Zimovane 7.5mg Film-coated Tablets

  • Name:

    Zimovane 7.5mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Zopiclone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/03/19

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Summary of Product Characteristics last updated on medicines.ie: 18/4/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 25 of 97 items.Total: 4 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 18 April 2019 SmPC

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)

Updated on 18 April 2019 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 March 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 14 August 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 August 2018 SmPC

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 10 - Date of revision of the text

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

Updated on 6 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 March 2015 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 4.8 – 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.1: the indication has been further expanded to include ‘in adults’

In section 4.2: Text has been added for paediatric population and that zopiclone should not be used in children and adolescents under the age of 18 years

In section 4.4: the term elderly has been changed to older patients and text added regarding paediatric population

In section 4.8: the term elderly has been changed to older patients and the ADR statement has been added

In section 10: the date of revision has changed

Updated on 6 March 2015 PIL

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: the indication has been further expanded to include ‘in adults’

In section 4.2: Text has been added for paediatric population and that zopiclone should not be used in children and adolescents under the age of 18 years

In section 4.4: the term elderly has been changed to older patients and text added regarding paediatric population

In section 4.8: the term elderly has been changed to older patients and the ADR statement has been added

In section 10: the date of revision has changed

Updated on 14 January 2013 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

·         In section 6.3: the shelf-life has been reduced from 5 years to 3 years

·         In section 10: the date of revision has changed

Updated on 14 January 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

·         In section 6.3: the shelf-life has been reduced from 5 years to 3 years

·         In section 10: the date of revision has changed

Updated on 9 March 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

In section 6.5; the HDPE presentation has been removed
In section 10; the date of revision has changed

Updated on 9 March 2012 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.5; the HDPE presentation has been removed
In section 10; the date of revision has changed

Updated on 11 January 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

In section 3; information has been added that the tablet can be devided in equal halves
In section 10; the date of revision has changed

Updated on 11 January 2012 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3; information has been added that the tablet can be devided in equal halves
In section 10; the date of revision has changed

Updated on 1 November 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

In sesction 4.4;There is an added warning regarding somnuambulism and associated behaviours
In section 4.8; There has been additional explainations of terms added to the table of undesirable effects. There also has been the addtional of musculoskeletal and connective tiisues orders. An reference to risk of falls is also included.
In section 4.9; additional information has been added regarding overdose

Updated on 1 November 2011 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

In sesction 4.4;There is an added warning regarding somnuambulism and associated behaviours
In section 4.8; There has been additional explainations of terms added to the table of undesirable effects. There also has been the addtional of musculoskeletal and connective tiisues orders. An reference to risk of falls is also included.
In section 4.9; additional information has been added regarding overdose

Updated on 26 October 2011 SmPC

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

In section 10; the date of revision has changed

Updated on 26 October 2011 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 10; the date of revision has changed

Updated on 7 April 2011 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

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: additonal text regarding excipients have been added
in section 6.4 addtional storage information has been added
In section 7: address of MAH has changed
in section 9; the date of last renewal has been changed
in section 10: the date of revision has changed to January 2010

Updated on 7 April 2011 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Free text change information supplied by the pharmaceutical company

in section 2: additonal text regarding excipients have been added
in section 6.4 addtional storage information has been added
In section 7: address of MAH has changed
in section 9; the date of last renewal has been changed
in section 10: the date of revision has changed to January 2010

Updated on 20 April 2009 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4: Minor change to text, addition of lactose warning
Section 4.8: Addition of MedDRA table, changes to text
Section 5.1: Addition of ATC Code
Section 10: Change to revision of text

Updated on 20 April 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Section 4.4: Minor change to text, addition of lactose warning
Section 4.8: Addition of MedDRA table, changes to text
Section 5.1: Addition of ATC Code
Section 10: Change to revision of text

Updated on 25 February 2008 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of Marketing Authorisation holder.

Updated on 25 February 2008 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-removal of trading style of Marketing Authorisation holder.

Updated on 4 October 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 4 October 2007 PIL

Reasons for updating

  • New SPC for medicines.ie