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Emcor

*
Pharmacy Only: Prescription

  • Company:

    Merck

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Bisoprolol Fumarate

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

Updated on 10 November 2020

File name

IE - Emcor 5mg-10mg Patient Leaflet - TW2351891.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

(Our ref. TW 2351891 )

Updated on 10 November 2020

File name

Emcor 5 mg 10 mg ROI TW 2351891 current - clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Angioedema added to section 4.8

(Our ref. TW 2351891 )

Updated on 12 February 2020

File name

Emcor 5 mg 10 mg ROI TW2037103 current v4.0 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  •  

Updated on 25 October 2018

File name

Emcor PIL - Brexit.pdf

Reasons for updating

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

Updated on 25 October 2018

File name

Emcor 5 mg 10 mg ROI TW1735731 Current v3.0.pdf

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 be renewed (B)

Updated on 15 October 2015

File name

PIL_15348_180.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 October 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 October 2015

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 4.8 - 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to the SPC to be in alignment with Master Data Sheet Version 10.

·                Section 4.2 Posology and method of administration

·                Section 4.3 Contraindications

·                Section 4.4 Special warnings and precautions for use

·                Section 4.8 Undesirable effects

·                Section 4.9 Overdose

·                Section 5.1 Pharmacodynamic properties


4.3 Contraindications

 

Bisoprolol is contraindicated in chronic heart failure patients with:

 

…

·                severe bronchial asthma

…

 

 

4.4 Special warnings and special precautions for use

……

Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless there are compelling clinical reasons for their use.  Where such reasons exist, Emcor may be used with caution.  In patients with obstructive airways diseases, the treatment with bisoprolol should be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g., dyspnea, exercise intolerance, cough). 

……….

 

 

10. Date of revision of the Text

 October 2015

 

Updated on 15 October 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Addition of information on reporting a side effect.

Updated on 22 July 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 07 May 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Minor editorial changes including information on the reporting of adverse reactions in section 4.8.

6.4 Special precautions for storage
Do not store above 30°C.

Updated on 18 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 April 2012

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

During combining of the SPC with 5mg and 10mg strengths, in section 6.1 List of Excipients - Red Iron Oxide (E172) (10 mg strength only) was inadvertently not listed.

There has been no change to the authorised formulation for either of these products.

Updated on 07 June 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reference to Al/PVDC removed from section 6.5 - Nature and Contents of Container

6.5.      Nature and Contents of Container

 

Cartons containing aluminium/PVC blister packs of 4, 14 or 28 tablets. Not all pack sizes may be marketed.

Updated on 01 July 2009

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Core safety data added to SPC. The changes are widespread throughout SPC

Updated on 28 May 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Correction to section 7: Marketing Authorisation Holder to include the correct postcode: TW14 8NX

Updated on 28 May 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 May 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 7) MA Holder Name and Address to include the following:
 

7.         Marketing Authorisation Holder

 

Merck Serono Limited

Bedfont Cross

Stanwell Road

Feltham           

Middlesex TW11 0RL

United Kingdom

Updated on 11 April 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes throughout SPC to incorporate safety data. Main changes to section 4.8 - Undesirable Effects

Updated on 20 December 2007

Reasons for updating

  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 8: Marketing Authorisation Number
 
Correction to Marketing Authorisation number for Emcor 10mg from PA 654/12/12 to PA 654/12/2

Updated on 23 November 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2. Qualitative and Quantitative Composition.
 
bisoprolol fumarate 2:1 is changed to bisoprolol hemifumarate
 
Section 3: Pharmcaeutical Form
 
Description of the colour of tablet is changed

Updated on 04 August 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Transfer of the Marketing Authorisation Holder from 'E Merck Ltd' to 'Merck Ltd' with consequential changes to the PA number.

Updated on 10 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)