Day Nurse Capsules

Product Information *

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 04 November 2019

File name

ie-spc-day-nurse-gds9-rfi-clean-190220EC_1572878517.pdf

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 4.5 - 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 04 November 2019

File name

ie-mockup-pl-daynurse-capsule-clean-oct2019_1572877325.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 February 2019

File name

ie-mockup-leaflet-day_1551120797.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 25 February 2019

File name

ie-spc-daynurse-clean_1551120890.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Updated on 19 September 2018

File name

m1-3-1-spc-PSE PRAC-180530EC_1537377044.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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 03 September 2018

File name

ie-mockup-leaflet-678-100-1_1535969292.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 03 September 2018

File name

ie-spc-678-100-1-clean_1535968793.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Paediatric posology changes

Updated on 26 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 26 October 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Reformatting of the Adverse Event frequency description.

Updated on 26 October 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Reformatting of the Adverse Event frequency description.

Updated on 17 July 2017

Reasons for updating

  • 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 - addition of a warning relevant to metabolic acidosis
In section 4.8 - addition of 'Very rare cases of serious skin reactions have been reported'

Updated on 17 July 2017

Reasons for updating

  • 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 4.4 - addition of a warning relevant to metabolic acidosis
In section 4.8 - addition of 'Very rare cases of serious skin reactions have been reported'

Updated on 18 October 2016

Reasons for updating

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 4.4 and 4.9 of the SPC.

Updated on 18 October 2016

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update to section 4.4 and 4.9 of the SPC.

Updated on 03 October 2016

File name

PIL_8682_538.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 May 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Updated Irish Office Address.

Updated on 03 May 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated Irish Office Address.

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 29 January 2015

Reasons for updating

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of a warning concerning ischaemic colitis.

Updated on 29 January 2015

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of a warning concerning ischaemic colitis.

Updated on 11 March 2014

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1 removal of isopropyl alcohol, n butyl alcohol and ammonium hydroxide from the black print ink

Updated on 11 March 2014

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1 removal of isopropyl alcohol, n butyl alcohol and ammonium hydroxide from the black print ink

Updated on 22 June 2012

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

All sections were updated in line with the newest GDS

Updated on 22 June 2012

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

All sections were updated in line with the newest GDS

Updated on 01 September 2011

Reasons for updating

  • Change to paediatric information
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration
Children 6 to 12 years: One capsule every four hours, up to a maximum of 3 doses in 24 hours if needed.

Children under 612 years: Not to be given to children under 612 years of age.


4.3       Contraindications

Do not give to children under 12 years of age.

Updated on 01 September 2011

Reasons for updating

  • Change to paediatric information
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration
Children 6 to 12 years: One capsule every four hours, up to a maximum of 3 doses in 24 hours if needed.

Children under 612 years: Not to be given to children under 612 years of age.


4.3       Contraindications

Do not give to children under 12 years of age.

Updated on 26 October 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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

Free text change information supplied by the pharmaceutical company

In section 1 (name of the medicinal product) the active ingredients and strengths were added.

In section 2 (Qualitative and Quantitative Composition)  the following was added:

"lso contains Allura Red (E129)

For a full list of excipients see section 6.1."

In section 3 (Pharmaceutical form) capsule was placed in brackets after hard. and "It contains a white powder" was added at the end of the last sentence in the section.

In section 6.1 (List of excipients)  a subheading "Capsule Content" was added at the start .

In section 6.5 (Nature and contents of container), "Not all pack sizes may be marketed" was added.

In section 9 (Date of Authorisation/Renewal of the Authorisation), the text was changed to read as follows:
Date of first authorisation: 04 November 2003
Date of last authorisation: 04 November 2008

In section 10 (date of revision of the text) the date was changed to September 2010

Updated on 26 October 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 1 (name of the medicinal product) the active ingredients and strengths were added.

In section 2 (Qualitative and Quantitative Composition)  the following was added:

"lso contains Allura Red (E129)

For a full list of excipients see section 6.1."

In section 3 (Pharmaceutical form) capsule was placed in brackets after hard. and "It contains a white powder" was added at the end of the last sentence in the section.

In section 6.1 (List of excipients)  a subheading "Capsule Content" was added at the start .

In section 6.5 (Nature and contents of container), "Not all pack sizes may be marketed" was added.

In section 9 (Date of Authorisation/Renewal of the Authorisation), the text was changed to read as follows:
Date of first authorisation: 04 November 2003
Date of last authorisation: 04 November 2008

In section 10 (date of revision of the text) the date was changed to September 2010

Updated on 19 August 2008

Reasons for updating

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 10 Change in date of revision of the text from May 2005 to June 2005

Updated on 19 August 2008

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 10 Change in date of revision of the text from May 2005 to June 2005

Updated on 09 January 2008

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1 List of excipients

Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate
Hard gelatine capsule
(containing: Gelatin, Quinoline yellow (E104), Allura red (E129), Titanium dioxide (E171).)
Black print ink
(containing: Shellac, Iron oxide black (E172), Propylene glycol.)

Updated on 09 January 2008

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1 List of excipients

Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate
Hard gelatine capsule
(containing: Gelatin, Quinoline yellow (E104), Allura red (E129), Titanium dioxide (E171).)
Black print ink
(containing: Shellac, Iron oxide black (E172), Propylene glycol.)

Updated on 28 June 2005

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Updated on 28 June 2005

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Updated on 04 June 2004

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 June 2004

Reasons for updating

  • New SPC for new product