Femoston-conti 1mg/5mg film-coated tablets

  • Name:

    Femoston-conti 1mg/5mg 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: 20/03/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 25/10/2019

Click on this link to Download PDF directly

Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ALDARA 5% CREAM Active Ingredients Imiquimod
Medicine Name Ancotil 2.5g/250ml Solution for Infusion Active Ingredients Flucytosine
Medicine Name Brufen 400mg film-coated Tablets Active Ingredients Ibuprofen
Medicine Name Brufen 600mg film-coated tablets Active Ingredients Ibuprofen
Medicine Name Brufen Paediatric 100mg/5ml Oral Suspension Active Ingredients Ibuprofen
Medicine Name Brufen Retard 800mg prolonged release tablets Active Ingredients Ibuprofen
Medicine Name Calvidin 600mg/400IU Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cibacen 10mg Film Coated Tablet Active Ingredients Benazepril Hydrochloride
Medicine Name Cibacen 5mg Film Coated Tablets Active Ingredients Benazepril Hydrochloride
Medicine Name Clozaril 100mg Tablets Active Ingredients Clozapine
Medicine Name Clozaril 25mg Tablets Active Ingredients Clozapine
Medicine Name Colifoam 10% w/w Rectal Foam Active Ingredients Hydrocortisone Acetate
Medicine Name Colofac 135mg Tablets Active Ingredients Mebeverine Hydochloride
Medicine Name Creon 10000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon 25000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon for Children 5000 Gastro-resistant Granules Active Ingredients Pancreatin
Medicine Name Cyklokapron 500mg Tablets Active Ingredients Tranexamic Acid
Medicine Name Dalmane 15mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Dalmane 30mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Desunin 4000IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Desunin 800IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name DIFFLAM 3% CREAM Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM ORAL RINSE Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM SPRAY Active Ingredients Benzydamine Hydrochloride
Medicine Name Dona 1500mg Powder for Oral Solution Active Ingredients Glucosamine Sulfate, Sodium Chloride
1 - 0 of 97 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 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 SmPC

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 SmPC

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 SmPC

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 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)

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 SmPC

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'

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 SmPC

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

Updated on 30 March 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 9 January 2015 SmPC

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

Updated on 6 January 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 31 March 2014 SmPC

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)"

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 SmPC

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;

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 SmPC

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 SmPC

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. 

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 SmPC

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 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 SmPC

Reasons for updating

  • New SPC for new product

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