:
MAH changed from Abbott Healthcare Products Ltd to BGP Products Ltd
Section 8:
PA number changed from PA 108/21/4 to PA 2007/8/4
MAH changed from Abbott Healthcare Products Ltd to BGP Products Ltd
Section 8:
PA number changed from PA 108/21/4 to PA 2007/8/4
Updated on 30 March 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 9 January 2015 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7
MA Holder address updated from Southampton to Maidenhead, UK
MA Holder address updated from Southampton to Maidenhead, UK
Updated on 6 January 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 31 March 2014 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 2 - Excipients listed changed to:-
Excipient with known effect: lactose monohydrate 114.7mg
For the full list of excipients, see section 6.1
In Section 4.3 - Editorial change
In Section 4.6 - "Studies in animals have shown reproductive toxicity (see section 5.3). The potential reisk for humans is unknown" has been removed from the Pregnancy paragraph.
A new Fertility paragraph has been added; Femoston conti 1mg/5mg is not indicated during fertility.
In Section 4.8 - MedDRA table updated - very rare undesirable effects have been removed and reclassified.
Other adverse reactions section has been amended with some additions and some deletions
In Section 4.9 - paragraph amended to read:-
"both estradiol and dydrogesterone are substances with low toxicity. Symptoms such as nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding could occur in cases of overdosing. It is unlikely that any specific or symptomatic treatment will be necessary.
Aforementioned information is also applicable for overdosing in children"
In Section 5.1 - Editorial change
In Section 5.2 - Pharmacokinetic mean data is presented in a new table, with update Distribution data
In Section 5.3 - The following line as been added:
"....that are additional to those already included in other sections of the Summary of Product Characteristics (SmPC)"
Excipient with known effect: lactose monohydrate 114.7mg
For the full list of excipients, see section 6.1
In Section 4.3 - Editorial change
In Section 4.6 - "Studies in animals have shown reproductive toxicity (see section 5.3). The potential reisk for humans is unknown" has been removed from the Pregnancy paragraph.
A new Fertility paragraph has been added; Femoston conti 1mg/5mg is not indicated during fertility.
In Section 4.8 - MedDRA table updated - very rare undesirable effects have been removed and reclassified.
Other adverse reactions section has been amended with some additions and some deletions
In Section 4.9 - paragraph amended to read:-
"both estradiol and dydrogesterone are substances with low toxicity. Symptoms such as nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding could occur in cases of overdosing. It is unlikely that any specific or symptomatic treatment will be necessary.
Aforementioned information is also applicable for overdosing in children"
In Section 5.1 - Editorial change
In Section 5.2 - Pharmacokinetic mean data is presented in a new table, with update Distribution data
In Section 5.3 - The following line as been added:
"....that are additional to those already included in other sections of the Summary of Product Characteristics (SmPC)"
Updated on 26 March 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 14 February 2013 PIL
Reasons for updating
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 12 December 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 16 October 2012 SPC
Reasons for updating
- Change to section 4 - Clinical particulars
- 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 - Pharmacological properties
- 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
Significant additional information in the SPC to have it in line with the Core HRTs SPC, available on the EMA webside.
The following sections have been updated:
4.1;
4.2;
4.3;
4.4;
4.5;
4.6;
4.8;
4.9;
5.1;
5.2;
5.3;
The following sections have been updated:
4.1;
4.2;
4.3;
4.4;
4.5;
4.6;
4.8;
4.9;
5.1;
5.2;
5.3;
Updated on 10 October 2012 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Change due to harmonisation of PIL
- Change due to user-testing of patient information
Updated on 17 August 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
In section 3, the tablet description has been updated due to the removal of the 'Solvay embossing'
Updated on 15 August 2011 PIL
Reasons for updating
- Change to further information section
Updated on 15 June 2010 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The name of the Marketing Authorisation Holder has changed to Abbott Healthcare Products Ltd.
Storage instructions have been made more specific.
Storage instructions have been made more specific.
Updated on 14 June 2010 PIL
Reasons for updating
- Change to storage instructions
- Change to marketing authorisation holder
- Change to name of manufacturer
Updated on 12 May 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 28 November 2005 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2005 PIL
Reasons for updating
- New PIL for new product
Updated on 6 August 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 4.4 - 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
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)