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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
E-mail: customer.relations@gsk.com
Medical Information Direct Line: 1800 441 442
Summary of Product Characteristics last updated on medicines.ie: 17/07/2017
SPC Day Nurse Capsules

When a pharmaceutical company changes an SPC or PIL, 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 17/07/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   13-Jul-2017
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 18/10/2016 and displayed until 17/07/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   23-Sep-2016
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 03/05/2016 and displayed until 18/10/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   07-Jul-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Updated Irish Office Address.
Updated on 10/07/2015 and displayed until 03/05/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   07-Jul-2015
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 29/01/2015 and displayed until 10/07/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   22-Jan-2015
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 11/03/2014 and displayed until 29/01/2015
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   12-Feb-2014
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 22/06/2012 and displayed until 11/03/2014
Reasons for adding or 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
Date of revision of text on the SPC:   05-Jun-2012
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 01/09/2011 and displayed until 22/06/2012
Reasons for adding or 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
Date of revision of text on the SPC:   29-Aug-2011
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 26/10/2010 and displayed until 01/09/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Sep-2010
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 19/08/2008 and displayed until 26/10/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2005
Legal Category:   retail sale 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 09/01/2008 and displayed until 19/08/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   05/2005
Legal Category:   prescription 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 28/06/2005 and displayed until 09/01/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Updated on 04/06/2004 and displayed until 28/06/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Paracetamol
   Pholcodine
   Pseudoephedrine Hydrochloride