GEODON 20mg Capsules *

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 27 July 2021

File name

DEC202110037-V_Reg SPC GE 23_0 20mg Capsules IE - clean_1627366571.pdf

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address

Section 8 - updated with new PA number for Upjohn EESV

Updated on 27 July 2021

File name

DEC202110037-V_Reg PIL GE 26 capsules IE - clean_1627366475.pdf

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 17 February 2021

File name

DEC202102600-V_Reg SPC GE 22_2 20mg Capsules IE-clean_1613585081.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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 February 2021

File name

DEC202102600-V_Reg PIL GE 24_3 capsules IE-clean_1613584996.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 19 December 2019

File name

DEC201971688_Reg SPC GE 21_1 20mg Capsules IE-clean_1576750586.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 19 December 2019

File name

DEC201971688_Reg PIL GE 23_1 capsules IE-clean_1576750454.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 20 November 2019

File name

DEC201964557_Reg SPC GE 20_0 20mg Capsules IE-clean_1574248292.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows: Section 6.5 – details of bottle presentation deleted

Updated on 26 November 2018

File name

Reg PIL GE 20_0 capsules IE_clean_1543219300.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 August 2018

File name

Reg PIL GE 19_0 capsules IE _clean_1533891239.pdf

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 10 August 2018

File name

Reg SPC GE 18_1 20mg Capsules IE_clean__1533895225.pdf

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 11 July 2017

File name

PIL_8722_689.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 July 2017

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 February 2017

Reasons for updating

  • New SPC for new product

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

Updated on 24 February 2017

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

The SPC has been updated as follows:

s4.8  CDS update to add adverse drug reaction frequencies.

Updated on 23 February 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 January 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

The SPC has been updated as follows:

1) Section 4.4 updated for all formulations to include a warning relating to the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and other Severe Cutaneous Adverse Reactions (SCAR) with ziprasidone.

2) Section 4.8 updated to add Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) as an adverse drug reaction and include an update in line with the latest QRD template

Updated on 22 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 02 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 20 March 2014

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic 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

Update to sections 5.2 & 10

Updated on 17 March 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 29 July 2013

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

To update section 4.8 that describe the adverse effects of Geodon in paediatric patients aged 10-17 years and 13-17 years, from Phase 3 placebo –controlled studies in bipolar mania and schizophrenia, respectively

Updated on 20 December 2012

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 4.6 - Pregnancy and lactation
  • 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

Sections 4.4, 4.5, 4.6 and 4.8

Updated on 13 December 2012

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 06 June 2012

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

Update of SPC

Updated on 31 May 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to dosage and administration

Updated on 31 May 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to appearance of the medicine

Updated on 06 November 2009

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
  • 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



Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 - updated to include details referring to the new indication for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in children and adolescents aged 10-17 years

Updated on 04 November 2009

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 03 March 2009

Reasons for updating

  • Change to side-effects

Updated on 03 March 2009

Reasons for updating

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

Sections 4.4 and 5.1 updated with outcomes of the ZODIAC study and section 4.8 updated with additional post-marketing adverse events

Updated on 10 September 2008

Reasons for updating

  • Change to name of manufacturer

Updated on 11 July 2007

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 11 July 2007

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

 
Section 4.5 deletion of ref to section 5.1 and addition of reference to section 4.8

Section 4.8 Update Section 4.8  (Undesirable effects)

Updated on 21 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.1 - Therapeutic Indications, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, 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 6.1 - List of Excipients, Change to section 6. 5 - Nature and Contents of Container, Change to section 9 - Date of Renewal of Authorisation, Change to section 10 (date of (partial) revision of the text

Updated on 21 August 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 13 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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